WASHINGTON - Dietary supplement associations this week took exception with the Food and Drug Administration for declaring the ingredient picamilon an "illegal" dietary supplement ingredient in an declaration made available to state lawmakers in September. It wasn't the fact that FDA expressed a concern that picamilon was available on the market, however, it was the way the agency went about communicating the action without affording the industry an opportunity to weigh in.
"[The Council for Responsible Nutrition] believes there are substantial policy implications stemming from this declaration, not only for dietary supplements, but for other FDA-regulated products as well," warned CRN president and CEO Steven Mister in a letter to FDA sent Tuesday. "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 law and regulations," he wrote. "It undermines the supremacy of the [Food, Drug and Cosmetics Act] and the ability of FDA to implement and enforce that law. 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."
Acting Deputy Director of the Dietary Supplement Programs at the Food and Drug Administration Cara Welch wrote in a signed affidavit on Sept. 28 that picamilon “does not fit any of the dietary ingredient categories” under the law. That affidavit was distributed to lawmakers and led to an action by the Oregon Attorney General's office. The AG's office filed a lawsuit against GNC, for selling nutritional and dietary supplements containing what the AG defined as illegal ingredients - picamilon and BMPEA - based on testimony supplied by FDA. The lawsuit alleged that the company violated the Oregon Unlawful Trade Practices Act by misrepresenting certain products as lawful dietary supplements when they are actually unapproved drugs.
The action, specifically regarding picamilon, came as a surprise to industry, however, as the agency has not yet issued any warning letters or other public indication that picamilon should not be sold as a dietary supplement.
"FDA has never made any public statements with regard to picamilon: it has not released any warning letters to the companies marketing picamilon, issued any recall on this ingredient, or announced any consumer advisories on it," Mister noted. "In fact, we are not aware that FDA has ever communicated publicly about picamilon in any regard. Moreover, we are not aware that picamilon has been the source of any significant number of adverse event reports or any other signals that it may present a public health or safety concern. Rather, the matter of picamilon’s status as a new dietary ingredient, or even as a dietary ingredient at all, is purely a matter of legal interpretation deserving of due notice to industry," he wrote. "Given FDA’s position on so many other issues — that the public interest and FD&CA are best served by providing adequate notice to industry prior to beginning an enforcement action — it is difficult to understand how that interest is served here."
“The FDA has both the authorities and tools in place to take action against harmful ingredients,” stated Dan Fabricant, executive director and CEO of the Natural Products Association. “It is concerning to us that the FDA is delegating its responsibilities to the states instead of using its own enforcement authority. If the FDA finds an ingredient to violate the law, then it should take immediate administrative action, not use taxpayer dollars to fund a state priority.”