“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. “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.”
Senators Wyden, Rand Paul (R-KY), and Jeff Merkley (D-OR) have introduced the Hemp Access and Consumer Safety Act, which would exempt hemp-derived CBD from the drug preclusion clause of the FD&C Act, allowing FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods, 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 in the press release. “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.”
Related: 2021 Phytocannabinoids Market Update: Troubleshooting & Trendspotting AHPA Releases Updated Entries to Botanical Safety Handbook Ahead of Botanical Congress CV Sciences Q1 Results Show Increased DistributionThe Act:
- Gives hemp-derived CBD products an opportunity to lawfully be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act.
- Prioritizes consumer safety, requiring manufacturers to comply with all existing federal regulations for the products that contain CBD.
- Ensures 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. “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 press release included industry reactions, including a statement from Jonathan Miller, General Counsel, U.S. Hemp Roundtable: “The Hemp Access and Consumer Safety Act is a huge win for American consumers, farmers, and the hemp industry as a whole. Consumers will benefit from knowing that CBD products must be manufactured according to FDA-approved CBD processes. Struggling American farmers will benefit from a stabilized marketplace. It also will stimulate innovation and job creation in the hemp industry. The U.S. Hemp Roundtable is deeply grateful to Senator Ron Wyden for crafting this smart, sensible, and critical legislation, and to Senator Rand Paul and Senator Jeff Merkley for serving as the original co-sponsors.”
Michael McGuffin, President, American Herbal Products Association, added: “The leadership of Senators Wyden, Paul, and Merkley in resolving this matter is greatly appreciated. Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated. AHPA supports this legislation since it would clarify the lawful pathways for bringing such products to market.”
The press release further included praise from the Oregon Farm Bureau, Vote Hemp, Oregon Industrial Hemp Farmers Association, Kentucky Hemp Works, and more.
Some of those associations pointed to massive amounts of money lost—Patrick Atagi, Board Chair, National Industrial Hemp Council, for one, stated: “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. NIHC supports Senators Merkley’s and Wyden’s recognition of hemp and CBD as an ingredient in both food and supplements, and we applaud their legislative approach to ensure that it’s regulated accordingly. This bill will deliver safe products to the marketplace and create a hemp economy that works for everyone.”
Others spoke more to those products, specifically, including Derek Selznick, Executive Director, Kentucky Guild of Brewers:“The Kentucky Guild of Brewers would like to thank Senator Paul and all of the other sponsors of this bill. Allowing breweries to use safe products like CBD in beer allows us to continue to innovate and respond to consumer demand by offering new and unique beers. Innovation is at the core of our industry and this is one more way we can further diversify our product portfolio.”
And still others spoke to concerns about small businesses, including Dawson Hobbs, EVP, Wine and Spirits Wholesalers of America: “The lack of clarity on the legality of hemp-derived CBD products used in foods and beverages has been a significant source of confusion in the marketplace. America's family-owned wholesalers are federally permitted and regulated businesses that need clarity from federal regulators regarding the legal status of CBD products. We applaud this action directing the Food and Drug Administration to affirm that CBD is legal in dietary supplements, including food and beverages. It will allow America’s wholesalers to continue providing U.S. consumers with the most diverse product selection in the world.”
And, speaking on behalf of consumers, Scott Melville, President & CEO, Consumer Healthcare Products Association, stated: “We strongly commend Senators Wyden, Paul and Merkley for their bipartisan bill which will provide a pathway for CBD to be legally marketed as a dietary supplement. A lawful regulatory pathway will provide long-term certainty in the hemp-derived CBD market and protect consumers from potentially unsafe products.”
The Natural Products Association also released a statement. Daniel Fabricant, Ph.D., President and CEO of NPA, stated: “Setting a safe level of daily exposure remains the number one issue when it comes to regulating CBD products. It’s Congress’ job to keep the FDA accountable, but this is like slapping a band-aid on a bullet wound. Setting a safe level of daily consumption will not only keep the FDA accountable, but also set an important precedent that will pave the way for future cannabinoids and hemp constituents in foods and dietary supplements.”