FDA and the Regulation of CBD-Infused Dietary Supplements


Cannabidiol (CBD), an active ingredient in cannabis, but without the high, has been finding its way into everything from dog treats to coffee and body lotion to bath bombs. With that growing popularity comes questions about how CBD should be regulated.

The Food and Drug Administration treats substances derived from CBD just like any other substances and they are subject to the same authorities. However, as laws and the market for CBD have changed, the FDA has made it clear that its role in the regulation of CBD also is evolving.

Under its statutory authority, if a product is marketed as a drug, then it’s regulated as such and can’t be sold without FDA approval (or, in the case of an over-the-counter drug, an FDA monograph).

However, food and dietary supplements are regulated differently and it is illegal to market CBD as, or in, a dietary supplement.

In July, the FDA issued a warning letter to Curaleaf Inc., a Massachusetts-based company that sells products infused with CBD. The letter cited the company for marketing and selling a wide range of products and making “unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.”

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019

The FDA pointed to Curaleaf’s website, social media sites and blogs, in which the company promoted everything from pain-relief patches to CBD oil used to treat anxiety.

Curaleaf issued a press release in which it said it would review all of its claims and take action. It also noted that its products “are all derived from hemp and meet the requirements of the Farm Bill,” which in 2018 legalized the commercial production of hemp, so long as the THC concentration does not exceed 0.3 percent.

https://www.prnewswire.com/news-releases/curaleaf-responds-to-fda-letter-300889588.html

Shortly thereafter, the company scrubbed its website and deleted social media posts that the FDA determined to be in violation of federal law and FDA regulations.

https://www.prnewswire.com/news-releases/curaleaf-responds-to-fda-letter-300889588.html

Curaleaf isn’t the only company to have received a warning letter this year. In March, the FDA and Federal Trade commission jointly issued three warning letters to companies selling products containing CBD.

Relievus, a chain of pain clinics operating in New Jersey and Pennsylvania, received a warning letter citing unsubstantiated claims the company made about its products’ ability to limit, treat or cure a number of serious diseases and conditions including cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/advanced-spine-and-pain-llc-565256-03282019

Relievus also was told it was in violation of Federal Trade Commission rules regulating the advertising of their product.

Nutra Pure LLC, based out of Vancouver, Washington also receive a joint warning letter for marketing its CBD infused products as dietary supplements used to treat everything from anxiety to Alzheimer’s disease.

https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nutra-pure-llc-567714-03282019

Fort Lauderdale, Fla.-based Pot Network Holdings was the third company to be cited for the sale and marketing of its Liquid Gold gummies and blue C.B.D. crystals isolate.

In May, the FDA conducted a public hearing to allow those who have a stake in the growing CBD industry to provide scientific data and other information related to cannabis and cannabis-derived compounds, including CBD.

FDA noted there are a number of questions that still need to be answered about the use of CBD products outside of the approved drug context. Among them are:

  • How much CBD is safe to consume in a day? How does it vary depending on what form it’s taken?
  • Are there drug interactions that need to be monitored?
  • What are the impacts to special populations, like children, the elderly, and pregnant or lactating women?
  • What are the risks of long-term exposure?

So far, the FDA has only approved the use of CBD as a treatment for two rare forms of epilepsy.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms
The FDA notes that it will continue to work toward a new regulatory framework for the use of CBD, while at the same time continuing to protect consumers from unsubstantiated claims.

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The information provided is meant to be a guide and not meant to be a substitute for professional advice. Readers are responsible for making their own assessment of the information presented here and any use of our products based on such information.

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