Thursday, March 03, 2016 by Claire Rankin
Recently, certain companies that marketed foods and medicines containing cannabis or cannabidiol (CBD) were sent letters from the FDA to warn them against claiming that their products were beneficial to health. Even labeling CBD products as a dietary supplement would appear to be against the law.
The companies that were sent warning letters were told to remove the offending labeling and send written notification of the steps that they intend to take to correct the violations as specified by the FDA.
CBD medicines are currently available to patients in 23 licensed medical marijuana states. However, the FDA has concluded that cannabidiol products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(ii) of the FD&C Act.
One company marketed their products as follows:
“CBD may relieve symptoms of rheumatoid arthritis, diabetes, chronic pain, schizophrenia, PTSD… Alzheimer’s, Parkinson’s, HIV, dementia, multiple sclerosis, anxiety, bipolar disorders, nausea… and inflammation, as well as inhibiting cancer cell growth.”
“CBD has been shown to reduce growth of aggressive human breast cancer cells in vitro and to reduce their invasiveness.”
In response to this advertising, the FDA let the company know that their products “are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are ‘new drugs’ under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.”
The FDA says neuroprotective claims, for example, are an illegal drug claim for products, all while the U.S. government owns a patent showing marijuana to be safe and effective for reducing inflammation and preventing brain damage and dementia.
The FDA will also go after a company who has not adequately labeled “directions for use” under which a layperson can safely administer the correct dosage. Prescription drugs can only be used under the supervision of a licensed practitioner.
So, any health product that contains cannabidiol and sold as a dietary supplement will be targeted by the FDA. Hopefully, more research into the benefits of cannabis will take place one cannabis is fully decriminalized.