Litigation is now a mainstay of American business and the nutritional supplement industry is no exception. Because Integrated Biomolecule is frequently called upon as a technical expert in these matters, we get a unique view of the events leading up to the lawsuit.
As with any industry, some of these disputes result from the attempt by one party to take advantage of another. But our experience is that these instances are rare. Rather, most of the disputes we see involve well-intentioned parties, one or both of whom made an unintentional mistake. Sadly, these mistakes were easily avoidable, or once made, detectable and easily rectifiable early in the process with minimal consequences. Once a product is produced and shipped, the ramifications of a mistake can be enormous and more than one company has gone bankrupt as a result.
We can learn a lot from others’ misfortune. Since lawyers are busy enough, we describe below some guidelines to follow at various stages of a product’s production that were not observed by those who now regret it.
Guideline No. 1: Be knowledgeable about the material you handle.
It seems obvious that the first step in getting the product right is to know exactly what the product is. For example, when buying an automobile you don’t go to a dealer and say, “I’ll take a car.” Rather, you study the various makes, models and options to decide what you want and then you ask specifically for it. Nutritional supplement products are no different. Some in our industry consider supplement ingredients to be indistinguishable commodities, but they are not; they come in various makes, models and options, so you must be educated.
A simple example is with the androstenedione/diol family of products. There are nine compounds composing this group, so you have to know which of them you want. Saying, “I’ll take 100 kilos of andro,” gives you only a one in nine shot of getting the correct material. Even specifying “19-Nor” is not enough, since there are four of them. (Can’t you just see the litigation coming—you order 19-Nor, the supplier provides 19-Nor, everyone is acting in good faith yet the product is wrong and your customer won’t pay for it.)
For botanicals, the concentration of a marker compound can vary widely from lot to lot, so you must know the concentration you want. Botanical extracts come in various concentrations, so here again you need to know which is the right one.
A good example of the need to know is a dispute concerning a shipment of material labeled as glucosamine sulfate. True glucosamine sulfate, which is found naturally in the human body, is a single chemically bonded compound of glucosamine with a sulfate functional group. This compound is very expensive and as a result we are not aware of any supplement company selling it. Rather, what is sold is glucosamine as a sulfate salt, which is properly labeled as glucosamine sulfate salt. Lately, we are seeing a third form of this product, a dry mix of glucosamine sulfate salt with yet more salt in the form of potassium chloride or sodium chloride; this would correctly be labeled as glucosamine sulfate salt salt. In the salt salt form the actual level of glucosamine present is only about 50% by weight.
Some creative soul mixed glucosamine hydrochloride and potassium sulfate together and suggested that a chemical reaction occurred, resulting in glucosamine sulfate and potassium chloride (so he could make a glucosamine sulfate label claim). Wrong! (If these permutations caught you by surprise you’re not alone—we found a recognizable analytical lab that didn’t realize the differences.)
Here’s another common mistake. Chondroitin sulfate cannot exist on its own, but only associated with a metal ion salt (generally sodium or calcium). This salt plus unavoidable moisture generally constitutes between 8-20% of the product’s weight. So a 50 kilo drum of chondroitin sulfate does not contain 50 kilos of chondroitin sulfate at all, but at most 46 kilos and potentially a lot less, with the balance being salt and moisture. The salt and moisture content should be considered in the price of the material.
Once you have the correct raw materials of good quality, the next danger zone is the formulation process. While it sounds simple enough—mix the materials and put them in the finished form (tablets, capsules, etc.)—in fact it’s an exacting process subject to all of the dynamic rules of chemistry. Every ramification of the formulation process must be considered and accounted for or all sorts of problems may arise (to the lawyers’ delight).
A great example involves the chondroitin sulfate issue just described. You must know and compensate for the percentage of salt and moisture of the chondroitin sulfate used in manufacturing to achieve proper formulation. Providing 100 milligrams of material simply labeled “chondroitin sulfate” in each capsule will not achieve a label claim of 100 milligrams of chondroitin sulfate, since at best only 92 milligrams of that material is chondroitin sulfate, with the balance constituting salt and moisture.
Similar situations include the amount of a desired metal ion in a chelate. When using a true inorganic species such as zinc oxide to deliver zinc, it is fairly straightforward to determine the zinc content as a percentage of zinc oxide (which does not vary from lot to lot) and make the necessary over-adjustment for the oxide component. But chelates are not exact chemicals; they are associations of metal ions with a counter ion and by their very nature the percentage of the desired metal species varies from lot to lot. The only correct way to use this material is to determine the exact metal content for each and every lot used and make the appropriate adjustment in the formulation.
Interaction between ingredients could destroy an otherwise properly formulated product. A combined product of kava kava and valerian might look good on paper but wreak havoc in a capsule. The valerenic acid in valerian degrades the kavalactones in kava kava, so as time passes the kavalactone level decreases.
