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Companies have been promoting unsubstantiated health and treatment claims.
While more drug store chains and independent pharmacies are selling OTC products containing cannabidiol (CBD), pharmacies need to be wary about which products they carry.
The FDA has warned several CBD product manufacturers-including four so far this year-that are marketing the products as drugs with claims to treat conditions or diseases.
“As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products,” FDA says in a notice on its web site.
The agency most recently warned Curaleaf Inc. for illegally selling unapproved products containing CBD online. Labeling for Curaleaf’s CBD Lotion, CBD Pain-Relief Patch, CBD Tincture, CBD Disposable Vape Pen, and Bido CBD for Pets make unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, and other conditions, FDA says.
In March, FDA warned NutraPure about unsubstantiated claims for its Hemp Oil and CBD Softgels. On its web site, NutraPure included statements such as: “Science also shows that CBD has anti-emetic, anti-convulsive, anti-inflammatory and analgesic properties. Because all of these come into play with Alzheimer’s, particularly brain inflammation, CBD is a viable option for minimizing these effects within the brain.”
“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 causing them to delay important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” says Acting FDA Commissioner Ned Sharpless, MD, in a statement about the Curaleaf action.
FDA is still grappling with how it will regulate CBD products in the future. It established a high-level internal working group to explore potential pathways for CBD products to be lawfully marketed. The agency held a public hearing in May, and opened a docket for written comments, to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.
“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” says FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, in the Curaleaf statement.