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70 Percent of Dietary Supplement Companies Violate FDA Regulations

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by Marc Sanchez -

Continued from page 1

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.

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