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FDA Cracking Down On Unsubstantiated Claims

What can we learn from the latest warning letters

Recently the FDA issued two dozen warning letters to companies for making unproven health claims about their CBD products. Curaleaf a well-known name in the industry was the most notable.


The FDA stated that Curaleaf made “unfounded claims about more than a dozen different CBD products” on its product webpages, online store and social media platforms. Some of the claims highlighted were the following:


• “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.


The official warning letter can be found Here


Curaleaf was given 15 working days to correct any violations. Since then Curaleaf has removed all statements from its blog, website and social media that the FDA identified as noncompliant.


Curaleaf CEO Joseph Lusardi said in a statement. “Our industry needs, wants and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace”.


In a news release, acting FDA Commissioner Dr. Ned Sharpless stated “Today’s action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer or Alzheimer’s disease”.


He also stated that "Selling unapproved products with unsubstantiated therapeutic claims -- such as claims that CBD products can treat serious diseases and conditions -- can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD".


While the FDA is expediting their push to roll out CBD regulations, companies should still be cautious when marketing their products. The FDA has made it clear that CBD companies should not make unsubstantiated health claims about their products. Unproven therapeutic claims should not appear on a company’s website, marketing materials, product labels, blogs or social media platforms.