[Federal Register: January 30, 2006 (Volume 71, Number 19)]
[Proposed Rules]
[Page 4839-4851]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ja06-16]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 73 and 101
[Docket No. 1998P-0724, formerly 98P-0724]
RIN 0910-AF12
Listing of Color Additives Exempt From Certification; Food, Drug,
and Cosmetic Labeling: Cochineal Extract and Carmine Declaration
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA, we) is proposing to
revise its requirements for cochineal extract and carmine by requiring
their declaration on the label of all food and cosmetic products that
contain these color additives. The proposed rule responds to reports of
severe allergic reactions, including anaphylaxis, to cochineal extract
and carmine-containing food and cosmetics and would allow consumers who
are allergic to these color additives to identify and thus avoid
products that contain these color additives. This proposed action also
responds, in part, to a citizen petition submitted by the Center for
Science in the Public Interest (CSPI).
With regard to drug products, FDA plans to initiate rulemaking to
implement the Food and Drug Administration Modernization Act of 1997
(FDAMA) (Pub. L.105-115) provisions that require declaration of
inactive ingredients for drugs. The FDAMA provisions have already been
implemented for over-the-counter (OTC) drugs.
DATES: Submit written or electronic comments by May 1, 2006. Please see
section VIII for the effective date of any final rule that may publish
based on this proposal.
ADDRESSES: You may submit comments, identified by Docket No.1998P-0724
and RIN number 0910-AF12, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
<bullet> Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
<bullet> Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
<bullet> FAX: 301-827-6870.
<bullet> Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
Electronic Submissions portion of this paragraph.
Instructions: All submissions received must include the agency name
and Docket No(s). and Regulatory Information Number (RIN) (if a RIN has
been assigned) for this rulemaking. All comments received may be posted
without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For detailed instructions
on submitting comments and additional information on the rulemaking
process, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number(s), found in brackets in the heading of
this document, into the ``Search'' box and follow the prompts and/or go
to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1278.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Description of Cochineal Extract and Carmine
A. Source and Identity of Cochineal Extract and Carmine
B. Uses of Cochineal Extract and Carmine
III. Regulation of Cochineal Extract and Carmine
A. The Provisional List of 1960
B. Color Additive Approval of Carmine
C. Color Additive Approval of Cochineal Extract
IV. Allergic Reactions to Cochineal Extract and Carmine
A. Descriptions of Allergic Reactions
B. Adverse Reaction Reports in the Literature
C. Adverse Reaction Reports in FDA Files
D. CSPI Citizen Petition
V. FDA Response to the Allergic Reaction Reports
A. Evaluation of the Allergic Reaction Reports
B. Options for Action
C. Tentative Conclusions
VI. FDA Response to the CSPI Petition
VII. FDA Proposed Action
A. Legal Authority
B. Food Labeling
C. Cosmetics Labeling
VIII. Proposed Effective Date
IX. Environmental Impact
X. Analysis of Impacts
A. Preliminary Regulatory Impact Analysis
B. Regulatory Alternatives
C. Small Entity Analysis
D. Unfunded Mandates
XI. Paperwork Reduction Act of 1995
XII. Federalism
XIII. Comments
XIV. References
I. Background
Cochineal extract is a color additive that is currently permitted
for use in foods and drugs in the United States. The related color
additive carmine is currently permitted for use in foods, drugs, and
cosmetics. FDA has listed these color additives, and conditions for
their safe use, in part 73 of Title 21 of the Code of Federal
Regulations (21 CFR part 73).
Allergic reactions to cochineal extract and/or carmine in a variety
of foods (grapefruit juice, the alcoholic beverage
[[Page 4840]]
Campari, a popsicle, candy, yogurt, and artificial crabmeat) and
cosmetics (face blush, eye shadow, eyeliner, and skin products) have
been reported in the scientific and medical literature since 1961.
Since 1994, we have received 11 adverse event reports of allergic
reactions, including anaphylaxis, experienced by individuals after
eating food or drinking a beverage containing cochineal extract or
carmine, or using cosmetics colored with carmine. We know of no reports
of allergic reaction to cochineal extract or carmine in drugs.
In 1998, we received a citizen petition (Docket No. 98P-0724) from
CSPI asking us to take action to protect consumers who are allergic to
cochineal extract and carmine. The CSPI petition, the reports from the
scientific literature, and the voluntarily submitted adverse event
reports provide the factual basis for the regulatory action we now
propose.
II. Description of Cochineal Extract and Carmine
A. Source and Identity of Cochineal Extract and Carmine
Cochineal is a dye made from dried and ground female bodies of the
scale insect Dactylopius coccus costa (Coccus cacti L.). Powdered
cochineal is dark purplish red. The chief coloring principle in
cochineal is carminic acid, a hydroxyanthraquinone linked to a glucose
unit. Cochineal contains approximately 10 percent carminic acid; the
remainder consists of insect body fragments.
Cochineal extract is the concentrated solution obtained after
removing the alcohol from an aqueous-alcoholic extract of cochineal.
The chief coloring principle in cochineal extract is carminic acid.
Cochineal extract is acidic (pH 5 to 5.5) and varies in color from
orange to red depending on pH.
Carmine is the aluminum or calcium-aluminum lake formed by
precipitating carminic acid onto an aluminum hydroxide substrate using
aluminum or calcium cation as the precipitant. The carminic acid used
to make the lake is obtained by an aqueous extraction of cochineal.
Carmine is a dark red to bright red powder depending on the amount of
carminic acid present. The lake is only slightly soluble in water, to
which it imparts a red color, and can be solubilized by strong acids
and bases.
The chemical identity, purity specifications, and use restrictions
for cochineal extract and/or carmine are provided in Sec. 73.100
(foods), Sec. 73.1100 (drugs), and Sec. 73.2087 (cosmetics). The
regulations require that cochineal extract contain not less than 1.8
percent carminic acid, not more than 2.2 percent protein, and between
5.7 and 6.3 percent total solid content, and that carmine contain not
less than 50 percent carminic acid.
Cochineal extract and carmine share the same E-number designation
in the European Union, E120. Neither color additive should be confused
with the unapproved color additive cochineal red (E124), a synthetic
azo dye that is sometimes called new coccin, Food Red 7, or Ponceau 4R.
Carmine also should not be confused with indigo carmine, which is
certifiable as FD&C Blue No. 2.
B. Uses of Cochineal Extract and Carmine
Cochineal, carmine, and cochineal extract have a long history of
use. Cochineal originated in Mexico and was used by the ancient Aztecs.
It was discovered there by 16th century Spanish explorers, who
introduced it to Europe and the rest of the world. Cochineal was listed
in the United States Pharmacopeia from 1831 to 1955 and in the National
Formulary until 1975.
Food uses for carmine include popsicles, strawberry milk drinks,
port wine cheese, artificial crab/lobster products, cherries in fruit
cocktails, and lumpfish eggs/caviar. Cochineal extract is used in fruit
drinks, candy, yogurt, and some processed foods.
FDA's Voluntary Cosmetics Registration Program database contains
information on the types of cosmetic products that contain carmine.
(Cochineal extract is not permitted for use as a color additive in
cosmetics.) Carmine has been reported to be used in 814 formulations
including lipsticks, blushers, makeup bases, eye shadows, eyeliners,
nail polishes, hair colors, skin care lotions, bath products, baby
products, and suntan preparations.
III. Regulation of Cochineal Extract and Carmine
A. The Provisional List of 1960
The Color Additive Amendments of 1960 (Public Law 86-618, 74 Stat.
397) amended the Federal Food, Drug, and Cosmetic Act (the act) to add
the definition of ``color additive'' and to establish conditions under
which color additives may be safely used. The Color Additive Amendments
required us to publish a provisional list of color additives that were
already in use or were certified as color additives prior to July 12,
1960. The provisional list was intended to permit the continued use of
the listed color additives for a limited time, during which sponsors
could submit data that established their safety and supported their
permanent listings.
FDA published a provisional list of color additives that included
cochineal extract in the Federal Register of October 12, 1960 (25 FR
9759). We provisionally listed cochineal for use in foods, drugs, and
cosmetics on the basis of prior commercial sale of color additives
which had not been subject to certification. In the Federal Register of
August 16, 1961 (26 FR 7578) FDA amended the provisional list to add
carmine for use in foods and cosmetics on the same basis.
B. Color Additive Approval of Carmine
On November 9, 1964, we received a color additive petition (CAP)
that requested the permanent listing of carmine as safe and suitable
for use in or on foods, drugs, and cosmetics. We designated the
petition CAP 20 and we published a notice of filing of the petition in
the Federal Register of August 17, 1965 (30 FR 10211).
Permanent listing of carmine for use in foods and drugs was
supported by safety data and other relevant information submitted in
CAP 20. The safety data included results of two 90-day toxicity
studies, both in rats. From these data we calculated an acceptable
daily intake (ADI) of 25 milligrams per kilogram (mg/kg) or 1,000 parts
per million (ppm) of the daily diet for a person, considering a 100-
fold safety factor. The petitioner had reported general usage in food
products to be 0.0025 percent or 25 ppm, and in a few selected products
as high as 75 to 100 ppm. We concluded that if a person's total diet
were colored with carmine, and if the amounts ingested from drugs,
cosmetics, and foods were combined, the total ingestion figures would
be well within the margin of safety.
