FDA Rejects Two Hemp Extract NDINs
Leading CBD companies Charlotte’s Web and Irwin Naturals submitted their nutritional dietary ingredient notifications (NDIDs) for full-spectrum hemp extracts to the Food and Drug Administration (FDA). The FDA rejected the notifications on the grounds of the drug-exclusion clause and the agency’s concern about safety substantiation.
FDA objected to two New Dietary Ingredient (NDI) notifications in July filed by industry-leading CBD companies Charlotte’s Web and Irwin Naturals. Both companies submitted their NDI notifications for full-spectrum hemp extracts, not CBD isolates. Despite this, the FDA rejected both notifications, citing a legal conflict with CBD isolate drug Epidiolex. The FDA also shared their concern over the substantiating scientific evidence the companies submitted with their NDI filings. In the FDA’s rejection letters to Charlotte’s Web and Irwin Naturals, the FDA stated that both companies’ full-spectrum hemp extracts “may not be marketed as or in a dietary supplement.”
In both letters, the FDA first cited the Food, Drug, and Cosmetic Act’s Investigational New Drug (IND) preclusion provision that states that articles first publicly studied as a pharmaceutical drug cannot be marketed as a dietary supplement. FDA’s ongoing argument has been that because GW Pharmaceuticals first studied and came to market with its Epidiolex drug, which is made from CBD isolate and not full-spectrum CBD, CBD is precluded from being sold as a dietary supplement ingredient.
FDA’s new objection letters make clear the agency is applying the preclusion clause to reject not only any CBD isolate ingredient as a supplement but also to object to full-spectrum CBD as a whole. Full-spectrum CBD not only contains CBD but also other constituents of the cannabis plant such as essential oils, terpenes, and other cannabinoids.
In early 2021, The Hemp Industries Association and dietary supplement industry trade groups, joined by major retail and farm organizations including the National Association of State Departments of Agriculture, united to express strong support for H.R. 841, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021. Passage of H.R. 841 would ensure that hemp-derived CBD and other non-intoxicating hemp ingredients could be lawfully marketed as dietary supplements. It would also require responsible product manufacturers to comply with the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), the existing comprehensive framework that regulates dietary supplements. This would assure consumers that the products they purchase are safe, properly labeled and manufactured in compliance with good manufacturing practices (GMPs) for dietary supplements.
The HIA’s strategic partner, the U.S. Hemp Roundtable issued a statement regarding the rejection letters stating that “The U.S. Hemp Roundtable is deeply disappointed to witness FDA’s rejection of two dietary ingredient notifications (NDINs) recently submitted for full spectrum hemp extracts. FDA’s actions send a discouraging message to the entire hemp and CBD industry, especially in light of the fact that these firms provided more than ample safety data and cooperated with FDA’s requests throughout the process.” You can read more of their statement HERE.
Additionally, the Council for Responsible Nutrition (CRN), a leading trade group for the dietary supplement and functional food sector, denounced the FDA’s rejection of Charlotte’s Web and Irwin Naturals NDID. In a statement from President & CEO Steve Mister, CNR said the following:
“CRN is extremely disappointed to learn that FDA rejected NDI notifications for full-spectrum hemp extract containing CBD submitted earlier this year by supplement manufacturers Charlotte’s Web and Irwin Naturals. Ultimately, it seems that the agency engaged these supplement companies in a months-long process unnecessarily.
“FDA has wrongly mischaracterized these products as the same article as a prescription drug and has ignored, dismissed, and downplayed ample evidence that these full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe. Meanwhile, the agency has done little to protect consumers from the unregulated marketplace it has created from more than two years of inaction.
“FDA continually asked the companies for meetings and safety data about their products containing full-spectrum hemp extract. After complying with FDA’s requests, these companies saw FDA reject their NDI notifications—disregarding published peer-reviewed toxicology studies and years’ worth of real-world safety evidence.”