FDA Under Fire for Role in Lawsuit between GNC and Oregon Attorney General

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It may be Oregon Attorney General Ellen Rosenblum who filed a lawsuit against supplement retailer GNC last week, but now it’s FDA that’s coming under fire from industry trade associations for its role in the dispute.

On October 22, Rosenblum filed a lawsuit against GNC, alleging that the retailer violated Oregon’s Unlawful Trade Practices Act by selling products that contained the “illegal ingredients” picamilon and beta-methlyphenylethylamine (BMPEA) over the course of several years. The lawsuit alleges that both ingredients were “unapproved drugs that may not be lawfully sold in the United States as a dietary supplement,” and that GNC was aware of the ingredients’ illegal status.

GNC, however, believes the lawsuit is “without merit” and rejects the notion that GNC should have known these ingredients were not legal for use in dietary supplements during that time. The retailer says it stopped selling products containing picamilon and BMPEA upon learning FDA did not view them as legal dietary ingredients, but that notice of FDA’s stance came at the end or after the period of time described in the lawsuit (January 2013-June 2015 for picamilon; January 2013-May 2015 for BMPEA).

“Neither picamilon nor BMPEA were included in a previous FDA warning letter or other FDA notification,” says GNC, in a press release. “Further, GNC took action to remove BMPEA and picamilon products even though FDA did not raise any safety concerns with respect to these ingredients, and neither notice constituted a legally binding FDA action on the legal status of these ingredients.”

Although FDA had known about BMPEA adulteration in dietary supplements for more than a year, the agency first took action against the amphetamine-like stimulant in April 2015, when it sent warning letters to five companies that listed BMPEA as a dietary ingredient in dietary supplements. GNC says it did not receive direct notice from FDA concerning BMPEA, but still stopped selling products containing the ingredient when it indirectly learned of FDA’s stance.

Picamilon, an ingredient created by synthetically combining niacin with gamma-aminobutyric acid (GABA), is a different story. GNC claims it only learned of FDA’s stance on the ingredient when Rosenblum filed the suit last week, which has led some supplement industry trade associations to criticize FDA for failing to publicize its stance and for abdicating its authority.

CRN Calls Out FDA for Setting “Dangerous Precedent”

On Tuesday, the Council for Responsible Nutrition (CRN; Washington, DC) questioned FDA’s handling of the picamilon issue in a letter to Ted Elkin, deputy director for regulatory affairs, Center for Food Safety and Applied Nutrition, FDA. In particular, CRN criticized the agency for privately sharing its stance on picamilon with certain state attorneys general without making any public statements about the ingredient.

On September 28, Cara Welch, PhD, acting deputy director of the Division of Dietary Supplement Programs at FDA, wrote a signed declaration to certain state attorneys general, with the conclusion that picamilon “does not fit any of the dietary ingredient categories” under the law. But, to date, CRN says it is not aware of FDA ever communicating publicly about picamilon in any regard.

“Our difficulty here is with the provision of a declaration privately to a state law enforcement agency on an issue of law that has never been raised by FDA,” says Steve Mister, president and CEO, CRN. “CRN believes this sets a dangerous precedent regarding the cooperation between FDA and state law enforcement on matters of federal law not previously noticed to the industry.”

In his letter to FDA, Mister also expressed concern that “the lack of public notice deprived industry of the ability to participate in the regulatory process and does a disservice to an industry that is seeking to comply fully with the laws and regulations.”

Instead of privately sharing its stance with the attorney generals, Mister says FDA should have issued a warning letter explaining why picamilon is not a legal dietary ingredient after becoming aware of its presence on the marketplace. Or, Mister suggests, FDA could have “declared the products containing this ingredient adulterated under Section 402(f)(1)(B) as a new dietary ingredient (NDI) which requires notification.”

Mister also criticized FDA for “what appears to be an abdication of federal authority under the [Food, Drug, & Cosmetic Act] by FDA to state law enforcement.” He called on FDA to evaluate the efforts of state law enforcement agencies more closely when it comes to dietary supplements, and avoid providing testimony to state agencies for matters on which FDA has not publicly spoken.

“While we appreciate FDA’s use of enforcement discretion and the need to prioritize resources, we respectfully urge the agency to reconsider the use of declarations or other testimony in state actions to which it is not a party and where the industry could benefit from FDA’s direct engagement,” says Mister.

NPA Slams FDA for “Delegating Responsibility”

The Natural Products Association (NPA; Washington, D.C) was also quick to criticize FDA for failing to use its enforcement power to restrict picamilon when it became aware it was not a legal dietary ingredient and instead leaving it to the Oregon Attorney General to take action.

“FDA has both the authorities and tools in place to take action against harmful ingredients,” says Dan Fabricant, PhD, executive director and CEO, NPA. “It is concerning to us that FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”

Fabricant also pointed to FDA’s handling of BMPEA as an example of when the agency did take the appropriate step by issuing warning letters. He concluded that NPA would encourage a similar type of action in response to picamilon, rather than FDA “delegating its regulatory and enforcement authority to states.”

Read more:

FDA Finally Enforces against BMPEA, Sends Warning Letters

The Dietary Supplements Industry Won the Bayer Case, but Still Needs to Watch the FTC, Leaders Warn

Michael Crane
Associate Editor
Nutritional Outlook Magazine
michael.crane@ubm.com