CAP 20 also included history-of-use information provided in 1965 by
several companies, both domestic and foreign. These companies either
supplied or used carmine and/or cochineal in food, drugs, and
cosmetics. This history-of-use information stated that the companies
had received no complaints during five decades of use. Also, the
companies had received no notification of toxicity or allergic
reactions from the use of the color additives.
From information in CAP 20, we concluded it would not be necessary
to require the batch certification of carmine. Since carmine is derived
from a natural source (insects), we concluded that there would be
little likelihood of contamination with toxic reactants or
intermediates that would be used in a synthesis. We also did not set a
quantitative limitation because we determined that use of the color
[[Page 4841]]
additive would be economically self-limiting.
In the Federal Register of April 19, 1967 (32 FR 6131), FDA
published a final rule that permanently listed carmine as a color
additive exempt from certification for use in foods (21 CFR 8.317, now
Sec. 73.100) and drugs (21 CFR 8.6009, now Sec. 73.1100).
On June 24, 1977 (42 FR 32228) FDA published a regulation
permanently listing carmine as a color additive exempt from
certification for use in cosmetics generally, including cosmetics
intended for use in the area of the eye (Sec. 73.2087).
C. Color Additive Approval of Cochineal Extract
On February 14, 1968, we received a color additive petition
requesting that we permanently list cochineal extract for general use
in foods and drugs. We designated the petition CAP 60 and published a
notice of filing in the Federal Register of March 15, 1968 (33 FR
4593).
Permanent listing of cochineal extract for use in foods and drugs
was supported by data in CAP 60 which showed that cochineal extract was
essentially similar, qualitatively, to carmine, including the protein
fractions. The petition also included information on the long history
of use of cochineal extract and argued that the use of cochineal
extract as a color additive in foods and drugs was comparable to that
for carmine.
We concluded that the toxicological data in CAP 20 could be
extrapolated to support the safety of cochineal extract. We further
concluded that certification of cochineal extract was not necessary. We
also did not set a quantitative limitation because we determined that
use of the color additive would be economically self-limiting.
In the Federal Register of December 14, 1968 (33 FR 18577), FDA
published a final rule that amended the listing regulation for carmine
to include the permanent listing of cochineal extract as a color
additive exempt from certification for use in foods (21 CFR 8.317, now
Sec. 73.100) and drugs (21 CFR 8.6009, now Sec. 73.1100).
IV. Allergic Reactions to Cochineal Extract and Carmine
A. Descriptions of Allergic Reactions
An allergic reaction is characterized by an abnormal or exaggerated
response of the body's immune system to a reaction-provoking substance
(i.e., allergen), usually a protein (Ref. 1). The majority of such
responses are immediate hypersensitivity reactions mediated by an
antibody, immunoglobulin E (IgE). Individuals with allergies produce an
excess amount of IgE antibodies that recognize specific allergens from
food or other substances in the environment. Once formed, these
allergen-specific antibodies attach to receptors on specialized white
blood cells (mast cells and basophils), found at key interfaces of body
contact with foreign substances (e.g., skin, gastrointestinal and
nasorespiratory tracts, and blood). The interaction between an allergen
and bound specific IgE antibodies at these interfaces stimulates these
cells to liberate histamine and other inflammatory mediators involved
in the allergic response (Refs. 2 and 3).
Allergic reactions typically manifest at the site of allergen
contact and vary widely in severity. Signs and symptoms include skin
manifestations of flushing, urticaria (hives), eczema, and angioedema
(tissue swelling); oral manifestations of lip and tongue swelling and
itchiness; gastrointestinal manifestations of stomach cramps, nausea,
vomiting and/or diarrhea; itchy and swollen eye manifestations;
nasorespiratory manifestations of nasal congestion and runniness, itchy
nose and throat, wheezing, chest tightness and/or difficulty breathing;
and cardiovascular manifestations of lightheadedness, chest pain, and
low blood pressure. In some cases, a massive release of inflammatory
mediators can lead to a more severe allergic reaction, often termed
anaphylaxis, characterized by multi-organ involvement. Anaphylaxis can
rapidly progress to severe respiratory manifestations of throat
swelling/airway closure or cardiovascular collapse/shock that, without
prompt medical management, ultimately result in death.
The allergen type, route of exposure, frequency, dose, extent of
mediator release, and presence of underlying illnesses (e.g., asthma)
are factors which determine the severity of IgE-mediated allergic
reactions (Ref. 4). Based on anecdotal reports of food allergic
reactions and confirmatory oral challenge diagnostic studies, minimal
amounts of food allergen can induce allergic reactions in sensitive
individuals (Ref. 5). Although the risk of adverse reactions to minimal
concentrations of allergenic ingredients in drugs and cosmetics would
be expected to be similar to foods, data on the incidence of
anaphylaxis resulting from ingestion and/or application of drugs and
cosmetics is lacking.
There are no tests to predict or determine which allergic
individuals are more likely to develop anaphylaxis. Current testing
methods (e.g., skin prick test (SPT) or in vitro radioallergosorbent
test (RAST)) may provide evidence of IgE-mediated antibody response to
allergens. However, such testing offers little predictive value for the
severity of response. (Ref. 6)
Most individuals become aware of their allergy to a specific
allergen prior to experiencing a severe reaction. However, once the
allergen is identified, there are no effective treatment methods to
prevent IgE-mediated reactions from occurring. Although treatments are
available that may limit the severity of harm from the allergic
reaction, they do not necessarily eliminate the harm nor, in some
cases, stop fatal reactions from occurring following exposure to an
allergen (Ref. 6). Fatal reactions have occurred despite appropriate
administration of treatment. Thus, avoidance of the allergen is the
only method certain to prevent harm and fatal reactions. Reading of
labels on food, drug, and/or cosmetic products, and/or education about
potential scenarios where contact with allergen-containing sources
could occur, are the cornerstone of risk prevention strategies for
allergic individuals and their families.
Allergens have been identified in food, drug, and cosmetic
products, and sensitization (production of IgE antibodies) to allergens
may occur through exposure to any or all of these products. Moreover,
once sensitized, an individual may develop an IgE-mediated allergic
reaction to the allergen by various routes of exposure: Topical (in
contact with skin or mucosa), inhaled, ingested, or intravenous.
Although anaphylaxis can result from exposure by any route, most cases
of severe reactions occur when the allergen is ingested or injected
intravenously. By these routes, allergens can be easily absorbed into
the systemic circulation, leading to life-threatening anaphylaxis in as
little as 5 to 15 minutes.
A range of adverse reactions has been reported to occur from
hypersensitivity to foods and cosmetics containing carmine or cochineal
extract, as well as from carmine, carminic acid, and cochineal extract
by themselves. As of February 2004, FDA is aware of 35 cases of
hypersensitivity to carmine, carminic acid, or cochineal extract
published in the scientific and medical literature and/or reported
directly to FDA. Eleven of the cases were reported directly to FDA via
consumer hotlines, letters, and/or MedWatch reports.
Hypersensitivity reactions to carmine, carminic acid, or cochineal
extract include contact dermatitis (4), urticaria/
[[Page 4842]]
angioedema (9), occupational asthma (10), and systemic anaphylaxis
(twelve). In more than half of these reports, there is evidence of an
IgE-mediated diagnostic response (e.g., positive SPT or positive IgE
RAST) to carmine and/or its derivatives. In a subset of individuals,
more specific testing identified allergenic proteins in the carmine
and/or its derivatives to which the individuals had been specifically
sensitized. All adverse reactions were strongly associated with
ingestion, topical application, or inhalation of products containing
carmine and/or derivatives by the persons making the reports. Moreover,
a subset of sensitized individuals developed adverse reactions to a
variety of different products containing carmine and/or derivatives. In
addition to the above cases, inhalation of carmine and/or derivatives
has been reported to induce an immunologic lung disorder, allergic
extrinsic alveolitis, also known as hypersensitivity pneumonitis, in
certain individuals.
B. Adverse Reaction Reports in the Literature
The first report of an allergic reaction to carmine was published
in 1961 (Ref. 7). The report described a contact allergic reaction to a
lip salve containing carmine, with evidence of positive patch tests in
three affected patients. Twenty years later an English physician
reported the first case of anaphylactic shock from topical exposure to
carmine. In the case of a military recruit involved in a casualty
simulation exercise, a makeup stick colored red with carmine was
applied directly to the skin of his body in the trunk area. Immediately
following application, he went into anaphylactic shock (Ref. 8).
Beaudouin, et al., (Ref. 9) published the first report of
anaphylaxis following ingestion of carmine. A 35-year-old woman was
seen with generalized urticaria, angioedema, and asthma that began two
hours after eating yogurt containing an estimated 1.3 mg of carmine.
The woman had positive SPT for carmine powder and carmine colored
yogurt.
A 1997 article (Ref. 10) describes allergic reactions (including
anaphylaxis) experienced by five patients after ingesting the alcoholic
beverage Campari, which contains carmine. All five patients were women;
three had a history of allergic respiratory disease, one had only non-
clinical sensitivity to mugwort, and one was nonatopic (had no history
of allergy). The time period between ingestion and onset of allergic
reaction was given for four patients and varied from 15 minutes to 30
minutes. Two of the five patients reportedly experienced ``severe''
anaphylactic reactions. Of these two, one required hospitalization; the
other was treated with inhalers and intravenous antihistamines. The
remaining three experienced angioedema.
