Washington, DC–Before vacating his office on April 5, former FDA Commissioner Scott Gottlieb, M.D., shared his thoughts on the most efficient pathway to legalize CBD. As WholeFoods previously reported, Dr. Gottlieb attended his final hearing before a Senate appropriations subcommittee in March. When questioned about CBD, he stated that the FDA was using enforcement discretion, taking action against manufacturers making “over-the-line claims.”
Such action was seen in early April, when FDA published three warning letters, issued jointly with the FTC, to three companies selling CBD: Advanced Spine and Pain, LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings, Inc.
In a statement on April 2, Dr. Gottlieb explained that the letters were made in response to the companies making unsubstantiated claims related to more than a dozen different products on multiple product webpages, online stores and social media sites. “The companies used these online platforms to make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval,” Dr. Gottlieb wrote. Examples of claims, as outlined on the FDA’s announcement:
- “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
- “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
- “CBD has demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
- “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
“I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients,” Dr. Gottlieb wrote, noting that FDA will continue to monitor the marketplace and take enforcement action as needed.
That said, Dr, Gottlieb concluded, FDA is “committed to exploring an appropriate, efficient and predictable regulatory framework to allow product developers that meet the requirements under our authorities to lawfully market these types of products.”
In the announcement, Dr. Gottlieb also outlined additional news steps to advance FDA’s evaluation of potential regulatory pathways for cannabis-containing and -derived products, including a public meeting, titled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds” that has been set for May 31, from 8:00 a.m. to 6:00 p.m. at FDA’s White Oak Campus in Silver Spring, Maryland. Details can be found here.
FDA will also form a working group, which will be charged with looking to potential legislative pathways to create a framework for getting dietary supplements and/or conventional foods containing CBD to be lawfully marketed. In past discussions on this topic, Dr. Gottlieb has said, “I think the most efficient way to get to a pathway would be through legislation, probably that would just be legislation specific to CBD.”
FDA will also be updating its webpage with answers to frequently asked questions to help the public understand how FDA’s requirements apply to CBD products.
Within the industry, the American Herbal Products Association (AHPA) had previously announced that it adopted a Guidance Policy for dietary supplement and food products containing hemp and CBD to help ensure that the industry complies with existing regulations. The policy recommends that any manufacturer, labeler, packer, holder, or marketer of dietary supplements or foods that contain hemp or CBD comply with federal regulations including:
- food facility registration;
- current good manufacturing and good agricultural practice regulations;
- labeling requirements, including nutrition labeling, allergen disclosure, listing of required contact information, absence of drug claims, etc.;
- new dietary ingredient and food additive provisions, where applicable; and
- applicable obligations for timely submission to FDA of any received serious adverse event reports associated with their products;
AHPA president Michael McGuffin said, “Hemp and CBD companies should maintain compliance with established regulations for dietary supplement and food products to ensure quality and safety.”