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FDA warns companies about ∆-8 THC, CBD products

The U.S. Food and Drug Administration issued warning letters on May 4, 2022 to five companies for the sale of products labeled as containing delta-8 tetrahydrocannabinol (delta-8). THC) in ways the FDA says “violates Federal Food, Drug, and Cosmetic.” Act (FD&C Act).

This is the first time the FDA has issued warning letters for products containing delta-8 THC. Delta-8 THC has psychoactive and psychotropic effects that the agency says “may be dangerous for consumers.”

The FDA allegedly received reports of adverse events experienced by patients who consumed these products. No details were provided as to what these claims were or how they were documented, leaving many people skeptical as to whether the claims were legitimate. The FDA has not responded to patients claiming medical benefits from ∆-8 THC for things like sleep disorders.

Delta 8 THC considered “new drug not approved”

There are no FDA-approved drugs that contain delta-8 THC. Any delta-8 THC product that claims to diagnose, cure, mitigate, treat or prevent disease is considered a new unapproved drug.

Considering that people have been using cannabis for at least 3500 years without a single fatality for recorded overdose, it can be expected to be acceptable for human consumption. However, the FDA has not evaluated whether these non-approved drug products are effective for the uses that manufacturers say, what might be an appropriate dose, how they might interact with FDA-approved drugs or other products, or whether they dangerous side effects or other safety. concerns.

Federal Agency for the Administration of Foodstuffs Act of the United States FDA
The White Oak Building is home to the federal FDA’s Washington DC office

The FDA has issued warning letters to:

Delta 8: An old and new drug

Delta-8 THC is one of more than 100 cannabinoids produced in the Cannabis sativa L. plant, but not found naturally in significant quantities. Concentrated amounts of delta-8 THC are typically manufactured from cannabidiol derived from cannabis (CBD) and have psychoactive and intoxicating effects. Products containing delta-8-THC are available in a variety of forms, including, without limitation, candy, cookies, breakfast cereals, chocolate, gummies, vape cartridges (carts), dabs, shatter, smokable hemp sprayed with delta extract. -8-THC, distillates, tinctures and infused beverages.

The warning letters address the illegal marketing of delta-8 THC products not approved by companies as treatments not approved for various medical conditions or for other therapeutic uses. The letters also cite violations related to drug misbranding (e.g., products lack proper directions for use) and the addition of delta-8 THC to foods such as gummies, chocolate, candy, chewing gum and fragile peanuts.

“The FDA is very concerned about the growing popularity of delta-8 THC products that are sold online and in stores across the country. These products often include claims that they treat or alleviate side effects associated with a wide variety. of medical illnesses or disorders such as cancer, multiple sclerosis, chronic pain, nausea and anxiety, “said FDA Chief Commissioner Janet Woodcock, MD.” It’s very worrying that some of the food products “We will continue to safeguard the health and safety of Americans by monitoring the market and taking action when companies sell illegal products that pose a risk to public health.”

“Exposure” to the nature cited

The FDA recently released a consumer update expressing serious concern about the potential health effects of delta-8 THC products. The FDA has received reports of adverse events involving delta-8 THC-containing products from consumers, health practitioners, and law enforcement, some of which have resulted in the need for hospitalization or emergency treatment. The agency is also aware of an increasing number of exposure cases involving delta-8 THC-containing products received from national poison control centers and warnings issued by state poison control centers describing safety concerns and events. adverse with products containing delta-8 THC.

CBD products have also received notices

In addition to violations related to FDA-regulated products that contain delta-8 THC, many of the warning letters outline additional violations of the FD&C act, including the marketing of CBD products that purport to treat medical conditions in humans and animals, promote CBD products as dietary supplements. , and add CBD to human and animal foods. CBD and delta-8 THC are food additives not approved for use in any human or animal food product, since the FDA is not aware of any basis for concluding that the substances are generally recognized as safe ( GRAS) or otherwise exempt from the requirements for food additives. One of the letters expresses concern about CBD products marketed for food-producing animals, and potential safety issues related to human food products (e.g., meat, milk, eggs) from animals we consume. CBD, since there is a lack of data on security. CBD residue levels.

The FDA has already sent warning letters to other companies selling illegally unapproved CBD products that claim to diagnose, cure, mitigate, treat or prevent various diseases, in violation of the FD&C Act. In some cases, there have been other violations because CBD has been added to food products. The FDA has not approved any CBD product other than a prescription human drug product to treat rare and severe forms of epilepsy.

The FDA has requested written responses from companies within 15 business days stating how to treat these violations and prevent their recurrence. Failure to promptly address violations may result in legal action, including seizure of the product and / or injunction.

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