Dietary supplement companies may violate the rules more frequently than other FDA regulated industries. At least this is the claim attributed to the director of the Food and Drug Aadministration’s Division of Dietary Supplement Program. In a recent interview Daniel Fabricant, Ph.D., stated 70 percent of dietary supplement companies violate Agency rules. The number is jarring when considering the broad range of companies regulated by the FDA. Fabricant pointed to the visible signs of non-compliance, recalls and adverse event reports from adulterated products, as proof of the industry’s compliance problems. Is it possible nearly three-quarters of the dietary supplement industry violate the regulations?
A wide range of violations are possible for the typical dietary supplement firm. Low-barriers to entry allow virtually anyone to start selling dietary supplements. Unlike medical devices or pharmaceuticals there are few substantial pre-market approval activities. New Dietary Ingredient applications or GRAS (generally recognized as safe) notifications/affirmations for new ingredients are not likely to cross the minds of entrepreneurs starting a new dietary supplement company. The regulations generally are an afterthought, in part because supplements are seen as all natural or as traditional home remedies. This combination alone can lead to new drug claims along with a laundry list of good manufacturing practices (GMPs) violations.
A culture of buying cheap foreign dietary ingredients also contributes to violations. Most dietary supplement companies not only neglect to consider the regulations before selling, but also overlook the risk of buying foreign dietary ingredients. On average, the recalls handled by my firm largely stem from foreign raw dietary ingredient tainted with active pharmaceutical ingredients (APIs) or pesticides. In some cases there are adverse events. In nearly every case a facility failed to implement GMPs to properly screen foreign raw ingredients before encapsulation and sale downstream. The culture of buying the cheapest is set for a paradigm shift, with a corresponding increase in the number of violations, as the Foreign Supplier Verification Program takes effect under the Food Safety Modernization Act (FSMA).
Labeling violations touch nearly every dietary supplement firm. Even the most cautious company will be affected by labeling violations. The nature of dietary supplements pushes the boundary on what claims a product can make. Structure/function claims offer a tantalizing way to gain marketability, but also present a common risk for litigation and warning letters. Structure/function claims are also the gateway for new products or traditional remedies to claim application to a wide range of symptoms and ailments. The FDA is pushing boundaries as well. An increasing number of warning letters cite Facebook comments or meta tags on websites. This broadening definition of what constitutes a label is increasing the number of cited violations.