FDA Warns 15 Companies Selling “Snake Oil” Cannabidiol Products

On Nov. 25, 2019, the Food and Drug Administration (FDA) announced that it had issued warning letters to 15 U.S. companies for selling cannabidiol products in ways that violate the Federal Food, Drug, and Cosmetic Act.[1] Other, similar letters involving cannabidiol have been issued by the agency in recent years.[2]

Cannabinoids are a group of substances found in the cannabis plant.[3] There are two main cannabinoids: tetrahydrocannabinol (or THC) and cannabidiol. Unlike THC, the major psychoactive ingredient found in marijuana, cannabidiol does not produce a “high”, which is characterized by a feeling of intense excitement and happiness.[4]

The FDA has approved only one purified form of cannabidiol,[5] the prescription oral solution EPIDIOLEX, which is used treat seizures associated with two rare and severe forms of childhood-onset epilepsy (Lennox-Gastaut syndrome and Dravet syndrome).[6]

All other cannabidiol products are marketed illegally in a variety of forms, including capsules, syrups and oil drops; topical lotions and creams; and food products, including chocolate bars and teas.

Grounds for FDA crackdown

In the announcement regarding the warning letters, the FDA noted that the violating companies are making claims on product web pages, online stores and social media that their cannabidiol products can be used for certain diseases and conditions, such as Alzheimer’s disease, antibiotic-resistant infections, cardiovascular disease, cancer, Crohn’s disease, diabetes, rheumatoid arthritis, schizophrenia, anxiety, depression and chronic pain.[7]

However, the agency has not approved these products for the diagnosis, cure, mitigation, treatment or prevention of any of these diseases or conditions, and promotion of cannabidiol for such uses is illegal.

The FDA explained that it requires drug manufacturers to conduct clinical trials that demonstrate that their products are effective and safe for specific intended uses. These studies also need to show the appropriate dose for each drug and how that drug could interact with other FDA-approved drugs. Except for the maker of Epidiolex, cannabidiol manufacturers have neither pursued such studies nor sought FDA approval for their marketed products. Moreover, the manufacturing processes for these products have not been inspected by the agency, which is another essential step in the drug approval process.

The FDA noted that it recently has tested the chemical content of cannabidiol compounds in some of these illegally marketed products and found that many of them do not contain the cannabidiol levels claimed by these companies.[8]

Importantly, the FDA is particularly concerned that some of these products are marketed for children and infants, who are likely at an increased risk of adverse effects of cannabidiols because they are less capable than adults of processing and excreting these substances.

Some of the warned companies market their cannabidiol products as dietary supplements, although they do not qualify as dietary supplements under the Food, Drug, and Cosmetic Act.

Other companies are selling cannabidiol as a food additive, which is illegal because federal law prohibits the sale of any food to which certain drug ingredients, such as cannabidiol, have been added. Also, there is no food-additive regulation that permits the use of cannabidiol as an ingredient in human or animal food.

Risks of cannabidiols

In addition to the largely unproven benefits of cannabidiols, their risks have not been well-studied. The FDA outlined certain potential risks associated with cannabidiols, such as liver injury.

The agency also noted that these products may impede fertility in men because animal studies show that they can interfere with sperm and testosterone production and can impair sexual behavior.

Cannabidiols also interact with many medications (particularly those that are broken down by the liver), which can either decrease or increase the effects of these medications.[9]

The adverse effects of these products include changes in alertness (either drowsiness or insomnia), gastrointestinal symptoms (such as abdominal pain, upset stomach, decreased appetite or diarrhea) and changes in mood (agitation and irritability).

There also have been reports of potentially unsafe levels of contaminants, such as pesticides and heavy metals, being found in cannabidiol products.

The FDA cautioned that the effects of cannabidiols on vulnerable populations, such as children, adolescents, the elderly, and pregnant or breastfeeding women, are not known.

Furthermore, the agency is still looking into the effects of cumulative exposure of these products in various amounts and routes (such as through skin or food) over time.

What You Can Do

Do not take any cannabidiol drug or supplement because they have not been shown to be effective or safe, contrary to the claims made by those selling them illegally. The only exception is taking Epidiolex for certain types of childhood-onset epilepsy when prescribed by a health care professional with appropriate monitoring for liver and other adverse effects. Likewise, do not take, or give your pets, any foods that contain these or other unapproved products.

If you have a medical condition or disease, seek medical help to learn about the best way to treat it with approved medications, as applicable.

Report all serious adverse events related to cannabidiol or similar products to the FDA’s MedWatch adverse event reporting program by visiting http://www.fda.gov/ MedWatch or by calling 800-FDA-1088.
 

References

[1] Food and Drug Administration. FDA news release: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns. November 25, 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Accessed March 31, 2020.

[2] Food and Drug Administration. Warning letters and test results for cannabidiol-related products. November 26, 2019. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. Accessed March 31, 2020.

[3] National Center for Complementary and Integrative Health. Cannabis (marijuana) and cannabinoids: What you need to know. November 2019. https://www.nccih.nih.gov/health/cannabis-marijuana-and-cannabinoids-what-you-need-to-know. Accessed March 31, 2020.

[4] Harvard Health Publishing. Cannabidiol (CBD) — what we know and what we don’t. August 27, 2019. https://www.health.harvard.edu/blog/cannabidiol-cbd-what-we-know-and-what-we-dont-2018082414476. Accessed March 31, 2020.

[5] Food and Drug Administration. FDA news release: FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns. November 25, 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details. Accessed March 31, 2020.

[6] Greenwich Biosciences. Label: cannabidiol (EPIDIOLEX). November 2018. https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365s002lbl.pdf. Accessed March 31, 2020.

[7] Food and Drug Administration. Warning letter to Natural Native LLC. November 22, 2019. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/natural-native-llc-593385-11222019. Accessed March 31, 2020.

[8] Food and Drug Administration. Warning letters and test results for cannabidiol-related products. November 26, 2019. https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products. Accessed March 31, 2020.

[9] Food and Drug Administration. What you need to know (and what we’re working to find out) about products containing cannabis or cannabis-derived compounds, Including CBD. March 5, 2020. https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis. Accessed March 31, 2020.