It appears the days of unregulated CBD-based products are nearing an end.
On July 22, 2019 the Food and Drug Administration (“FDA”) sent a Warning Letter to a major producer and distributor of CBD in Florida and elsewhere. The FDA reviewed the company’s web site, which accepted orders for various CBD-infused products. The FDA concluded that the CBD products were “unapproved new drugs sold in violation of” various provisions of the Food and Drug Act (“Act”). Further, the agency concluded that the company’s CBD products were misbranded under the Act. The company’s CBD tinctures for pets also were determined to be “unapproved for new animal drugs that are unsafe and adulterated” pursuant to the provisions of the Act. The FDA advised the company: “Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.”
Florida’s CBD businesses recognize there are many challenges yet to overcome. The FDA is not the only agency regulating these products. The Florida Department of Agriculture and Consumer Affairs also has jurisdiction over CBD products distributed in the state. Commissioner Nikki Fried has made clear the Department’s intention to regulate the production and distribution of CBD products in order to protect the public’s health and safety and to ensure that what is being sold matches what consumers understand they are buying.
Parties interested in becoming involved in the medical marijuana or CBD business in Florida (or elsewhere) will be well served to work with legal counsel and other consultants who have experience in this emerging industry. For the moment, it appears that the rush to capture the less-restrictive CBD market has encountered a very significant impediment. It is not possible to anticipate all the consequences of this development, but it seems likely the distribution of CBD products will be limited to those who take the time and invest the resources to ensure they are doing so correctly.