Will CBD-oil capsules be available as a dietary supplement one day?
On December 20, 2018, President Trump signed the Agriculture Improvement Act of 2018, also known as the Farm Bill, into law. This law removes hemp and hemp products that contain less than 0.3% THC from the Controlled Substances Act, thus making them legal under federal law. However, the FDA maintains that CBD is illegal as an ingredient in food and dietary supplements. To clear up this confusion, the FDA has just issued some guidance in the form of a question and answer session on their web site. Here are some key excerpts from their site dated 04/02/19. The link to the site is below.
Q. Can THC or CBD products be sold as dietary supplements?
A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201 … Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved … then products containing that substance are excluded from the definition of a dietary supplement.
Q Is it legal, in interstate commerce, to sell a food (including any animal food or feed) to which THC or CBD has been added?
A. No. Under section 301 … it is prohibited to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which has been added a substance which is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355] …
In summary of both answers above, the FDA says you can’t add an ingredient to a food or dietary supplement that is already used as an active ingredient in a drug. The drug they are referring to in this case is Epidolex, which contains CBD and was approved by the FDA for the treatment of seizures. The FDA will not allow an ingredient that was approved for a drug to be subsequently used as an ingredient in a food or dietary supplement.
The FDA makes it very clear that you can’t use CBD as an ingredient in dietary supplements or food, but but says you might be able to use it in cosmetics. Here is another excerpt.
Q What is FDA’s position on cannabis and cannabis-derived ingredients in cosmetics?
A. A cosmetic is defined in 201(i) as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … Certain cosmetic ingredients are prohibited or restricted by regulation, but currently that is not the case for any cannabis or cannabis-derived ingredients …
The answer goes on to say that if you cannot use an ingredient in a cosmetic if it causes the product to be adulterated or misbranded in any way.
In summary, you can’t use CBD as an ingredient in dietary supplements or food, but you might be able to use it in cosmetics. The passage of the Farm Bill is an important first step in making legitimate CBD products available to the public, but ultimately it will depend on the FDA to make it happen.
Here is the link to the FDA page: https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-questions-and-answers#legaltosell
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