These businesses were also warned against using CBD in human and animal food as the FDA "cannot conclude that CBD is generally recognized as safe" for that use, the release stated.
The issues outlined in the warning letters are violations of federal law, according to the FDA.
CBD, or cannabidiol, is a chemical compound derived from cannabis plants such as hemp. Although the federal government decriminalized hemp with the passage of the 2018 U.S. Farm Bill and retailers are allowed under Texas law to sell CBD products, there is heavy scrutiny in the way they are marketed.
“Based on our review of published, scientific literature, existing data and information do not provide an adequate basis to conclude that the use of CBD in food meets the criteria for [generally recognized as safe] status,” the warning letter to Noli Oil reads.
The companies have 15 working days to respond with how they intend to correct the alleged violations or else face legal action.
“We are working with counsel to review the FDA letter and working to address the issues it raised,” Noli Oil owner Heather King said in a statement. “We are doing a comprehensive review of our website, labels and marketing materials and amending it as necessary.”
King also said that the issue is related to labeling, not the quality of featured products.
“We stand behind what we do, and we stand behind our products,” King’s husband, Randy, said.
Noli was the only company in Texas to receive a warning letter. The other businesses were located in California, Oklahoma, Colorado, Oregon, New York, Florida, Arizona, North Carolina and Kentucky.
Other companies who add CBD to food or brand their products as therapeutic treatments may also be at risk for enforcement actions, despite not receiving letters, FDA media specialist Peter Cassell said. Cassell said he could not comment on why the 15 companies were specifically identified to receive the warnings.
Because the industry is relatively new in the eyes of the law, more guidelines and research are needed for the sale of CBD products. The FDA plans to provide more information regarding its approach to handling these products in the coming weeks.
“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns,” FDA Principal Deputy Commissioner Amy Abernethy said in the Nov. 25 news release.
Only one prescription drug containing CBD has received FDA approval. Epidiolex was approved in 2018 to treat two pediatric epilepsy disorders. The worry is that consumers will use “unsubstantiated claims associated with CBD products” in place of bona fide medical advice from experts, especially considering unknown, potential health effects, according to the FDA.
“We recognize the significant public interest in CBD, and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products,” Abernethy said in the news release.
A consumer update about CBD products is available here.