A bipartisan group of lawmakers on Thursday introduced a bill to ensure hemp-derived CBD products are regulated by the U.S. Food and Drug Administration, while on the same day, a Republican representative announced a hearing to examine the agency’s refusal to regulate the cannabinoid following the legalization of hemp five years ago.
In 2018, Congress legalized hemp agriculture and commerce with the passage of that year’s Farm Bill. But since then, the FDA has refused to regulate hemp-derived CBD for use in foods, beverages and dietary supplements, and in January announced it would not do so without further legislation from Congress.
On July 20, U.S. Representative Earl Blumenauer and Senators Ron Wyden and Jeff Merkley, all Oregon Democrats, joined Kentucky Republican Senator Rand Paul to introduce the Hemp Access and Consumer Safety Act, a bill that would direct the FDA to regulate hemp-derived CBD as an ingredient for foods, beverages and dietary supplements. In a joint statement, the bipartisan group of lawmakers characterized the development as “an action that is essential to protecting consumer safety and treating hemp producers fairly.”
“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Wyden said in a joint statement from the lawmakers. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”
Federal Law Limits CBD Uses
Currently, the Federal 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 not yet exempted hemp-derived CBD, despite congressional action to legalize the production and sale of the cannabinoid. By exempting hemp-derived CBD from the prohibition, the Hemp Access and Consumer Safety Act would allow the FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods and beverages.
If passed, the legislation would give hemp-derived CBD products an opportunity to be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act. The bill also includes provisions that prioritize consumer safety by requiring manufacturers to comply with all existing federal regulations for products that contain CBD and ensure such products are properly labeled.
Paul, who had a career as an ophthalmologist for more than 15 years before being elected to the Senate, noted many consumers are already using CBD products for their reputed health and wellness benefits.
“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,” said Paul. “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.”
The bipartisan bill is supported by stakeholders in the hemp and CBD industries, including the Oregon Farm Bureau, Wine and Spirits Wholesalers Association (WSWA), Vote Hemp, American Herbal Products Association (AHPA), Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA), Veterinary Cannabis Society, Midwest Hemp Council, Colorado Hemp Association, Kentucky Hemp Association, Georgia Hemp Association, iHemp Michigan, and the Virginia Hemp Coalition.
“This bill provides a much-needed pathway for FDA to establish a clear and consistent framework for the production, marketing, and sale of hemp-derived CBD to ensure consumer safety while fostering a thriving, regulated market,” said Jonathan Miller, general counsel of the industry group the U.S. Hemp Roundtable. “We look forward to supporting his efforts and appreciate his longtime commitment to unlocking the full potential of the hemp industry.”
Michigan Lawmaker Schedules Hearing
Also on Thursday, Michigan Republican Representative Lisa McClain, the chair of the House Subcommittee on Health Care and Financial Services, scheduled a hearing to investigate the FDA’s refusal to regulate CBD for use in dietary supplements, foods and drinks. The hearing, titled “Hemp in the Modern World: The Yearslong Wait for FDA Action,” will take place at the Rayburn House Office Building on Thursday, July 27.
“The FDA has failed for too long to do its job to ensure the safety of legalized hemp-derived products,” McCain said in a statement on Thursday. “Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market. We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction. We need to ensure that the FDA is not setting what would be a dangerous precedent and using this as an opportunity to seek more authority and resources from Congress.”