FDA signals it will continue enforcement against CBD, delta-8 without Farm Bill

With little prospect for CBD to be regulated in the absence of an updated US Farm Bill, the US Food and Drug Administration (FDA) appears likely to continue its past practice of trying to continue enforcement by issuing warnings to producers while waiting for Congress to set rules.

Congress failed to craft a comprehensive Farm Bill this year, meaning hemp and other issues likely won’t be resolved until September 2024. Regulations for CBD, and delta-8 and other synthetic, high production compounds made from CBD, are among the main issues. still to be resolved, and likely to be controversial as hemp stakeholders disagree on policy and rules.

Stakeholders are counting on the 2023 Farm Bill (officially, the Agriculture Improvement Act of 2023), a $1 trillion spending package passed every five years, to clarify hemp rules for businesses and protect consumers. The changes are especially necessary to preserve language in the 2018 Farm Bill, which legalized hemp federally but did not set rules for hemp extracts such as CBD, or for psychoactive hemp products made from the flowers of the hemp plant.

FDA playbook

Returning to its usual playbook, the FDA has signaled it will continue enforcement, recently warning a North Carolina company that its products containing CBD 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 allows the use of CBD. The FDA continues to issue warnings that adding CBD to a food means that those products are adulterated.

The company, GCHNC LLC, has also been warned about its products containing delta-8 THC synthetic, high-producing concoctions made from CBD that have not been tested for safe use, and have sparked adverse reports on event.

The agency has repeatedly warned that delta-8 THC products can contain dangerous chemicals, and should be kept away from children and pets. Unregulated and therefore often unsafe products have developed at an alarming rate and are openly sold in smoke shops, convenience stores, gas stations and online.

Not GRACE

The FDA wrote that delta-8 THC is not categorized under GRAS (generally recognized as safe) guidelines and any food containing the compound is therefore also adulterated.

GCHNC LLC, which does business under 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 is addressed to Alaa Odeh Mahmoud Hamed and Abdulraouf B. Allamandani, registered agents of the Greensboro, NC company, which also operates under the names Hemp XR, Gate City Hemp, and Allaziya Enterprises, LLC.

Concerns with minors

Rend Al-Mondhiry, a Washington, DC-based attorney at Amin Talati Wasserman, said the letter, in part, reflects the FDA’s concern over minors’ access to delta products. -8.

The FDA, and I think rightly so, is focused on delta-8 THC products that resemble conventional foods, especially those that appeal to children, he told Natural Products Insider.

The concern is accidental consumption by children or even accidental overconsumption by adults. It is likely that the FDA will continue to focus on this group of products that pose the greatest risk Wasserman added.

Targeting

The FDA and the Federal Trade Commission (FTC) earlier this year targeted companies in several states for their online sales of products containing delta-8 THC, which occurs naturally in hemp but in trace amounts only.

Taking advantage of unclear current laws, shady producers create high concentrations of delta-8 and other psychoactive compounds by putting hemp-derived CBD through a lab process. Delta-8 has been reported to produce a psychoactive effect that is milder than that associated with delta-9 THC, the more common THC variety found naturally in marijuana.

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Image Source : hemptoday.net

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