The five patients demonstrated IgE sensitization to carmine by SPT
and to carmine and cochineal extract (provided by the Campari company)
by RAST. Serum from three patients was also tested for specific IgE
response to carminic acid. Serum from one of the three (the nonatopic
patient) revealed evidence of IgE antibodies directed against carminic
acid. Given their previous history of adverse reactions to Campari, all
five patients refused oral challenge to carmine.
Of particular note in the above study, sensitization to carmine was
shown to occur in a nonatopic individual. This sensitization was
attributed to previous use of an eye shadow containing carmine, from
which the patient had experienced eye itching and skin burning
sensation. An SPT result for this product was positive in the patient.
Thus, this case highlights the probability that an individual, with no
previous history of allergy, became sensitized to carmine from use of
carmine-containing cosmetics and subsequently experienced a systemic
allergic reaction (urticaria and angioedema) following the ingestion of
a food containing carmine.
In 1997, Baldwin, et al., (Ref. 11) reported the case of a 27-year-
old woman who experienced anaphylaxis within three hours of eating a
popsicle labeled as colored with carmine. The woman received emergency
medical care with intravenous fluids, epinephrine and diphenhydramine
and was briefly hospitalized. Her past medical history included
allergic rhinitis. The woman recalled that her only other known
exposure to carmine was when she used a carmine-containing face blush.
Use of this blush caused an immediate, pruritic, erythematous eruption
when she used it directly on her facial skin but not when she applied
it over a face foundation. When she was later tested, she exhibited
highly positive SPT to the popsicle and carmine, but had negative
responses to the other components of the popsicle. A passive transfer
test (which indicates transfer of IgE sensitization) to carmine was
also positive.
In 1999, DiCello, et al., (Ref. 12) described two cases of allergic
reaction to carmine. A 27-year-old woman developed anaphylaxis after
ingestion of yogurt which listed carmine on the ingredient list. She
also experienced pruritis and swelling after application of carmine-
containing eye shadow. The second case involved a 42-year-old woman who
experienced multiple episodes of facial angioedema and nasal congestion
after ingestion of crabmeat. She also had severe reactions requiring
emergency room visits after ingesting Campari.
In 2001, Chung, et al., (Ref. 13) described three patients, one
with history of anaphylaxis and two with histories of urticaria and/or
angioedema following ingestion of carmine-containing foods. The
patients' allergies to carmine were confirmed by controlled food
challenges and SPT to commercial carmine preparations. Two of three
patients also had experienced pruritis and erythema after applying
blush containing carmine.
This study also evaluated the protein content of dried pulverized
cochineal insects and commercial carmine, and compared and analyzed the
specificity of the patients' sera (reflecting serum IgE) to these
proteins. Several protein bands were separated by electrophoresis from
cochineal insects; none were separated from commercial carmine. Despite
the fact that no protein bands were separated from commercial carmine,
sera from all three patients recognized several protein bands from both
pulverized cochineal insect extract and commercial carmine. Also, using
immunoblotting techniques, addition of commercial carmine inhibited
patients' sera from recognizing cochineal insect proteins. Thus, these
results suggest that commercial carmine retains proteinaceous material
that is antigenically identical (or similar) to other cochineal insect
proteins found in cochineal extract, and that could potentially induce
IgE sensitization or response in sensitive individuals. Although one or
more such proteins were recognized by the patients' sera, no single
protein was recognized by all three patients, making determination of a
single allergenic component in carmine-derived products not possible at
this time.
Although potentially inconsequential to regulatory decisions
regarding foods, drugs, and cosmetics, carmine has been noted in
reactions associated with inhalational exposure. Carmine has been
implicated in occupational asthma among workers in factories where the
dye is manufactured or added to products (Refs. 14, 15, and 16) and in
extrinsic allergic alveolitis (Refs. 17 and 18). With regards to
occupational asthma secondary to inhalation of carmine powder, the
first report was published in 1979 (Ref. 15) in the case
[[Page 4843]]
of a 54-year-old man who had worked as a blender of cosmetics. Five
years after carmine was introduced as a coloring agent, he developed
attacks of breathlessness at work, which would start within 20 minutes
of exposure to the coloring agent. Bronchial provocation testing
established that carmine was responsible for his wheezing attacks. He
was also tested with an extract of cochineal insects prepared in Coca's
solution; inhalation of this provoked his asthma. Although a lung
function test suggested pre-existing emphysema, his attacks were
reproducible when exposed to carmine powder. A second report of
occupational asthma secondary to inhalation of carmine powder was
published in 1987 (Ref. 16). A 1994 study (Ref. 14) demonstrated the
formation of specific IgE antibodies against carmine and cochineal
extract in a worker who had developed occupational asthma.
C. Adverse Reaction Reports in FDA Files
Since 1994, we have received 11 voluntarily submitted reports of
allergic reactions, including anaphylaxis, experienced by individuals
after eating food or drinking a beverage containing cochineal extract
or carmine or using cosmetics colored with carmine.
1. On June 20, 1995, a 27-year-old woman experienced anaphylaxis
within 3 hours of eating a popsicle labeled as colored with carmine. A
report of this case was also published in the medical literature as
described previously (Ref. 11).
2. On April 22, 1997, a 30-year-old woman experienced urticaria,
angioedema, and respiratory distress after consuming ruby red
grapefruit juice with carmine. She had experienced similar reactions
after eating purple candy colored with carmine. She also reported
having a skin rash after using a purple eye shadow containing carmine.
SPT to ruby red grapefruit juice, purple candy, purple eye shadow, and
carmine dye were all positive.
3. A 26-year-old woman experienced anaphylaxis on July 22, 1997,
with generalized pruritus, urticaria, and angioedema, after eating
custard-style strawberry-banana yogurt containing carmine. During the
episode, she was found to have an elevated serum tryptase level of 18
(upper limit of normal is 13.5), which is indicative of massive
activation/release of mast cells. Following the episode, she
demonstrated positive SPT to both custard-style strawberry-banana
yogurt containing carmine and to carmine itself.
4. On May 16, 1998, a 50-year-old woman reported having a severe
allergic reaction within 15 minutes of drinking a 16 ounce bottle of
fruit drink, which was labeled as containing extracts of cochineal. She
experienced swelling in the area of her eyes and tightness in her
throat. She was treated and hospitalized overnight.
5. A 49-year-old woman who had no other allergies and mild
hypertension reported on August 30, 2000, that she made two visits to
an emergency room for treatment of severe anaphylactic reaction after
eating small amounts of food colored with carmine: Crab soup, yogurt,
candy, ruby red grapefruit juice, and pasta salad with artificial
crabmeat. She subsequently had a positive SPT to carmine.
6. An atopic woman around the age of 50 called to report having
experienced recurrent episodes of swollen eyelids after consuming jelly
or gelatin dessert containing carmine. At the time of her call, she had
not had an allergic workup regarding her reactions.
7. A woman reported experiencing an allergic reaction she
attributed to eating a custard-style yogurt containing carmine. Shortly
after eating the yogurt, she experienced an anaphylactic reaction, with
trouble swallowing, hives, itching, and swelling of the eyelids. She
was treated by an allergist. She also reported past sensitivity to eye
shadows and other cosmetics which she thought contained carmine.
8. A letter from a law firm informed us of the experience of one of
their clients indicating that carmine might be implicated in allergic
reactions. The firm did not provide any clinical details but enclosed a
copy of a publication on carmine allergenicity from the journal Lancet.
9. On May 2, 2000, a woman reported anaphylactic shock from carmine
in foods and cosmetics applied to her skin and stated that she carries
an injectable medication for treatment when needed.
10. On September 21, 2000, a woman reported an allergic reaction by
her eyes to an eyeliner containing carmine.
11. In a letter dated March 26, 1999, a physician reported treating
a patient who experienced an anaphylactic reaction after eating yogurt
containing carmine and had a positive SPT to diluted carmine.
D. CSPI Citizen Petition
CSPI submitted a citizen petition (Docket No. 98P-0724), dated
August 24, 1998, requesting that we take action to protect consumers
who are allergic to carmine and cochineal extract. The petitioner
specifically requested that we do the following:
1. Immediately require that cochineal extract and/or carmine be
listed by name in the ingredient lists of all foods, drugs, and
cosmetics to help protect individuals who know they are sensitive to
the colorings;
2. Immediately require labeling of animal (insect) origin of
cochineal extract and carmine;
3. Undertake or require scientific reviews or studies to determine
the specific allergenic component of cochineal extract and carmine and
whether it could be eliminated from the coloring, as well as to
determine the prevalence and maximum severity of allergic reactions;
4. If necessary, prohibit the use of cochineal extract and carmine
entirely.
In support of its requested actions, CSPI provided six articles
from the scientific and medical literature describing adverse reactions
to cochineal extract and/or carmine after inhalation of the color
additive, ingestion of foods and beverages containing the color
additive, or topical application of products containing the color
additive. These articles are discussed in section IV.B of this
document.
V. FDA Response to the Allergic Reaction Reports
A. Evaluation of the Allergic Reaction Reports
The data show that a person may become sensitized and reactive to
carmine and cochineal extract from ingestion, inhalation, or topical
exposure to the color additives. Evidence for this is provided by
published case reports of allergic reactions to foods containing
carmine and cochineal extract (Refs. 10, 11, and 12), occupational
asthma from exposure to carmine (Refs. 15, 16, and 17), and allergic
reactions to topically applied cosmetics containing carmine (Refs. 9,
13, and 14). The data in the published reports establish that the
allergic reactions result from IgE-mediated antibody response to
carmine or cochineal extract. The data also establish that individuals
may become sensitized and reactive to carmine from use of cosmetics
containing that color additive. These same individuals have been shown
to subsequently experience more severe allergic reactions, including
life-threatening IgE-mediated anaphylaxis, following the ingestion of
carmine or cochineal extract in foods.
