WASHINGTON — Bipartisan legislation introduced in the US Senate on May 19 would ensure hemp-derived CBD (cannabidiol) products are regulated by the Food and Drug Administration like other legal products used in dietary supplements, foods and beverages. The bill, the Hemp Access and Consumer Safety Act, was sponsored by Senator Ron Wyden of Oregon, Senator Rand Paul of Kentucky and Senator Jeff Merkley of Oregon.
“CBD products are legally being used and produced across the nation,” Mr. Wyden said. “Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone. It’s been more than two years since I worked with colleagues to have Congress legalize hemp and hemp-derived products. It’s long past time for the FDA to get with the program, for the sake of American consumers and farmers.”
In 2018, Congress passed the Agriculture Improvement Act, the current farm bill, a provision of which removed hemp from schedule I of the Controlled Substances Act. This legalized the production and sale of industrial hemp and hemp derivatives, including CBD.
But the FDA prohibits any new dietary ingredient, food or beverage from entering interstate commerce if it has been studied or approved as a drug, as was the case of CBD. The FDA earlier approved one drug, Epidolex, which contains a highly purified form of CBD, for the treatment of seizures associated with Lennox-Gastaut syndrome.
The FDA has the authority to exempt substances from this prohibition, but the agency has asserted it still has only a limited understanding of the safety profile of CBD and other cannabis-derived compounds.
The FDA has sought information and comments on CBD safety and regulation from stakeholders, and hopes were the agency eventually would define legal ways to use CBD in foods, beverages and dietary supplements. But progress has been slow, in good part because of demands placed on agency resources by the COVID-19 pandemic.
Recent FDA actions with regard to CBD largely have been limited to dispatching warning letters to companies making therapeutic claims for the substance. For instance, products using CBD as an ingredient have been promoted for treating pain for arthritis, alleviating cancer pain, improving functioning for consumers with Alzheimer’s, and even treating or preventing COVID-19.
It took one act of Congress to legalize the farming of hemp, and sponsors of the Hemp Access and Consumer Safety Act suggested it may take another act of Congress to clear the path for legal CBD use in food, dietary supplements, and beverages.
“Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement,” Dr. Paul said. “The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors and merchants.”
Mr. Merkley said, “Every day that the FDA drags its feet to update its CBD regulations, hemp farmers are left guessing about how their products will be regulated, and real economic gains for workers and business owners in Oregon and across the country are left on the table. Hemp-derived CBD products are already widely available, and we all need FDA to issue clear regulations for them just like they do for other foods, drinks and dietary supplements.”
The Hemp Access and Consumer Safety Act would allow hemp-derived CBD products to be lawfully used in dietary supplements, food and beverages under the Federal Food, Drug and Cosmetic Act. Sponsors said the bill would give priority to consumer safety, requiring manufacturers to comply with all existing federal regulations for products that contain CBD.
The bill also would ensure the products will be properly labeled. To that end, the bill said the Secretary of Health and Human Services may “establish labeling requirements for dietary supplements and food that contain hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp.”
Jeff Daulby, senior vice president of government affairs, Consumer Brands Association, said, “The CBA commends Senators Wyden, Paul and Merkley for shining a spotlight on a product that has been a catalyst for a conflicting patchwork of states laws and regulations. Consumer Brands has long advocated for a national regulatory framework for CBD that empowers FDA to establish smart, consistent regulations and gives them the resources they need. Today’s action is a first step in delivering these much-needed regulations for American consumers.”
Patrick Atagi, board chair, National Industrial Hemp Council, said, “Last year, nearly $15 billion in economic benefits were left out of the economy because CBD wasn’t regulated appropriately. If the FDA can’t act, Congress should fulfill its oversight role and pass this legislation.”