The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) recently made public three letters that they issued to companies that advertise and sell cannabidiol (CBD) products and make federally-unsubstantiated claims of associated health benefits.
The letters are consistent with recent statements made by FDA Commissioner, Scott Gottlieb who warned that the agency was sending multiple warning letters to companies that market CBD products with “egregious and unfounded claims aimed at vulnerable populations.”
On March 28, the FDA and FTC sent letters to Nutra Pure, Advanced Spine and Pain (Relievus), and PotNetwork Holdings, Inc., advising them that certain products for sale on their websites violate multiple federal regulations.
The letters cite numerous instances where CBD and hemp oil products are mislabeled as dietary supplements or advertised as treatments for conditions like cancer and Alzheimer’s disease without having the scientific data that is required by law.
The FDA requires manufacturers to possess reliable scientific evidence, including controlled human studies, to substantiate their claims before they can legally market products that are intended to prevent, treat, or cure a human disease.
Last year, the FDA gave final approval to G.W. Pharmaceutical’s CBD formulation, Epidiolex after it had been through substantial clinical trials.
In the letters, the FTC strongly urged the companies to review the claims for all of their products to be sure that they are supported by competent and reliable scientific evidence. They warned that violations of the FTC Act could result in a Federal District Court injunction or an Administrative desist order which may also require companies to reimburse customers.
The letters state that failure to comply promptly could result in legal action, including seizure and injunction.
The FDA is currently seeking public input as they work toward establishing federal regulations for the lawful marketing and interstate commerce of cannabis products.
Nutra Pure Letter
Advanced Spine and Pain/Relievus Letter
PotNetwork Holdings, Inc. Letter