U.S. Food Drug Administration Cosmetics Compliance Program
Cosmetics Compliance Program
CHAPTER 29 - COSMETICS AND COLOR TECHNOLOGY
|DOMESTIC COSMETICS PROGRAM (FY 00/01/02)||IMPLEMENTATION DATE: UPON RECEIPT|
COMPLETION DATE: 9/30/02
|PRODUCT CODES: Industry Code 53|
PRODUCT ASSIGNMENT CODE: 29001
Completed questionnaire should be mailed or faxed to:
Brenda K. Aloi
Food and Drug Administration/CFSAN
Domestic Cosmetics Monitor
HFS-636, Rm. 5113
200 C Street, S.W.
Phone (202) 205-8168, FAX (202) 205-9670
Report all analyses into the Field Accomplishment and Compliance Tracking System using the following Problem Area Flags for the various types of analyses.
Microbiological Analyses - MIC
Color Additive Analyses - COL
Label Reviews - FDF (Result Flag = FDL)
*Conduct inspections only at firms manufacturing or repacking eye area cosmetics and skin care preparations and lotions. These products present the greatest potential health hazard if they become contaminated with bacteria. The questionnaire on bovine-derived tissue (Attachment B) applies to all cosmetic products being manufactured or imported by the firm being inspected and is not limited solely to eye area cosmetics and skin care preparations and lotions.*
Collect samples for color analysis, prohibited ingredients, or label reviews on a compliance basis only.
Do not report inspections, sample collections or analyses of drug products under this program.
Cosmetics are defined in the Food, Drug, and Cosmetic Act as articles intended to be applied to, or introduced into, the human body for cleansing, beautifying, promoting attractiveness or altering the appearance without affecting the body's structure or function. Articles intended for use as components of cosmetic products are also considered cosmetics. Soap meeting the parameter of 21 CFR 701.20(a)(1) and (a)(2), is excluded from the term "cosmetic".
Some products perceived by consumers to be cosmetics may also be drugs if they are intended to cure, mitigate, treat or prevent disease, or to affect the structure or any function of the human body. These products usually make drug as well as cosmetic claims. Typical examples are: antiperspirant/deodorant products, sunscreen/suntan products, toothpaste/fluoridated toothpastes, and medicated cosmetics. Except for sunscreen/suntan products containing octyl dimethyl PABA and a nitrostating agent such as 2-bromo-2-nitro-1, 3-propanediol (BronopolTM), sunscreen/suntan products are not covered under this program.
It has been estimated that consumer expenditures for cosmetics exceed *35 billion* dollars annually. It is further estimated that the marketed cosmetics are being produced in more than 1400 domestic manufacturing and repacking establishments and represent more than 25,000 product formulations. About *10,500* different cosmetic ingredients and a similar number of fragrance ingredients are being used by the cosmetic industry.
In recent years, there have been several recalls of cosmetic products contaminated with pathogenic microorganisms or containing non-permitted color additives.
Refer to the Division of Emergency and Investigational Operations (DEIO) Guide to Inspections of Cosmetic Product Manufacturers; February 1995 (hereinafter referred to as the DEIO inspection guide) for discussions of problems of current interest.
PROGRAM MANAGEMENT INSTRUCTIONS
Any inspection under this Compliance Program must:
Criteria for selecting firms to inspect are listed below in order of relative priority.
Coverage of Bovine-Derived Ingredients for Bovine Spongiform Encephalopathy (BSE)
By letter dated May 9, 1996 (ATTACHMENT C), FDA recommended that firms that manufacture or import cosmetic products and their ingredients containing specific bovine tissues, including extracts or substances derived from such tissues, take whatever steps necessary to assure themselves that such ingredients do not come from cattle born, raised, or slaughtered in countries where bovine spongiform encephalopathy (BSE) exists. BSE is a fatal transmissible spongiform encephalopathy similar to Creutzfeldt-Jakob disease in humans. BSE continues to be prevalent in Great Britain (including Northern Ireland and the Falklands), Belgium, Luxenbourg, the Netherlands, France, Switzerland, Republic of Ireland, Oman, and Portugal. This list of BSE countries is subject to change. Refer to I.A. #17-04 for the most up-to-date list.
Immediate and concrete steps should be taken by manufacturers to reduce the potential risk of human exposure to, or transmission of, the agent which causes BSE in cattle.
Manufacturers and importers of cosmetic products and their ingredients should have planned, systematic procedures in place to provide assurances to themselves and to consumers that bovine-derived tissues do not come from cattle in countries where BSE occurs. Inspections under this compliance program will include completion of the questionnaire (ATTACHMENT B) to determine whether the firm being inspected is aware of our concerns about the transmission of BSE as outlined in the May 9, 1996 letter, and whether the firm has procedures in place to provide assurance that bovine-derived tissues do not come from countries where BSE exists.
