The FDA recently warned some companies against selling CBD goods in ways that breach the old FD&C Act. For your information, the FDA is a federal agency that also establishes CBD laws and regulations. The companies that got the warning letters from the FDA were marketing CBD goods in ways that were not yet approved.
As of January 2021, the federal agency has approved just a single CBD item as a treatment option, for certain forms of epileptic seizures. That means it is federally permissible to market cannabidiol for Epidiolex, that FDA-approved product with CBD oil for seizures.
The goods in the agency’s letters are yet to undergo its drug approval procedure, so it regards these as unapproved drugs. The so-called FD&C Act defines a drug as follows.
- Any item meant for diagnosing, mitigating, preventing, treating, or curing a disease.
- Any product except for a food item that is meant to have an effect on the human/animal body function or structure.
One of those CBD companies’ claims was that cannabidiol may lessen rheumatoid arthritis- and multiple sclerosis-related pain, depression, anxiety, cancer treatment-related symptoms, and acne. The interesting thing is that the above-mentioned claim may be true, but making it directly breaches the federal government’s FD&C Act. Another company claimed that cannabidiol could aid in dealing with rheumatoid arthritis and PTSD.
It stands to reason that all of those claims are genuine, but the FDA would not allow making these until more scientific research backs them.
Delivering the warning notices means that the marketing aspect of CBD goods is still on the FDA’s radar. Amy Abernethy of the FDA said something that suggests the lawful marketing of CBD goods is in the agency’s plans. She said that the FDA stays focused on investigating possible pathways for the goods to be legally marketed, at the same time as educating people on CBD safety-related questions.
On the other hand, the agency would keep monitoring and taking action, when required, against companies that illegally promote their goods, said Abernethy. At the center of the recent FDA action is the Federal Food, Drug, and Cosmetic Act, which authorizes the agency to oversee drug safety. While many regard cannabidiol as a dietary supplement, it is a product with medicinal properties. Therefore, the laws that come in the aforesaid act also applies to cannabidiol.