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You created a high-quality CBD product. You tested it for safety and compliance, and now you’re ready to create the label that perfectly markets its profound benefits. You want your product’s unique selling points to stand out from the growing crowd of competitors.
We get it. CBD is possibly the most exciting natural compound to hit the market in years, and companies like yours are vying for loyal customers. Plus, the scientific research to date shows that CBD is a powerful anti-seizure, anti-inflammatory, anti-anxiety compound with an ability to promote healing both inside and out. But here’s the problem: You can’t say any of that in your packaging or marketing materials. Unfortunately, unless you’re selling an FDA-approved drug or have received FDA approval to make claims, you may not say anything that hints of your product’s medicinal value. Words like inflammation, seizures, anxiety, and healing are off the list of acceptable marketing claims, along with a whole host of other terms.
So, how can you be sure that your CBD dietary supplement, food, drink, or beauty product is compliant with Federal Trade Commission (FTC), Federal Drug Administration (FDA), and National Advertising Division (NAD) claims guidelines?
CBD SUPPLEMENTS & FOOD PRODUCTS
If you are selling a CBD food or supplement product, you must be especially careful about the claims you make. That’s because CBD products are excluded from the dietary supplement definition until the FDA completes its investigation into the compound’s safety for human use. The only exception is if you marketed your product as a dietary supplement or conventional food before the FDA’s new drug investigations were authorized. If that exception doesn’t apply to you, as in the case of Rooted Apothecary, then technically, you’re not supposed to create or market these types of products.
At the same time, the FDA is aware that companies are rampantly selling CBD supplements, food, and drinks to meet growing consumer demand. The FDA has indicated that it may or may not take enforcement action against such companies. Instead, this federal oversight agency stated it will consider many factors, including available resources as well as the product in question’s level of threat to public health. So, if you are selling a CBD supplement or food product, it’s important to be aware that your brand is under a higher threshold of scrutiny.
DON’T MAKE HEALTH CLAIMS ABOUT YOUR CBD PRODUCT.
Any product that is intended to have a medicinal use, and any product that is used to affect the structure or function of the body, must be reviewed or approved by the FDA. This definition could apply to cosmetics that claim to eliminate wrinkles, or supplements that claim to reduce insomnia, for example. Since Epidiolex is the only FDA-approved CBD drug, and CBD is not approved for food and supplement use, any sort of health claim may be considered misleading.
DON’T MAKE STRUCTURE-FUNCTION HEALTH CLAIMS.
According to the FDA, structure-function claims for supplements relate to general well-being and nutrient deficiencies. Most of these claims describe the role of an ingredient (like CBD) in affecting the normal function of the body.
These types of claims are not pre approved for supplements, and companies must notify the FDA of the claim no later than 30 days after marketing the product. They must also include a disclaimer on the label that says: “These statements have not been reviewed by the FDA.” However, since CBD in general is not approved for use in supplements, your safest bet is to avoid these claims altogether.
DON’T say things like…
- “Calcium builds strong bones”
- “Fiber maintains bowel regularity”
- “Antioxidants maintain cell integrity”
- “Prevents diseases related to vitamin C deficiency”
- “Collagen strengthens joints”
- “Omega 3s improve brain health”
- “Eliminates wrinkles”
DON’T STATE DISEASE CLAIMS.
Disease claims are any language that explicitly states or infers that a product can treat, prevent, or mitigate symptoms of an illness or the illness itself, such as cancer, the common cold, or insomnia.
You may only make a drug claim if your product has been approved by the FDA as a medication.
DON’T say things like…
- “Treats acne”
- “Prevents inflammation and chronic pain”
- “Improves symptoms of PTSD”
- “Shrinks tumors in breast cancer”
- “Reduces rosacea”
- “Prevents cold and flu symptoms”
- “Treats anxiety and depression”
DON’T IMPLY DISEASE CLAIMS.
You may be tempted to find creative solutions to claims restrictions by featuring images and unique product names to imply medicinal value. However, the FTC explicitly states that implied claims count the same as stated claims.
