By: Jessica Wasserman and Nabil Rodriguez*
Today FDA Commissioner Scott Gottlieb, M.D., announced that the FDA would hold a public hearing on May 31
st to give stakeholders an opportunity to comment on new steps to advance the agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products. This much-anticipated hearing is viewed as the first step toward FDA establishing a regulatory pathway for CBD as a dietary supplement or food ingredient.
The hearing announcement was accompanied by a statement from Commissioner Gottlieb that reaffirmed FDA’s commitment to establishing a regulatory framework: “Ultimately, we remain 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. The actions we’re announcing today will allow us to continue to clarify our regulatory authority over these products and seek input from a broad range of stakeholders and examine a variety of approaches and considerations in the marketing and regulation of cannabis or cannabis-derived products, while continuing to protect the public’s health and safety.”
Specifically, the FDA is asking for information from stakeholders on safety and the impact on drug research incentives:
“As part of the public hearing and related public comment period, the agency is interested in whether there are particular safety concerns that we should be aware of as we consider the FDA’s regulatory oversight and monitoring of these products. For example, we’re seeking comments, data and information on a variety of topics including: what levels of cannabis and cannabis-derived compounds cause safety concerns; how the mode of delivery (e.g., ingestion, absorption, inhalation) affects the safety of, and exposure to, these compounds; how cannabis and cannabis-derived compounds interact with other substances such as drug ingredients; and other questions outlined in the hearing announcement.
Additionally, we’re interested in how the incentives for, and the feasibility of, drug development with CBD and other cannabis-derived compounds would be affected if the commercial availability of products with these compounds, such as foods and dietary supplements, were to become significantly more widespread. We don’t want companies to forgo research that might support approval through the FDA’s drug review process, which could potentially lead to important safe and effective therapies. We also don’t want patients to forgo appropriate medical treatment by substituting unapproved products for approved medicines used to prevent, treat, mitigate or cure a particular disease or condition. For example, in the case of Epidiolex, the adequate and well-controlled clinical studies that supported its approval, and the assurance of manufacturing quality standards, can provide prescribers confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes. It’s important that we continue to assess whether there could be medical ramifications if patients choose to take CBD to treat certain diseases at levels higher or lower than studied in well-controlled clinical studies.”
Along with the announcement and details about the hearing, the FDA issued several new warning letters along with some strong language about the danger of certain claims:
“Today, the FDA is announcing that it has issued warning letters, in collaboration with the Federal Trade Commission, to three companies – Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC, and PotNetwork Holdings Inc. – in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites. 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. Examples of claims made by these companies include:
“CBD successfully stopped cancer cells in multiple different cervical cancer varieties.” “CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.” “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.” “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. 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.” “Cannabidiol May be Effective for Treating Substance Use Disorders.” “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.” “CBD may be used to avoid or reduce withdrawal symptoms.”
I believe these are egregious, over-the-line claims and we won’t tolerate this kind of deceptive marketing to vulnerable patients. The FDA continues to be concerned about the proliferation of egregious medical claims being made about products asserting to contain CBD that haven’t been approved by the FDA, such as the products and companies receiving warning letters today. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. Often such products are sold online and are therefore available throughout the country.
Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk. These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. Additionally, because they are not evaluated by the FDA, there may be other ingredients that are not disclosed, which may be harmful.”
*Nabil Rodriguez is not an attorney