CBD Labeling Requirements
by Melanie Neff
July 20, 2020
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What you should & shouldn’t include on your CBD product labels
Labeling CBD products can be an incredibly confusing process with the lack of specific regulations surrounding the product’s booming popularity. Unfortunately, the lack of strict CBD label requirements is leading to mislabeled CBD products, violations and a trend of lawsuits being filed against companies dues to mislabeled CBD packaging or misleading marketing. Whether it’s the amount of THC contained in products or false claims about products’ “benefits”, some manufacturers are pushing the envelope on their CBD product labels.
The Food and Drug Administration (FDA) recently reported to Congress on rampant mislabeling in the CBD industry. According to law firm Akin Gump, the FDA sent a report to Congress in July on the excessive mislabeling of CBD products. The report outlines testing of 200 hemp products being sold online.
Akin Gump states that “Of the products tested thus far that indicated a specific amount of CBD, almost 55 percent contained a CBD level that differed from the labeling by more than 20 percent. Just under half of the products tested contained THC or a related compound. Hemp products must contain no more than 0.3 percent THC to avoid potentially facing scrutiny for containing marijuana, which remains an illegal substance under federal law.”
The testing has currently been put on hold due to the coronavirus, however, the FDA plans a more comprehensive study in the near future.
FDA Sends Out Warnings
One example of the warnings the FDA is sending to CBD manufacturers is a letter sent to The Dragon Tree Apothecary. The warning letter stated the CBD company is in violation for using false claims on their product labels and website.
“Based on the inspection and a review of your product labels and your websites, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations,” the FDA said in the letter.
It goes on to say, “…the claims on your company’s product labels and websites establish that your products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body.”
The letter contains a laundry list of violations the company has committed in its product labeling and website claims by calling their products dietary supplements or stating they are intended for use as a drug, such as “relief of cold and flu symptoms” and “anxiety relief.”
The FDA has also sent out numerous warning letters to CBD companies trying to take advantage of the COVID 19 pandemic. Cbdgaze.com received a letter a for violations stating the company had “claims on your website representing or implying that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” The website has since been taken down.
What you need to know
Since the FDA doesn’t currently allow the sale of CBD ingestible products, it’s important to note the labeling requirements on a state-by-state basis. Some states permit the sale of CBD in foods and dietary supplements but require specific label information and warning requirements. To help you understand where your product fits, the FDA has put together a list of the 26 most common questions about cannabis products and their regulations.
We’ve put together some important things every CBD seller should include on their CBD product labels. We’ve also included some common mistakes you should avoid.
At a minimum, you should follow the FDA regulations for cosmetic product labeling for your CBD-infused products below. If you’re selling in a state that allows edible CBD products, then make sure to check state regulations for CBD label requirements.
- Do not make any false or misleading claims of treating or preventing disease. The FDA has already sent warning letters to companies selling CBD products that have made these false claims.
- Properly display your label information (See 6 items below) and make sure it’s legible.
- Do not violate the Poison Prevention Packaging Act of 1970.
CBD Labeling Guidelines
Basic requirements you should include on your CBD product labels:
1. Product identity
This is what your CBD product is or does. It must be included on the Product Display Panel (PDP) of your product. This is not the brand or trade name but it must be easy to locate and see. It doesn’t have to be on the inner container of a product, but putting it in both places is often helpful to consumers.
2. Net quantity of contents
You must state the amount of the actual product without any of the packaging or container, as well as the amount of active CBD per serving. This must be measured by volume for liquids or by weight for solids. The net contents must appear within the bottom 30% of the PDP of the outer container and on an informational panel on an inner container.
3. Name and place of business
Customers must have a way to contact the manufacturer or distributor. The name and address are required on an informational panel on both the outer and inner packaging of your CBD product. Including a phone number is also a good idea or a QR code where consumers can get more information.