The FTC offers an example of an ad for an herbal supplement company that claimed its product boosted the immune system by maintaining a healthy nose and throat during winter season.
The product was called Cold Away, and the ad graphics showed people sneezing.
While the ad didn’t explicitly make a health claim, the FTC deemed that the implication was just as harmful and misleading to consumers.
DON’T RECOMMEND A PRODUCT TO SUBSTITUTE OR AUGMENT PHARMACEUTICAL THERAPIES.
While it might be anecdotally true that thousands of people are using CBD in place of pharmaceutical drugs for conditions ranging from autism to PTSD, you cannot recommend your product in this way.
“Studies show that CBD is an effective, natural sleep aid that can replace harmful pharmaceuticals. Try our CBD product for safe and effective results.”
WHAT HAPPENS IF I DO A “DON’T”?
If the FDA or FTC determines your product contains false or misleading claims, they may first send a warning letter. That letter will outline the exact transgression and ask that you review packaging for all potential violations. At that point, you have 15 days to notify the office of the steps you’ve taken to rectify the issue, along with proof of the action taken. Unfortunately, by this time, the only option might be to remove all products from shelves and create brand-new labels. If you fail to do so, the FDA may take “legal action without further notice, including, without limitation, seizure and/or injunction.” All of this adds up to headaches, brand reputation damage, and financial loss.
DO INCLUDE TERMS RELATED TO TEMPORARY STATES OR EMOTIONS.
Words related to temporary emotions are generally permissible, as long as they do not imply disease prevention or treatment. They may also help you tell a story about your product that the customer will understand without feeling misled or overpromised.
DO say things like…
- “Supports uplifted mood”
- “Eases stress”
- “Supports focus”
- “Targets irritability”
DO USE PUFFERY.
Puffery refers to advertising language that is highly vague or highly subjective, and therefore not threatening to consumer well-being. For this reason, the FTC does not pursue companies that utilize puffery in their labels and marketing materials.
DO say things like…
- “The best CBD oil ever”
DO USE COSMETIC CLAIMS.
Cosmetic claims relate to language about beautifying one’s outer appearance without affecting the structure or function of the body. Cosmetic claims for CBD products do not need pre-approval or post-approval by the FDA, but the product must be safe for use, and its claims cannot be misleading.
DO say things like…
- “Improves the appearance of wrinkles”
- “Balances uneven skin tone”
- “Smooths and resurfaces”
- “For dry, rough skin”
- “Helps tighten and firm”
Consumer research shows that one of the biggest draws to CBD is its ability to work naturally within the body. Moreover, the trend toward natural products is exemplified by the growing number of stores that have added “natural” sections to their layouts. The problem (or potential opportunity) with marketing a product as all-natural is there is no legal definition of what that means. Therefore, you can never really be out of or fully in compliance when making this claim. However, the FTC, FDA, and NAD are still on the lookout for deceiving claims, and if you are marketing your product as all-natural, you should review the ingredients list first. TIP: Whole Foods’ natural standards can give you an idea of industry-best practices for natural product designations.
SO, SHOULD I SAY NATURAL?
If you make this claim, you are taking a calculated risk. Make sure that you understand the ingredients in your product and their sources. Then take the appropriate actions to feel more confident in your statements.
HOW CAN I BE SURE MY CLAIMS ARE COMPLIANT?
This is an exciting time to be in the CBD business, where you have the unique opportunity to innovate as one of the earliest players to the market. At the same time, as a trailblazer, you are also taking risks because you can’t rely on established regulations for guidance.
That said, the best way to ensure your claims are true and compliant is to test your product for safety and potency. This will guarantee that you can label your product accurately. Then consider sending your ad, packaging, or marketing materials to a focus group to get their opinions. Last, before hitting print, you may want to call a lawyer to review your materials with an extra level of scrutiny.
There is no guarantee that future regulations will not change all of the rules mentioned in this blog; however, if your product passes all the tests above, you can feel at ease knowing that the FDA, FTC, and NAD have bigger fish to fry.
Questions? Contact ACS today to find out about our safety and potency tests to guarantee that your label matches your ingredients