The CBD market is catching the interest of consumer goods producers across a range of categories. No longer reserved for the fringe element, CBD products are anticipated to become increasingly mainstream, catching the attention of major multinational brands. But while a brave few are diving in with both feet, many are dipping their toes to test the safety of the waters. And with good reason.
While hemp and hemp-derived CBD became legal in the U.S. in December 2018 under the Agriculture Improvement Act of 2018, also known as the Farm Bill, the FDA is still catching up. As the governing body for cosmetics, as well as both human and veterinary drugs and the nation’s food supply, the FDA has the ultimate say on how CBD can legally be used in these products in the U.S. And they haven’t yet solidified their stance on its safe and effective use.
Because the FDA regulates cosmetics differently than drugs—including lifting the requirement for pre-market product approval—cosmetics hold particular appeal for those investigating the potential uses of CBD. Given that personal care products accounted for nearly 25% of the hemp-based product market in the U.S. as of 2016, and that was before legalization, this should come as no surprise. If the now-legal CBD market grows as anticipated—becoming a $50-100B industry according to Piper Jaffray analysts—then beauty and personal care brands stand to profit in big ways.
“The beauty and personal care industry will
be a major beneficiary of growth in cannabis.”
Source: Murphy, Erinn. “Weeding” through the Natural Beauty Trend.
Piper Jaffray Investment Research. Jan 10, 2019.
Those who were quick to take the plunge into CBD products are figuring it out as they go. And some are learning hard lessons. The FDA has issued a number of warnings to companies that it believes have crossed the line by making unsubstantiated claims, including Curaleaf Hemp, the largest American cannabis retail dispensary brand, who was cited for making unsubstantiated health claims and, in doing so, essentially misbranding their products as drugs. The FDA has also issued similar warnings to cannabis brands Greenroads Health and Natural Alchemist.
While these cases might cause some companies to remain on the sidelines until the FDA provides clear and specific guidance on CBD, they can also provide guardrails for those companies looking too cautiously introduce CBD cosmetic products. Here are three things you can do to err on the side of safety.
1. Know the Difference Between Cosmetics and Drugs
The FDA hasn’t made a formal ruling on the effectiveness of CBD for cosmetics yet, but it does have clear definitions for cosmetics vs. drugs. And knowing the differences is key to staying on the safe side.
The FDA defines cosmetics as ”articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part of the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.” It defines drugs 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.”
Using these definitions, products like hand lotions, lip balms, lipsticks, and perfumes—as well as shampoos, conditioners, and toothpastes—are typically considered cosmetics products. But just because a product fits into the typical cosmetic mold doesn’t make it a cosmetic. The use of the words “intended to be” and “intended for use” cannot be overlooked in the FDA’s definitions.
Furthermore, the FDA regulates cosmetics and drugs differently. While each must adhere to specific regulations, cosmetics can be introduced to market without prior approval by the FDA, but drugs must receive FDA approval first. This is a key distinction and a primary driver behind the allure of CBD cosmetics for consumer products companies. It’s also where those companies that have received FDA citations have most often slipped up.
2. Ensure You’re Marketing Your CBD Cosmetics Correctly
While “intended use” may seem a bit ambiguous, the FDA determines a product’s intended use by how that product is explicitly marketed, its implied effects, and consumer perception. For example, an explicit marketing claim like “proven to reduce inflammation” would classify the item as a drug. Similarly, if a product is marketed to have an implied effect, like preventing bone fragility, a symptom linked to a disease like osteoporosis, it would also be classified as a drug. Finally, consumer perception can also lead a product to be labeled a drug by the FDA, though this is a bit more nuanced.
In the Curaleaf case, they made claims about several products, including a CBD lotion, that caught the FDA’s attention. Their CBD lotion specifically appears to be a cosmetic product since it’s rubbed on the body. But Curaleaf made marketing claims on their website that implied their products can be used to treat the symptoms of conditions like chronic pain, anxiety, and ADHD.
These marketing claims change the intended use of the lotion (and their other products, too), making it a new drug per the FDA’s definition. Per the FD&C Act, 21 USC Section 321, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA. Of course, Curaleaf hasn’t received any such approval, nor have the others who’ve received FDA warning letters.
To avoid making claims that potentially position your cosmetic product as a drug, here are some basic guidelines:
Make only truthful claims that aren’t misleading
Avoid making claims that a product treats or prevents disease
Avoid making claims that a product affects the structure or function of the body, including the skin
Avoid the use of terms like “proven to,” “prevents,” “treats,” and “eliminates”
3. Follow Best Practices for Producing and Selling CBD Cosmetics
While the FDA’s requirements for cosmetics may appear less stringent, you must still adhere to specific regulations. To ensure product safety and demonstrate responsibility, cosmetic producers should follow these best practices:
Meet all FDA labeling requirements for cosmetics. The label for a cosmetic must include: the identity of the product (what it is); net contents (how much is in the package); ingredient declaration (what ingredients it’s made of); and any required warning labels. Ensure you meet all requirements by reviewing Code of Federal Regulations Title 21, Sections 700 - 740.
Follow the FDA’s guidance on cosmetic GMP. While the FDA requires that drug manufacturers adhere to good manufacturing practice (GMP), it only recommends that cosmetic manufacturers do the same. Even though you’re not required to do so, the safest best is to adhere to the FDA’s Cosmetics - Good Manufacturing Practices to demonstrate a commitment to safety and responsibility.
Ensure your CBD meets legal requirements. Beyond the FDA regulations, businesses considering selling CBD products must also follow state regulations to ensure their product meets the legal requirements of the states where it’s sold, such as California’s assembly bill: AB-228 on industrial hemp products.
Choose a supplier that can provide supply chain transparency. Any hemp supplier should be compliant and able to verify each step from seed to shelf in their hemp farming and extraction process. This should include verifying organic provenance, validating THC levels, and adhering to testing and regulations as directed by both state and federal agencies.
Playing it Safe with CBD Cosmetics
While many believe CBD may provide potentially life-changing health benefits and are understandably eager to deliver CBD into the hands of the public, the FDA is also within its purview for exercising caution as it determines how to regulate the safe and effective use of this newly legal substance.
Until such time as the regulations are more clearly defined, there is some risk in introducing products containing CBD to the U.S. market. But because the FDA regulates cosmetics less stringently, these products are attracting the attention of early CBD adopters. And for those ready to take the plunge, there are ways to err on the safe side.
If you’re interested in bringing CBD cosmetics to market, you’ll also need a reliable and trustworthy CBD supplier. Integrated CBD is a vertically integrated supplier of organic hemp-derived CBD with the capacity to support large-scale CBD product production needs and the technology to provide seed-to-shelf supply chain transparency. To learn more, visit www.integrated-cbd.com.