What you need to know in under 1 minute
A current industry trend, “beauty from within” refers to a focus on health – physical, mental and lifestyle health – and how it affects beauty. Oral supplements that consumers can use to provide aesthetic benefits to their skin, hair, and nails are central to this trend.
From a U.S. Food and Drug Administration (FDA) regulatory perspective, oral supplements fall under the food subcategory of dietary supplements. Under this trend, attractive claims about beauty and cosmetics, such as “helps reduce the appearance of fine lines and wrinkles,” can have unintended consequences. In FDA's view, this claim applied to oral supplements (rather than topical cosmetics) makes oral supplements unapproved drugs because this and similar claims purport to change the structure of the skin. It will change.
In less than a minute, we'll tell you what you need to know about beauty-from-within product claims.
Triad: Cosmetics, Supplements, and Pharmaceutical Claims
Cosmetics and dietary supplements can be considered drugs and regulated by the FDA based on advertising claims. Therefore, small exaggerations or mistakes can have big consequences.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cosmetics Generally refers to products applied to the human body for the purpose of “purifying, beautifying, promoting attractiveness, or altering appearance,” and acceptable claims focus on these listed functions.
on the other hand, diet supplements Products intended for consumption and contain substances (vitamins, minerals, herbs, etc.) to supplement the diet. Supplements have a “structural-functional” meaning that refers to dietary components and their ability to support or maintain already healthy structures (e.g., skin, eyes, or hair) or functions (e.g., metabolism, digestion, or immune function). Display is permitted. ) of a body.
Cosmetics and supplements are not covered. drug claims For the purpose of “diagnosing, treating, mitigating, curing, or preventing disease” or “affecting the structure or function of the body” under Section 201(g)(1) of the FD&C Act.
iron out wrinkles
“Beauty from within” supplement and cosmetic claims can be confusing, especially when manufacturers sell both products for the same purpose. Certain types of claims are always in the crosshairs of the FTC or FDA. The following general examples highlight general arguments raised regarding claim language alone, based on his recent combined FTC and FDA actions.
Hypothesis Concept 1: Helps reduce the appearance of skin conditions (wrinkles, fine lines, redness, etc.).
- Acceptable claims for cosmetic products: This claim for cosmetic products, such as moisturizers, is generally acceptable because it focuses on the product's effect on the appearance of the skin.
- Unapproved drug claim on beauty-from-within supplements: This claim can pose a risk when applied to oral supplements. It does not remain within the permissible 'maintenance' area of structure-function claims (e.g. 'helps maintain healthy skin'), but rather is intended to change the structure of the skin, making this a drug claim. This is the interpretation.
Hypothesis Concept 2: Helps maintain (e.g. healthy skin and circulation).
- Unapproved drug claims for cosmetics: Similar claims are subject to the argument that they do not fall within the scope of cosmetic claims because the claims do not focus on cleaning, beautifying, enhancing attractiveness, or changing appearance. This often happens. Rather, any suggestion that the product affects the structure of the skin classifies this as a structure-function claim, which is not permitted for cosmetics and could potentially make the product an unapproved drug. The argument claims.
- Acceptable structure-function claim for beauty-from-within supplements: As long as there is proper substantiation, this claim is unlikely to raise similar pharmaceutical claims for supplement use.
- Substantiation Considerations: Regardless of the FDA's classification of a supplement as a drug or dietary supplement, advertising claims must be true, not misleading, and supported. Claims about the health benefits of supplements must be substantiated in the form of competent and reliable scientific evidence from actual product testing. In general, claims of health-related benefits to humans require randomized controlled clinical trials that are conducted in a methodologically sound manner and that achieve statistical significance (95% confidence level). The FTC and FDA have publicly announced their intention to harmonize substantive standards.
Hypothesis Concept 3: Increase/assist collagen production.
- Pharmaceutical claims for both cosmetics and internal beauty supplements: Claims on topical cosmetics and oral supplements that increase or assist collagen or fat production are based on the claim that such claims refer to a change or effect. has been interpreted as a label for pharmaceutical products. About the structure of the skin. Apart from the claim language itself, other factors can influence this analysis, such as whether the product's active ingredients have been approved by the FDA to function as a drug.
Government and class action enforcement risks
The FDA regulatory distinctions regarding permissible labeling for cosmetics, supplements, and drugs are very clear. It is also clear that there are many examples on the market of cosmetics that claim medicinal benefits in the form of structure-function claims, and internal beauty supplements that claim medicinal benefits in the form of cosmetics. However, this risk has not resulted in a series of class action lawsuits, as is currently the case in the food sector.
In 2017-2018, several manufacturers of biotin supplements marketed for healthy “hair, skin, and nails” (i.e., with acceptable structure-function claims) announced that their products were A class action lawsuit was filed on charges of fraud for failing to improve the system. And nails. In other words, these claims allege that there was no adequate demonstration to support the structure-function claims. These lawsuits had little success.
The FDA and FTC have both filed complaints and issued warning letters to cosmetic companies (e.g., noting that drug claims have been made for both cosmetic and supplement products). However, these are relatively few given the number of products on the market.
peer into a crystal ball
The cosmetics and nutraceutical industry has had a much lower risk of class action lawsuits than the food industry over the past 20 years. But recent activity in California suggests that the same plaintiffs' lawyers who have taken food seriously may be looking to the cosmetics and nutritional supplement markets as new hunting grounds. This trend is already being observed in the area of California's Proposition 65 enforcement, with increased enforcement on cosmetics and supplements. Cosmetics companies and their affiliates that are cashing in on this beauty-from-within trend may find comfort in continuing to stay in the crowd when it comes to advertising, but be aware of the risks. There is a need. K&L Gates' Litigation and Dispute Resolution and Policy and Regulatory teams regularly advise clients on the unique risks associated with FDA-regulated products.
As always, the beauty industry is buzzing with new trends. As we have discussed in this article, some trends lead to notable adaptations of existing laws, while others drive new laws and precedents or operate in parallel. Future editions of this litigation docket series will focus on the tightrope walked by cosmetics brands considering natural, clean, or ESG-based product claims, as evidenced by recent class action lawsuit filings. We also examine the impact of new lifecycle and end-of-life packaging laws and guidelines on the cosmetics industry, with a focus on new state laws and expanded brand responsibility.
