The legalization of cannabidiol products across many U.S. states has skyrocketed its sales.
In 2020, the cannabidiol (CBD) market saw sales upwards of $1 billion and this number is expected to reach $23 billion in 2025. However, the CBD market is still in the nascent stages, and labeling regulations vary from state to state.
As a result, manufacturers have a tough time figuring out what must go on their labels to avoid product recalls, re-printing, and loss of reputation. That's why we've created a general labeling guide for CBD food products, including dietary supplements, using relevant FDA resources.
Disclaimer: This guide doesn't include specific labeling laws laid down by states for CBD products. Please direct CBD labeling queries to relevant state authorities if you can't find adequate and appropriate information in this guide or have doubts regarding the same.
Let's get started with the legal definitions of terms to avoid confusion between CBD and Hemp products.
Cannabis refers to the plants from the Cannabacae family which contain more than eighty active chemical compounds like delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
Marijuana or "Marihuana" refers to the drug class containing parts of the Cannabis Sativa plant.
Note: The Controlled Substances Act (CSA) has listed Marijuana as a Schedule-1 drug due to the high potential for abuse and absence of accepted medicinal use.
According to the Agriculture Improvement Act of 2018, hemp refers to any part of the Cannabis Sativa plant (whether growing or not).
It includes seeds, derivatives, extracts, cannabinoids, isomers, acids, salts, and isomers with a concentration of THC not greater than 0.3% on a dry weight basis.
The low concentration of THC excludes hemp from being listed as a controlled substance under Federal Law, as any cannabis plant or its derivative is exempted from the CSA if the THC is less than 0.3%.
The PDP is the most conspicuous part of your label, i.e., it's the part of the label the consumer will see first when they pick up your product.
In most cases, the PDP is the front portion of the label's external container, but you may also have alternate PDPs if another area or side of the product is suitable for display.
The Information Panel (IP) is the panel to the immediate right of the PDP. If you can't use said panel because of the package design or shape, you may treat the most distinguished panel to the right of the unusable panel as the IP.
The following table shows states that have legalized the use of cannabidiol/marijuana products for either medical or recreational use.
To date, the FDA has approved only one cannabis-derived and three cannabis-related drug products. Only a licensed healthcare provider may prescribe these products.
Epidiolex is an FDA-approved drug containing a purified form of THC. It's used to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome for patients aged 1 and older.
No other cannabis-related or cannabis-derived drug may make an FDA approval claim on their label.
All CBD products, including foods, supplements, etc., must come with a warning which states that the product isn't FDA approved.
Not meeting CBD label management compliance guidelines can lead to recalls. Here are some of the most common reasons for CBD product recalls.
Dietary supplements are foods that complement your diet and don't constitute an entire meal.
According to the FDA's CBD labeling requirements, CBD products can't be labeled dietary supplements as its active ingredient (THC or CBD) is used in a drug approved under the Food, Drugs, and Cosmetics (FD&C) act.
Under the same provision, substances publicly investigated for new drugs are also exempt from being labeled Dietary Supplements.
The only exception is drugs previously marketed as dietary supplements, but the FDA has determined that CBD or THC products don't fall in this category either.
Note: If your dietary supplement contains ingredients derived from cannabis plants but doesn't contain any THC or CBD, you may label it as a dietary supplement.
However, you must adhere to all other legal dietary supplement requirements, including the Current Good Manufacturing Practices (CGMP).
The FD&C Act prohibits the sale of any food (including animal feed and food) containing substances which are:
The only exceptions to the rule are:
The FDA has determined that these exceptions don't apply to food or feed containing CBD or THC.
Therefore, selling such products on interstate commerce is forbidden unless they have regulations approving their sale. To date, the FDA hasn't approved any such regulations.
Note: You may sell food products on the Interstate Commerce if they don't contain THC or CBD, although they are sourced from cannabis plants as long as you meet other legal requirements. For example, your product might be derived from hemp seeds. As hemp-seed-derived ingredients contain no THC or CBD or have only trace amounts of these compounds, they're not capable of making consumers high.
The 2018 Farm Bill legalizing CBD products opened the floodgates for various products with unproven health claims, including curing chronic diseases like Alzheimer's.
This practice is dangerous because consuming products with unsubstantiated health and therapeutic claims may result in adverse side effects or prevent the user from seeking appropriate treatment at the right time.
That's why the FDA has prohibited CBD product manufacturers from adding health claims to their labels.
The FDA has recalled many CBD products as the liquid droppers provided by third-party suppliers had high lead content.
So, take care to ensure that your product isn't contaminated if you're enlisting the service of third-party suppliers for such droppers.
Here's a handy CBD checklist to get your product labeling right.
The following section contains FDA labeling requirements for foods and dietary supplements tailored for CBD products. Contact the FDA's office to avoid misprinting labels and product recall if you've queries regarding labeling.
All required label statements must be present on the PDP or IP of your product label and remain visible to the consumer.
