More CBD Advertising Warnings by FDA
As previously blogged about here, the Federal Trade Commission and Food and Drug Administration have recently been engaged in joint efforts to warn companies about the potential legal consequences of making unsupported health and efficacy claims in the advertising of CBD-infused products.
According to the FDA, marketing CBD by adding it to food products or labeling CDS as a dietary supplement is illegal.
Most recently, the FDA announced that it cannot conclude that CBD is “generally recognized as safe” among qualified experts for use in human or animal food. In doing so, the FDA confirmed that there still exist “unanswered questions and data gaps about CBD toxicity,” including those related to use by children and the elderly.
See revised FDA CBD information, here. To date, the FDA has approved but one drug that contains CBD – a prescription drug to treat some epilepsy conditions.
Importantly, the FDA states that it possesses “limited data about CBD’s safety”
The foregoing suggests that the FDA plans on aggressive enforcing CBD-related violations. It is probably safe to presume that FTC defense lawyers may also soon by busy assessing claims by CDB marketers that have drawn the ire of regulators.
The recent slew of FDA warning letters to CBD manufacturers allege that recipients marketed products in violation of the Food, Drug, and Cosmetic Act. Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug.
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. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. 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.”
Qualified FTC defense attorneys caution marketing clientele that products containing CBD are not considered dietary supplements and are not permitted to be lawfully marketed that way.
Typically, warning letters from the FDA and the FTC provide recipients with the opportunity to take corrective measures in order to avoid enforcement. However, it is reasonable to assume that at some point the warning will stop and actual enforcement lawsuits will be filed.
Those in the CBD marketing niche should consult with experienced FTC defense attorneys to prospectively reduce the likelihood of regulatory attention. As with any advertising campaign, all express and implied claims must be substantiated prior to dissemination thereof. Applicable state and federal regulations must be adhered to. Avoid “structure and function” claims.
Disease prevention claims are almost certain to draw scrutiny.
Informational purposes only. Not legal advice. May be considered attorney advertising