With the enactment of the 2018 Farm Bill, legalizing industrial hemp in America, there has been an undeniable surge in the sale and growth of the hemp-derived CBD market into 2019. Since removing industrial hemp from the Controlled Substances Act’s definition of “marijuana” the crop has fallen into a legal gray area spurring a flurry of inquiries – Is it a supplement? Is it safe for consumption? What claims can CBD companies make?
The FDA has as of yet to provide a clear ruling on labeling, packaging and medical claim requirements on the ever-growing CBD-infused product category, which includes everything from CBD tinctures to CBD infused creams, tablets, foods and drinks. CBD companies can stay ahead of the very likely restrictions on packaging by following the FDAs existing framework for labelling.
FDA Packaging Rules – A Baseline for Packaging Your CBD Products
The FDA outlines two primary ways to label packages and containers, and these should most definitely apply to CBD products as well:
- Place all label statements on the front label panel (also known as the “principal display panel” or “PDP”), which is the portion of the package label that is most likely to be seen by the consumer at the time of purchase (i.e., the front of the package or container); or
- Place certain statements on the PDP and others on the information panel, which is the label panel immediately to the right of the PDP, as seen by the consumer facing the product.
Although the FDA allows room for companies to determine whether they place all labeling information on the PDP or choose to split the information between the PDP and the secondary information panel, they do require that the following does appear on the PDP:
- The statement of identity or name the food is commonly known as (e., cashews, jelly); and
- The net quantity statement or the total amount of product contained in the packaging.
In addition to the statement of identity and the net quantity statement, labels will have to provide:
- Manufacturer/Distributor Information.
- Ingredients List: More specifically, each ingredient must be listed in descending order of amount, from the highest concentration to the least.
- Nutrition Labeling: All companies must include this unless they qualify for the small business exemption. Good to note that to qualify for this exemption you cannot make any nutritional claims about your product, which definitely pertains to the sale of CBD.
- Serving Size: Which includes amount per serving and total servings per package.
- Font and Font Weight Restrictions.
Should We Label CBD as a Supplement?
Up until now, the FDA has held fast that CBD would not qualify as a “dietary supplement,” because CBD is currently an ingredient in some FDA-approved drugs.
Because of this standard, CBD companies have responded by re-branding their products as “hemp plant extracts”, instead of as an isolated extraction of the CBD chemical itself. However, this still does not protect companies from additional enforcement unless the quantity of CBD in the hemp extract matches the dose found naturally occurring in the plant. It cannot be artificially concentrated.
Making Health Claims
When it comes to CBD, a product in a notoriously precarious position, we recommend being safe rather than sorry. The FDA treats products making health claims as drugs and not as food or sometimes even as supplements. For the foreseeable future, it is safe to assume that the FDA will hold this industry to a higher standard, and investigate any such claims made.
While there is no officially required approval process for food labels, CBD tincture, edible and topical producers have everything to gain by getting ahead of labelling requirements – despite the fact that we may not see officially updated rules from the FDA until 2020.
We highly recommend having an attorney who is familiar with FDA law review your packaging before putting it out on the shelves.