A company promoting an intravenous form of cannabidiol (CBD) has been sent a warning letter from the U.S. Food and Drug Administration.
Cannabidiol is a non-intoxicating cannabinoid that is most commonly available in oral forms for ingestion.
According to the FDA, firm in question is marketing an intravenously administered CBD product as a dietary supplement claiming it qualifies as such. But the FDA says the Federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term “dietary supplement” as a product that is “intended for ingestion.” The definition of ingestion varies, but the Merriam-Webster dictionary describes it as “the act or process of taking in something for or as if for digestion”.
The FDA is particularly concerned about this product, as the Administration says:
“Injectable products are delivered directly into the body and therefore bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions.”
The FDA says based on its review of the company’s website and other marketing materials, the IV CBD product is a drug. It considers the product a “new drug” that doesn’t have approved application from the agency, therefore violating certain sections of the FD&C Act.
The company has been requested to notify FDA in writing within fifteen working days after having received the letter of the specific steps taken to correct any violations, or the firm’s reasoning and any supporting information why it considers it doesn’t violate the FD&C Act. Consequences for not doing so could see legal action from the FDA, including seizure and injunction. The full text of the letter can be found here.
At the time of publishing this article, the company’s website was still live, but much of its content that was previously publicly available was behind a provider login.
The letter is the first the FDA has sent out this year in relation to firms marketing cannabis-derived products.
“FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” states the agency.
Only nine letters were sent last year. A list of all the letters the FDA has sent out since 2015 can be viewed here.
A company promoting an intravenous form of cannabidiol (CBD) has been sent a warning letter from the U.S. Food and Drug Administration. Read More
