The petition requests that FDA either:
- Determine that CBD is not excluded from the definition of a dietary supplement, allowing the Commissioner to exercise enforcement discretion in cases where an ingredient has undergone the premarket safety review of a new dietary ingredient notification (NDIN), or
- Recommend that the Secretary of Health and Human Services issue a regulation after notice comment, finding that CBD would be lawful.
Four years ago, the Farm Bill legalized CBD. In that time, the press release notes 36 U.S. states have established regulatory standards and the European Union has decided on an interim level for CBD consumption. Plus, the U.K.’s Food Standards Agency has spent months ascertaining the safety of many CBD products on the market, and is set to release a list of legal products.
Related: Senate Confirms Califf as FDA Commissioner U.K. Set to Release List of CBD Products Permitted for Sale Associations Submit Comments on FDA’s Tentative Response to NAC Petitions“While we wait for a broader regulatory path for CBD, today’s action by NPA paves the way for the agency to review individual products and render an opinion on a case-by-case basis,” says Daniel Fabricant, Ph.D., President and CEO of NPA. “Both issues surrounding NAC and CBD are glaring examples of the FDA fundamentally failing consumers and industry. Today’s citizen’s petition positions NPA to have all options available and will ensure CBD’s regulatory uncertainty is rectified.”