FDA News

FDA warns company for selling unapproved CBD products to treat Alzheimer’s, cancer, opioid withdrawal

Ned Sharpless

The FDA has issued a warning letter to Curaleaf Inc. for illegally selling unapproved products containing cannabidiol, or CBD, online, claiming to treat Alzheimer’s disease, cancer, opioid withdrawal, pain and other conditions, according to a press release.

The FDA issued the warning letter because the company used product webpages, its online store and social media to make unproven and unapproved claims about more than a dozen different CBD products and their benefit regarding cancer, chronic pain, opioid withdrawal, pet anxiety and mental health disorders — such as Alzheimer’s disease, anxiety, depression, ADHD, PTSD and more. The Agency has requested Curaleaf respond within 15 working days on how it will fix the violations.

“Consumers should beware of purchasing or using any such products,” Ned Sharpless, MD, acting FDA Commissioner, said in the release. “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.”

Consumers should talk to a health care professional about the best way to treat diseases or conditions with approved treatments, according to the FDA, which also cautions pet owners against the use of such products and recommends talking with a veterinarian about appropriate treatments for their pets, according to the release.

Although CBD is marketed in a variety of product types, often online, the FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, according to the release. Responding to interest in products containing cannabis or cannabis-derived compounds, the FDA continues to address the regulation of products made from CBD that fall under its jurisdiction and explore potential pathways for various types of CBD products to be lawfully marketed.

Ned Sharpless

The FDA has issued a warning letter to Curaleaf Inc. for illegally selling unapproved products containing cannabidiol, or CBD, online, claiming to treat Alzheimer’s disease, cancer, opioid withdrawal, pain and other conditions, according to a press release.

The FDA issued the warning letter because the company used product webpages, its online store and social media to make unproven and unapproved claims about more than a dozen different CBD products and their benefit regarding cancer, chronic pain, opioid withdrawal, pet anxiety and mental health disorders — such as Alzheimer’s disease, anxiety, depression, ADHD, PTSD and more. The Agency has requested Curaleaf respond within 15 working days on how it will fix the violations.

“Consumers should beware of purchasing or using any such products,” Ned Sharpless, MD, acting FDA Commissioner, said in the release. “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.”

Consumers should talk to a health care professional about the best way to treat diseases or conditions with approved treatments, according to the FDA, which also cautions pet owners against the use of such products and recommends talking with a veterinarian about appropriate treatments for their pets, according to the release.

Although CBD is marketed in a variety of product types, often online, the FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy, according to the release. Responding to interest in products containing cannabis or cannabis-derived compounds, the FDA continues to address the regulation of products made from CBD that fall under its jurisdiction and explore potential pathways for various types of CBD products to be lawfully marketed.