U.S. Senators Ron Wyden (D-Ore.), Rand Paul (R-Ky.), and Jeff Merkley (D-Ore.) have introduced legislation to ensure hemp-derived CBD products are regulated by the U.S. FDA like other legal products used in dietary supplements, food, and beverage.
Currently, the Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food, or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition, but has yet to exempt hemp-derived CBD despite Congressional action to legalize its production and sale, according to Sen. Wyden.
“CBD products are legally being used and produced across the nation. Yet because the FDA has failed to update its regulations, consumers and producers remain in a regulatory gray zone,” Wyden said in a statement. “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.”
If passed, the Hemp Access and Consumer Safety Act would give hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act. In addition, the act would prioritize consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD and ensure that these products are properly labeled.
“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,” said Merkley, in a statement. “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.”
Jeni Lamb Rogers, attorney at PSL Law Group, told SFA News Daily that this is an exciting development.
"Although the FDA already has the authority to regulate the addition of CBD to foods and beverages through initiating notice and comment rulemaking, it has been incredibly reluctant to do so," Rogers said. "As of the end of this month, it will be almost two years since FDA held its first hearing relating to the marketing of cannabidiol in dietary supplements, foods, and beverages after the passage of the 2018 Farm Bill, yet relatively little has changed. This reluctance on the part of the agency has led to a proliferation of products produced and marketed without the benefit of federal food safety oversight."
She continued, "In the meantime, a number of states have stepped up to attempt to fill the gap left by the FDA to provide direction on the labeling and safety of these products. Unfortunately, these laws are not always consistent with each other. As an attorney advising companies marketing hemp and cannabidiol products in many different states, piecing together these myriad laws to market a product can be a challenging and frustrating experience for hemp brands. Overarching FDA regulations will create uniformity and a clearer pathway for companies to bring these products to market, and I strongly support the passage of legislation directing the FDA to regulate the safety and labeling of cannabidiol in dietary supplements, foods, and beverages."
Related: New York Legalizes Adult-Use Cannabis; RTD Coffee With CBD Experiences High.