NOTE: The list of tissues contained in the Agency's 5/9/96 letter has been expanded (ATTACHMENT A) to include additional bovine tissue or tissue-derived ingredients with a suspected risk of infectivity. The tissues and tissue derived-ingredients marked with asterisks are considered to present the highest risk of infectivity (hereinafter referred to as high risk tissues).
The following instructions apply to the inspections performed under this Program. Refer to the DEIO inspection guide for additional instructions.
Upon completion, the questionnaire (Attachment B) must be mailed or faxed to the Domestic Cosmetics Monitor at the address listed on Page 1 of this compliance program.
Currently, BSE is prevalent in the following countries:
Great Britain (including Northern Ireland and the Falklands), France, *Belgium, Luxembourg, Netherlands,* Republic of Ireland, Oman, Switzerland, and Portugal.
This list is subject to change, and investigators must refer to I.A. #17-04 for current information prior to conducting each inspection.
As indicated in item (3) above, the origin of all bovine tissue and tissue-derived ingredients used by the firm and the products containing them will be collected and noted on Attachment B.
Additional documentation in the EIR as outlined below is required only when a firm is manufacturing or importing cosmetic products or their ingredients using high risk bovine tissue or tissue-derived ingredients from any country listed on I.A. #17-04. High risk tissues and tissue-derived ingredients are identified by asterisks on Attachment A.
The following items should be included in the EIR *and a documentary sample should be collected* for possible regulatory consideration: (1) the high risk tissue or tissue-derived ingredient being used; (2) the finished product(s) containing the high risk ingredient; (3) the specific country of origin; (4) the name and address of the importer or other responsible party; and *(5) the entry number assigned by U.S. Customs.*
NOTE: Due to the termination of its provisional listing, FD&C Red #3 (and its lakes) are not permitted in cosmetics manufactured on/or after January 29, 1990.
The following certified color additives have recently been approved for coloring eye-area cosmetics:
|Color||Effective Date||21 CFR Cite|
|FD&C Blue #1 and Aluminum Lake||March 19, 1994||74.2101|
|D&C Green #5||September 12, 1994||74.2205|
|FD&C Red #40 and Aluminum Lake||March 19, 1994||74.2340|
|FD&C Yellow #5 and Aluminum Lake||December 30, 1994||74.2705|
In determining whether non-permitted color additives are being used, it is important to note that a label declaration of, for example, "C.I. 45410" or Phloxine B (common designations for a color additive which is certifiable as D&C Red No. 28), is NOT synonymous with a certified lot of the color additive. Furthermore, laboratory analysis of a cosmetic cannot be used to determine whether a lot of color used was certified.
With respect to individual colors subject to certification, investigators should document instances where bulk color additive ingredients used in cosmetics (other than those used in hair dye products) are not labeled with the appropriate color additive nomenclature found at 21 CFR section 74 and 82 and/or do not contain appropriate FDA certification lot numbers on the labels of the bulk color additive. In the case of color additive mixtures, the label should declare a control number that can be traced to the FDA certification lot numbers of the colors present in the mixture. This control number should be documented for verification.
"Warning--This product does not contain a sunscreen and does not protect against sunburn. Repeated exposure of unprotected skin while tanning may increase the risk of skin aging, skin cancer, and other harmful effects to the skin, even if you do not burn."
If cosmetic ingredients derived from imported animal products are encountered, determine the source country and report findings for appropriate follow-up by U.S.D.A. (See Import Alert 17-03.)
The significance of the investigators' findings will be determined on a case-by-case basis. Contact the Division of Enforcement and Programs (DOEP) at (202) 205-5235 to discuss the findings and appropriate follow-up which may include documenting findings in the EIR and sending a copy to DOEP for review.
Before following up on any complaint, contact the Complaint Coordinator, Cosmetics Programs and Regulations Branch (HFS-106) on (202) 205-4706. If the Branch cannot be reached (e.g., because the complaint is received after hours) and the adverse reaction is serious, initiate follow-up immediately and contact the Branch as soon as possible.
Record on FD-2516 all complaints regarding cosmetics. See current IOM Subchapters 925 and 926 for guidance. See PART IV, consumer complaint sample analysis.
Submit samples to the District servicing laboratory or specialized Headquarters laboratory as appropriate to conduct the intended analysis as indicated in PART IV, A.
The following analysis will be performed on a compliance basis only:
General microbiological analysis and speciation of gram negative bacteria will be performed by the District's customary microbiological servicing laboratory. (See Appendix III of the current ORA Workplan for a listing of servicing laboratories.)
