FDA cracks down on Delta-8 THC and CBD products, sending out warnings to five companies

05 May 2022 --- The US Food and Drug Administration (FDA) has issued warning letters to five companies for illegally marketing products containing unapproved delta-8 THC, amid increasing reports of adverse reactions and poison scares surrounding the ingredient.

“Delta-8 THC is an unapproved and unsafe food additive; food products containing the substance are adulterated and illegal under the FD&C Act,” an FDA spokesperson tells NutritionInsight.

Warning letters were sent to ATLRx, BioMD Plus, Delta 8 Hemp, Kingdom Harvest and M Six Labs, for violating the Federal Food, Drug and Cosmetic Act (FD&C Act). The companies have 15 working days to respond in writing, detailing how they plan to rectify the breaches and prevent them.

If infractions are not addressed promptly, legal action may be taken, including product seizure or injunction, the FDA notes. NutritionInsight reached out to the five companies which did not respond in time for publication.

Appealing to children?
Delta-8 THC is one of more than 100 cannabinoids produced by the Cannabis sativa L. plant. However, it isn’t found at significant levels naturally. Delta-8 THC in concentrated form is often made from hemp-derived cannabidiol (CBD), making it psychoactive and intoxicating.

The FDA has received complaints from people who have had adverse reactions to these products.

This is the first instance of the FDA issuing warning letters for products containing delta-8 THC.“The FDA has received reports of adverse events experienced by patients who have consumed products [containing delta-8 THC] and there has been an uptick in reports to the nation’s poison control centers.”

Manufacturers are packaging and labeling these products in ways that may appeal to children (for example, gummies, chocolates, cookies and candies), the FDA spokesperson explains.

“These products may be purchased online and at a variety of retailers, including convenience stores and gas stations, where there may not be age limits on who can purchase these products.”

Breaching federal law
The five companies had breaches concerning one or all of the following: dietary supplement labeling, unapproved new human drugs, misbranded human drugs and adulterated human foods. The warning letters detail breaches involving drug misbranding and the use of delta-8 THC in foods such as gummies, caramels and peanut brittle.

These violated the FD&C Act as the breaches include marketing CBD products claiming to treat medical conditions in humans, promoting CBD products as dietary supplements and adding CBD to human foods, with the violations related to FDA-regulated products containing delta-8 THC.

“We are aware that some products on the market may add CBD to food or label CBD as a dietary supplement. Under federal law, it is illegal to market CBD this way,” the FDA spokesperson adds.

Tougher regulation
The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients in need of appropriate medical therapy.

Manufacturers are packaging and labeling these products in ways that may appeal to children (for example, gummies and chocolates).“Unlike drugs approved by the FDA, products that have not been subject to FDA review as part of the drug approval process have not been evaluated as to whether they work, what the proper dosage may be if they do work, how they could interact with other drugs, or whether they have dangerous side effects or other safety concerns.”

“The FDA continues to believe that the drug approval process represents the best way to help ensure that safe and effective new medicines, including any drugs derived from cannabis, are available to patients needing appropriate medical therapy,” the FDA spokesperson says.

Public health concerns
According to the warning letters, the five companies illegally market delta-8 THC products as unapproved treatments for various medical problems or other therapeutic reasons.

“The FDA’s top priority is to protect public health. This priority includes making sure consumers know about products that put their health and safety at the greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases,” says the FDA spokesperson.

“Under the FD&C Act, any product intended to have a therapeutic or medical use and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.”

Drugs must generally either receive premarket approval by the FDA through the New Drug Application (NDA) process or conform to a “monograph for a particular drug category, as established by the FDA’s over-the-counter (OTC) drug review, the FDA spokesperson explains.

“CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.”

In addressing how fatal unapproved therapies may be to public health, the FDA spokesperson adds: “This deceptive marketing of unproven treatments also raises significant public health concerns because patients and other consumers may be influenced not to use approved therapies to treat serious diseases.”

Previously, the need for tighter regulation of hemp-derived products was highlighted following the FDA’s rejection of two new dietary ingredient notifications for full-spectrum hemp extract containing CBD.

By Nicole Kerr