Regulatory Update: FDA Cracking Down on CBD Products
By RDBA Executive Director, Annette Maggi, MS, RDN, LD, FAND
In November, the FDA sent warning letters to five companies for illegally selling products containing CBD. This adds to a total of 13 CBD warning letters in 2022, with nearly 40 sent since 2019.
The FDA’s key issues with products containing CBD and as indicated in these warning letters are as follows:
- Companies are selling CBD in products that people may confuse for regular foods or beverages, which can lead to unintentional consumption or overconsumption of CBD. This is especially a concern for accidental intake by children, as CDB is being added to product forms including gummies, hard candies, cookies, and brownies.
- Companies are making claims that these CBD-containing products, cure, mitigate, treat, or prevent diseases, which are considered unsubstantiated claims.
- Adding CDB to animal foods, such as pet treats, which violates the FD&C Act.
- Because some retailers are reluctant to sell CBD products given current FDA regulations, companies are not spelling out on the package that it contains CBD, instead using terms such as “hemp extract.” FDA considers this misleading, as consumers may not understand the products contain CBD and may unknowingly consume them.
- Detailed safety information, indicating the levels of CBD that can be consumed and for how long, is not currently available. There is some research that suggests possible harm to the male reproductive system and liver issues as well as interactions with some medications. Data around safety of consumption is of specific concern for vulnerable populations like children and pregnant or breastfeeding individuals.
Some industry experts believe the issuance of these warning letters suggest FDA may be taking more aggressive action on CBD at the federal level in the coming months, and retailers selling CBD products should remain attentive to the situation.
For a comprehensive review of the FDA’s view on CBD products since the 2018 Farm Bill separated CBD from the definition of marijuana, click here.