FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety

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

Today, 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. “As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. 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 ...

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Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths

Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths

The U.S. Food and Drug Administration is alerting horse owners and veterinarians that one lot of a compounded combination drug product containing pyrimethamine and toltrazuril has been associated with adverse events in at least three horses. Two horses in Maine and one in Ohio ultimately died or were euthanized as a result.

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For all the compounding pharmacies that have received a 483 from the FDA the last several years what, if anything, have state boards of pharmacy done to fine or followup with these pharmacies? For state boards of pharmacy who have received referral letters from the FDA, how many of these pharmacies have state enforcement action been taken against? Are state boards of pharmacy doing a better or worse job since the DQSA was passed?