Further evidence is provided in the 11 voluntarily submitted
adverse reaction reports we have received that describe
[[Page 4844]]
allergic reactions, including anaphylaxis, experienced by individuals
after eating food or drinking a beverage containing cochineal extract
or carmine or using cosmetics colored with carmine. Because events were
reported from a population of unknown size, estimates of overall
frequency of allergy to these color additives cannot be made.
B. Options for Action
Individuals with known sensitivity to carmine or cochineal extract
need to avoid products that contain these color additives in order to
prevent potentially life-threatening allergic reactions. There are
several possible ways to accomplish this. One way is to prohibit use of
carmine and cochineal extract in all foods, drugs, and cosmetics. A
second way is to identify and eliminate the allergenic component of
carmine and cochineal extract. If an allergen is a contaminant of the
color additive, rather than the coloring principle, then FDA can set
additional limiting specifications in the regulations for the color
additives and, if necessary, require certification for each batch of
carmine and cochineal extract to ensure compliance with these
specifications. A third way is to require declaration of the presence
of these color additives on the labels of all foods, drugs, and
cosmetics.
C. Tentative Conclusions
We have tentatively concluded that it is unnecessary to prohibit
the use of carmine and cochineal extract in all foods, drugs, and
cosmetics. Although the color additives have been shown to produce
allergic responses in certain sensitized individuals, there is no
evidence of a significant hazard to the general population when the
color additives are used as specified by the color additive regulations
in part 73.
We have also tentatively concluded that requiring additional
testing to identify and remove the allergenic component in carmine and
cochineal extract would do little to protect the health of individuals
sensitive to those additives because: (1) Given evidence that different
people appear to react to different components of the color additives,
it may not be technically or economically feasible to identify and
reduce the allergenic component of carmine and cochineal extract to a
low enough level so that it would no longer induce an allergic response
in sensitized individuals; and (2) additional testing and the
rulemaking required to implement the results of the testing would delay
our resolution of the issue for sensitive individuals.
Instead, FDA proposes to require declaration of carmine or
cochineal extract on the labels of all foods and cosmetics that contain
them. We plan to address prescription drugs in a separate rulemaking.
This labeling requirement will enable sensitized individuals to
recognize that a product contains carmine or cochineal extract by
reading a product's labeling, and will thereby enable those individuals
to avoid products that contain the color additives. This labeling
requirement will also enable consumers and health care professionals to
more quickly identify sensitivities to these color additives.
1. Foods
There is currently no requirement that the presence of cochineal
extract or carmine be declared in food labeling. Section 403(i) of the
act (21 U.S.C. 343(i)) requires that a food label declare the
ingredients in the food, using the common or usual name of the
ingredient. However, this section allows the food label to designate
certification-exempt color additives as coloring without naming the
additives. The implementing regulation, Sec. 101.22(k)(2) (21 CFR
101.22(k)(2)), permits label declaration of a certification-exempt
color additive with a general phrase such as ``Artificial Color,''
``Color Added,'' or some other equally informative term that makes it
clear that a color additive has been used in the food.
Section 403(k) of the act requires that a food that bears or
contains any artificial coloring must bear labeling stating that fact,
but states that the provisions of this section and of section 403(i)
described previously do not apply to butter, cheese, or ice cream.
Section 101.22(k)(3) states that color additives need not be declared
on the labels of butter, cheese, and ice cream unless such declaration
is required by a regulation in part 73 or 21 CFR part 74. We have
reviewed published and submitted reports describing allergic responses
to food products containing cochineal extract or carmine. These reports
are sufficient to demonstrate a hazard to the health of consumers who
are sensitive to the color additives. Therefore, we tentatively
conclude that the labels of all foods containing cochineal extract or
carmine should declare the presence of those color additives in the
ingredient statements as a condition of safe use. To that end, we
propose the following amendments.
FDA proposes to amend Sec. 73.100(d) by adding new paragraph
(d)(2) to require the declaration of cochineal extract and carmine on
the labels of all foods. Because Sec. 101.22(k)(2) does not refer to
any labeling requirements in part 73, FDA also proposes to amend Sec.
101.22(k)(2) to provide that certification-exempt color additives need
not be declared on the labels of foods unless such declaration is
required by a regulation in part 73. We do not propose to amend Sec.
101.22(k)(3) to require the declaration of cochineal extract or carmine
on the labels of butter, cheese, and ice cream because that declaration
would be required by reference to proposed new Sec. 73.100(d)(2).
2. Drugs
With respect to OTC drugs, Sec. 201.66(c)(8) (21 CFR 201.66(c)(8))
requires the outside container or wrapper of the retail package, or the
immediate container label if there is no outside container or wrapper,
to contain a listing of the established name of each inactive
ingredient. If the OTC drug product is also a cosmetic, then the
inactive ingredients must be listed in accordance with specific
provisions of Sec. Sec. 701.3(a) or (f) (21 CFR 701.3(a) or (f)) and
21 CFR 720.8, as applicable. Therefore, whether the OTC drug is or is
not also a cosmetic, there is a preexisting regulatory requirement for
declaration of inactive ingredients, including carmine and cochineal
extract under Sec. 201.66(c)(8). Failure to comply with this
regulation would render an OTC drug misbranded and subject to
enforcement action under section 502(c) of the act (21 U.S.C. 352(c)).
Furthermore, section 412 of FDAMA amended the misbranding
provisions in section 502(e) of the act to require declaration of
inactive ingredients for drugs, including prescription drugs. We plan
to initiate a separate rulemaking to implement these FDAMA
provisions.\1\
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\1\ These provisions of FDAMA have already been implemented for
OTC drugs as described in the preceding paragraph. See 64 FR 13254,
13263 (March 17, 1999). Note also that current 21 CFR 200.100(b)(5)
requires the label of a prescription drug that is not for oral use
(such as a topical or injectable drug) to bear the names of inactive
ingredients, but permits certain color components to be designated
as ``coloring'' rather than being specifically named.
---------------------------------------------------------------------------
3. Cosmetics
Cosmetics that are offered for retail sale are subject to the
labeling requirements of Sec. 701.3. Section 701.3(a) requires that
the labels of cosmetics offered for retail sale bear a declaration of
the name of each ingredient in descending order of predominance, except
that the individual ingredients of fragrances and flavors are not
required to be listed and may be identified together as ``fragrance''
or ``flavor.'' However, Sec. 701.3(f) permits color additives to be
declared as a group at
[[Page 4845]]
the end of the ingredient statement, without respect to order of
predominance.
Cosmetics that are manufactured and sold for use only by
professionals, called ``professional-use-only'' products, are not
subject to the requirements of Sec. 701.3 and thus need not bear
ingredient labeling. Cosmetic products that are gifts or free samples
also need not bear ingredient labeling.
Professional-use-only products include: (1) The makeup used in
photography studios and by makeup artists for television, movie, and
theater actors/actresses, (2) products intended for use only by
professionals in beauty salons, skin care clinics, and massage therapy
shops, and (3) camouflage makeup dispensed by physicians and
aestheticians to clients with skin conditions such as scarring.
Cosmetics that are gifts or free samples need not bear ingredient
labeling because they are not intended for retail sale as consumer
commodities. However, in the case of a gift that is actually a ``gift-
with-purchase,'' we have stated in our trade correspondence (Ref. 19)
that the ``gift'' is not considered a free gift per se, because it can
only be obtained by consumers who purchase the product to which the
gift is attached. Therefore, such a ``gift'' must currently bear a
complete ingredient declaration on the label of the package in
accordance with the requirements of Sec. 701.3.
We have reviewed published and submitted reports of allergic
responses, including anaphylaxis, to cosmetic products that contain
carmine. Furthermore, we have discussed the possibility that consumers
sensitized to carmine from use of cosmetics containing that color
additive may subsequently experience more severe allergic reactions,
including anaphylaxis, from ingestion of carmine or cochineal extract
in foods. We have tentatively concluded that all cosmetic products
should declare the presence of carmine in their labeling. Therefore,
FDA proposes to amend Sec. 73.2087 to require declaration of carmine
on the labels of cosmetics that are not subject to the requirements of
Sec. 701.3. The amended regulation will require that the cosmetics
specifically declare the presence of carmine prominently and
conspicuously at least once in the labeling and will provide the
following statement as an example: ``Contains carmine as a color
additive.''
VI. FDA Response to the CSPI Petition
FDA's response to the actions requested in the CSPI petition is as
follows:
1. CSPI requested that FDA immediately require that cochineal
extract and carmine be listed by name in the ingredient lists of all
foods, drugs, and cosmetics.
We believe that requiring the declaration of cochineal extract and
carmine would provide sensitized consumers with the information needed
to avoid products that contain those color additives. For the reasons
stated in section V of this document, FDA proposes to require the
declaration of carmine and cochineal extract on the labels of all foods
and cosmetics, and plans to address drugs in a separate rulemaking.
2. CSPI requested that FDA immediately require labeling of animal
(insect) origin of cochineal extract and carmine.
We do not believe requiring the declaration of animal (insect)
origin of cochineal extract and carmine in the labeling of products
containing these color additives is necessary. FDA has tentatively
concluded that the proposed labeling requirement will provide
sensitized consumers sufficient information to avoid products
containing these color additives.
