mdi Consultants, Inc
We have been warning clients on the use of CBD and the FDA regulatory requirements.
You need to be very careful on the claims you want to make on your products that contain CBDs.
Here is some recent FDA actions.
The FDA has recently issues 5 warning letters to companies for violating Federal Food, Drug, and Cosmetic Act (FD&C Act) by selling products containing CBD. The FDA is unaware whether these products are effective in the claims being made, the appropriate dose, how they interact with other FDA-approved drugs or if they have dangerous side effects or other safety concerns. The products under question have not gone through the drug approval process and are considered unapproved new drugs.
The warning letters were issued to:
- Bee Delightful
- G&L Wellness (C Better Daily)
- New Leaf Pharmaceuticals
- NextL3vel Services Group, LLC doing business as This Stuff is Good For You
- Wellness BioSciences
These warning letters contain CBD products are concerning due to the route of administration, including nasal, ophthalmic and inhalation. Violations are also addressed relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Additionally, two letters address CBD products illegally marketed for pets, including a product for use in the eye.
These are not the first set of warning letters the FDA has sent out to companies illegally selling unapproved CBD products that claim to prevent, diagnose, mitigate, treat or cure various diseases, which is in violation of the FD&C Act.
For further information on this update, please visit the FDA’s website.
If you have any further questions or need assistance with FDA regulation, please email mdi Consultants at info@mdiconsultants.com RE: CBD.