FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims - FDA.gov

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Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety - FDA.gov

Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

According to the news release:

"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases."  ... 

"The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

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What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

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Read the FDA article: What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD - FDA.gov

According to the FDA article:

"The FDA is committed to sound, science-based policy. The FDA is raising these safety, marketing and labeling concerns with you now because we want you to know what we know. We hope that you will provide any data that you have to the public docket.

Today’s Consumer Update includes a practical summary of what we know to date. As we learn more, our goal is to update you with the information you need to make smart choices about CBD products. Also, as the regulatory pathways are clarified we will take care to notify all stakeholders as quickly as possible.

More information is available at: FDA Regulation of Cannabis and Cannabis-Derived Products: Questions and Answers."

FDA releases statement underlining their powers to manage a selection of cannabis products

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Read the entire press release:  FDA issues statement underlining their powers to manage a selection of cannabis products on FDA.gov

"Today, the Agriculture Improvement Act of 2018 was signed into law. Among other things, this new law changes certain federal authorities relating to the production and marketing of hemp, defined as cannabis (Cannabis sativa L.), and derivatives of cannabis with extremely low (less than 0.3 percent on a dry weight basis) concentrations of the psychoactive compound delta-9-tetrahydrocannabinol (THC). These changes include removing hemp from the Controlled Substances Act, which means that it will no longer be an illegal substance under federal law. 

Just as important for the FDA and our commitment to protect and promote the public health is what the law didn’t change: Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act. In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways for products containing cannabis and cannabis-derived compounds."

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