Review of the Recent FDA Letters to CBD Companies

In February 2015, the U.S. Food and Drug Administration (FDA) issued 11 warning letters to companies for a host of health claims made on product labels and websites, as well as on Facebook comments.

Products sold by these companies claim to cure, mitigate, treat or prevent issues such as bone fractures, cancer, viral tonsillitis, viral hepatitis, herpes, common cold, influenza, measles, mumps, chicken pox and more in humans and animals.

The companies sell products claiming to contain Cannabidiol (CBD) and market the products for a host of conditions, including cancer, neuroinflammation, schizophrenia, anxiety and more.

A search of all the letters and statements from FDA for the words “controlled,” “CSA” or “illegal” return a result of zero.

Takeaways: It appears FDA agrees with those of us that have known it for years: Cannabidiol in hemp is not a “Controlled Substance.” Period. Otherwise, FDA would be talking about the R.I.C.O Act (Racketeer Influenced and Corrupt Organizations) with multiple underlying felonies against the officers of the business. FDA did not include the test results in the letters, but instead released them to the public as a warning, which is unprecedented.

Drugs, botanicals and supplements are routinely the subject of sensationalistic reporting as to lack of stated potency. It happened recently with ginseng, Echinacea, St. John's Wort and ginkgo biloba. It is clear FDA are monitoring Facebook posts. Even pet products are subject to the same laws as human foods or medicines.

Companies that make Cannabinoid products, take notice: this is what FDA enforcement looks like. Step One. No more of that DEA Swat Team business. Although FDA does use their SWAT, they start with a nasty letter, as we see here.

As for the health claims which are the reason for these letters, we have been down this road already with dietary supplements in the '80s and '90s. This exact same kind of enforcement happened back then on Echinacea health claims and the like. FDA was ruthless in enforcing “no information on health benefits in the store.” Therefore, the industry developed the Dietary Supplement Health and Education Act of 1994 (DSHEA) to protect themselves. We need a version of DSHEA for Cannabinoids, or we will all be at risk, except Big Pharma. This year, that takes the form of H.R. 1635* or the Charlotte’s Web Medical Access Act of 2015.

To prevent this type of enforcement, one routinely sees the standard FDA disclaimer on websites: “These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.”

Remember: one cannot market unapproved drugs for the diagnosis, cure, mitigation, treatment or prevention of diseases in either humans or animals, even if it is legal, safe, efficacious, nontoxic and inexpensive.

*H.R. 1635, or the Charlotte’s Web Medical Access Act of 2015, is in place to amend the Controlled Substances Act to exclude cannabidiol and cannabidiol-rich plants from the definition of marijuana, and for other purposes.

Richard Rose helped start the soyfoods revolution in 1980, the hemp foods revolution in 1994, and now is helping today's CBD Hemp revolution. He's introduced 150 foods over 35 years, and has run 4 hemp trade associations.

Posted on 6/4/2015


Posted 6/4/15