There is no doubt that the enactment of the 2018 Farm Bill, which legalized industrial hemp by removing the crop from the Controlled Substance Act’s definition of “marijuana,” will lead to increased sales and growing opportunities for hemp-derived cannabidiol (“Hemp-CBD”) companies in the new year. In fact, we have already seen an uptick in new and current client inquiries, even in the past few weeks.
As we previously explained, however, there is little information provided by the Food and Drug Administration (“FDA”) about how Hemp-CBD products, including foods, dietary supplements, and cosmetics, should comply with the basic mandatory requirements imposed by the FDA. According to a report released by the Brightfield Group, we will need to wait another 18 to 24 months before the FDA makes a decision regarding the approval of Hemp-CBD products.
Until then, Hemp-CBD companies should handle these uncertainties and the lack of specificity regarding the legal status of Hemp-CBD by being extremely prudent when marketing their CBD products. To that end, we previously discussed the FDA labeling rules and regulations imposed on foods. We now turn to the marketing and labeling requirements imposed on dietary supplements.
For the last three years, 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 FDA-approved drugs and was the subject of substantial clinical investigations before it was marketed as a dietary supplement.
In response to the federal agency’s position on CBD not qualifying as a dietary supplement, 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. Yet, aside from general legal risk, it is important to understand that 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. (We will further discuss this issue in an upcoming post).
In addition to navigating the muddy waters surrounding the product’s nomenclature, Hemp-CBD companies that manufacture, package or distribute dietary supplements must also ensure that their labels contain the basic required components. Generally, a dietary supplement label must include:
- An Identity Statement: For example, “dietary supplement” or “botanical supplement”.
- A Net Quantity of Contents Statements: An accurate statement of the quantity of the content in weight, 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 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.
Each component must appear in the correct format, or the product will be considered misbranded and subject to FDA enforcement action, unless an exemption applies.
Lastly, Hemp-CBD companies must refrain from making claims that their dietary supplement prevents, diagnoses, treats or cures serious diseases, such as cancer. The FDA deems any product containing a health claim as a drug for human use and must go through the FDA drug approval process before it is marketed in the U.S.
As this post highlights, the marketing and labeling rules surrounding CBD, or more accurately, hemp extract dietary supplements are incredibly complex and nuanced. Also, given the lack of precise FDA guidelines regarding Hemp-CBD products, companies in this space should consult with attorneys who specialize in federal regulations to discuss the potential liability of introducing their product into interstate commerce and ensure the legally defensible marketing of their products.