Wednesday 24 January 2018

Anonymous FDA Official: “70% of supplements companies violate agency rules”; Number Likely Inflated

A jarring headline this morning out of Long Island. Newsday (sub. required), a regional newspaper, quotes a US Food and Drug Administration official as saying “70% of [dietary] supplements violate agency rules. The article focuses on an interview with Dr. Daniel Fabricant, Ph.D. the director of FDA’s Division of Dietary Supplement Program. The quote however is not attributed to him, but to a “top agency official.” Food Court contacted Dr. Fabricant and the FDA Center for Food Safety and Applied Nutrition for comment. Specifically asking if the quote was a rough number or pulled from Establishment Inspection Reports, 483s and Warning Letters, or Recall database(s).  The figuring is surprising. The low barriers to entry for food and dietary supplement companies tend to lead to more issues when compared to drug or device. Still the number sounds on the high-end.

The figure is misleading and likely inflated for a number of reasons. 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 lumped together with food and cosmetics in the Center for Food Safety and Applied Nutrition (CFSAN). Under this products-oriented centers approach the FDA tracks seizures, recalls, 483s, warning letters – essentially all compliance activities. This approach makes it difficult to determine what percentage of a single product group within a center, like dietary supplements, contributes to compliance statistics. Take a look at the FDA’s 2012 Enforcement Statistics to gain a sense of how the approach can quickly inflate a category. In 2012  CFSAN seized the most products of any of the centers – 5 seizures versus 2 drug and 1 device. CFSAN issued the second most warning letters, beat only by the Center for Tobacco Products. CFSAN was also neck and neck with the Center for Biological Evaluation and Research and the center for devices in recalls, 2,615 (CBER), 2,475 (CDRH) and 2,464 (CFSAN). The examples go on to show CFSAN is a large category and as such gains a good deal of enforcement attention.

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% of those purchases. The Center estimates it regulates $417 billion worth of domestic food, $49 billion worth of imported foods, and over $60 billion worth of cosmetics sold across state lines. Faced with a limited budget and personnel, it’s not surprising CFSAN is heavily focused on 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 with that category, however, is much more difficult.

Compliance matters, but the Agency should provide a balanced view of what market segments routinely violate the regulations. Perpetuating a view one market segment flagrantly violates the rules risks creating a bias that could impact the Agency’s enforcement capabilities. It also creates a misconception on the behalf of consumers who rely on the Agency for accurate information about the products they consume.

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