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 LLCand PotNetwork Holdings, Inc.
In astatementon 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.”
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 foundhere.
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. Inpast discussionson 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, theAmerican Herbal Products Association(AHPA) had previously announcedthat 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;
