This article was originally published on Hoban Law Group, and appears here with permission.
As the hemp industry has come to understand by now, marketing hemp and/or CBD products with improper and unsubstantiated “disease” claims in the labeling violates a number of federal regulations. Since about 2015, the U.S. Food and Drug Administration (“FDA”) and/or U.S. Federal Trade Commission (“FTC”) has issued at least 70+ warning letters to businesses for marketing hemp products with illegal disease claims.
Marketing CBD Products
Of course, most of us know that marketing CBD products with disease claims, regardless of evidence or any studies to support the claim, will typically render the product an “unapproved drug” under the Federal Food, Drug & Cosmetic Act (“FDCA”). Simply put, only products correctly positioned as drugs can legally make these types of claims. For example, Epidiolex (a CBD isolate drug) has been approved by the FDA to treat epilepsy, but FDA’s approval of this drug does not mean that all similarly situated CBD isolate products can also claim to be an effective treatment for epilepsy. To make that type of claim, the product must undergo FDA’s stringent drug approval process required for all drugs to be marketed in the U.S.
In addition to these types of claims amounting to violations of the FDCA, the Federal Trade Commission Act (“FTC Act”) similarly provides that advertising that a product can prevent, treat, or cure human disease is unlawful unless you possess competent and reliable scientific evidence (including, when appropriate, well-controlled human clinical studies) substantiating that the claims are true at the time they are made. Thus, while the “disease” nature of the claim alone is typically …