FDA Sends Warning Letters to Curaleaf

By Aaron G. Biros
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• July 24, 2019


• Categories: Business Analysis, Concentrates & Extracts, Dispensaries & Retail, Edibles & Processing, Product Development, Regulatory

Curaleaf Hemp, a well-known and publicly traded cannabis company, made headlines this week for all the wrong reasons. The US Food & Drug Administration (FDA) sent a warning letter to Curaleaf President Joseph Lusardi for making unsubstantiated health claims and for misbranding their products as drugs.

The health claims in question appear to be removed from their website and social media accounts. In the warning letter, the FDA cites numerous claims made on Curaleaf’s website, Twitter and Facebook accounts. You can check out the health claims they found here, but it’s essentially a list of instances where Curaleaf said their products can be used to treat specific conditions. They claimed their CBD vape pen can be used for chronic pain and said another one of their products is a “[S]oothing tincture for chronic pain.”

For most of the health claims the FDA cited, it appeared they were articles or blog posts on Curaleaf’s website. Take a look at some examples of statements that should not be posted on a CBD products website (taken from the warning letter found here):

• “CBD has also been shown to be effective in treating Parkinson’s disease.”
• “CBD has been linked to the effective treatment of Alzheimer’s disease . . ..”
• “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
• “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
• “CBD has been demonstrated to have properties that counteract the growth of spread of cancer.”
• “CBD was effective in killing human breast cancer cells.”
• “Heart disease is one of the leading causes of death in the United States each year, and CBD does a number of things to deter it. The two most important of these are the ability to lower blood pressure, and the ability to promote good cholesterol and lower bad cholesterol.”

While the FDA is expediting their push to roll out hemp and CBD regulations, companies should still be cautious when marketing their products for interstate commerce. Dr. Amy Abernathy, Principal Deputy Commissioner and Acting CIO, said in a series of tweets earlier this month that the FDA is eager to get to work and plans to report on their progress by the end of summer. The public hearing they held back in May helped jumpstart their efforts to begin investigating regulation of the market.

Still, companies need to be careful when marketing CBD products. The FDA has made it abundantly clear in a lot of warning letters that drug claims are not allowed. Here are two articles that give advice on how companies should proceed with marketing and how to go about properly labeling their products.