NOTE: Identification of yeast and mold isolates will be done by the Microanalytical Branch, Division of Natural Products, CFSAN (HFS-315).
NOTE: Initial analysis may be accomplished by the servicing District laboratory. Either the original or check analysis for any potentially violative sample must be done by an experienced color analyst. *Contact ORA/Division of Field Science (HFC-141) at (301) 827-7605 with questions regarding servicing laboratories and analyses.*
CFSAN's Color Technology Branch (HFS-126) (202) 205-0291, is available to advise the district servicing laboratory on analyses involving difficult color samples.
All servicing District laboratories will conduct label reviews for declaration of ingredients, warning statements, and directions for use as required by 21 CFR Part 700.
The following analysis will be performed on a compliance basis:
Identification of Yeasts and Molds - Microanalytical Branch (HFS-315) will conduct analyses. See instructions below for preparing isolates for shipment to HFS-315.
The following analyses will be performed by CFSAN/Division of Science and Applied Technology, Office of Cosmetics and Colors (HFS-125):
Determination of Toxicity
Consumer Complaint Sample Analysis
Refer to Bacteriological Analytical Manual, *8A Edition 1998*, Chapter 23 or later edition for methods to determine microbial contamination of cosmetics.
All Gram-positive microorganisms present in cosmetic products at levels greater than 500 colony forming units (CFU) per gram for eye area cosmetics or 1000 CFU per gram for non-eye area cosmetics are to be identified according to the methods in the Bacteriological Analytical Manual, *8A Edition 1998*, Chapter 23 or later edition.
All Gram-negative isolates from cosmetic products are to be identified at any level as to genus and species.
Identification of yeast and mold isolates will be conducted by the Division of Microanalytical Evaluations/CFSAN (HFS-315).
Prepare cultures for forwarding and further classification as follows:
All determinations of color additives in cosmetic products will be performed in accordance with the instructions contained in Newburger's Manual of Cosmetic Analysis, 2nd Edition, Chapter 19; Determination of Color in Cosmetics, published by AOAC 1977. For additional color additive analytical instructions refer to the AOAC 15th or 16th Editions, Chapter 46. See also compliance program 7303.803 (Domestic Food Safety; Attachment C, Analytical Guidance); or 7309.006 (Imported Foods - Food and Color Additives; Part IV).
Determine whether proper labeling practices are followed. See 21 CFR 701 and 740.
Report analytical results into FACTS using the following Problem Area Flags (PAF):
Samples submitted by the Field to specialized laboratories are analyzed as follows:
The Microanalytical Branch (HFS-315) will identify submitted yeast and mold isolates.
The Division of Science and Applied Technology, Cosmetics Technology Branch (HFS-127) will analyze cosmetic products for prohibited or other potentially harmful ingredients or contaminants.
The Division Science and Applied Technology, Color Technology Branch (HFS-126) will conduct color additive analyses on samples of cosmetic products not amenable to the typical analytical methods.
The Division of Science and Applied Technology, Cosmetics Toxicology Branch (HFS-128) will determine topical toxicity or the potential for systemic toxicity as requested by the Division of Programs and Enforcement Policy (HFS-105).
The Division of Science and Applied Technology, Cosmetics Technology Branch (HFS-127) will perform chemical analyses and direct the other analytical activities required in the investigation of consumer complaints.
The Division of Programs and Enforcement Policy (HFS-105) will provide assistance for determining violations of cosmetic labeling requirements.
The absence of procedures to preclude use of bovine tissue from known BSE-countries, is not by itself a sufficient basis for a regulatory recommendation.
Attachment A--Bovine Tissue and Tissue-Derived Ingredients
Attachment B--Questionnaire on Bovine Tissue and Tissue-Derived Ingredients
Attachment C--Agency's May 6, 1996 Letter
During the course of this program, the Office of Cosmetics and Colors will monitor and evaluate the progress and results of the field operations conducted under this program.
The Director, Office of Cosmetics and Colors, will prepare a yearly written evaluation of this program and submit it to the Director, Division of Enforcement and Programs (HFS-605) by April 1, for the previously completed fiscal year.
MATERIALS WITH SUSPECTED RISK OF INFECTIVITY
Basal ganglia/basal ganglion
Colon (proximal and distal)**
Elastin (source: oxen neck ligaments)
Galactosylcerebroside (sulfate ester)
Intercellular Lipids (ICL's)
Olfactory bulb or gland**
Pancreas (including pancreatin)
Thymus gland (sweet-bread)
**Considered high risk for infectivity. If any of these tissues are obtained from known BSE countries, refer to Part III, Page 2 of the compliance program for additional information to be obtained for possible regulatory follow-up.
|Inspecting District:||Date of Inspection:|
|Firm Name and Address
||Central File Number:|
|Does the firm manufacture or import products containing bovine tissue or tissue-derived ingredients?