Here are two conditions your labels must meet to ensure conspicuousness:
The following table shows where each required label statement must go on the label.
Product Identity or Statement of Identity describes the nature of your CBD product and its purpose.
If your product is a CBD gummy that promotes better sleep, then your Product Identity would be:
Relaxation & Natural Sleeping Aid
The statement of identity is usually placed on the PDP, parallel to its resting base. If your CBD product is a dietary supplement that doesn't contain any THC or CBD, you may use the term "dietary supplement" in the statement of identity. You may also add essential information to lengthen the statement of identity. E.g., you may write Full-Spectrum CBD Oil instead of CBD oil.
Note: As brand names aren't part of the statement of identity, they shouldn't be more conspicuous than the statement of identity.
Consumers must be able to get in touch with you if they've any queries regarding your product.
That's why it's important to include the Name and Place of Business along with other ways to contact you. E.g., phone number, Q.R. code, etc.
The name and place of business include details of the manufacturer, packer, or distributor, i.e., the firm name or principal place of business.
If you can't include the address of your firm because the products are manufactured elsewhere, you must add "manufactured by" or "distributed by" in front of the address.
Note: All addresses must be declared in the format "'street address, city name, state name, and zip code."
The net quantity of contents is the amount of product your container has, and you must represent it accurately using the U.S. Customary system.
The following table lists the acceptable units of measure for weights and liquids
You may include measures of individual units and serving sizes along with the net quantity of contents. For example, you can represent as the net quantity of contents for CBD capsules:
Net wt. 30 g
The net quantity of contents must always appear within the bottom 30% of the PDP in lines parallel to its resting base.
The net quantity of contents is a standalone statement that must stay separate from printed matter above and below it with a spacing equal to the height of the letters used in the declaration.
There should also be sufficient spacing to the left and right of the declaration, and this must be at least twice the width of the letter "N" of the typestyle your declaration uses.
The type size of the net quantity of contents is calculated based on the area of the PDP, and the height to width ratio of the letters must be no more than 3:1.
We've listed the acceptable type sizes in the table below.
Note: Type size of fractions must be one-half the minimum height requirements set for the remaining text.
Ingredient lists help consumers decide if the product is beneficial for their health and look out for potential allergens.
You may list your ingredients before or after the nutrition facts and the name and place of business.
Here are a few points to remember while declaring ingredients on your labels:
If your CBD product contains any allergens, declare them along with the ingredients or use a separate "Contains" statement after the ingredient list.
For more information on allergen declarations, check out the FDA's allergen labeling requirements.
The Nutrition labeling section lists all the nutrients that a product contains, and it includes:
Total calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, protein, vitamin A, vitamin C, calcium, iron, etc.
It usually appears on the IP along with the ingredients listing and the name and place of business.
You may set the nutrient labeling section perpendicular to the label's base if it doesn't hinder visibility and legibility at the time of purchase.
If your CBD product is a dietary supplement, you must use a "Supplement Facts" panel instead of a nutrition labeling panel.
The major difference between a nutrition labeling panel and a "Supplement Facts" panel is that the latter lists dietary ingredients without the Recommended Daily Intake (RDI) or Daily Reference Values (DRVs).
Check out our FDA labeling guide for dietary supplements to learn more about the supplement facts panel.
We’ve listed a few important facts you must disclose on the label to help your consumers understand product usage and its potential side-effects.
Cannabidiols are classified into three types depending on the purity of CBD and the amount present.
Full-spectrum CBD products contain all compounds naturally found in the cannabis plant, including trace amounts of THC (<0.3%).
Broad-spectrum CBD also contains all the natural extracts found in the cannabis plant, but the amount of THC present may be greater than 0.3%.
The date on which your CBD product is manufactured following Good Manufacturing Practices (GMP).
The date after which your product mustn't be consumed is called the expiry date.
Both dates are stamped on the bottom of a container or printed on the bottom of the label along with other required label statements.
Batch codes are a string of numbers and letters obtained from your product batch's Certificate of Analysis (CoA).
It allows consumers to learn important information like:
To ensure that consumers use your product right and prevent an overdose, you must specify usage instructions, consumption method, and product dosage.
As CBD products are not FDA approved, you must include a disclaimer statement on the label to warn your consumers.
Here's an example of a warning statement:
"These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
You must also include a warning statement when your product contains allergens or is unsuitable for pregnant or breastfeeding women.
Note: Some states may also ask you to include a state-specific icon on your label. So, you must read the labeling regulations for your state thoroughly to avoid any errors.
Labeling laws for CBD products are vague and vary from state to state as their legalization is relatively new. However, your products must include a few compulsory label statements to avoid product recalls and a bad reputation. We've included these labeling statements in our guide and created a checklist to help you eliminate the ambiguity surrounding CBD product labeling.
Curious about how Artwork Flow can help you meet CBD and hemp labeling requirements? Get your questions answered here.