CBD Excluded From FDA’s Dietary Supplement Definition
According to the FDA’s consumer update, dated 25 November 2019, there is a lack of scientific information supporting the safety of CBD in food, stressing that:“It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”
In short, CBD is not legal for use in food, animal feed or supplements. The only FDA approved CBD product is a Rx drug for the treatment of 2 severe forms of epilepsy.
In fact, the FDA’s downgrading of CBD with minimal THC content to a Schedule 5 drug was in direct response to its approval of Epidiolex, which is approved for the treatment of Lennox-Gastaut syndrome and Dravet syndrome.
As mentioned, CBD can also be derived from hemp, which can now be grown and sold legally in the US per the 2018 Farm Bill.
In order to not fall within the definition of marijuana in the Controlled Substances Act, the hemp must, under the Farm Bill contain less than 0.3% THC on a dry weight basis.
With the legalization of hemp, hemp-derived CBD products grew fast and furious. But, it is important to recognize that CBD isolates from hemp are still illegal as a dietary ingredient. By approving a CBD-only drug (Epidiolex), CBD cannot per FDA rules, be sold as a supplement, even if it’s derived from legal hemp.
So, to clarify, whole hemp oil can be legally sold across the US, even if it contains naturally occurring CBD, but CBD isolates cannot be sold as a nutritional supplement, even if it is derived from legal hemp.
And to stay within the legal framework, companies cannot advertise or list CBD on the label. Nor can they make any specific health or disease claims.
As reported by Forbes, the 15 companies that received warning letters from the FDA:“… are using product web pages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.”
Considering the FDA’s strengthened position on CBD, it would be wise to leave any CBD products at home when traveling.
Again, companies are not allowed to list CBD content if they want to sell hemp oil legally, and this really puts consumers in a bind, as it is impossible to know just how much CBD any given hemp oil might contain.
Karen Howard, CEO and executive director of Organic & Natural Health, said: “It’s really important for consumers to know that because Amazon doesn’t allow the sale of products with CBD, there are no reputable companies selling CBD on Amazon.com’s site …
Amazon states it has banned the sale of CBD supplements on its site, but allows advertising and tagging of CBD instead, inviting an influx of products to consumers that the FDA has been warning about …
Essentially, the public is being defrauded 2X, 1st Amazon’s best-seller, New Age Premium Hemp Oil contains CBD even though its label does not list CBD. 2nd, those searching for CBD products are being misled into buying products containing zero CBD.”
Now, for the 1st time in 4 years, warning letters have been issued to 15 companies for CBD products sold in violation of the Federal Food, Drug, and Cosmetic Act.
The FDA has also issued a general consumer update detailing various CBD safety concerns.
Companies that received warning letters include the following:
|Koi CBD||Pink Collections Inc.|
|Noli Oil||Natural Native|
|Whole Leaf Organics||Apex Hemp Oil|
|Bella Rose Labs||Sunflora|
|Healthy Hemp Strategies (DBA Curapure)||Private I Salon|
|Organix Industries (DBA Plant Organix)||Red Pill Medical|
|Sabai Ventures||Daddy Burt (DBA Daddy Burt Hemp Co.)|
|Infinite Product Company|
On 14 May 2019, New York Times article stated: “… cannabidiol is everywhere. We are bombarded by a dizzying variety of CBD-infused products: beers, gummies, chocolates and marshmallows; lotions to rub on aching joints; oils to swallow; vaginal suppositories … CVS and Walgreens each recently announced plans to sell CBD products in certain states.”
Importantly, CBD has also been shown to provide valuable benefits for those struggling with opioid addiction.