If the answer is no, do not complete the remainder of questionnaire. Give firm management a copy of the Agency's 5/6/96 letter (Attachment C) for future reference and mail or fax the questionnaire to CFSAN as instructed on page 2.
Indicate the origin(s) of the bovine tissue or tissue-derived ingredients used by the firm. Domestic____
If import origin, list below the country(ies) of origin.
Note: Investigators must refer to I.A. #17-04 for an up-to-date list of BSE-countries. If one of the countries listed on I.A. #17-04 is the country of origin, refer to Part III of the compliance program (7329.001) for guidance on documentation for possible regulatory follow-up.
|Product Name (Including Any Brand Name(s) Used)||Specific Bovine-Derived Material in Product|
TO MANUFACTURERS AND IMPORTERS OF COSMETICS:
As the media have widely reported, the British government announced on March 20, 1996, that new information had been gathered about bovine spongiform encephalopathy (BSE) in cattle that suggests a possible relationship between BSE and ten cases of a newly identified form of Creutzfeldt-Jakob disease (CJD), a similar fatal transmissible spongiform encephalopathy (TSE), in humans. To serve our mutual interest in protecting public health, the Food and Drug Administration (FDA) believes it is prudent to reiterate concerns we have previously expressed on this issue.
BSE is an infectious neurologic disorder of cattle and is prevalent in certain parts of the world. BSE has never been diagnosed in cattle in the United States. It is believed that the rapid spread of BSE in cattle in some countries, particularly Great Britain, was caused by the feeding of certain infected cattle and sheep tissues to cattle. While transmission of the causative agent of BSE to humans has not been definitively documented to date, inter-species transfer has been demonstrated (e.g., mice can be infected by exposure to infected bovine tissues). Recent developments in Great Britain raise serious questions regarding potential hazards of the use of animal tissues containing the causative agent of BSE.
We strongly recommend that firms manufacturing or importing cosmetic products which contain specific bovine tissues (see appendix A), including extracts or substances derived from such tissues, take whatever steps are necessary to assure themselves and the public that such ingredients do not come from cattle born, raised, or slaughtered in countries where BSE exists. FDA believes that immediate and concrete steps should be taken by manufacturers to reduce the potential risk of human exposure to, or transmission of, the infectious agent which causes BSE in cattle.
The list of countries where BSE is known to exist is maintained by the U.S. Department of Agriculture (USDA) and codified in Title 9, Code of Federal Regulations, Part 94.18. A current list of these countries follows:
Great Britain (including Northern Ireland and the Falklands)
Republic of Ireland
A range of research projects into the exact nature of both the BSE agent and other TSE agents is ongoing. Available scientific information indicates that these agents are extremely resistant to inactivation by normal disinfection or sterilization procedures.
The cosmetic industry has historically been a user of bovine-derived raw materials. These materials include extracts of bovine organs, including brain, placenta, liver, thymus, heart, mammary gland, marrow, ovary and spleen, as well as ingredients derived from animal tissues such as glycosaminoglycans, bovine lipids, proteins, amino acids, and most recently, sphingolipids isolated from central nervous system tissue.
The information that is currently available suggests that exposure of healthy, intact skin with BSE infectious agent represents an unlikely route of infection. Nevertheless, some ingredients used in cosmetics are derived from tissues that are considered highly infectious, and, if obtained from infected animals, may contain the BSE infectious agent. The possibility of infection cannot be completely ruled out, especially if exposure occurs with abraded or damaged skin or from contact of the infectious agent with the eyes or through ingestion.
Although there is still no definitive evidence that the use of bovine tissues that contain the infectious agent for BSE causes CJD in humans, FDA is concerned that appropriate measures to eliminate the use of bovine tissues from BSE-countries be instituted industry-wide.
At a future date, we will contact you with guidance on how best to provide assurance that your products do not contain potentially BSE-infected materials.
We appreciate your attention to and cooperation in this matter. If you need more information, please contact Dr. Elisa Elliot by phone at (202) 205-5140.
Michael A. Friedman, M.D.
Deputy Commissioner for Operations
Category I (High infectivity)
Category II (Medium infectivity)
Category III (Low infectivity)
List taken from Report of a WHO Consultation on Public Health Issues Related to Animal and Human Spongiform Encephalopathies, World Health Organization, Office of International Epizootics, Geneva, Switzerland, November 12-14, 1991.
Hypertext updated by bxm/dav 2001-APR-26