FDA Claims Products Containing CBD Cannot Be Sold As Dietary Supplements
The FDA has concluded that products containing cannabidiol (CBD) cannot be sold as dietary supplements. However, the agency claimed that it could allow CBD oil supplements in the future if it receives conclusive evidence that they’re “safe and effective.”
The FDA recently posted a question and answer page about marijuana at FDA.gov. That question and answer page discussed everything from the FDA’s stance towards states that have legalized marijuana to whether or not the FDA would ever legalize marijuana supplements for pets.
About halfway down that page, the FDA answered the following question:
Question: Can products that contain cannabidiol be sold as dietary supplements?
“No. Based on available evidence, FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act.”
The FD&C Act is the Federal Food, Drug, and Cosmetic Act.
Over the past few months, we’ve seen many CBD oil manufacturers try to advertise their products as dietary supplements. The FDA only regulates foods and drugs (hence the name “Food and Drug Administration”). For years, products wishing to avoid FDA regulation have been able to call themselves “dietary supplements”, which helps them avoid FDA scrutiny.
Preworkout supplements, for example, have commonly used this loophole, as have many bodybuilding supplements.
So why weren’t CBD oil supplement manufacturers allowed to use this loophole?
The FDA claims it’s because CBD oil was attempted to be marketed as a food or drug before it marketed itself as a dietary supplement.
Under the provision 201(ff)(3)(B)(ii) of the FDA&C Act, that’s not allowed:
“Under that provision, if a substance (such as cannabidiol) has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement.”
The FDA claims there is one exception to this rule. If the substance was marketed as a dietary supplement or as a conventional food before the new drug investigations were authorized, then it may be sold as a dietary supplement. The FDA “concluded that this is not the case for cannabidiol.”
The FDA points people towards this article regarding dietary supplement marketing for further assistance understanding the ruling.
Manufacturers Had Previously Received FDA Warnings
The FDA’s announcement that it was banning the sale of CBD oil dietary supplements wasn’t exactly a surprise. Earlier this year, the agency warned six CBD manufacturers for making illegal statements on their websites.
Those manufacturers made claims that CBD oil could treat diseases. As soon as a dietary supplement claims that it can treat a disease, it becomes an “unapproved new human or animal drug” according to the FDA.
The FDA tested products created by the six manufacturers and found that “seven of them didn’t even contain the chemicals that are found within the Cannabis sativa plant: cannabinoids.”
Of the products that were tested, very few contained their stated amount of CBD oil. One company called Natural Organic Solutions was selling a product called 26% CBD Hemp Oil Treatment. That product was found to contain 0.14% CBD. Another product from that company called 21% CBD Hemp Oil Treatment was found to contain absolutely no CBD or cannabinoids of any type.
In other words, a number of low-quality manufacturers were attempting to capitalize on the popularity of CBD oil by selling supplements that didn’t even contain CBD oil, but still claimed to treat conditions like cancer and anxiety. That’s why the FDA was forced to crack down.
Will the FDA Actually Enforce the Ban?
The FDA answered vaguely when asked the following question:
Question: Will FDA take enforcement action regarding cannabidiol products that are marketed as dietary supplements?
The FDA claims that it takes multiple things into consideration when deciding whether or not to ban a substance and punish manufacturers, including these two primary factors:
The FDA also consults with “federal and state partners in making decisions about whether to initiate a federal enforcement action.”
Ultimately, the FDA’s ruling brings an end to the “grey area” and “loophole” status occupied by CBD oil manufacturers.
But the FDA claims that if it receives enough science-based evidence from high-quality clinical trials in controlled settings that demonstrate the safety and effectiveness of CBD, then it could change its stance (which is the FDA’s same approach to every new drug).