Furthermore, information on the origin of these color additives is
readily available to those consumers who want it. This information is
provided in standard dictionaries under the definitions for the words
``cochineal'' and ``carmine.'' This information is also provided in the
color additive regulation governing use of cochineal extract and
carmine in foods ( Sec. 73.100). Thus, we do not propose to require
labeling of animal (insect) origin of cochineal extract and carmine.
3. CSPI requested that FDA undertake or require scientific reviews
or studies to determine the specific allergenic component of cochineal
extract and carmine, and whether it could be eliminated from the color
additives, as well as to determine the prevalence and maximum severity
of allergic reactions.
We could not identify the specific allergenic component in carmine
and cochineal extract from our review of the published literature,
except to state that it is likely to be of insect origin. One study we
reviewed found that no universal protein was recognized by patients
known to be allergic to carmine and that it remains unclear whether the
allergenic component consists of proteins from the cochineal insects or
a protein-carminic acid complex. We believe that additional scientific
reviews or studies to determine the specific allergenic components of
cochineal extract and carmine may be helpful if successful; however,
they would be unnecessary to ensure the safe use of cochineal extract
and carmine in foods, drugs, and cosmetics for the majority of
consumers in the general public. Thus, we have not undertaken and we do
not propose to require the requested scientific reviews or studies.
4. CSPI requested that, if necessary, FDA prohibit the use of
cochineal extract and carmine entirely.
As noted previously, we have tentatively concluded that it is
unnecessary to prohibit the use of cochineal extract and carmine in
foods, drugs, and cosmetics. Although the color additives have been
shown to produce allergic responses in certain sensitized individuals,
there is no evidence of a significant hazard to the general population
when the color additives are used as specified by the color additive
regulations in part 73. Requiring declaration of carmine and cochineal
extract on the labels of all foods and cosmetics will enable sensitized
individuals to inform themselves of the presence of the color additives
by reading a product's label and will thereby enable the individuals to
avoid those products that contain carmine or cochineal extract. Thus,
we do not propose to prohibit the use of cochineal extract and carmine.
VII. FDA Proposed Action
A. Legal Authority
The legal authority for the regulations prescribing the safe use of
color additives in foods, drugs, and cosmetics comes from section
721(b) of the act (21 U.S.C. 379e(b)). Under section 721(b), FDA has
the authority to prescribe conditions, including labeling requirements,
under which a color additive may be safely used. Products containing
color additives that are not used in compliance with the color additive
regulations are adulterated under sections 402(c) (foods), 501(a)(4)
(drugs), or 601(e) (cosmetics) of the act (21 U.S.C. 342(c), 351(a)(4),
and 361(e), respectively). We have concluded that cochineal extract and
carmine may cause potentially severe allergic responses in humans.
Thus, we believe label information about the presence of these color
additives in all foods and cosmetics is necessary to ensure their safe
use. We note that, with respect to OTC drugs, declaration of inactive
ingredients is already required under Sec. 201.66(c)(8), and we plan
to initiate a rulemaking to implement the FDAMA provisions that require
declaration of inactive ingredients for drugs, including prescription
drugs.
Additional legal authority for requiring disclosure of a coloring
that is,
[[Page 4846]]
or that bears or contains, a food allergen comes from section 403(x) of
the act. Under that section, a coloring determined by regulation to be,
or to bear or contain, a food allergen must be disclosed in a manner
specified by regulation.
B. Food Labeling
FDA proposes to amend the color additive regulation (Sec. 73.100)
that permits the use of cochineal extract or carmine in foods by adding
new paragraph (d)(2) to require that all food (including butter,
cheese, and ice cream) that contains cochineal extract or carmine
specifically declare the presence of the color additive by its
respective common or usual name, ``cochineal extract'' or ``carmine,''
in the ingredient statement of the food label. Failure to adhere to
this requirement would make any food that bears or contains cochineal
extract or carmine adulterated under section 402(c) of the act.
FDA also proposes to amend Sec. 101.22(k)(2) of the food labeling
regulations to disallow generic declaration of color additives for
which individual declaration is required by applicable regulations in
part 73. Currently, that paragraph allows any certification-exempt
color additive to be declared in a generic way as ``Artificial Color''
or ``Artificial Color Added,'' rather than by its specific common or
usual name.
C. Cosmetics Labeling
FDA proposes to amend the color additive regulation (Sec. 73.2087)
permitting the use of carmine in cosmetics to require that cosmetics
containing carmine that are not subject to the requirements of Sec.
701.3 specifically declare the presence of carmine prominently and
conspicuously at least once in the label or labeling. The amended
regulation will provide the following statement as an example:
``Contains carmine as a color additive.'' Including this requirement in
the color additive regulations will make any cosmetic that contains
carmine and that does not declare its presence on the label adulterated
under section 601(e) of the act.
VIII. Proposed Effective Date
The proposed effective date for any final rule that may issue based
on this proposal is 2 years after its date of publication in the
Federal Register.
IX. Environmental Impact
The agency has determined under 21 CFR 25.30(k) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
X. Analysis of Impacts
A. Preliminary Regulatory Impact Analysis
We have examined the economic implications of this proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity). Executive Order 12866 classifies a
rule as significant if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $100
million, adversely affecting a sector of the economy in a material way,
adversely affecting competition, or adversely affecting jobs. A
regulation is also considered a significant regulatory action if it
raises novel legal or policy issues. We have determined that this
proposed rule is not an economically significant regulatory action as
defined by Executive Order 12866.
B. Regulatory Alternatives
We considered the following regulatory alternatives in this
analysis. We request comments on these and any other plausible
alternatives: (1) Take no action; (2) take the proposed action; (3)
take the proposed action, but make the effective date later; (4) take
the proposed action, but make the effective date sooner; or (5) ban
carmine and cochineal extract.
1. Option One: Take No Action
We treat the option of taking no action as generating neither costs
nor benefits. We use this option as the baseline in comparison with
which we determine the cost and benefits of the other options. Any
favorable or unfavorable results from taking no action will be captured
in the costs and benefits of the other options.
2. Option Two: Take the Proposed Action
a. Costs. This proposed rule would increase the cost of using
cochineal extract and carmine in foods and some cosmetics because it
would require firms using these substances to list them on product
labels. In the case of foods, the proposal would require firms to list
the additives as ingredients in their products. In the case of
cosmetics, the proposal would require firms to declare the presence of
carmine on products not subject to the requirements of Sec. 701.3
(e.g., professional-use-only products or free gifts). Cosmetics which
are consumer commodities and subject to the requirements of Sec. 701.3
are already required to list carmine as an ingredient.
Although we discuss these costs as though they accrued to the
affected firms, these costs are actually social costs that firms may
pass on to consumers via higher product prices, depending on market
conditions. The costs would be greatest for firms currently producing
products containing these additives and for firms that begin using
these additives in existing products after the final rule based on this
proposal has taken effect but before their next regularly scheduled
label change. Costs would be greatest for these firms because they
would need to change labels before their next regularly scheduled label
redesign, and they may lose some inventory of already printed labels.
The costs would be much smaller for firms that begin using these color
additives in new products that are introduced after the final rule
based on this proposal has taken effect and for firms that begin using
these additives in existing products after their next regularly
scheduled label redesign after the final rule based on this proposal
has taken effect. Costs would be much smaller for these firms because
they could incorporate the requirements of this rule in their label
design during their label design phase, and they would not lose label
inventory. The costs for these firms would be the loss of otherwise
free label space. These costs would be minimal because this rule
requires the use of only a small portion of the total available label
space.
Firms would respond in one of two ways to the increased costs of
using carmine and cochineal extract. First, firms might use these
additives and label products containing these additives as required by
the final rule based on this proposal. Second, firms might decide not
to use these additives or to delay using them until after their next
regularly scheduled label change. Firms would decide which action to
take based on estimated profits, which would vary with changes in
consumer demand for the relabeled or reformulated products, the costs
of relabeling or reformulating, and changes in consumer demand
resulting from changes in product prices. We assume in this analysis
that the required labeling would not significantly reduce
[[Page 4847]]
demand because relatively few consumers are sensitive to these color
additives. (If the required labeling did significantly reduce demand,
then we would need to distinguish the costs of firm activity that
result from changes in the costs of using carmine and cochineal extract
from the costs of firm activity that result from changes in product
demand. The former would represent social costs; the latter would
represent distributive effects.) In addition, we assume that all firms
would relabel rather than reformulate because relabeling is generally
much less costly than reformulating.
For foods and cosmetics, we estimated relabeling costs using a
model developed by Research Triangle Institute (RTI) under contract to
FDA. This model estimates labeling costs based on the length of the
compliance period (that is, the length of time we give firms to comply
with the requirements of the final rule upon publication of the final
rule), the parts of the label that are affected, and the North American
Industry Classification System (NAICS) codes or descriptions of the
type of products. The label cost model does not cover cosmetics, so we
estimated relabeling costs for cosmetics by extrapolating from the data
on food.
