By Sean Moloughney, Editor11.04.21
The U.S. FDA’s rejection of two New Dietary Ingredient Notifications for full-spectrum hemp extracts (FSHE) containing cannabidiol (CBD)—submitted by Charlotte’s Web and Irwin Naturals—effectively means it’s up to Congress to clarify what it intended with the passage of the 2018 Farm Bill.
Are hemp extracts off the table because CBD is an active ingredient in Epidiolex, a drug from GW Pharmaceuticals that FDA approved to treat seizures associated with rare and severe forms of epilepsy? Or can hemp extracts that contain CBD still be lawfully sold as dietary ingredients because they are distinctly different “articles” that do not impart the same pharmacological effect?
FDA’s position appears to be that all CBD is the same, which would mean that substantial clinical investigations by GW Pharma preclude the use of CBD in dietary supplements. However, according to Todd Harrison, a partner with Venable, a careful reading of the statutory definition of a “dietary supplement” under section 201(ff) of the Food, Drug, and Cosmetic Act (FDCA) suggests FDA’s position is contrary to Congressional intent.
“Congress intended to strike a balance between maintaining the incentive to develop new drugs while allowing access to dietary supplements that may contain a constituent that is the active moiety in the drug, but would not be expected to have the same pharmacological effect,” Harrison argued. “This interpretation is consistent with the Tenth Circuit’s decision in Pharmanex v. Shalala—the seminal case interpreting this provision of section 201(ff).”
According to Steve Mister, president and CEO of the Council for Responsible Nutrition, FDA has mischaracterized FSHE as the same article as Epidiolex “and has ignored, dismissed, and downplayed the ample evidence that these full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe. Epidiolex ... is a highly-concentrated CBD isolate that contains 10-times more CBD than either of the full-spectrum hemp ingredients and plainly is not the same ‘article’ supplement companies are producing.”
States like California, which recently legalized the sale of hemp-derived extracts like CBD in supplements, foods, and cosmetics, seem to agree. But a patchwork of inconsistent regulations state to state has created too much uncertainty and opportunities for rogue players to take advantage of consumers with low-quality, untested products.
It’s high time for Congress to clarify its intentions on this matter, and to legalize cannabis at the federal level, ending the demonization of a plant that has clear therapeutic benefits. Though legislation must protect small businesses and account for a tidal wave of national competitors.
Sean Moloughney has been the Editor of Nutraceuticals World since 2012. He can be reached at SMoloughney@RodmanMedia.com.
Are hemp extracts off the table because CBD is an active ingredient in Epidiolex, a drug from GW Pharmaceuticals that FDA approved to treat seizures associated with rare and severe forms of epilepsy? Or can hemp extracts that contain CBD still be lawfully sold as dietary ingredients because they are distinctly different “articles” that do not impart the same pharmacological effect?
FDA’s position appears to be that all CBD is the same, which would mean that substantial clinical investigations by GW Pharma preclude the use of CBD in dietary supplements. However, according to Todd Harrison, a partner with Venable, a careful reading of the statutory definition of a “dietary supplement” under section 201(ff) of the Food, Drug, and Cosmetic Act (FDCA) suggests FDA’s position is contrary to Congressional intent.
“Congress intended to strike a balance between maintaining the incentive to develop new drugs while allowing access to dietary supplements that may contain a constituent that is the active moiety in the drug, but would not be expected to have the same pharmacological effect,” Harrison argued. “This interpretation is consistent with the Tenth Circuit’s decision in Pharmanex v. Shalala—the seminal case interpreting this provision of section 201(ff).”
According to Steve Mister, president and CEO of the Council for Responsible Nutrition, FDA has mischaracterized FSHE as the same article as Epidiolex “and has ignored, dismissed, and downplayed the ample evidence that these full-spectrum hemp products can be marketed in a manner that is reasonably expected to be safe. Epidiolex ... is a highly-concentrated CBD isolate that contains 10-times more CBD than either of the full-spectrum hemp ingredients and plainly is not the same ‘article’ supplement companies are producing.”
States like California, which recently legalized the sale of hemp-derived extracts like CBD in supplements, foods, and cosmetics, seem to agree. But a patchwork of inconsistent regulations state to state has created too much uncertainty and opportunities for rogue players to take advantage of consumers with low-quality, untested products.
It’s high time for Congress to clarify its intentions on this matter, and to legalize cannabis at the federal level, ending the demonization of a plant that has clear therapeutic benefits. Though legislation must protect small businesses and account for a tidal wave of national competitors.
Sean Moloughney has been the Editor of Nutraceuticals World since 2012. He can be reached at SMoloughney@RodmanMedia.com.
