In addition to six warning letters sent out in April 2015, the U.S. Food and Drug Administration (FDA) has sent out eight more warning letters to companies marketing unapproved new drugs containing cannabidiol (CBD). CBD is a compound found in the cannabis plant that has been used as a treatment for its pain-alleviating effects in humans and animals.
The eight companies that received letters, include:
- ABC Productions
- Dose of Nature
- Green Garden Gold
- Michigan Herbal Remedies
- Sana Te Oils
The FDA’s letters specify that the CBD products being sold do not contain the amount of CBD that they claim to and that the companies are making numerous health claims that are not backed by medical studies. Unless the product was marketed before GW Pharma published clinical trials, the companies are not allowed to make any health claims.
As per the warning letters, the FDA has concluded that, “CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the Act [21 U.S.C. § 321(ff)(3)(B)(ii)]. Under that provision, if a substance (such as CBD) 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. There is an exception if the substance was “marketed as” a dietary supplement or a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.”
The CBD products are considered “new drugs” by the FDA and may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA. These companies cannot market or sell unapproved drugs to diagnose, mitigate, treat, or prevent diseases in humans or animals.
The FDA provided the companies fifteen working days to notify their office in writing of the specific steps they are going to take in order to correct the violations. Cannabis companies that ignore federal commercial regulations do so at their own peril.
If the FDA takes legal action, this will not be the first legal case related to marijuana.