Posted November 1, 2017

Hemp Oil and Cannabidiol (CBD) Marketers Warned by FDA Over Claims

On November 1, 2017, the FDA announced it issued warning letters to four companies promoting products containing cannabidiol (CBD), a compound derived from cannabis (also known as marijuana), for the treatment of cancer, as well as other diseases, such as Alzheimer's disease. In the U.S., cannabidiol is not permitted to be sold as an ingredient in dietary supplements.

(See ConsumerLab.com's CL Answer to the question Is CBD (cannabidiol) helpful? Is it legally available? >>) ConsumerLab.com will be testing products claiming to contain CBD and reporting results in the near future. (You can join the CL newsletter to be alerted when results are published.) 

The FDA's news release explained, "Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective." 

Use the links below to read the warning letter for each company:

  • That's Natural! Marketing & Consulting, promoted its CBD All-Natural Hemp Oil and other CBD products with statement such as "Scientific research by doctors have shown it actually kills cancer cells and provides a protective coating around our brain cells."
  • Green Roads of Florida LLC, promoted its CBD products, including CBD Oil and CBD Tincture with statements such as "CBD [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow," and "Almost all studies recognize CBD's potential in preventing both cancer spread and growth..."
  • Natural Alchemist, which sells product such as Natural Alchemist CBD (Cannabidiol) Capsules and Natural Alchemist 300mg Hemp Oil drops promoted its products with statements such as "Combats tumor and cancer cells."
  • Stanley Brothers Social Enterprises, LLC, which sells product such as Everyday Dietary Supplement promoted its products with statements such as "A patient of mine uses this for Cancer and it gives lots better relief than prescription drugs!"
FDA Commissioner Scott Gottlieb also explained, "We recognize that there's interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process - not through unsubstantiated claims made on a website." 

Unlike other compounds found in cannabis, such as THC, cannabidiol is not a psychoactive compound. Preliminary evidence suggests cannabidiol may modestly reduce anxiety, and certain measures of dystonia (a movement disorder) and glaucoma in some people (Health Canada 2013). In the U.S. cannabidiol has been authorized for investigation as a new drug for cancer pain and a rare form of epilepsy, Dravet's syndrome. Cannabidiol appears to be a controlled substance in Canada. 

The FDA has published the amounts of CBD, THC and other cannabis compounds found in its recent testing these products, as well as from tests of other products in 2015. Many were found to not contain the levels of CBD they claimed to contain and the FDA cautions that "Consumers should beware purchasing and using any such products." Most products contained very small concentrations of CBD, similar to what is normally found in hemp oil (about 0.0025%), while others contained very large amounts of CBD (25% to 35%) yielding doses similar to those used in clinical trials (typically 200 mg or more per day). 

See related recalls and warnings:

Cannabis Compound Not Permitted in Supplements, FDA Warns

To read the FDA's news release, use the link below.