Since the passage of the 2018 Farm Bill, the Food and Drug Administration (FDA) has been hard at work researching safe daily intake values for hemp-derived products such as CBD isolates and concentrates. More notably, the agency has been laying out product labeling requirements and distribution regulations for these products in a bid to tame the wild west atmosphere of a multi-billion dollar market with a lack of expressly written federal rules.
While this development is largely welcomed by well-established hemp and CBD companies, it’s now more important than ever for smaller producers and manufacturers to grasp the basics of FDA-compliant labeling.
FDA Crackdowns on Product Labeling Requirements & Mislabeling of CBD Products
Two recent examples of the FDA enforcing their new product labeling requirements against misleading product labels include a warning letter to the Dragontree Apothecary for falsely identifying their products as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.” A similar warning was sent to the Puerto Rico-based CBD Gaze for claiming on their website that their products could ameliorate symptoms of COVID-19. CBD Gaze has since shut down their site.
Prospective costs in damages and harm to CBD or hemp branding campaigns could prove impossible to recover from for businesses in their nascent stages. For this reason, it’s crucial to produce competently designed private label products (not an affiliate link) in order to avoid costly penalties or potentially devastating mass product recalls.
While large companies are able to make use of CBD or hemp marketing and consulting services, it certainly pays for smaller enterprises — such as fledgling partnerships or family-owned operations — to know current industry labeling best practices. Let’s take a quick look at four examples below.
Compliance with the Food, Drug & Cosmetic Act (FDCA)
The FDCA enumerates the bare minimum guidelines a CBD or hemp product must meet in order to officially be authorized for sale in the United States. Under these product labeling requirements, all products must contain the following basic elements:
- A product identity statement, which clearly and unambiguously defines the product (ex. “CBD for pets,” or “sleeping aid”). This is not to be confused with the product’s brand name or trade name.
- The net quantity of contents must be clearly printed; in volume for liquid products and in weight for solid products. This clarifies the amount of product excluding all packaging elements including inner leaflets, as well the amount of active CBD per serving.
- A legible list of all ingredients used. In states like Colorado and New Mexico, CBD and/or hemp must be clearly identified in applicable products. This is to counteract companies using euphemistic phrases like “hemp extract” or “full-spectrum hemp” in order to avoid CBD regulations.
- The name and complete address for the product manufacturer, along with relevant packing companies and/or distributors. An increasing number of states are also mandating the inclusion of website info, or scannable QR codes leading to web pages with complete company addresses and contact information.
It’s worth noting that only the CBD or hemp branding, product identity, and net quantity of contents are required to be on the front panel of a product package label. The ingredients list and contact information are allowed and typically encouraged to be on the right-side panel, commonly known as the “information panel.” However, these must be no less than 1/16th of an inch in height to legally be considered legible.
Transparency on Material Facts & Caution Statements
There are several factors potential buyers are not only likely to deem important, but appreciate easy access to in product packaging. If a product is unsafe for children or pregnant women, this should be clearly disclosed.
Items such as batch identification numbers, batch dates, certifications of analysis, and so on are other examples of product transparency that separate ethical companies from odious ones.
Avoiding Spurious Medical or Health Claims
It’s one thing to highlight a product’s positive differentiators (ex., GMO free, vegan) as a means of playing one’s strengths in a competitive market. However, companies making unfounded claims of their products’ health benefits or therapeutic value overstep CBD product labeling requirements and regulations by implying their products can be used to treat disease, which is classified by the FDA and state authorities as the marketing of unapproved drugs in violation of the FDCA. For this reason, many states require that CBD and hemp products make no health claims whatsoever on their labels and packaging.
Recognizing the Role of Aesthetics in Attracting Consumers
Making use of color, fonts, or even textures on labels and packaging are solid strategies in product design as in any industry. Going on to create branding homogeneity across physical marketing and digital channels — such as in a company’s web presence — is taking the extra step to ensuring products have both the stellar design and recognizability to pop from shelves.
If you have any questions about product labeling requirements and whether your CBD or hemp products align with the existing regulations, reach out to us for a consultation.