The proposed effective date for this rule will be 24 months
following the publication of the final rule. The rule will affect only
the ingredient list for most affected products. We estimated the
labeling costs for cosmetic products based on the costs of changing the
ingredient lists for the relevant product types that appeared in the
label cost model. We do not know the number of food products or
cosmetics that contain carmine or cochineal extract. According to
industry literature, these additives are technically suitable for use
in a wide variety of food including dairy products such as ice cream
and yogurt; popsicles; baked goods including doughnuts, bakery mixes,
cones, and fruitcake; confections and candy including chewing gum base,
hard candies, soft-toffee/caramel, and gum types/jellies; fruit
fillings and puddings, jellies, and gelatin dessert; canned cherries;
seasonings; snacks; canned meat products; pork sausage; surimi
(artificial crabmeat); soup and soup mixes; tomato products; vinegar;
beverages and fruit-based drinks; fruit-based liquors; and syrups. All
of the food products featured in the adverse event reports that we
discussed previously in this preamble fall into one of these
categories. Carmine is also suitable for use in a variety of cosmetics,
including lipsticks, blushes, and eye shadows. However, this rule
affects the following categories of cosmetics which are not subject to
the requirements of Sec. 701.3: (1) Professional-use only products,
including, makeup used in photography studies and television, movies,
and theater; makeup used by professionals in beauty salons, skin care
clinics, and massage therapy shops; and camouflage makeup given by
physicians and estheticians to clients with skin conditions such as
scarring; (2) free samples or gifts, if not linked to a purchase. We
already require all other cosmetics to declare the presence of color
additives on the label.
Based on this list of products, the most relevant product
categories and NAICS codes appearing in the labeling cost program are
as follows: Fluid Milk (311511), yogurt and flavored milk portion only;
Ice Cream and Frozen Dessert Manufacturing (311520); Commercial
Bakeries (311812) bakery snacks, pies, and cakes only; Frozen Cakes,
Pies, and Other Pastries Manufacturing (311813); Cookies and Cracker
Manufacturing (311821), cookies only; Flour Mixes and Dough
Manufacturing from Purchased Flour (311822), baking mixes only;
Chocolate and Confectionery Manufacturing from Cacao Beans (311320);
Nonchocolate Confectionery Manufacturing (311340); Fruit and Vegetable
Canning (311421) juices, jams/jellies/preserves, fruit, and tomato
products only; Specialty Canning (311422) entrees, side dishes, and
soup only; Dried and Dehydrated Foods (311423), soup only; Spice and
Extract Manufacturing (311942), spices and seasonings only; Other Snack
Food Manufacturing (311919) except unpopped popcorn; Seafood Canning
(311711); Fresh and Frozen Seafood Manufacturing (311712); Frozen
Specialty Food Manufacturing (311412); Mayonnaise, Dressing, and Other
Prepared Sauce Manufacturing (311941), vinegar only; Frozen Fruit,
Juice, and Vegetable Manufacturing (311411), juice concentrate only;
and Soft Drink Manufacturing (312111) carbonated beverages and non-
fruit drinks only; and All Other Miscellaneous Food Manufacturing
(311999) baking ingredients, drink mixes, desert toppings, gelatin
puddings, syrups, and side dishes only. In addition, the following
relevant NAICS codes do not appear in the labeling cost program: Retail
Bakeries (311811); Confectionery Manufacturing from Purchased Chocolate
(311330); Flavoring Syrup and Concentrate Manufacturing (311930); Meat
Processed from Carcasses (311612); Distilleries (312140); and Toilet
Preparation Manufacturing (325620). We used the average labeling costs
of the other NAICS categories to estimate the costs for the NAICS
categories that did not appear in the labeling cost program.
We then reduced the estimated labeling costs for some of the NAICS
categories based on information from U.S. Census Bureau industry
reports based on the 1997 economic census. We made these corrections
only on those NAICS categories for which we were unable to limit the
product categories to the most relevant products using the product
categories provided in the label cost model.
For Seafood Canning (311711), we assumed that the primary type of
product that might contain carmine or cochineal extract is surimi
(imitation crab). This product comprised about 9 percent of the total
value of shipments for this NAICS code (Ref. 20). Therefore, we
estimated that the labeling costs would be 9 percent of the estimated
costs for the entire NAICS code.
We made a similar correction to the cost estimates for Fresh and
Frozen Seafood Manufacturing (311712). The Census report did not
provide the value of shipment figures for fresh surimi products in
order to avoid disclosing data on individual companies. However, the
report included the data in higher level totals. Therefore, we
estimated an upper bound on the size of the value of shipments for
fresh surimi products by subtracting off from the total value of
shipments all of the value of shipments of the categories for which the
report provided data. We did not need to use this approach for frozen
surimi products because the report provided data on those products.
Using these figures, we estimated that surimi products comprised a
maximum of 8 percent of the total value of shipments for this NAICS
code (Ref. 21).
For Meat Processed from Carcasses (311612), we assumed that the
primary types of products that might contain carmine or cochineal
extract are canned meat and sausage. These products comprised about 34
percent of the total value of shipments for this NAICS code (Ref. 22).
For Distilleries (312140), we assumed that the primary types of
product that might contain carmine or cochineal extract are bottled
cordials and liqueurs. These products comprised about 13 percent of the
total value of shipments for this NAICS code (Ref. 23).
For Toilet Preparation Manufacturing (325620), we assumed that the
primary types of product that might contain carmine or cochineal
extract is cosmetics (lip, eye, and blushers). These products comprised
about 11 percent of
[[Page 4848]]
the total value of shipments for this NAICS code (Ref. 24).
For Retail Bakeries (311811), we assumed that the primary product
types product that might contain carmine or cochineal extract are
cakes, cookies, doughnuts, pies, and other sweet goods (sweet rolls,
coffeecake, pastries, Danishes, muffins, etc.). These products
comprised about 32 percent of the total value of shipments for this
NAICS code (Ref. 25).
We do not have information on the proportion of those products that
are suitable to contain carmine or cochineal extract that actually
contain those color additives and that do not already list them on the
ingredient list. However, the proportion of products that contain these
additives is probably only a small portion of the total number of
suitable products. Therefore, we assumed that between 1 percent and 10
percent of the products in the most relevant product categories
actually contain carmine and cochineal extract and do not already
voluntarily list these substances in the ingredient list. Under these
assumptions, we estimate the one-time labeling costs to be
approximately $0 million to $3 million.
b. Benefits. This rule would generate health benefits by reducing
the number of adverse events involving cochineal extract and carmine
via two potential pathways: (1) Consumers who know they are sensitive
to these color additives would be better able to avoid products
containing these color additives, and (2) consumers and health care
professionals would be able to more quickly identify sensitivities to
these color additives. In addition to the health benefits, this rule
would allow consumers who know they are sensitive to these color
additives to consume products that they may otherwise avoid because of
uncertainty over whether the products contain these color additives.
We have identified three adverse events from the FDA files and the
literature that involved products containing carmine or cochineal
extract in which those color additives did not or probably did not
appear on the ingredient list. All three cases involved crabmeat. In
one case, we know that these additives did not appear on the product
label. In the other two cases, we do not have information on whether
the additives appeared on the labels or not. However, our experience is
that crabmeat containing carmine or cochineal extract rarely indicates
these additives in the ingredient list. Therefore, we assumed that
these additives did not appear on the product label in these two cases.
These three cases are part of a group of 14 cases involving adverse
events in the United States involving carmine or cochineal extract in
food or cosmetics that we identified in the literature and in our FDA
files. The other 11 cases did not contain information on the labeling
of the product that caused the reaction or involved products that were
already labeled as containing carmine or cochineal extract.
The first of these events occurred in May 1994. The last of these
events occurred in 2001. However, our literature search covered the
period up to February 2004.
Passive reporting systems generally capture only a small fraction
of adverse events. The actual fraction of adverse events captured by
those systems is difficult to estimate because it depends on a number
of factors, including public and physician awareness of a problem, the
timing of press releases and other actions, the degree to which the
adverse events are considered unusual or notable, and the severity of
the adverse events. Estimates of reporting rates for particular type of
problems under these types of systems tend to range from about 10
percent to less than 1 percent (Refs. 26, 27, and 28). The reporting
rate for adverse events involving allergic responses to products
containing unlabeled carmine would be probably be toward the low end of
the scale because it would be difficult for consumers or physicians to
relate the problem to carmine or cochineal extract if those substances
were not listed on the product package. Therefore, we assume that we
are aware of only about 1 percent of the adverse events involving these
products. Under this assumption, we estimate that 300 adverse events
involving these substances may have occurred between May 1994 and
February 2004 (a reporting period of 9 years and 9 months) involving
products covered by this rule, containing these additives, and not
already listing these additives on the ingredient list. This
corresponds to an annual rate of 31 adverse events.
We do not have sufficient information to estimate the percentage of
these adverse events that this rule would eliminate. However, the
reports involving products that already list these ingredients on the
ingredient list suggest that this type of labeling will not eliminate
all of these adverse events. Therefore, we assume that this rule would
eliminate between 10 percent and 90 percent of these cases.
Although we do not have estimates of the value of avoiding severe
and non-severe allergic reactions to carmine and cochineal extract, we
do have estimates of avoiding severe and mild allergic responses in
general. In a study done under contract to FDA, RTI estimated the value
of avoiding a severe allergic response to be approximately $58,000
(Ref. 29). This estimate was based on a quality adjusted life year of
approximately $200,000. We have revised our estimate of a quality
adjusted life year to a range of $100,000 to $500,000 (68 FR 41489,
July 11, 2003). Therefore, we have adjusted the estimate of the value
of avoiding a severe allergic response to a range of between $26,000
and $132,000. This estimate accounted for the probability of death or
coma due to a severe allergic response; however, it did not account for
medical costs. Severe reactions involve anaphylaxis and typically
require hospitalization and often emergency room care. These
hospitalizations typically last 48 hours to 72 hours. One nationwide
study found the mean cost of a hospital stay for a severe allergic
reaction involving respiratory symptoms to be approximately $6,500
(Ref. 30). Therefore, we estimate the average total cost of a severe
allergic reaction to carmine or cochineal extract to be approximately
$33,000 to $139,000. We have two estimates of the value of avoiding a
mild allergic response $54 and $437 (Ref. 29). The average of these two
estimates is about $250.
