Throughout the last several years mainstream media, consumers and other “authorities” have lived under the perception that FDA has no regulatory authority over the dietary supplement industry. Unfortunately, this piece of misinformation is often quoted in articles, on TV shows and radio, and repeated ad nauseum by those ignorant to the Dietary Supplement Health Education Act (DSHEA) of 1994 and any of the subsequent legal rulings that place FDA in the specific position of authority over dietary supplements.

Nevertheless, as we know, bad news and misinformation can travel just as quick, if not quicker, as good news. And while PR companies offering a positive spin may provide some assistance in staving off the negativity, this isn’t the only solution. Research, in this day and age, is the only way forward.
Many dietary supplement firms start developing a product in “reverse order.” In other words, first a market need is identified (i.e., weight control) and then a formulator comes in to develop the product.

Once the product category is determined, the product type is discussed. This is where individual ingredients are selected due to their specific effects. In the case of weight control, for example, the desired ingredients may be chosen based on their ability to induce satiety or raise metabolic rate.

Once the product formulator has chosen the ideal ingredients, pricing and compatibility are considered. Next, the “claims” or intended use and population are defined. At this point, typically a scientist is brought in order to determine what prior published literature exists on the desired ingredients. This is where “third-party” reference data-also known as “borrowed science”-is sought and utilized. How third party publications can be supportive of ingredient selection should not to be overlooked or underestimated-many companies, very small and very large, use these resources to substantiate their products.

In deciding how to support a product in the marketplace, companies must understand the potential cost (i.e., risk) of not having a Product Specific Dossier (a dietary supplement version of a Product/Drug Master File). Some companies will engage a law firm, who will be responsible for vetting out supportive science and precedent case law. Most of the time, these law firms will outsource the science requests to doctorate level scientists or research firms to comb the peer-reviewed indexed science.

Sifting through the science that exists for specific ingredients will help companies identify common themes as well as weaknesses. Knowing the weaknesses will allow them to fill in the gaps with their own research. In turn, creating new, company-owned science will help grow a product’s intellectual property (IP).

Direct-owned science includes anything ranging from open label to proof of concept studies to full-blown randomized, double-blind, placebo-controlled clinical trials. The latter trials-especially when you have more than two well-designed, adequately powered studies-are usually the most supportive of a product and often carry more weight in the eyes of regulatory agencies.

FDA and FTC, along with industry trade associations such as the Council for Responsible Nutrition (CRN), the Natural Products Association (NPA), the American Herbal Products Association (AHPA) and the United Natural Products Alliance (UNPA) offer plenty of advice and information on all laws, rules and regulations companies need to follow with regard to making and marketing dietary supplements. Further, within the NIH is the Office of Dietary Supplements, which is very open to working with industry in terms of building the research and evidence for these products.

If your company is unsure of its position as it relates to product-specific portfolios (dossiers), consider consulting with a leading trade organization or utilizing any of the aforementioned ideas. The best offense is a strong defense. Your best defense is having direct-owned science (product-specific and ingredient-specific studies), coupled with prior published science.