The US Food and Drug Administration (FDA) announced through a consumer advisory on the danger of using a dietary supplement to treat concussions or traumatic brain injuries (TBI). The announcement follows a series of Warning Letters issued in 2012 and a new warning letter to Star Scientific of Virginia. There are two components to the FDA’s advisory – consumers should be weary of marketing claims about treating TBIs and some products may contain unapproved new dietary ingredients.
The first question tests the limits of what we are to believe a dietary supplement can do. The FDA continues to operate under what some may deem an antiquated notion of a dietary supplement. It follows the traditional model of vitamins, which would be naturally consumed in food sources for most individuals. A vitamin is intended to supplement the diet should the nutrient be missing from our daily meals. The market has exploded with new products, many of which see dietary supplements as natural or traditional remedies for a wide range of ailments. One litmus test for assessing whether a dietary supplement claim is marketable is to ask whether the condition it seeks to address is suitable to self-diagnosis and what are the risks if the self-diagnosis is incorrect. This is the litmus test the FDA used on Star Scientific and other companies marketing turmeric and Omega 3 dietary supplements to treat TBIs. The FDA concluded a concussion or other TBI is not prone to self diagnosis. A misdiagnosis or reliance on a dietary supplement in lieu of medical treatment could lead to serious complications and exacerbate the injury.
The challenge for industry in marketing dietary supplements is the push to make drug claims without gaining drug approval. There are some companies that legitimately seek a route to market for an herbal or traditional remedy. Other companies seek to enter the market either unaware of intentionally ignorant of marketing restrictions in the hope of slipping past FDA scrutiny. The FDA acknowledges in the consumer advisory products will slip through the cracks, “FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product registration, products making false claims can slip through, at least for a time.” Entering the market requires careful review of all desired claims for compliance with structure/function rules, nutrient content claim restrictions, FTC regulation, and substantiation. In the end it may mean the claims are less overt or watered down, but the cost of adverse events, such as injuries that lead to recalls, and managing warning letters, which will ultimately reign the claims in anyway, make the product stronger.
It is important to also note the role of new dietary ingredients. Star Scientific sought to add Antabloc to its supplement for TBIs. While marketing the dietary supplement it also sought an Investigational New Drug exemption for the ingredient. It is difficult if not impossible for an ingredient to be both a new drug and a dietary ingredient. It must be one or the other. This raises the point that all dietary ingredients must be assessed to determine whether they are Generally Recgonized as Safe (GRAS) or sold on the market prior to 1994 when the Dietary Supplement Health and Education Act was implemented.
Leave a comment