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The Need for Substantiation in the Sports Nutrition Category

Players in the dietary supplement sports nutrition sector must take heed when making product claims to ensure they comply with FDA and FTC regulations.

The dietary supplement industry appears to have been put on notice from one regulatory agency that seems to be willing to go somewhere with industry that has far-reaching implications. As you may know, the current administration is vastly different than the last two in how regulations are enforced, interpreted and perhaps on some level, created. In general, FTC regulates the marketing of products within the United States. One such category that falls under this jurisdiction is marketing and marketing methods. How a product is advertised, what is said about the product directly, indirectly or otherwise all falls under FTC. The agency is partially funded through the sanctions that are agreed to or by court order. FDA, comparatively, regulates many industries including foods, food additives, dietary supplements, beverages and, of course, prescription medications. FDA further regulates certain aspects of marketing of any product in the free market that is deemed by FDA to be in violation of a particular act, rule or law.

FTC previously appeared to define what it is looking for in research or support for a product. It noted in the Nestle and Iovate consent decrees that an adequate and well-controlled human clinical study “means a human clinical study conducted by persons qualified by training and experience to conduct such study. Such study shall be randomized, and, unless it can be demonstrated that blinding or placebo control cannot be effectively or ethically implemented given the nature of the intervention, shall be double blind and placebo-controlled." For the first time (perhaps since 1994), FTC had given a clear definition of what it is looking for in product substantiation studies. Of note, FTC first defined what it thought substantiation meant—a re-affirmation statement—in 1983.

Newer FTC actions and activities coupled with litigation have once again opened the discussion of “substantiation." These later rulings have, in essence, held that perhaps only one single study is enough to be substantiation, whereas the definition of just whom or what constitutes an “expert" has also come under fire. In fact, the question has also been raised as to how many experts are needed for a company to believe their evidence and marketing is substantiated. This underscores the importance of two things. First, prospective research on finished products will always be needed; and second, just what constitutes enough evidence or optimal design or adequate number of studies or just who the expert is must be better defined.

The cost of research is always lower than the cost of legal help after one receives a query from FDA or FTC or both as well as any type of legal query (civil, state, federal, etc.). Pharmaceutical companies typically allocate 10 to 12 percent of their marketing budget to research and development (R&D). Dietary supplement companies may wish to start looking into this coupled with IRS State and Federal “R&D Tax Credits" as a means to afford to have an aggressive controlled research program.

In the world of dietary supplements—whether positioned in the sports nutrition catalog or not, research is needed related to substantiation for claims. And the type of research that is typical and sorely needed for growing the sector is human intervention trials designed to determine whether a product has an effect (ergogenic for example) and to support the marketing platform. Having sponsored research on a finished product also strengthens the intellectual property (IP) portfolio, which affects company valuation. This is all connected and can be driven by the R&D program.

Recently, FTC had asked for public comment on the topic of substantiation. The agency’s current working definition of competent and reliable science is:

1. at least two adequate and well-controlled human clinical studies,

2. of the product at issue or substantially similar product,

3. conducted by different experts independently of each other,

4. that conform to acceptable designs and protocols and whose results, when considered in light of the entire body of relevant and reliable scientific evidence, are sufficient to substantiate the health claim.

This also brings up what is known as the “reasonable basis doctrine." This appears to be central to understanding what the average consumer would reasonably take away from a claim. The reasonable basis doctrine also states that the substantiation be accumulated before the advertisement is placed. This may or may not be common practice, but it is good to be aware of.

Douglas Kalman, Ph.D., has been involved in more than 200 clinical trials and projects within the pharmaceutical, medical and nutrition fields. He has published more than 75 abstracts and more than 30 peer-reviewed manuscripts. He is also a co-editor of one journal (JISSN) and on the editorial board of three scientific journals. Kalman received his undergraduate degree from Florida State University, master’s degree from Hunter College - City University of New York and doctorate in exercise and nutritional biochemistry (Health Research) from Touro University International. He is an active member and/or spokesperson with many organizations (ISSN, NSCA, APS, ACSM, etc.) and a co-founder of The International Society of Sports Nutrition (ISSN).

Looking for more information on Sports Nutrition Substantiation?

Douglas Kalman, Ph.D., will speak on “Science and Substantiation in Sports Nutrition" as part of the Sports Nutrition Workshop at SupplySide West. The three-hour workshop will take place on Friday, Oct. 9, at Mandalay Bay in Las Vegas. Visit http://west.supplysideshow.com/workshops.aspx for the complete agenda and to get registered.

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