Washington, D.C.—Senator Ron Wyden (D-OR) urged FDA to promptly issue guidance that ensures the regulatory pathway Congress intended for the lawful use of CBD as a food additive and a dietary supplement, according to a statement on Senator Wyden’s website.
In a letter to Alex Azar, secretary of the Department of Health and Human Services (HHS), and Ned Sharpless, acting commissioner of FDA, Wyden urged FDA to issue a formal enforcement discretion policy by August 1, 2019. He also requested that the agency initiate rulemaking to allow the manufacturing and sale of products containing hemp-derived CBD under existing statutory and regulatory frameworks. Wyden also, the statement says, expressed his support for FDA undertaking a process to find a safe level for CBD in foods and dietary supplements.
Wyden wrote in the letter: “I fully embrace FDA’s commitment to the promotion and protection of public health… I certainly acknowledge the challenges that FDA faces in expeditiously creating a legal pathway for hemp-derived CBD in foods and dietary supplements, especially since the agency has never used these rulemaking authorities before. However, I, and many in the CBD industry, find FDA’s indication that it may take three to five years to issue a final regulation authorizing the lawful use of hemp-derived CBD in foods and dietary supplements fully unacceptable. The regulatory confusion and uncertainty surrounding CBD cannot continue for that length of time.”
Michael McGuffin, president of the American Herbal Products Association (AHPA), said in a press release: “AHPA is extremely pleased to see Senator Wyden showing leadership in advocating for the Secretary of the HHS and the Commissioner of the FDA to move promptly to resolve the current regulatory uncertainty surrounding CBD. At the same time, the approach outlined by the Senator ensures that these agencies’ commitment to public health is fully maintained.”
The same day, the House of Representatives passed legislation that would appropriate $100,000 for FDA to perform a Health Hazard Evaluation and set a safe level of CBD for consumers to use each day, according to a press release from the Natural Products Association (NPA). The release notes that the process would follow the same precedent as red yeast rice, which allows a natural product to contain a level of a drug ingredient that the FDA has determined to be safe.
Daniel Fabricant, Ph.D., president and CEO of NPA, said in the release: “This is a promising new product that Americans are excited about, but science and public health concerns must always come first. NPA is leading this effort because we believe strongly in a clear and fair regulatory approach for all new ingredients.”