We as humans often tend to buy things based on the pretty looks. When buying supplements and vitamins, or food or cosmetics items though, we’re used to finding the same information on each package. You might not even think about it, but things like ingredient list, weight of the product, and how many calories are in a thing are all always the same in a product, no matter the brand. That formatting is not a coincidence, the FDA has very strict guidelines to make sure everyone complies with these consumer protection guidelines. These same guidelines apply to CBD and hemp products too, as they are under the federal FDA guidelines.

According to the CBD Academy, up to 70% of purchases are made at the shelf level, and a product’s label is what the customer sees first. But food, drugs, and cosmetics labels aren’t just playgrounds for pretty designs; they must also display regulatory information required by the FDA. So how can you create an appealing compliant hemp CBD label while remaining legal with state and federal labeling requirements?

Hemp product laws – legal, but also kinda not

The Farm Bill in 2018 legalized industrial hemp, which opened up hemp-derived CBD products to state and federal regulations. Currently, The Food & Drug Administration (FDA) is still researching CBD to determine safe daily usage and establish rules for product labeling. But they have been stepping up enforcement. So following their rules is a wise business decision.

Many states, like California, have brought their own regulatory frameworks for hemp-derived CBD products. In some states, hemp products are legal to buy anywhere, and in some states, they’re only sold in dispensaries alongside THC products.

Products can be called hemp when they’re under 0.3% THC by volume. Anything higher than that is considered cannabis and not federally legal. Sometimes this can even happen during the growing, this is what is called “hot hemp” when the cultivar is stronger than intended. Cannabis and hemp are the same plant, both are biologically the same. Full spectrum is the best, so go for products with that 0.3% THC for the most benefit – products with 0% THC are made with isolate, and are missing out on the entourage effect. Anyways, that’s a side tangent for another day.

State hemp regulations

In addition to the guidelines and rules from the FDA, and their federal supplements and cosmetics and food requirements, you also need to check your state laws for CBD product legality and final labeling guidance. 

All states have hemp laws in place, but not all have put together comprehensive CBD hemp product labeling requirements. The best way to find out if your state requires additional labeling, is to research your Agricultural Department or simply google “your state + hemp regulations final” and you’ll likely find the correct page.

What are dietary supplements, and can you call a CBD product a dietary supplement:

According to the FDA, dietary supplements are defined as products that can add onto your diet or contain one or more of the following ingredients: A vitamin, mineral, botanical or amino acid. Dietary CBD supplements may include ingestible oils, tinctures, and gummies. It’s always tricky to add active ingredients into a CBD product, because then you venture into medical claims territory through the active ingredient. This is not legal advice, always consult a cannabis and hemp lawyer who knows FDA regulations and state cannabis laws and regulations.

WHAT NEEDS TO GO ON A DIETARY SUPPLEMENT LABEL?

For the full list of labeling requirements for all dietary supplements click here

  • Name of the supplement
  • The net quantity of contents 
  • Nutrition information
  • Ingredient list 
  • Name of manufacturer, packer or distributor

WHERE DOES ALL THIS INFO GO ON THE LABELS?

  • The product name and net quantity must be on the front display panel
  • All other statements must be placed either on the front panel or directly to the right (the information panel)

No medical claims for CBD packaging – paint the picture without saying directly what it’s for

Key benefits of your hemp CBD product should be celebrated

We all know hemp is amazing. CBD is wonderful. But educating your customers is a huge part of the challenge. Since we cannot claim any of our products have any medical or therapeutic results – because that’s then considered a drug, and drugs need to go through years of clinical testing for proving those active ingredients work. For example, you cannot say that your CBD product with added valerian relieves anxiety because anxiety is a medical condition. What you can say it relieves feelings of everyday stress. Or you can say a product for sleep is soothing or calming, but you can’t say it’s for insomnia, because insomnia is a medical diagnosis.

Imply with design choices what it’s for, instead of making medical claims you can’t back up. No using banned medical terms. No claiming to cure medical conditions. If it’s for sleep, have clouds and stars on the package design, and use sleepy colors.

Creative names can also hint at the suggested use without making any direct health claims. You can tell customers why they may want to try the product, and when to use it, but you just can’t mention medical ailments or promise a cure. 

Examples of this kind of creative language could be “use at bedtime for a good night’s rest” for a sleep product, or for stress relief, you could say “take a moment and enjoy a relaxing moment – when the day winds down, make time for yourself. You’ve earned it.”

What about topicals? Cosmetics guidelines from the FDA

Cosmetics also fall under the purview of the FDA. A cosmetic is defined as something that is used on the surface level, mainly for looks. Whether a product is considered a cosmetic or a drug under the law is determined by a product’s intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

Is my product defined as a cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers and lotions, things like perfumes, makeup like lipsticks and eye shadow, nail polish, shampoos, perms, hair colors, and deodorants etc.

