In the words of our “protectors” …

Good Cop, Bad Cop

D id you know that while you weren’t following the news, the FDA announced the creation of the Office of Dietary Supplement Programs (ODSP), elevating the program from its previous status as a division under the Office of Nutrition Labeling and Dietary Supplements? This means that the new office will have new and extensive policing powers, under the control of the FDA. It is interesting to note that the new acting director of the new office is a litigation lawyer rather than a doctor (PhD or MD).

All the Legal and Enforcement Tools

In the recent letter from Dan Fabricant, Executive Director and CEO of the Natural Products Association (NPA)—the nation’s largest and oldest nonprofit association dedicated to the natural products industry—the new commissioner of the FDA, Robert Califf, was asked what his plans are to use all of the legal tools at his disposal to enforce the laws and regulations related to the supplement industry.

Then Dr. Fabricant asked Califf if he was willing to collaborate with the Department of Justice (DOJ) to take up misdemeanor cases to deter unscrupulous companies selling adulterated or mislabeled supplements, which have traditionally flown under FDA’s radar because of their small size. Fabricant also asked Califf if he would be working to identify dietary ingredients found to be unsafe and remove them from the marketplace through the use of the 402(f)(1)(B) charge more frequently; and using all tools available, including mandatory recall authority, administrative detentions, and the use of seizures, in favor over injunction, as a method to more appropriate curb and deter adulteration and misbranding.

No Answers Yet

In the hearings leading to confirmation of the FDA’s new commissioner, Dr. Fabricant had asked, “Does Dr. Califf actually think that vitamin C should be regulated the same way as OxyContin?” OxyContin (oxycodone) is an opioid pain medication that is highly addictive. Addicts crush the pills and mainline oxycodone by injection.

Then Fabricant said, “Treating supplements like pharmaceuticals would raise production costs to a level that would limit consumers’ access to the supplements they take everyday. We are hopeful that Dr. Califf gets the opportunity to clarify his position during his confirmation hearing next week [he did not] … with the hope that we can work together in order to protect consumers and encourage the safe and effective use of dietary supplements and natural products.

Fighting Supplement Criminals and Protect Consumers

“It is and has been NPA’s position that the FDA should enforce the laws currently on the books to prevent criminals from tarnishing our industry. Given the FDA’s power and enforcement authority over the supplement industry, NPA is interested in hearing more about your plans to use all of the legal tools at your disposal, specifically.

Chief Enforcer for Three Years

“As the former head of the Dietary Supplement Division at the FDA from 2011-2014, I [Fabricant] oversaw more enforcement measures than in the entire decade before. Our first-hand experience tells that the aggressive pursuit of individuals and companies that sell misbranded or illegally manufactured supplements is the best approach to successfully overseeing the supplement industry. To that end, we are very interested in hearing your plans to take similar actions as FDA commissioner.

NPA’s Support for the New Office of Command

“NPA also strongly supported the elevation of the Division of Dietary Supplements at FDA to an Office. This is a long overdue step within FDA that we hope will empower the ODSP to exercise all the authorities it has to regulate this important industry. To that end, we are interested knowing when a strategic plan for the new office of dietary supplements will be developed and what the FDA anticipates its budget will be for FY 17. We would also like to express concerns regarding some of your past comments suggesting that the same standard in which pharmaceutical drugs are tested be applied to supplements. We would ask that you please clarify these comments, as such a drastic change in regulatory practice would not only significantly increase the cost it takes to produce, manufacture and sell supplements, but also limit consumers’ access to millions of supplements that are taken safely each and everyday.

“At your earliest convenience we would welcome the opportunity to sit down in person with you and your staff to discuss these important issues in greater detail. We look forward to having a constructive dialogue that furthers our shared interests in protecting American consumers, including the millions of those who safely use dietary supplements everyday.”

The meeting has not yet occurred. There has been no clarification.

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