4. Ingredient declaration
All CBD products require a full declaration of all ingredients. They must be listed on an informational panel on the outer packaging. It isn’t a requirement on inner containers if on the outer packaging. If no outer packaging, it must be on the product container itself.
5. Warning or caution statements
It’s a good idea to include the standard warnings for children and pregnant women as well as any complications for people taking other medications. It’s also a good idea to include a warning that users could fail a drug test if consuming hemp products as well.
6. Disclosure of material facts
These are any facts that a reasonable person would deem to be important, significant or essential when buying your CBD product. For instance, if your CBD oil is only good for nighttime use, then that should be disclosed.
Other things that you should consider including for consumers:
- Whether your product is full-spectrum, broad-spectrum or isolate
- Expiration date
- Manufacturing date
- Batch codes
Please note: The suggestions above are just guidelines. You should consult all federal, state and local regulations that pertain to your CBD product before completing your labels.
What CBD labels are right for you?
Avery offers a huge catalog of CBD labels that are easy to create and order online. You can simply personalize a free CBD label template and order professionally printed CBD labels by the roll or by the sheet. Or you can order blank CBD labels by the sheet that you can print from a laser or inkjet printer.
Find the right material for your CBD including waterproof and CBD oil-resistant films, metallics, glossy, clear and many more. Avery also offers thermal transfer roll labels available in white, chrome and metallic film.
You can easily create and order your CBD labels, CBD tincture labels and CBD bottle labels to your exact specifications, all online. We can print your barcodes or QR codes or custom compliance labels for your specific state. Just customize with your compliance needs and order.
If you have any questions or need help choosing the right labels, please call our California-based Customer Care Center at (800) 942-8379. Or let us know in the comments below and we’ll respond within 24-48 hours.Check out the latest CBD label requirements & what you need on your CBD labels. Read about companies that are doing it wrong & wher the FDA stands.
How to label CBD and Hemp Products Correctly
Following FDA Requirements for CBD labeling and Hemp Products is critical to the marketing of your product. Also staying up with the regulatory requirements by State. We took a look at one of the most current States to approve a Senate Bill allowing the distribution and retail sales of low-THC hemp extract. This State has some of the most extensive regulations of hemp CBD labeling. The State is Indiana. The Indiana Senate utilized lawyers that worked on Washington State, Oregon State, and California’s packaging and labeling requirements.
Understand that all of this information is not required for every State. We are just selecting the most stringent requirements for this example. After a nice design is developed for the CBD or Hemp label, Indiana requires the following to be represented:
First – A clear scannable barcode or QR code that links to a web document which contains the following information – The batch number, product name, batch date, expiration date (which must be not more than two years from the date of manufacture), The batch size, total quantity produced, the ingredients used (must include name, company that made it, product id code, ingredient lot number), and this link must be downloadable.
That was just for the barcode link. Now on to the other items required on this label. Indiana requires the Batch Number printed on the label, the Internet address to obtain the batch information, the expiration date, and the number of milligrams of low THC hemp extract on the label, the manufacturer, and finally the fact that the product contains not more than three-tenths of a percent totaldalta-9-tetrahdrocannabinol which is (THC).
As long as these requirements are followed, the CDB Hemp Label will be marketable in all States. A unique fact about Indiana is that it allows CBD and regulates its sale in distribution and retail so strongly. The only States this regulated on labeling the CBD and Hemp products are California, Oregon, and Washington.
As for FDA requirements on CBD and hemp labeling, you need to know what not to do. Do not make any health claims about your product. Do not make claims on the label that CBD or hemp will cure a particular condition. The FDA will take swift action against any CBD company that makes this kind of statement and will send a warning letter first. Stay clear of these issues and utilize the most stringent requirements outlined above on your CBD label and you will not have an issue. If you would like a quote on CBD or hemp labels, please contact us. We would be happy to get a quote in your hands.How to label CBD and Hemp Products Correctly Following FDA Requirements for CBD labeling and Hemp Products is critical to the marketing of your product. Also staying up with the regulatory ]]>