FDA, Get It Done! Says Senator In Bipartisan Push To Regulate CBD Products Prior To Committee Hearing

A bipartisan group of U.S. lawmakers reintroduced a measure on Wednesday that aims to secure the Food and Drug Administration’s (FDA) regulation of hemp-derived CBD products. On the same day, the Subcommittee on Health Care and Financial Services chairwoman Lica McClain (R) announced a hearing with the title “Hemp in the Modern World: The Yearslong Wait for FDA Action.”

What happened: Democratic Senators Ron Wyden, Jeff Merkley, Rep. Earl Blumenauer and Republican Senator Rand Paul reintroduced Hemp Access and Consumer Safety Act. The move comes seven months after the FDA announced it will not regulate CBD products as food and dietary supplements.

Even though in May the agency presented a potential framework for CBD, it recently reaffirmed that Congress is in charge.

The Hearing

The goal of the announced subcommittee hearing is to examine the FDA’s failure to regulate hemp-derived and cannabidiol (CBD) products under existing authorities for years.

“The FDA has failed for too long to do its job to ensure the safety of legalized hemp-derived products. 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," stated McClain. "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.”

Witnesses include Jonathan S. Miller general counsel at U.S. Hemp Roundtable, Rayetta G. Henderson, Ph.D. senior managing scientist at ToxStrategies, LLC and Richard A. Badaracco president-elect, Kentucky Narcotic Officers Association, (Retired) assistant special agent in charge, DEA.

The Problem?

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 approved Jazz Pharmaceuticals JAZZ Epidiolex, which is a CBD-based drug for treating children with severe forms of epilepsy. Epidiolex was initially approved for treating seizures connected to Lennox-Gastaut and Dravet syndromes and in 2020 for treating seizures related to tuberous sclerosis complex.

Bipartisan lawmakers reminded that 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.

“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 stated “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”

Rep. Merkley urged the FDA to get a move on. “Our hemp farmers need updated CBD regulations to thrive—FDA get it done!”

The Act Highlights

The proposed hemp-related 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;

• 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.

The bill is endorsed by U.S. Hemp Roundtable, Oregon Farm Bureau, Wine and Spirits Wholesalers Association (WSWA), Vote Hemp, We Are For Better Alternatives (WAFBA), 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.

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Photo: Courtesy of Kindel Media via Pexels