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)]. So a cosmetic would be a nail polish. A drug would be a nail fungus cure. Moisturizer would be a lotion that says it hydrates skin. A cortisone ointment is a drug.

Some products are both a cosmetic and a drug!

Some products meet the definitions of both cosmetics and drugs at the same time. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to wash hair to make it pretty. But an antidandruff treatment is a drug because its intended use is to treat dandruff and it has the active ingredients to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic-drug combinations are things like toothpastes that contain fluoride to fight cavities, deodorants that are also antiperspirants, and moisturizers and makeup that have SPF sunscreen claims. Such products must comply with the requirements for both cosmetics and drugs. And no, “cosmeceuticals” is not a thing for the FDA, that’s just a marketing word.

Are essential oils active ingredients?

Apply same logic as other active ingredients. As an example, if a fragrance is marketed as something that will make you attractive and smell nice, then it’s a cosmetic. But if that same fragrance is marketed with claims around aromatherapy – like that the scent aids in sleep or quitting smoking, that then becomes a drug, based on those marketing claims. Another example from the FDA: if a massage oil is simply intended to lube up the skin and smell nice, then it’s is a cosmetic, but if the product is intended for therapeutic uses, such as muscle pain, then it’s a drug. Messaging around intended use can be made through literature, social media posts, website, or the packaging. And the FDA follows all of those, and will send a warning letter, and hefty fines, for those who aren’t compliant. Working with an expert in FDA compliance can save you a lot of headache, and potentially a lot of money. Here’s a advisory tale of going against the FDA:

https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing-cannabidiol-agency-details

What needs to be on the front label?

This information must be on the front display panel

  • Name of the product
  • The net quantity of contents (in milliliters and ounces usually)

What needs to be on the other label(s)?

  • Ingredient list, organized by predominance 
  • Name of manufacturer, packer or distributor
  • FDA 740.10 warning (where applicable)
  • How to use the product guidelines

WHERE DOES ALL THIS INFO GO ON THE LABELS?

  • The product name and net quantity
  • All other statements must be placed either on the front panel or directly to the right (the information panel) 

FDA Type size & minimum font size regulations for hemp CBD packaging

  1. Panel Size. The label must be large enough so that all required details are visibly displayed.
  2. Font style & size. Letters must be at least one-sixteenth (1/16) inch in height.
  3. Label background. The background must have enough contrast with text for easy reading. 
  4. Label design. FDA required statements cannot be hidden or distracted by any design elements 
  5. Label content. Label content cannot make any misleading claims

FDA sues CBD companies – a confusing mess of lawsuits

The gist of it is: don’t make medical claims. And make sure your product packaging is compliant, and that your potency matches what’s actually inside the product. Otherwise you could find yourself in a world of trouble: the FTC has joined the FDA is this pursuit and announced settlements with six different CBD companies involving fines ranging between $20,000-$85,000 (yikes!) in addition to notifications provided to consumers. Pursuant to these settlement agreements the respondent companies are also prohibited from similar marketing efforts in the future, any health claims must have scientific evidence to support them. Don’t make medical claims!

The jury is still out on the overall legality of CBD products

In January 2020, the Southern District of Florida in a case stayed a CBD class action relating to the marketing and sale of CBD products, on the claims of jurisdiction. Basically saying, that until the FDA figures out a legal path for the manufacturing and sales and marketing of CBD products, they can’t treat them any different from other supplements or cosmetics. The case is in limbo, as the court concluded a judgment was premature because “FDA regulations currently provide little guidance with respect to whether CBD ingestibles, in all their variations, are food, supplements, nutrients or additives and what labeling standards are applicable to each iteration,” and so the existing regulatory framework won’t work to resolve these issues.

https://www.ftc.gov/news-events/press-releases/2020/12/ftc-announces-crackdown-deceptively-marketed-cbd-products

“some or all CBD products are food additives, supplements, or nutrients that can be safely marketed to the public and, if nutrients, whether the labeling standards and requirements for CBD products will be different or the same as for other nutrients.”

So what kind of claims can you make?

Make sure that you prominently display your brand’s value propositions, like packaging that’s made from recycled materials or keto-lifestyle friendly CBD gummies. Below are a few ideas to help you think about values you can highlight without making medical claims:  

  • Independently lab tested
  • Grown without pesticides
  • GMO Free
  • Wellness
  • Organic hemp / organic ingredients
  • Natural
  • Plant-based
  • Vegan and cruelty free
  • Sun grown hemp
  • Sustainable packaging
  • Free of sugar / gluten free ingredients /
  • Made in America
  • Handcrafted with love
  • Delicious without artificial flavors
  • Women-owned company
  • 1% of proceeds go to cause X

It is in this regulated environment with all kinds of rules to follow, it’s important to find a way to design something that looks great and communicates your values. Something that is clear for the consumer, without any misleading hype – the goal is to educate, create trust. Being authentic can be the thing that separates your product from your competitors.

I can help with that. Let’s talk.

No commitment, would love to talk to you.