The US Food and Drug Administration has published a Report to the US House Committee on Appropriations and the US Senate Committee on Appropriations regarding Cannabidiol (CBD).
This long awaited report provides many answers, and poses many more questions. We hope you find this information valuable. There is a link to the full FDA report at the bottom of the page. The FDA has also updated their website’s CBD Regulation page.
“Enforcement Policy: FDA is currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors FDA intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to balance the goals of protecting the public and providing more clarity to industry and the public regarding FDA’s enforcement priorities while FDA takes potential steps to establish a clear regulatory pathway. As we move forward, FDA intends to continue taking action to address violations we identify that put the public at risk.“
The FDA Report Focuses On:
Safety
FDA continues to be concerned about the potential safety risks of using CBD and about problems related to a number of currently marketed CBD consumer products under FDA jurisdiction, like mislabeling or the potential for contamination with delta-9- tetrahydrocannabinol (THC), pesticides, and heavy metals.
Human & Animal Drugs
FDA encourages and supports research to explore the therapeutic potential of CBD for human and animal drugs and has exisitng regulatory pathways available for CBD drug development and review of new drug applications and new animal drug applications.
Dietary Supplements
While CBD products cannot currently be lawfully marketed as dietary supplements, FDA is actively considering potential pathways for certain CBD products to be marketed as dietary supplements.
Human & Animal Food
It is not currently lawful to add CBD to human or animal food, and the data currently available to FDA raise safety concerns about the use of CBD in food.
Cosmetics
Those marketing a cosmetic product are responsible for ensuring the safety of the product. FDA is aware of only limited data on CBD when used topically.
Products Outside FDA’s Jurisdiction
It is possible that some individual products containing CBD fall outside of FDA’s jurisdiction-in such cases FDA does not have authority to exersice regulatory oversight over such products.
Enforcement
As FDA works to evaluate potential pathways for the lawful marketing of CBD in products regulated by FDA, FDA is actively obtaining more data about potentially safe levels of CBD and evaulating issuance of a risk-based enforcement policy.
Any enforcement policy would need to balalce the goals of protecting the public and providing more clarity to industry and the pulic regarding FDA’s enforcement priorities based on the known risks to public health.
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If you’d like further understanding of this report and how it affects your business, feel free to schedule a phone consultation. We are open for business and offer phone consultations for your ease and safety. Our founding Principal Courtney N. Moran, LL.M. is accepting new clients in 2020.