CRN still awaits substantive response from FDA on citizen petition addressing agency’s drug preclusion policies

The Council for Responsible Nutrition (CRN, Washington, D.C.) has announced receipt of an interim response from the U.S. Food and Drug Administration (FDA) to the Council’s recent citizen petition requesting that the agency change the way it applies the drug preclusion clause to the Food, Drug, and Cosmetic Act (FD&C Act). The agency’s current approach has resulted in the retroactive determinations that ingredients such as beta-nicotinamide mononucleotide (NMN) and N-Acetyl Cysteine (NAC) are not dietary ingredients because of their prior investigation as a drug by pharmaceutical companies. This application of the drug preclusion clause, says CRN, disproportionately favors the pharmaceutical industry at the expense of dietary supplement companies that have invested significant time and resources into investigating the safety and efficacy of their ingredients.

The interim response, unfortunately, does not address CRN’s concerns. It merely informs them that FDA was unable to reach a decision by the 180-day deadline, but that the staff continues to evaluate the petition. In a press release, CRN expressed disappointment that FDA has not reached a decision, but remains optimistic that the agency is carefully evaluating the petition and has been receptive to industry’s concerns.

“We remain committed to helping the FDA understand how vital this issue is to our industry and public health, and how important it is to level the playing field between pharmaceutical companies and supplement manufacturers when it comes to creating incentives for innovating first-to-market products,” said Steve Mister, president and CEO of CRN, in a statement. “If the FDA is truly in favor of innovation, a thorough, if not timely, analysis and response to our petition, would be a great place to start. And if FDA continues to believe the current statute is unclear or lacking a balanced approach, we call on the agency to work with us and Congress to address these issues in legislation.”