Washington, DC—On May 19, Senators introduced the Hemp Access and Consumer Safety Act (S. 1698) which directs the U.S. Food and Drug Administration (FDA) to regulate hemp-derived cannabidiol (CBD) products as dietary ingredients or supplements. The National Consumers League (NCL) has long been concerned about the risks posed to consumers by unapproved cannabis-derived products. There is little research on the health and safety of CBD products, and as such the NCL does not support any legislation that would bypass the FDA’s regulatory authority and rigorous scientific review.
Currently, manufacturers and distributors of products containing CBD can petition the FDA for review and approval of a new ingredient as a dietary supplement (21 U.S.C. 350b). This approval process requires manufacturers and distributors to submit scientific data showing that the product is generally regarded as safe (GRAS). “Not only is there insufficient data to designate CBD products as GRAS, the FDA needs further data to determine safe dosage and concentration levels in order to set manufacturing and labeling requirements that ensure consumer safety,” said Jeanette Contreras, NCL Director of Health Policy.
As demonstrated in a white paper published by NCL, companies selling CBD products often focus their research efforts on weak and inexpensive studies, and then use the results for marketing purposes. “Current studies have not enhanced our scientific understanding of CBD, and policymakers should focus on incentivizing further clinical studies to bring new proven medical treatments to patients,” said Contreras. By mandating the FDA to regulate CBD as a dietary ingredient, S. 1698 would only further incentivize CBD manufacturers to forego rigorous clinical trials and the development of FDA-approved medicines. Easier approval as a dietary supplement will disincentivize real scientific research into any potential health benefits or risks of CBD products.
Under S. 1698, CBD manufacturers that make unwarranted claims of treating medical issues will seek expedited approval for their products as dietary supplements, rather than as drugs. We should be encouraging the development of new cannabis-derived medicines that have gone through the rigorous processes of randomized controlled trials and FDA approval. Considering the lack of existing research on CBD, this bill classifying CBD products as dietary supplements would irresponsibly lead to increased consumption of these products and limit the future development of cannabis-derived FDA approved treatments—while putting consumers at risk.
About the National Consumers League
The National Consumers League, founded in 1899, is America’s pioneer consumer organization. Our mission is to protect and promote social and economic justice for consumers and workers in the United States and abroad. For more information, visit www.nclnet.org.