Everything going into a finished product must be carefully considered before production begins and this includes fillers and flow agents, which are routinely overlooked. Although they are ancillary materials to the finished product, fillers and flow agents are, nonetheless, chemical entities that affect the finished product. Learn from the encapsulator who added a filler of protein origin to a protein product and, low and behold, the product’s protein level greatly exceeded its label claim. In addition, the amino acid profile (the fundamental units that make up the protein) of the total protein in the capsule differed from the desired active protein, so you cannot verify that the original protein was even used in the formulation.
And there’s the formulator who added magnesium sterate (a common flow agent) to a mineral product and, voila, the product’s magnesium level went out of spec. The same happens frequently when calcium salt fillers are added to mineral products, thereby greatly exceeding the product’s calcium label claim.
Even the capsule material must be considered. For example, soft gel capsules are composed of gelatin, which is highly absorbent and can absorb components meant to remain inside the capsule. A test of only the contents of the capsule could result in a label claim deficiency.
Nutritional supplement ingredients should not be considered as commodity items like grain, but rather as chemical entities subject to specific characterization (referred to as specifications) and the dynamic rules of chemistry. The effects of these factors must be considered at all stages of a product’s production. As you can see from the above examples, the relevant information is easily understandable so you don’t need a Ph.D. in chemistry to participate in this business, but you do need to have that information. If you do not have the technical expertise in-house ask your analytical lab or other outside source for assistance. Too much is at stake to ignore this.
Guideline No. 2: Specify what you want.
Now that you know what you want you have to specify it. You wouldn’t sign a purchase agreement merely saying that you will pay $25,000 for a Ford, giving the dealer the option to deliver any old Ford for that price. Rather, you would specify the year, model, colors and options so you are sure you get exactly what you want. The same is true for supplement ingredients. With four versions of 19-Nor you better specify 19-Nor-4-androsten-3 b, 17b-diol if that’s what you want. Say you want the glucosamine sulfate salt and not the salt salt and that your chondroitin sulfate sodium salt must have a combined salt and moisture content of less that 10%.
Tell your encapsulator you want a list of everything (and we mean everything) that will go into the finished product and make sure nothing on the list will adversely affect the desired result.
Do your specifying in writing. Lawyers make a lot of money sorting through a “he said/she said” scenario and when there is a lack of proof the bad guy has the advantage.
Do not accept any product, whether a raw ingredient or finished product, without receiving a certificate of analysis for the lot in question. It is the material’s “ticket to admission” and your first line of defense. An acceptable certificate will detail the material’s specifications so you can determine if the material is what you want. In addition, the certificate will be invaluable in the event of a subsequent dispute.
Guideline No. 3: Testing (spend a little now or a lot more later).
As an analytical lab you knew one of our guidelines would be to test, but it is simply a step that can’t be skipped. The only way to be sure a material is what you want is to test it. Whether you test it in-house or by an outside lab is your call, but testing is an absolute necessity.
Sure, no one likes to spend money on testing, but we can’t count the number of times someone didn’t want to spend $155 on a test and instead is now responsible for a bottle run costing tens of thousands of dollars because of a deficient raw ingredient or other problem. Significant companies have vanished because of it. We can assure you that those who have made this mistake and survived have done so only once, so take note.
To recoup the cost of analysis of material you cannot use you could consider instituting a policy with your suppliers we sometimes refer to as “put up or pay up.” If you test a supplier’s product and it meets specifications, then everyone is happy. If, however, the product is substandard then your supplier reimburses you for the cost of analysis. This puts your suppliers on notice that they will be held accountable for selling deficient material.
And when you do test a product, first make sure the lab you use is competent and service-oriented. There is no point testing if the lab’s results are inaccurate or if the lab won’t stand behind you in times of crisis. Ask the lab how often they test the product in question and what method they use; if a lab refuses to disclose the method go elsewhere. Be sure the method and standards used have been properly validated (otherwise the test won’t be consistent from sample to sample). Be critical of the service and documentation you receive from the lab; if either is in a state if disarray, what do you think the lab looks like?
Also, make sure the sample you send for testing is representative of the lot in question. There are simple but routinely ignored procedures to follow to insure this. And please do not fall for the “pre-production sample bait and switch” routine we see too often, where we’re given a “primo” sample to test but the customer gets “junk” delivered to its warehouse. You must be sure the lab tests what you are buying.
One final note: be sure to retain a sample of all materials passing through your hands. It is only with a retained sample that you have the ability to exonerate yourself should someone downstream blame you for a problem.
So you see, the nutritional supplement business is not a commodity business where every product with the same name is identical, but more akin to the chemical business where all products have specifications that must be met and where this attainment must be demonstrated. In addition, these products are chemical entities and obey (for better or for worse) the dynamic rules of chemistry. If you want to get your supplement right and avoid disaster you must be fully familiar with the products you handle and take proactive steps to be sure that’s what you have on hand. NW
About the author:
Robert S. Green is the president of Integrated Biomolecule Corporation, a biotechnology company that conducts nutritional supplement ingredient and finished product testing and provides research, development, production and technical marketing services. He writes extensively as part of IBC’s mission to provide practical technical information to the supplement industry. He can be reached at 520-799-7566; Fax: 520-799-7562; E-mail: firstname.lastname@example.org; Website: www.integratedbiomolecule.com.