There is little information provided by the Food and Drug Administration (“FDA”) about how Hemp-CBD products for human consumption (foods, dietary supplements, and cosmetics) should comply with the FDA requirements, and it could be another 18 to 24 months before the FDA makes a decision regarding the approval of Hemp-CBD products. Currently, it is “unlawful under the FDCA to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.”
Until the FDA issues new guidelines, Hemp-CBD manufacturing companies should be cautious and conservative when labeling and marketing their CBD products.
The FDA regulates the content of labels on dietary supplements. Generally, a dietary supplement label must include:
- An Identity Statement: (such as “dietary supplement” or “botanical supplement”)
- A Net Quantity of Contents Statements: An accurate statement of the quantity of the content inside the container by weight, concentration, measure, or numerical count.
- An Ingredient Statement: A list of the product’s ingredients in descending order of predominance by weight in the product.
- A Responsibility Statement: The name and place of business (city and state) of the manufacturer, packer, or distributor.
- A Nutrition Statement: Must appear by way of a prescribed format that provides detailed “Nutrition Facts” and “Supplement Facts” on the product. (The standard format can be seen on any typical product at your local pharmacy or other food supplement retailer.)
Additionally, supplement manufacturers and distributors must refrain from making claims that their dietary supplement prevents, diagnoses, treats or cures serious diseases or conditions unless it has gone through the FDA drug approval process.
Failure to comply with these requirements would be deemed misbranding and subject the manufacturer, packer, or distributor to FDA enforcement action (absent an exemption).
However, products containing CBD cannot legally be sold as dietary supplements. The FDA has taken the position that CBD is excluded from the definition of “dietary supplement” under the Federal Food, Drug & Cosmetic Act (“FDCA”) because CBD is an active ingredient in at least one FDA approved drug. One legal blog focused on cannabis law (the Canna Law Blog) has reported that “an increasing number of Hemp-CBD companies have embraced a change in nomenclature and have begun manufacturing products that contain hemp extracts standardized for total cannabinoid content rather than isolated CBD” and warns that using “the terminology “hemp extract” will not shelter a Hemp-CBD company from FDA enforcement should the concentrations of CBD present in the dietary supplement be disproportionate to their naturally occurring levels in the plant and/or in the levels occurring in traditional hemp extract preparations.”
The marketing and labeling rules surrounding CBD and hemp extract dietary supplements are incredibly complex and nuanced. CBD businesses should consult with attorneys to minimize the potential liability of introducing their product and ensure the legally defensible labelling and marketing of their products.