Cosmeceuticals: How to Navigate the Claim Game

Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits. Though the concept may have struck a chord with some consumers, the term is unrecognized in any official capacity by the FDA. As a result, a lot of unknowns surround cosmeceuticals and their true benefits.

Joshua Zeichner, MD, associate professor of dermatology for the Icahn School of Medicine at Mount Sinai, New York, New York, drew his extensive expertise in this growing field to help dermatology professionals get a clear picture of cosmeceuticals and their verifiable efficacy and safety. He provided an in depth view of these products in his session the 2022 Fall Clinical Dermatology Conference for PAs & NPs entitled, “What You Really Need to Know About Cosmeceuticals,” looking to clear up any misconceptions.¹

Zeichner began by explaining that the cosmetic industry uses the word “cosmeceuticals” to

refer to cosmetic products that have medicinal or drug-like benefits. However, he noted that this term “has no meaning under the law” according to the FDA.²

He compared them to cosmetics and drugs, noting that both are regulated by the Federal Food, Drug & Cosmetic Act (passed by Congress in 1938 and, among things granted authority to the FDA to oversee the safety of food, drugs, medical devices, and cosmetics).³ According to the FDA, Cosmetics work to beautify or cleanse the skin, while drugs act to impact the structure or function of the skin.⁴

Cosmetics, such as skin moisturizers, perfumes, lipsticks, makeup, and shampoos, are used to beautify, promote attractiveness, cleanse, or alter the user’s appearance, but they are not subject to FDA premarket approval. Still, Zeichner noted that companies have a legal responsibility for the safety of their products and ingredients.

When labeling cosmetic products, claims must be truthful and not misleading, but there is no FDA approval for cosmetic product claims.

Conversely, drugs are products intended to treat of prevent disease, with Zeichner pointing out how they can impact the structure or function of the body and still have cosmetic benefits.

In this regard, drugs must conform to special regulations, known as “monographs” for their category and have an active ingredient. These product types are used to help control skin conditions such as acne, eczema, and dandruff.

Debunking the Myths

For the next part of his presentation, Zeichner delved into the question, “what is natural skincare?” He pointed out that the FDA has no regulatory definition of what qualifies a product as “natural.” According to Zeichner, the accepted industry wisdom is that “natural” applies to products without fragrances, sulfates, parabens, formaldehyde releasers, dyes, butylated, hydroxytoluene, phthalates, propylene glycol, or cyclic silicones.

These products sometimes can include chemical UV blockers, but most must have natural, sustainably sourced ingredients to earn a dermatologist’s vote of approval. These cosmeceuticals are used to improve the appearance of the skin and may include vegan or cruelty-free options, which are becoming more in-demand by patients.

Natural skincare products can claim to improve the appearance of the skin but cannot claim to change the structure or function of the skin or to prevent disease, Zeichner noted.⁵

Some of the common claims associated with natural skincare products are “dermatologist tested,” “dermatologist approved,” “clinically proven,” “hypoallergenic,” or “patented ingredients,” but Zeichner warned that often these phrases have little meaning other than to imply that they meet the specialty’s standards for efficacy and/or safety.

When comparing “clean” (which implies the product does not have certain compounds that are considered harmful) vs natural products, Zeichner noted that clean products account for a quarter of total skincare sales, with the latest recorded figures coming in at more than $1.6 billion.⁶

He also explored the meaning of the word “organic,” explaining that this too is a word that has no official FDA definition regarding skincare, though organics are regulated by the US Department of Agriculture. He contended that, despite what people may believe, organic cosmetics are not safer for consumers.

While the public perception may be that anything that markets itself as natural or organic must be good for them, that may not be the case. For example, he noted that some ingredients can cause irritation or skin disorders. He listed some of the most common naturals associated with contact dermatitis, including aloe, arnica, cucumber, ginkgo, lavender oil, peppermint, sage, and more. He also shared a list of essential oils, such as collagen-stimulating oils, carrot seed, frankincense, geranium, lavender, tea tree, and patchouli that can trigger contact dermatitis.

Zeichner warned that many of these contain photosensitizing furocoumarins. He emphasized that harmful chemicals are found both in nature and in the lab.

Skincare products need preservatives, he said. Zeichner noted they should contain 0.8% (mixtures of parabens) or up to 0.4% (single paraben); while paraben-free products contain ingredients such as phenoxyethanol, ethylhexylglycerin, and methylisothiazolinone that are also important.

A chief takeaway from all this is that there are no commercially available skincare products that are completely natural, and Zeichner questions whether they should really be called something akin to “based on natural,” “scientifically modified natural,” or even “natural-ish.”

How to Build a Cosmeceutical Regimen

The next portion of Zeichner’s presentation dealt with how dermatologists can best design a cosmeceutical routine for their patients. “Skincare does not need to be complicated,” he said.

He named some of the most important building blocks of a regimen are protection and prevention from environmental damage. This can include an antioxidant serum and sunscreen in the morning and, in the evening, moisturizer, collagen stimulating ingredients, retinol, AHAs, and peptides.

Sun protection, not surprisingly, is the number 1 way to protect the skin, he said.

He also spoke about the dangers of UV light exposure, showing how it causes premature wrinkling, lentigines, hyperpigmentation, melasma, neovascularization, and malignancies.

“Daily sunscreen use can prevent premature skin aging and skin cancer,” he said, and then asked the audience the rhetorical question, “can sunscreen actually reverse aging skin?”

Then, he showed a slide with a photo of Oprah and her familiar “Yaaaaaasss!” to answer.

Zeichner then pointed to various data showing how sunscreen alone improves clinical parameters of skin aging. Other parts of his talk dealt with antioxidant serums, hydroxy acid effects on the skin, and chemical exfoliation.

He concluded his presentation reviewing how cosmeceuticals offer a hybrid of cosmetic and pharmaceutical benefits, and noting that while there may be data showing efficacy in the skin, companies cannot claim changes to the structure or function of the skin.

References

1. Zeichner J. What you really need to know about cosmeceuticals. Presented at: 2022 Fall Clinical Dermatology Conference for PAs & NPs. Held June 3-5, 2022, Scottsdale, Arizona and virtual.
2. US Food and Drug Administration. Cosmetic labeling claims: Cosmeceuticals. Published July 6, 2017. Updated February 25, 2022. Accessed June 4, 2022. https://www.fda.gov/cosmetics/cosmetics-labeling-claims/cosmeceutical
3. US Food and Drug Administration. Federal Food, Drug, and Cosmetic Act. Enacted June 25, 1938. Updated: March 29, 2018. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act
4. US Food and Drug Administration. Resources for consumers on cosmetics: Cosmetic safety Q&A: Personal care products. Updated February 25, 2022. Accessed June 4, 2022. https://www.fda.gov/cosmetics/resources-consumers-cosmetics/cosmetics-safety-qa-personal-care-products
5. US Food and Drug Administration. Cosmetic labeling: Cosmetic labeling claims. Updated February 25, 2022. Accessed June 4, 2022. https://www.fda.gov/cosmetics/cosmetics-labeling/cosmetics-labeling-claims
6. Rubin CB, Brod B. Natural Does Not Mean Safe—The Dirt on Clean Beauty Products. JAMA Dermatol. 2019;155(12):1344–1345. doi:10.1001/jamadermatol.2019.2724