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FDA, FTC Warn CBD Sellers About Making Disease-Treatment Claims

Agencies say health benefits need to be backed by evidence

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Federal agencies sent warning letters Tuesday to three companies that sell products containing cannabidiol (CBD), a chemical component of marijuana and hemp, and claim to treat Alzheimer’s disease, cancer and other diseases.

The joint letters from the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) highlighted potential legal consequences of making “unsupported health and efficacy claims” in advertising and urged the companies to review all product claims to ensure they are supported with “reliable scientific evidence.”

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CBD, though a marijuana derivative, is not associated with intoxication, according to a report by the World Health Organization.  

“In humans, CBD exhibits no effects indicative of any abuse or dependence potential…. To date, there is no evidence of public health-related problems associated with the use of pure CBD,” the World Health Organization said in 2017. 

The FDA and FTC letters said they are concerned, however, with claims that the products can alleviate symptoms or cure serious diseases. The federal agencies sent letters to officials associated with CBDPure, Diamond CBD and Relievus, which sell a variety of CBD products such as oils, infused gummies, creams and soft gels.

The FDA said examples of claims made by these companies include:

  • “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
  • “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
  • “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders”

The letters instruct the companies to notify the FTC within 15 days of their proof supporting the claims.

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Young Lee, M.D., the CEO and president of Relievus, told AARP that “CBD products have been an excellent treatment option for some patients who have different types of pain disorders with chronic inflammation, anxiety and many other associated symptoms.” But he added that Relievus will “comply fully with the FDA.”

He said that with CBD, some patients have been able to avoid or decrease their use of opioid painkillers, which are addictive and have led to overdose deaths across the country.  

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“CBD products are not covered by the insurance, and the patients have to purchase these products with cash or credit cards,” Lee said in an email. “If these products are not working, the patients would not spend $50 to $100 for these products,” he said.

Nevertheless, he said his company has removed its CBD web page, stopped posting ads on social media and is holding off on selling CBD products until it can communicate clearly with the FDA on the rules and regulations. 

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The other two companies, CBDPure and Diamond CBD, appear to have removed the heath claims cited by the government from their websites. They did not immediately respond to requests for comment.

Peter Grinspoon, a primary care physician at Massachusetts General Hospital, instructor at Harvard Medical School and board member of the advocacy group Doctors for Cannabis Regulation, told AARP: “I’m sort of glad the FDA is going after these outrageous claims.… CBD is a pretty nontoxic substance, so people will have a hard time harming themselves from it. But at the same time, if they use it to forgo other treatments, such as chemotherapy, that’s obviously very harmful.”

In June 2018, the FDA approved the first drug containing CBD, Epidiolex, to treat rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome.

The FDA said it is aware that CBD products are being used for the treatment of a number of other medical conditions but it has not approved a “marketing application” for broad usage. It “relies on applicants and scientific investigators to conduct research,” the FDA said on its website, which adds its role is to “review data submitted to the FDA in an application for approval.” 

The FDA will hold a public hearing on May 31 in Silver Spring, Md., for stakeholders to share their experiences with CBD. Additionally, it said it's forming a “high-level internal agency working group” to explore ways for dietary supplements and foods containing CBD to be lawfully marketed.

Consuming a CBD product can raise levels of other medications in your blood, the same way grapefruit juice does, Grinspoon said in a blog post. If you decide to try CBD, he recommended talking to your doctor to make sure it won’t affect other medications you are taking. 

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