Six of 14, or 43 percent, of the adverse events reports involving
food and cosmetics involved severe adverse events that required
emergency treatment or hospitalization. We assume that the same
proportion of unreported adverse events would be severe. Under the
assumption that about 43 percent of adverse event are severe, and based
on the estimated number of adverse events eliminated by this rule and
the estimated value of avoiding severe and mild allergic reactions, we
estimate the potential annual health benefits of this rule to be
between $0 million and $2 million. The total discounted value of this
stream of health benefits at a discount rate of seven percent is
between $1 million and $26 million. We are unable to quantify the non-
health benefits of this rule for consumers who know they are sensitive
to these substances and who would be able to consume some products that
they might currently avoid because of uncertainty over whether the
products contain these additives.
3. Option Three: Take the Proposed Action, but Make the Effective Date
Later
Increasing the compliance period to 36 months would reduce the cost
of revising labels because more firms could
[[Page 4849]]
time the revisions to coincide with regularly scheduled label changes.
We estimated that the cost of revising labels under Option 2 would be
$0 million to $3 million under a 24-month compliance period. Therefore,
the cost of revising labels under a 36-month compliance period would be
$0 million to some amount less than $3 million. However, delaying the
effective date would also reduce benefits. For example, if we set the
effective date to 36 months, then we would eliminate the $0 million to
$2 million in benefits that would have taken place in months 24 to 36
under Option Two. The ranges of estimated cost and benefit reductions
overlap. Thus, we have insufficient information to determine if this
option would generate higher or lower net benefits than Option Two.
4. Option Four: Take the Proposed Action, but Make the Effective Date
Sooner
Decreasing the compliance period would increase the cost of
revising labels because fewer firms could time the revisions to
coincide with regularly scheduled label changes. For example, based on
the labeling cost model that we discussed under Option Two, we estimate
that the costs of this rule under a compliance period of 12 months
would be approximately $3 million to $55 million. The estimated costs
under Option Two were $0 million to $3 million. Therefore, moving up
the effective date by 12 months would increase costs by $3 million to
$52 million. However, moving up the compliance date would also increase
benefits relative to Option Two by providing benefits during months 12
to 24 after the publication date of the final rule. These benefits
would amount to approximately $0 million to $2 million. Thus, this
option would reduce net benefits by $1 million to $52 million relative
to Option Two.
5. Option Five: Ban Carmine or Cochineal Extract
a. Costs. Banning carmine or cochineal extract would require firms
currently using these additives in products covered by this rule to
reformulate all such products. Although a number of potential
substitutes exist, each of these substitutes has technical and
functional characteristics that differ from those of cochineal extract
and carmine. We estimated reformulation costs using a model developed
by RTI under contract to FDA. For purposes of providing the necessary
inputs for the reformulation cost model, we assumed that firms would
probably replace carmine or cochineal extract with another substance,
that one could best describe carmine or cochineal extract as a non-
critical minor ingredient, that firms would find that discrimination
testing was sufficient to gauge consumer acceptance of the new
formulations, and that firms would not need to perform any analytical
or consumer sampling tests. We estimated reformulation costs using the
same approach that we used to estimate labeling costs, except that we
were unable to estimate reformulation costs for Commercial Bakeries
(311812) bakery snacks, pies, and cakes only using the reformulation
cost model. Therefore, we based our estimate of the reformulation costs
for that product category on the average reformulation cost for the
product type categories that appeared in the reformulation cost model.
The estimated one-time total reformulation cost was $3 million to
$1,390 million.
In addition to the one-time reformulation costs, this option may
also increase the costs of producing affected products or reduce the
value that consumers place on those products. However, one cannot infer
that these results would necessarily occur based on the current use of
these additives because the one-time costs of reformulation might have
led firms to continue using these additives even though substitutes
existed that were equally costly and did not reduce the value that
consumers placed on those products. If these results--increased
production costs or reduced consumer valuation--were to occur, they
would not be one-time costs but recurring costs. However, extrapolating
such costs to infinity would not be reasonable because technical
improvements in substitutes for carmine and cochineal extract could
eventually eliminate such costs. Nevertheless, these costs could be
much greater than the corresponding recurring costs under Option Two,
which were generated by the permanent loss of a small amount of
otherwise free label space.
This option would also generate significant distributive effects by
reducing the profits of firms that produce, import, or process carmine
and cochineal extract and by increasing the profits of firms that
produce, import, or process substitutes. In some cases, the same firms
that handle cochineal extract and carmine may handle substitutes for
these additives. The distributive effects generated by this option
would probably be much greater than the distributive effects generated
by Option Two because under Option Two most firms using carmine or
cochineal extract would probably continue to use these additives.
b. Benefits. Banning these additives would generate health benefits
by eliminating the possibility that sensitive consumers would ingest
these substances. These health benefits would be greater than the
health benefits of Option Two because they would include all of the
adverse events eliminated under Option Two as well as some additional
adverse events involving people who do not yet realize they are
sensitive to these additives or who realize they are sensitive to these
additives but fail to read the ingredient list. In particular, this
option would eliminate cases of the type captured in the 11 adverse
event reports discussed previously that involved food or cosmetics
containing carmine or cochineal extract in which these color additives
probably appeared on the product label. The reporting rate for adverse
events involving products that are labeled as containing carmine or
cochineal extract should be significantly higher than reports rates for
adverse events involving products that are not so labeled. Therefore,
we assumed that the reporting rate for labeled products is
approximately 10 percent. Based on this assumption, this option would
prevent 42 annual adverse events and generate annual health benefits of
approximately $1 million to $3 million. The total discounted value of
this stream of health benefits at a discount rate of 7 percent is $9
million to $36 million.
In addition to health benefits, banning these additives would also
generate benefits by allowing consumers who know they are sensitive to
these additives to consume some products that they might otherwise
avoid. We do not have sufficient information to quantify this benefit.
However, this benefit would probably be greater than the comparable
benefit under Option Two because, under this option, consumers would
not have to read product labels to determine whether they could consume
particular products.
6. Summary of Costs and Benefits.
We do not have good information on the current usage of carmine and
cochineal extract or the current number of adverse events associated
with those additives. However, under the assumptions we used in this
analysis, we estimate that taking the proposed action would generate
one-time relabeling costs of between $0 million and $3 million and some
small but permanently recurring costs associated with the loss of
otherwise free label space. We also estimate that taking the proposed
action would generate permanently recurring annual health benefits of
between $0 million and $2
[[Page 4850]]
million, with a total discounted value under a 7 percent discount rate
of between $1 million and $26 million. In addition, taking the proposed
action would generate recurring benefits for consumers who are
sensitive to these substances and who would be able to consume some
products that they might otherwise have avoided. Based on these
estimates, taking the proposed action has the potential to produce
significant net benefits but also has some potential to produce small
net costs. We estimate that delaying the compliance date to 36 months
after publication of the final rule rather than 24 months after
publication of the final rule, as proposed, would reduce the one-time
reformulation costs to between $0 million and some amount less than $3
million and reduce health benefits by between $0 million and $2
million. Thus, we cannot determine if delaying the effective date to 36
months after the publication of the final rule would increase net
benefits. We also estimate that moving up the compliance date to 12
months after publication of the final rule would increase the one-time
reformulation costs by $3 million to $52 million and increase benefits
by approximately $0 million to $2 million. Thus, moving up the
effective date to 12 months after the publication of the final rule
would decrease net benefits. Banning carmine and cochineal extract
would generate a one-time reformulation cost of $3 million to $1,390
million, plus possible recurring costs from increased production costs
caused by the use of substitutes or from reduced consumer valuation of
the reformulated products. A ban would generate benefits of
approximately $1 million to $3 million per year, with a total
discounted value under a 7 percent discount rate of $9 million to $36
million. Therefore, we estimate that a ban would generate potentially
large net social costs.
C. Small Entity Analysis
We have examined the economic implications of this proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
regulatory options that would lessen the economic effect of the rule on
small entities. We find that this proposed rule would have a
significant economic impact on a substantial number of small entities.
The Small Business Administration (SBA) publishes definitions of
small businesses by NAICS code. We presented a list of relevant NAICS
codes in the preceding cost benefit analysis. For most of the relevant
NAICS codes, SBA defines a small business as a business with 500 or
fewer employees. The exceptions are NAICS codes 311821 and 312140, for
which the cutoff is 750 employees, and 311422, for which the cutoff is
1,000 employees. We used the 1997 Economic Census to check the number
of firms that would be classified as small businesses under the SBA
definitions. We found that virtually all (98 percent) of the firms in
the relevant NAICS code categories are small businesses according to
the SBA definitions.
Total costs potentially incurred by small businesses will be
virtually equal to the social costs estimated in the cost benefit
analysis because the vast majority of the affected firms discussed in
the cost benefit analysis are small businesses. These costs may or may
not be borne by small businesses because firms may be able to pass on
some or all of these costs to consumers in the form of higher prices,
depending on market conditions. If the total costs accruing to small
businesses are proportional to the number of affected food and cosmetic
firms that are small businesses, and if these firms are unable to pass
on any costs to consumers, then we estimate that the one-time costs
accruing to small businesses from taking the proposed action would be
$0 million to $3 million, plus some small but permanently recurring
costs associated with the loss of otherwise free label space.
