CBD, or cannabidiol, is one of the most popular emerging industries across the globe in recent years. In the United States, the FDA approved drug Epidiolex is CBD based and used to treat rare forms of epilepsy. However, it has also emerged as a consumer product, and is being sold across the country in a wide variety of consumable and topical end products. Apart from Epidiolex, which is classified as a drug, the FDA has not classified CBD as a supplement, food additive, or any other type of substance defined in federal regulations.
For this reason, packaging and label requirements for consumer CBD products exist in a regulatory grey area. Legal teams take what they know about the requirements for supplements and food products based on FDA and state policy to offer legal advice on what should and should not be included on a label.
In this article, we visually outline and define the main requirements for CBD boxes and labels. Please note, we do not intend for this article to be taken as legal advice, it is a basic overview of the requirements. We recommend consulting an attorney to ensure that your CBD product is in compliance with existing and future requirements.
Principal Display Panel (PDP) –
The side of the box or label meant to be displayed for retail. It must include:
Declaration of Identity –
The generic name of the product, along with a short description.
Should be parallel to the base of the Principal Display Panel
Declaration of Quantity –
The total quantity of contents, displayed clearly in relevant terms of measurement.
Must be included in the bottom 30% of the PDP
Must have appropriate spacing.
Must be parallel with the bottom of the PDP
Font Size Requirements –
The minimum font size is determined by the surface area of the PDP.
If the area of the PDP is less than or equal to 32cm2 , the smallest font size allowed is 1/16th of an inch.
All fonts have slightly different sizes, so it’s important to measure each font to ensure you are in compliance.
Pro Tip: Create a reference square that is 1/16 of an inch (or whatever min. size your font is required to be) and use this to easily compare to the letters o and d, common reference letters for measuring font size.
Supplement Facts –
An information panel that includes standard dietary information for the product based on a 2,000 calorie diet.
Must be included on the panel to the right of the PDP.
Only needed for ingestible products.
For topical products, only an ingredients list is required.
Anything with zero value does not need to be included.
The manufacturer/formulator should be able to provide all of this information.
Ingredients List –
A list of ingredients in order from greatest quantity to smallest quantity.
If it is a consumable product it must be on the panel to the right side of the PDP.
If it is a topical product the ingredients can be included on the back.
Declaration of Responsibility –
The full company address of the manufacturer must be included on the package and label.
Topical products may not require the full address, only city and state.
FDA Disclaimer –
A statement which indicates that the product has not been approved by the FDA must be included on the packaging.
“The FDA has not evaluated this product for safety or efficacy. These products are not intended to diagnose, treat, cure, or prevent any disease.”
Suggested Use –
A short description of how to use and/or consume the product.
Should include the amount recommended per person per day.
Should match the supplement facts serving size recommendation.
Required legal statements and safety information.
“Keep out of reach of children”
“Topical Use Only “
Only needs to be included on topical products.
“Consult your doctor before taking if you are pregnant or nursing, have a medical condition, or take pharmaceutical drugs.”
No Medical Claims –
It is illegal to make any statements about CBD mitigating, treating, curing, or preventing any diagnosable condition.
Do NOT use any statements such as:
“Stops chronic pain”
“Helps reduce opioid addiction”
Product Labels –
If a CBD product does not have a package or box, but rather is sold directly in bottle or container, all of the information included above must be included on the container label.
If a product does have a separate box or package, most of the information can be excluded from the label.
The label must always include the logo, Declaration of Identity, Declaration of Quantity, Declaration of Responsibility, and the statement: “See box for safety information.”
Note from the designers: If there is no box or packaging for your product, and you must therefore put all of the information on the product label itself, we advise you to keep it as simple as possible. Since these labels are so small, they become cluttered and difficult to digest for consumers. Keeping the label simple and clean will be much more effective than trying to add additional information beyond the requirements.
In addition to the requirements pointed out in this article, there are other requirements and details that may be specific to the state these products are manufactured or sold in. An example of state specific requirements include QR Codes and traceability information such as a batch number. Some states are beginning to require these items. The requirements for CBD products are more stringent than other industries, and it is important to seek professional legal advice to ensure that your company is in compliance.
In general, CBD boxes and labels are very small in size. This presents a large challenge for designers and copywriters. It is important to be mindful of the detailed spacing and font size requirements to ensure that the product is in compliance and is not crowded with unnecessary information.
Again, we should reiterate that CBD is currently caught in a regulatory and legal gray area. It is important to look into these requirements in detail, as there are many more rules in addition to the ones discussed here that your team should be aware of. Make sure to seek professional legal advice, even if you have done a packaging / labeling project in the past. These regulations and industry standards are always changing, so it is important to stay on top of them!
Free Box and Label Templates
Are you designing a CBD product label or box and don’t know where to start? We’ve got you covered! Fill out this form to download the templates.
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By Adam Higelin
Adam Higelin is a University of California, Berkeley graduate with a BA degree in Integrative Biology. He is a passionate writer with a love for the environment, botany and music. A special focus on research based, scientific writing has allowed Adam to pursue his dream of educating and inspiring people to better themselves and the lives of others.