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When I started Alchimie Forever, one of the first things I did was to hire a great law firm. In the world of beauty and cosmetics, I was told, legal advice is not an expense to penny pinch on. My thoughts immediately went to the nightmare of lawsuits due to product side effects, but I soon learned that the most useful work that my lawyer does for me is U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) advising. He regularly reviews our claims and labeling, usually as they appear on our packaging. Right after hiring this great law firm, I purchased the ICMAD labeling guide, a little blue book of useful tips which to this day, 10 years later, I still own and consult.
The Regulatory Perspective
In referring to the ICMAD labeling guide, I found the following to be the most useful excerpts:
“The cosmetics marketed in the United States, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act, the Fair Packaging and Labeling (FP&L) Act, and the regulations published by the Food and Drug Administration under the Authority of these two laws.”
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As defined in section 201(i) of the FD&C Act, a cosmetic is a product intended to be applied to the human body for cleansing (though “soap” is addressed elsewhere), beautifying, promoting attractiveness or altering the appearance. Thus, one may say that a cosmetic is a product intended to exert a physical, and not a physiological, effect on the human body.
In section 701.20 of Title 21 of the Code of Federal Regulations [21 CFR 701.20], the FDA defines the term “soap” as a product in which the non-volatile portion consists principally of an alkali salt of fatty acids, (i.e. the traditional composition of soap), the product is labeled as soap and the label statements refer only to cleansing. If cosmetic claims—e.g. moisturizing, deodorizing, skin softening etc.—are made on a label, the product is a cosmetic. Synthetic detergent bars are also considered cosmetics, although they may be labeled as “soap.”
A cosmetic is legally also a drug if it is intended to exert a physical and physiological effect because the FD&C Act defines in section 201(g) the term “drug” to mean, among other things, “articles intended for use in the ... cure, mitigation, treatment, or prevention of disease ... and ... articles ... intended to affect the structure or any function of the body ...”
Section 509 of the FD&C Act provides that the categories of “drug” and “cosmetic” are not “mutually exclusive.”
In addition to claims of efficacy, another significant portion of the cosmetics regulatory framework refers to labels—namely what needs to be written and where on both the inner and outer packaging, in what font size as a proportion to the package, in what language, in what order, and on and on. Most consumers today, for example, know that the ingredient listing must be in descending order of % in the formulation—and brand owners must present this information in standard INCI nomenclature. Of course, this has recently changed for sunscreen ingredients, which must now be listed in alphabetical order.
On that note, it should be mentioned that the most recent and comprehensive labeling changes from a regulatory standpoint have surrounded claims and packaging of products with SPF ingredients and sunscreens themselves. The FDA’s most recent changes are still being implemented by many smaller manufacturers, who have until December 2013 to comply.
The Marketing Perspective
Given the above definitions and regulations, and the examples of cited claims in the “FDA Warnings” sidebar, it behooves brand owners to be conservative in their claims. It should also be recognized, however, that while the term “anti-aging” might be interpreted as implying a physiological effect, it is widely used in the beauty industry and not specifically defined by the FDA. Similarly, the term “cosmeceutical,” which is well-known by consumers, is not a term the FDA officially recognizes, yet one that is often used in marketing literature.
How does one reconcile the marketing perspective with the regulatory requirements of our industry? As my lawyer explained it to me in one of our first meetings, “Look at Estée Lauder ads and packaging... They flirt with the line between drug and cosmetics claims in the most elegant and appropriate manner.” I have never forgotten that piece of advice, and here are some specific examples of leading claims that illustrate.
Clinique: Anti-Gravity Firming Eye Lift Cream
Densely hydrating cream lifts, firms around the eyes. Helps erase the look of lines. Builds cushion into time-thinned skin. Brightens eye area. International and U.S. Patents Pending.
Estée Lauder: Advanced Night Repair Series: Serum, Eye
Inspired by groundbreaking DNA research-brings your skin a dramatic reduction in the visible signs of aging.
Now a year-long clinical study proves skin gets better and better: women continued to experience a dramatic reduction in the major signs of visible aging, day after day, month after month.
Skin looks smoother, younger, more radiant and healthy-looking.
Exclusive Chronolux Technology repairs the appearance of past damage. You’ll see a visible improvement in the signs of aging—specifically lines, uneven skin tone and immediate hydration.
Enhanced Environmental Repair means Advanced Night Repair neutralizes up to 90% of environmentally generated free radicals (in vitro testing) before they can affect skin’s appearance.
Enjoy Continuous Hydration as Advanced Night Repair creates the optimal environment for repair with nature’s long-proven moisture magnet, Hyaluronic Acid-increasing skin’s levels of moisturization dramatically.
Clinical Studies and Consumer Testimonials
In addition to effective word-smithing and use of terms such as “visible signs of,” numerous brands rely on consumer testimonials and clinical studies to convey the results one can expect from products—avoiding crossing the cosmetic/drug line and sacrificing claims while effectively marketing the products. Here are some examples:
Firm Baby Firm, clinical study:
after 4 weeks
- 90% showed an improvement in skin firmness around the eyes;
- 100% showed an improvement in skin elasticity in the chin area.
after 8 weeks
- 90% showed an improvement in overall facial volume and plumpness.
Thinny Thin Chin, clinical studies show:
- 68.2% of testers reported a reduction in sagginess of the neck and décolleté areas;
- 76.2% of testers felt that skin on the neck area was toned and supple;
- 63.6% of testers reported a decrease in the appearance of wrinkles in the neck area.*
*Results reported from an independent clinical study conducted over a 6 week period.
Peeling Groovy, after three weeks, testers reported the following results*:
- 100% saw a decrease in pore size;
- 100% saw a decrease in fine lines;
- 95% felt the product bettered skin complexion;
- 95% felt their skin was more radiant;
*Results reported from an independent clinical study over a 21 day period.
- 82.7% improvement in pore size for all ages;
- 73.1% improvement in skin texture (rough vs smooth) for all ages;
- 64.7% improvement in fine lines/wrinkles for all ages;
- 56.8% improvement in pigment irregularities for all ages;
- 94% improvement in active acne for all ages;
- 83.3% improvement in acne scars for all ages.
Pro-Heal Serum Advance
Clinically proven to reduce erythema and inflammation.
I remember when I was a product manager working in the medical device field, I “belonged” to the marketing department. My role was to support the sales team and make their job (and selling) easier. I recall many meetings with the regulatory team, butting heads about promotional materials and verbiage. Those arguments made our product better in the end, and made us stronger in the sales and marketing of our devices, as is often the case with cosmetic products today.
I do prescribe to the philosophy of under-promising and over-delivering, and I believe the beauty consumer is smart enough to know the difference between what a topical cosmetic product can and cannot do. Will our eye cream erase your wrinkles like Botox? Absolutely not—but will it help minimize the visible signs of skin aging? Probably… at least, it won’t hurt.
Research assistance was provided by Rachel Ametsitsi, Alchimie Forever intern.
Ada Polla is the co-creator of the Swiss antioxidant skin care line Alchimie Forever, which launched in the U.S. in 2004. Her strategic focus and implementation have yielded double-digit annual revenue growth for the company. She holds an MBA from Georgetown University, majored in art history and political science at Harvard University and graduated magna cum laude with a Bachelor of Arts degree in 1999. She is also a GCI magazine editorial advisor.