With little chance of regulating CBD in the absence of an updated US Farm Bill, the US Food and Drug Administration (FDA) appears to be continuing past practices of trying to keep enforcement in check by issuing warnings to producers while waiting for Congress to set rules. .
Congress failed to pass a comprehensive farm bill this year, meaning hemp and other issues likely won’t be resolved until September 2024. Regulations on CBD and delta-8 and other synthetic, high-yielding compounds made from CBD are key issues still unresolved and likely to be controversial as hemp stakeholders disagree on policy and regulations.
Stakeholders had been counting on the Farm Bill of 2023 (officially the Agriculture Improvement Act of 2023), a $1 trillion spending package passed every fifth year, to clarify hemp rules for businesses and protect consumers. In particular, the changes are needed to strengthen language in the 2018 Farm Bill that legalized hemp at the federal level, but did not set rules for hemp extracts such as CBD or psychoactive hemp products made from the flowers of the hemp plant.
Returning to its normal playbook, the FDA announced it will continue enforcement, recently warning a North Carolina company that its CBD-containing products are illegal under the federal Food, Drug, and Cosmetic Act (FD&C Act). The agency reminded the company that there is no food additive regulation that would allow the use of CBD. The FDA has consistently warned that adding CBD to food means the products are adulterated.
The company, GCHNC LLC, was also warned about its products containing synthetic delta-8 THC, a high-yield blend made from CBD that has not been evaluated for safety and has caused adverse events.
The agency has repeatedly warned that delta-8 THC products may contain harmful chemicals and should be kept out of the reach of children and pets. Unregulated and therefore often harmless products have flourished at an alarming rate and are openly sold in smoke shops, convenience stores, gas stations and online.
The FDA wrote that delta-8 THC is not classified under GRAS (generally recognized as safe) guidelines and that any food containing this compound is therefore also adulterated.
GCHNC LLC, which goes by several other names, makes cookies, gummies, candies and honey products that contain CBD and/or delta-8 THC, according to the FDA.
The warning letter was addressed to Alaa Odeh Mahmoud Hamed and Abdulraouf B. Allamandani, the registered representatives of the Greensboro, NC company, which also operates under the names Hemp XR, Gate City Hamp and Allaziya Enterprises, LLC.
Concern for minors
Washington, DC attorney Rend Al-Mondhiry Amin Talati Wasserman said the letter partly reflects the FDA’s concern about minors’ access to delta-8 products.
The FDA, and I think rightly so, has focused on delta-8 THC products that resemble regular foods, especially those that appeal to children, he told Natural Products Insider.
The concern is accidental consumption by children or even accidental overuse by adults. Well, the FDA will probably continue to focus on this group of products that pose the greatest risk. Wasserman added.
Earlier this year, the FDA and Federal Trade Commission (FTC) targeted companies in several states for online sales of products containing delta-8 THC, which occurs naturally in hemp, but only in small amounts.
Taking advantage of unclear current laws, shady producers produce high concentrations of delta-8 and other psychoactive compounds by putting hemp-derived CBD through a laboratory process. Delta-8 is said to produce a psychoactive effect that is milder than delta-9 THC, which is the more common variety of THC found naturally in marijuana.
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