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 Aadministrations 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 industrys 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.

There also remains the possibility the number of violations is inflated. Dietary supplements are not a separate category within the FDA. The FDA divides itself into six product-oriented centers. Some products are large enough to warrant their own category, like the Center for Drug Evaluation and Research (CDER), or the Center for Veterinary Medicine (CVM), which is the only category to regulate non-human products. Dietary supplements are currently regulated as food in the Center for Food Safety and Applied Nutrition (CFSAN). Under this products-oriented centers approach the FDA tracks seizures, recalls, 483s, warning letters and all other enforcement activities. This approach makes it difficult to determine what percentage a single product group within a center, like dietary supplements, contributes to compliance statistics.

A high number of violations may be the result of the size of the industry. CFSAN is one of the largest product centers. The FDA estimates consumers spend twenty-five cents of every dollar on FDA regulated products. CFSAN accounts for 75 percent of those purchases. The Center estimates it regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and more than $60 billion worth of cosmetics sold across state lines. Faced with a limited budget and personnel, it is not surprising CFSAN is a central focus given its relative size to other product centers. The more focus, the more compliance reports, which means it becomes easy to identify a product category as a big offender. Singling out one group within that category, however, remains much more difficult.

Violations by any measure stand only to increase under FSMA. The overarching aim of FSMA is to push responsibility for monitoring and maintaining safety solely from the shoulders of the FDA to industry itself. The dietary supplement industry will be particularly impacted by the proposed FSVP rule. The FSVP rule establishes one set of standards for finished dietary supplements and another for raw ingredients. The FSVP focus for both categories is on GMP compliance. It also provides the FDA authority to refuse entry to foreign shipments from facilities who cannot demonstrate compliance with GMPs. The rules abound with detail and specific standards, which will provide the FDA and plaintiffs plenty of material to ensure compliance with the new regulations. This background to the new rules requires strategic compliance over strict compliance.

No matter the true number of violations there is always more work to be done. Given the low-barriers to entry, the blind trust of imported raw dietary ingredients and the strong reliance structure/function claims the number of violations may be accurate. Regardless of what percentage of companies violate the rules GMPs require serious attention for all facilities. Contamination of products with potentially harmful pharmaceutical ingredients and pesticides erodes public trust. It also undermines trust with the FDA. Compliance activities, like properly screening for common hazards, present an immediate short-term cost, but are the front-line in protecting a brand and avoiding civil enforcement or penalties. Whether the number is 70 percent or 7 percent, a proactive compliance mindset must be built and maintained. 

Marc Sanchez is senior counsel and founder of Contract In-House Counsel and Consultants LLC.  He was recently named adjunct professor at Northeastern University where he will lecture on US FDA and International regulations and law.

See Sanchez's presentation at SupplySide West, "How FSMA Could Increase Food Industry Litigation," on Wednesday, Nov. 13 at 4:00 p.m.