Drug or Cosmetic? Promoting Health Benefits in Personal Care Products
John is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. John retired from the FDA’s Office of Cosmetics and Colors in June 2019 where he served as an SME in the areas of personal care product microbiology and manufacturing (GMP’s). Prior to FDA John served in a global capacity with Estee Lauder Companies responsible for regulatory compliance in all manufacturing facilities. In 1982 John took over the helm of Food and Drug Standards Manager for the State of Wyoming Department of Agriculture, where he became an internationally recognized leader in the adaptation of HACCP principles to regulatory programs. John was promoted to Deputy Commissioner of Agriculture prior to leaving for Este Lauder.
John Grew up on a farm in Ohio where he learned a great deal about self-reliance, resilience, and creativity. Leaving the farm to start his journey, John graduated from The Ohio State University and the University of Wyoming. The skills that John learned in those early years bring him to you today. If you have a chance, ask John about his experience as a shepherd in Wyoming’s Big Horn Mountains. John is also a musician and vocalist, something he has enjoyed since performing professionally at age 16.
FDA has a history of avoiding discussion of popular issues and leaving the course of history to the imagination of the industry to push the boundaries of regulatory compliance. The unwillingness by FDA to address issues like “natural”, “probiotic”, “CBD” and other popular issues, creates an opportunity to add market potential, but it also creates hazards to avoid for FDA regulated products. Assuming that dietary supplement claims apply to cosmetics is a mistake. Dietary supplements, as a group, are usually early to jump on board creating new marketing avenues that eventually move into the cosmetic/personal care space. Since dietary supplements and cosmetics do not require pre-market approval, barriers to entrance to the market are much lower than OTC drugs. Once you have decided to promote the health benefits of your product you should do your homework and avoid making claims that say “drug” in the eyes of the FDA.
CBD in FDA-regulated products is a classic example of the FDA’s reticence to get in front of issues. This is much different than other countries that tend to come out early with restrictive legislation. FDA regulated industries are smart to take advantage of the FDA’s lax stance on regulatory compliance of popular issues. If you have an idea goes for it! To avoid regulatory backlash, make sure you are not breaking existing laws and regulations. Current regulations are not clear thus there is a considerable amount of speculation as to what is acceptable and what isn’t.
For cosmetics, the biggest problem is avoiding making drug claims and clearly stating a cosmetic function for the special ingredients that support claims. Cosmetics are unique because there is no requirement to substantiate cosmetic claims. Even if FDA does not provide guidance specific to issues like natural, probiotics, or other popular marketing spaces, The Federal Trade Commission can take action against marketers if their claims are deemed to be misleading or inflated. Finally, if you claim to be better than your competitors, The Better Business Bureau’s National Advertising Division can step in to level the playing field. This usually comes about when one competitor calls another to the carpet for unsubstantiated claims that their product is superior. If BBB mediation does not work, there is always court!
Vegan claims are not an issue as long as it is in fact true. Companies that operate as vegan or vegan friendly often call each other out for stretching the truth. Being certified as a vegan has no regulatory significance, but can be challenged by competitors and the blogosphere. This is true for all “certified” label claims. An important thing to remember is the distinction between “labels” and “labeling”. FDA considers both when determining regulatory compliance. If you are making claims, everything that is available on your website is labeling, including testimonials.
Making changes to your products to avoid negative connotations regarding ingredients, such as preservatives and other ingredients currently in the public’s eye can be problematic. Knowing the facts is a must. Changing formulations to avoid negative attention should not be made hastily. Removing preservatives in order to be able to say “preservative-free” can result in big problems, including recalls.
This webinar will outline issues that should be considered when changing marketing strategies as a result of an unclear regulatory atmosphere.
- Definition of “drug”
- Definition of “Cosmetic”
- Examples of non-acceptable vs acceptable claims
- FDA/FTC/BBB – what are their roles?
- Regulatory compliance
- Making claims
- Claim substantiation
- Competitive advantage
- Probiotics, prebiotics
- Natural, gluten-free GMO-free
- Label vs labeling
- CBD, Hemp, THC
Course Level - Intermediate and Advanced
Who Should Attend
- Marketing Directors
- Brand Owners
- New start-ups
Why Should You Attend
If you intend to create a competitive advantage by making product claims that may be judged as drug clams by FDA or if you market products that contain ingredients that are in regulatory limbo you should attend this webinar. Although drug claims in cosmetics are not clearly regulated by the FDA, they can still be problematic when you choose to go down the path. You can avoid regulatory problems if you know where the lines are and stay away from the edge. If you are willing to step into these markets make sure you know all of the risks. Is it worth jumping into the next big craze? When does a marketing claim become an actionable drug claim? What happens when the FDA or FTC decides to take action? How did we get from yogurt to probiotics? Can you use cannabinoids in cosmetics? What is natural, gluten-free GMO-free, etc?
FDA does not place a high priority on clarifying regulatory issues that arise as a result of marketing trends and health issues that are in the public psyche. As a result, the public’s expectations and regulatory boundaries often collide, breeding a mountain of misinformation that morphs into headaches for consumers and manufacturers. FDA leaves the interpretation of vague guidance on many issues up to the industry to figure out. If the industry cannot get it right the Federal Trade Commission (FTC) can step in to bring order to the marketplace. Also, the Better Business Bureau can get involved if FDA and FTC fail to take action.