All of the regulatory alternatives discussed in the cost benefit
analysis would change the potential impact of this rule on small
businesses. Taking no action would eliminate all potential impacts on
small businesses. Taking the proposed action but increasing the
compliance period from 24 months to 36 months would reduce the
potential impact on small businesses to between $0 million and some
amount less than $3 million. However, as discussed in the cost benefit
analysis, extending the compliance period from 24 months to 36 months
would also reduce benefits by the amount that would otherwise have been
generated in the first 12 months. Taking the proposed action but
decreasing the compliance period from 24 months to 12 months would
substantially increase the potential impact on small businesses to
between $3 million and $55 million. Banning carmine and cochineal
extract would significantly increase the potential costs for small food
and cosmetic firms to between $3 million and $1,390 million. In
addition, a ban would also generate significant distributive effects on
small businesses that manufacture, import, or process these color
additives and do not also handle substitutes. These distributive
effects would also be considered costs from the perspective of the
affected small businesses. Other firms, including small firms, would
benefit from these distributive effects. However, we are unable to
consider positive effects on small businesses for purposes of this
analysis.
D. Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 (Public Law 104-4),
requiring cost-benefit and other analyses, in section 1531(a) defines a
significant rule as ``a Federal mandate that may result in the
expenditure by State, local, and tribal governments in the aggregate,
or by the private sector, of $100,000,000 (adjusted annually for
inflation) in any 1 year.'' FDA has determined that this rule does not
constitute a significant rule under the Unfunded Mandates Reform Act.
XI. Paperwork Reduction Act of 1995
This proposed rule contains information collections that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). The
labeling requirements in this proposed rule cross-reference labeling
requirements in other regulations; therefore, FDA is not estimating the
burden of this proposed rule separately. The burden hours for 21 CFR
70.25 cross-referenced in Sec. Sec. 73.100(d)(1) and 73.2087(c)(1)
have been estimated and approved under OMB control number 0910-0016.
The burden hours for 21 CFR 101.4 cross-referenced in Sec.
73.100(d)(2) have been estimated and approved under OMB control number
0910-0381. The burden hours for Sec. 73.2087(c)(2) will be submitted
for OMB review and approval in a future submission for Sec. 701.3.
XII. Federalism
We have examined this proposal following the principles of
Executive Order 13132, ``Federalism.'' We have determined that a final
rule based on this proposal would not contain policies that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the different levels of government. We have
therefore concluded that, because it does not have implications for
federalism as defined in the Executive order, this proposal does not
need a summary impact statement on federalism.
[[Page 4851]]
XIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Identify comments with the docket number found in brackets in the
heading of this document. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
XIV. References
1. Sampson, H. A., The Journal of Allergy and Clinical
Immunology, vol. 103, number 5, part 1, pp. 717-728, 1999.
2. Lucas, C. D. and J. B. Hallagan, Advances in Food and
Nutrition Research, vol. 43, pp. 195-216, 2001.
3. Sampson, H. A., Allergy, vol. 53, pp. 125-130, 1998.
4. Sampson, H. A., Pediatrics, vol. 111, pp. 1601-1608, 2003.
5. Taylor, S. L., S. L. Hefle, C. Bindslev-Jensen, et al., The
Journal of Allergy and Clinical Immunology, vol. 109(1), pp. 24-30,
2002.
6. Sicherer S. H., E. H. Morrow, H. A. Sampson, Journal of
Allergy and Clinical Immunology, vol. 105(3), pp. 582-586, 2000.
7. Sarkany, I., R. H. Meara, and J. Everall, Transactions and
Annual Report of the St. John's Hospital Dermatological Society,
vol. 46, p. 39, 1961.
8. Park, G. R., Journal of the Royal Army Medical Corps
(London), vol. 127, pp. 85-86, 1981.
9. Beaudouin, E., G. Kanny, H. Lambert, et al., Annals of
Allergy, Asthma, & Immunology, vol. 74, pp. 427-430, 1995.
10. Wuthrich, B., M. K. Kagi, and W. Stucker, Allergy, vol. 52,
pp. 1133-1137, 1997.
11. Baldwin, J. L., A. H. Chou, and W. R. Solomon, Annals of
Allergy, Asthma, & Immunology, vol. 79, pp. 415-419, 1997.
12. DiCello, M. C., A. Myc, J. R. Baker, and J. L. Baldwin,
Allergy and Asthma Proceedings, vol. 20, pp. 377-382, 1999.
13. Chung, K., J. R. Baker, Jr., J. L. Baldwin, et al., Allergy,
vol. 56, pp. 73-77, 2001.
14. Quirce, S., M. Cuevas, J. M. Olaguibel, et al., Journal of
Allergy and Clinical Immunology, vol. 93, pp. 44-52, 1994.
15. Burge, P. S., I. M. O'Brien, M. G. Harris, et al., Clinical
Allergy, vol. 9, pp. 185-189, 1979.
16. Durham, S. R., B. J. Graneek, R. Hawkins, et al., Journal of
Allergy and Clinical Immunology, vol. 79, pp. 398-406, 1987.
17. Christiansen, M. L., G. Ahlbom, W. Frank, et al., European
Journal of Respiratory Diseases, vol. 62 (suppl. 113), pp. 82-83,
1981.
18. Dietemann-Molard, A., J. J. Braun, B. Sohier, et al.,
Lancet, vol. 338, pp. 460, 1991.
19. Letter from A. Halper, FDA to N. Bravo, Elf Sanofi, Inc.,
October 27, 1993.
20. U.S. Census Bureau (http://www.census.gov/prod/ec97/97m3117a.pdf
)
21. U.S. Census Bureau (http://www.census.gov/prod/ec97/97m3117b.pdf
)
22. U.S. Census Bureau http://www.census.gov/prod/ec97/97m3116b.pdf
23. U.S. Census Bureau (http://www.census.gov/prod/ec97/
97m3121f.pdf)
24. U.S. Census Bureau (http://www.census.gov/prod/ec97/97m3256d.pdf
)
25. U.S. Census Bureau (http://www.census.gov/prod/ec97/97m3118a.pdf
)
26. Goldman, S. A., D. L. Kennedy, D. J. Graham, et al., ``The
Clinical Impact of Adverse Event Reporting,'' MedWatch Continuing
Education Article, pp. 1-11, 1996.
27. Chyka, P. A. and S. W. McCommon, Drug Safety, vol. 23, pp.
87-93, 2000.
28. Rawlins, M. D. Journal of the Royal College of Physicians of
London, vol. 29, No. 1, January/February 1995.
29. Research Triangle Institute, ``Estimating the Value of
Consumers' Loss From Foods Violating the FD&C Act, vol. II,'' Final
Report, pp. G-11, G-22, September 1998.
30. Weighted National Estimates From HCUP Nationwide Inpatient
Sample (NIS), 1997, Agency for Healthcare Research and Quality
(AHRQ), based on data collected by individual States and provided to
AHRQ by the States, estimates found on HCUPnet at http://198.179.0.16/HCUPnet.asp
.
List of Subjects
21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
73 and 101 are proposed to be amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.
2. Section 73.100 is amended by revising paragraph (d) to read as
follows:
Sec. 73.100 Cochineal extract; carmine.
* * * * *
(d) Labeling requirements. (1) The label of the color additives and
any mixtures intended solely or in part for coloring purposes prepared
therefrom shall conform to the requirements of Sec. 70.25 of this
chapter.
(2) The label of food products intended for human use, including
butter, cheese, and ice cream, that contain cochineal extract or
carmine shall specifically declare the presence of the color additive
by listing its respective common or usual name, ``cochineal extract''
or ``carmine,'' in the statement of ingredients in accordance with
Sec. 101.4 of this chapter.
* * * * *
3. Section 73.2087 is amended by revising paragraph (c) to read as
follows:
Sec. 73.2087 Carmine.
* * * * *
(c) Labeling. (1) The color additive and any mixture prepared
therefrom intended solely or in part for coloring purposes shall bear,
in addition to any information required by law, labeling in accordance
with the provisions of Sec. 70.25 of this chapter.
(2) Cosmetics containing carmine that are not subject to the
requirements of Sec. 701.3 shall specifically declare the presence of
carmine prominently and conspicuously at least once in the labeling.
For example: ``Contains carmine as a color additive.''
* * * * *
PART 101--FOOD LABELING
5. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371; 42 U.S.C. 243, 264, 271.
6. Section 101.22 is amended by revising paragraph (k)(2) to read
as follows:
Sec. 101.22 Foods; labeling of spices, flavorings, colorings and
chemical preservatives.
* * * * *
(k)(2) Color additives not subject to certification, and not
otherwise required by applicable regulations in part 73 of this chapter
to be declared by their respective common or usual names, may be
declared as ``Artificial Color,'' ``Artificial Color Added,'' or
``Color Added'' (or by an equally informative term that makes clear
that a color additive has been used in the food). Alternatively, such
color additives may be declared as ``Colored with ------------'' or
``------------color,'' the blank to be filled in with the name of the
color additive listed in the applicable regulation in part 73 of this
chapter.
* * * * *
Dated: October 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-1104 Filed 1-27-06; 8:45 am]
BILLING CODE 4160-01-S