FDA Issues Warnings About CBD Products

By Daniel Shortt

Companies are allegedly making medical claims about cannabis products and the federal government has taken notice.

A depression era bottle of cannabis extract.

A depression era bottle of cannabis extract.

The cannabis plant contains dozens of compounds called cannabinoids, the two most prominent being tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is known for having a psychoactive effect. In contrast, CBD has a very mild or no psychoactive effect. CBD has gained notoriety in part due to reports that it is effective in treating severe seizures in children. One of the most famous stories is that of Charlotte Figi, who successfully used high-CBD marijuana to treat symptoms of Dravet’s Syndrome. A strain of cannabis that has a high CBD and low THC content called Charlotte’s Web was named in her honor.

As CBD gains recognition as a effective medicine, its market potential is growing rapidly. The Federal Government has taken notice, with the Drug Enforcement Agency (DEA) recently easing restrictions which inhibit universities from studying CBD. In turn, many companies have started to sell high CBD products online. The has garnered some attention from another federal agency, the Food and Drug Association (FDA).

Generally, when a company makes a medical claim about a product, the FDA classifies the product as a drug. Under the Federal Food, Drug and Cosmetic Act (FDCA), new drugs are not allowed to enter the market without first being tested by the FDA unless they meet the definition of a dietary supplement (which doesn’t require such testing). When these types of claims are made without the requisite testing, the FDA takes action under the FDCA. The FDA does not consider CBD to be a dietary supplement; it considers CBD to be a new drug. The testing required to approve a new drug costs millions of dollars. Additionally, CBD is still illegal under federal law because it is derived from cannabis which serves as another barrier to FDA approval. However, these impediments have not deterred some companies from making medical claims about CBD products.

In early February, the FDA issued a series of warning letters to companies allegedly making unfounded medical and therapeutic claims about their CBD products. For example, in a letter to a Michigan Herbal Remedy, the FDA took issue with the following statements listed on one of the company’s websites:

  • Gold Label Hemp Oil
    • “Studies show CBD is a natural anti-inflammatory with great potential towards issues including anti-anxiety, anti-pain, anti-psychosis, anti-spasm, and more.”
  • Blog post titled “CBD Neuroprotective Effects Shown in Studies”
    • “CBD . . . could have many properties including anti-inflammatory, anti-psychotic, anti-tumor, and more.”
  • Blog post titled “Research on CBD Anti Inflammatory Effects”
    • “Research suggests that cannabidiol may be a useful tool for reducing systemic inflammation, application towards multiple sclerosis, and implications from colorectal cancer.”
    • “CBD provided long-lasting protection against the deleterious effects of inflammation in a viral model of multiple sclerosis . . ..”

The practice of issuing these warning letters is not a new one. Last year, the FDA issued similar warning letters to companies making medical claims about their CBD products.

These companies should have a few days to comply or respond to the letters, so it is unclear whether they will continue to sell these products or to make these claims. The issues raised here are very complicated. The legality of CBD itself is far from clear. We will continue to observe this story as it continues to develop and encourage you to ask us questions in the comment section.

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