July 25, 2023
A bipartisan, bicameral federal bill has been introduced to make the trade in CBD and other hemp-derived products fully legal.
The bill, "The Hemp Access and Consumer Safety Act," was introduced yesterday by U.S. Sens. Ron Wyden, D-Ore., Rand Paul, R-Ky., and Jeff Merkley, D-Ore., and U.S. Rep. Earl Blumenauer, D-Ore.
Breaking the logjam
After years of deliberating on the issue, FDA said in January that it lacked the authority to regulate CBD. It threw the matter back to Congress to come up with a regulatory solution for the products.
FDA has sent warning letters to companies marketing CBD and other hemp-derived products, including delta-8 THC, but the letters have focused predominantly on the claims being made on the products.
Marketers of the products who are not making non-compliant disease claims seem to have little to fear from FDA. But the regulatory limbo surrounding the products has served to restrict market growth and stymie investment.
The bill's sponsors said their measure is meant to remove that logjam and bring to full fruition the market that was envisaged with the passage of the 2018 Farm Bill.
"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," Sen. Wyden said in a statement that accompanied the introduction of the bill. "The FDA says it needs Congress to act. We've got the bill to ensure equal and safe access to hemp-derived CBD."
"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," Sen. Paul said in the statement.
Hearing set on FDA's inaction
The introduction of the bill took place on the same day as the announcement of a hearing on the status of hemp products and FDA's inaction on the issue.
The hearing, "Hemp in the Modern World: The Yearslong Wait for FDA Action," is scheduled for July 27 and will be hosted by the Health Care and Financial Services Subcommittee of the U.S. House Committee on Oversight.
Carving out specific exemption for hemp
The bill introduced on July 20 would amend the so-called drug exclusion clause of DSHEA (Dietary Supplement Health and Education Act of 1994) to specifically exempt hemp products. Current law excludes an ingredient like CBD from being introduced to the dietary supplement market if it has been first studied or approved as a drug.
According to its sponsors, the legislation 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 these products are properly labeled.
AHPA among bill's supporters
The legislation has received endorsements from several trade groups, including the U.S. Hemp Roundtable and the American Herbal Products Association (AHPA).
"The leadership of Senators Wyden, Paul and Merkley in resolving this matter is greatly appreciated," AHPA president Michael McGuffin was quoted in the lawmakers' news release. "Americans deserve to have assurances that the hemp and CBD products they include in their food and dietary supplement choices are properly regulated."
This piece originally appeared on Natural Products Insider, a New Hope Network sister website. Visit the site for information on ingredients, product development and regulatory issues.
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