What You Need to Know About Delta 8 THC Products and FDA Approval

Are you considering buying a product containing delta-8 THC? If so, it's important to understand the legal implications of doing so. Delta-8 THC is a psychoactive substance found in the cannabis sativa plant, of which marijuana and hemp are two varieties. While products containing delta-8 THC are available in stores and online, they are not FDA-approved. The FDA has issued warning letters to five companies for selling products labeled as containing delta-8 THC, and any product that claims to diagnose, cure, mitigate, treat, or prevent diseases is considered a new drug not approved in violation of Act FD&C.In California, where medical and recreational cannabis is legal, products containing THC delta-8 are available at gas stations and tobacco stores, as well as in dispensaries.

The FDA is also concerned with marketing, including online advertising, which makes these products attractive to children. The agency issued five warning letters to five different companies to market products with names such as Delta 8 Chocolate, CBD Sleep Gummies, CBD Pain Relief Cream, CBD Fair Trade Coffee, CBD Pet Treats and CBD Canna Rocks Popping Candy by Magnolia Botanicals.Kingdom Harvest, Hendersonville, North Carolina, received a warning letter for its D8 sublingual oil, Delta 8 disposable vaping cartridge, full spectrum hemp extract, CBD vaporizer, blood sugar, CBD gummies, Stella's Baby Care diaper cream, pain relieving CBD cream, and freeze roll-on menthol pain, Immune Boost water-soluble blend, organic broad-spectrum honey without THC, fair trade coffee with CBD, organic CBD-infused tea, Delta 8 chewing gum, Delta 8 gummies and Delta 8 brittle peanuts. Delta 8 Hemp, Los Angeles, received a warning letter for its Delta 8 THC distilled oil, its Delta 8 THC vaping cartridge, the Delta 8 THC disposable vaporizer, the Delta 8 THC tincture, the Delta 8 infused gummies and the Delta-8 infused acid gummies. The FDA is also concerned about the proliferation of products containing delta-8 THC and that are marketed for therapeutic or medical uses. Joanne advises global clients on regulatory and distribution-related considerations for bringing a new FDA-regulated product to market and on how to ensure continued compliance after a product is marketed. The FDA is aware of the growing concern surrounding delta-8 products with THC that are currently sold online and in stores. It is possible that because delta-8 THC is converted from CBD using a catalyst it is a THC of synthetic origin and therefore is a Schedule I controlled substance. Cooper's role in the UCLA Cannabis Research Initiative is to study the health aspects of cannabis products and to educate the public.

He says it's important for consumers to be aware of these products as more types of cannabis products are proliferating in the market. The FDA is concerned that some of the food products are packaged and labeled in ways that may attract children. Overall the FDA seems to have adopted a more aggressive application strategy with respect to products containing THC delta-8 than with CBD products given the psychoactive effects of THC delta-8.And FDA enforcement against products containing CBD and delta-8 THC is expected to continue as is the activity against products that carry a significant risk of youth attractiveness. In conclusion it's important to understand that any product containing delta-8 THC that claims to diagnose cure mitigate treat or prevent diseases is considered a new drug not approved by the FDA. Consumers should be aware of these products as more types of cannabis products are proliferating in the market. The FDA has issued warning letters to five companies for selling products labeled as containing delta-8 THC and will continue to monitor the cannabis market for public health risks.

Elmer Purtle
Elmer Purtle

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