The FDA recently sent warning letters two four CBD companies.
Written by Orion Inskip, Attorney at Gleam Law, PLLC.
The Federal Drug Administration (FDA) regulates medicine throughout the United States. Their power flows from the Federal Food, Drug, and Cosmetic Act (FDCA), enacted by Congress in 1938. Under the FDCA companies cannot advertise that a drug will benefit someone’s health or treat any illness unless those claims and that drug have passed FDA review procedures.
Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting and Stanley Brothers Social Enterprises LLC each learned this the hard way. The FDA sent warning letters to each, demanding that they not make medical claims nor advertise their products as medical drugs. All four companies produce cannabidiol (CBD) products such as tinctures, oils, edibles, and dabs.
The FDA regularly sends warning letters to food and supplement companies warning them to comply with the FDCA. These four companies and many other cannabis firms scattered across the US have long been a target. More than 90 warning letters were issued against Cannabis companies in the last ten years and more than a dozen this year alone. These four more cannabis and hemp producers can now join that select and infamous club.
The way to avoid these threatening letters is either not make any medical claims in advertising or gain formal approval from the FDA to sell your product as a pharmaceutical drug with verifiable medical applications.
Gaining FDA approval is hard for any drug, but for Cannabis, it is practically impossible. Compared to most pharmaceuticals, relatively little research exists on medical cannabis that measures up to FDA standards. That lack of research makes it very hard to prove any of the health claims.
Th lack of data on medical cannabis is mostly due to restrictions on research under the Controlled Substances Act (CSA). The CSA is a federal law that classifies cannabis is a schedule 1 drug. That means that, legally, it has no useful purpose, is not safe to use (even under medical supervision), and is highly addictive. Because federal law declares that cannabis has no useful purpose, research into its effects and uses is extremely limited.
Public opinion and many policymakers agree that cannabis has valid medical uses and can be safe for consumers. That is shown by the fact that 29 states have legalized medical marijuana in one form or another. Public opinion and state law do not limit the power and reach of the FDA.
The medical claims that the FDA cited in these four most recent letters included consumer testimonials that CBD will help or cure conditions such as Alzheimer’s disease, bipolar disorder, asthma, and cancer. Because these claims have not been proven scientifically to FDA standards, the FDA views them as violations of the FDCA.
So, if you are a cannabis company, how can you avoid FDA scrutiny?
A cannabis company can avoid the FDA’s ire by never making a claim or suggestion that their products are medical drugs, treat any illness, cure any condition, or will improve health. Those limitations are not limited to your statements. They undoubtedly include customer testimonials if the company displays those testimonials on their website or other advertisements.
This limitation conflicts with the most basic purpose of medical marijuana as authorized by 26 states’ laws. That conflict between the states and the federal government sits at the heart of current cannabis law and is exactly why changes to Federal cannabis policy area are absolutely necessary.