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FDA Cracks Down on Illegal Marketing of CBD Products

marijuana and cannabis oil bottles

Nov. 26, 2019 -- The FDA is warning people to be cautious when buying foods or supplements that claim to contain CBD.

The agency says many of the flood of new CBD products being sold in stores and online are being marketed illegally, have not been reviewed for safety, and may pose harm to people who take them.

Some of those harms include liver damage and drug interactions. CBD can also make people feel sleepy and alter mood, causing irritability and agitation.

FDA also says not enough is known about the health effects of taking CBD. For example, is it harmful to take it long term? Could it harm a developing fetus or a breastfed baby? Does it interact with other herbs and botanicals?

That’s assuming all that the products contain is CBD. Recent lab testing by the company LegitScript found some CBD products contaminated with high amounts of lead and ethylene oxide, a cancer-causing gas that’s sometimes used to sterilize spices. The tests also found that many of the products contained much less or more CBD than they claimed.

On Monday, the FDA sent a new round of 15 warning letters to companies that market CBD products online. The letters warn the companies that the products they sell are claiming to cure or prevent disease, which is illegal under the Food, Drug, and Cosmetic Act. Seven similar letters were sent earlier this year.

In taking action, the FDA is trying to rein in what has become a red-hot market for the alternative therapy, which claims to do everything from treat pain to prevent diabetes and seizures, improve mood, and help sleep. CBD products are so popular that market research firm BDS Analytics estimates U.S. sales tallied $1.9 billion in 2018 and are only expected to surge, reaching $20 billion by 2024.

The FDA has only approved one drug derived from CBD, brand named Epidiolex, which treats two rare and severe seizure disorders in children over the age of 2. It is only available by prescription.

The agency also warned companies that adding CBD to foods or dietary supplements is illegal because it has not been declared to be GRAS, or generally recognized as safe.

The FDA was careful to make a distinction between oil or powder that comes from hemp seeds and oil that comes from the rest of the hemp plant. Hemp seeds, and the oil and powder made from hemp seeds, has been declared GRAS, but products must be labeled as containing hemp seed. Hemp seeds, the agency notes, do not naturally contain either CBD or THC. THC is the chemical in cannabis plants that makes people feel high.

The National Organization for Reform of Marijuana Laws (NORML) cheered the FDA’s actions. NORML has been urging the agency to move more quickly to regulate the production, marketing, manufacturing, and testing of CBD products, citing both confusion over the legality of such products and a greater number of predatory companies that have becoming increasingly pervasive in this space.

The U.S. Hemp Roundtable also applauded the agency for taking action against CBD sellers who were breaking the law. But they took issue with the agency’s decision that CBD could not be considered GRAS. In a statement posted to their website, the Roundtable said the decision “overstates the health risks of hemp-derived CBD and that ignores much of the scientific evidence of CBD’s safety, in particular at dosage levels typically found in foods and dietary supplements.”

WebMD Health News Reviewed by Neha Pathak, MD on November 26, 2019

Sources

News release, FDA.

National Organization for Reform of Marijuana Laws (NORML).

NORML, RE: Docket No. FDA-2019-N-1482 for “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments, May 10, 2019.

U.S. Hemp Roundtable.

BDS Analytics.

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