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How Cosmetic Companies Get Away With Pseudoscience

Anti-aging creams make absurd claims that they repair DNA damage or use stem-cell treatments. When cosmetics companies and dermatologists partner to maximize profits, who is responsible for protecting the consumer?
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(Photo: grmarc/Shutterstock)

(Photo: grmarc/Shutterstock)

My mother is the least vain woman I know. She is a loyal patron of Supercuts, always keeps her nails clipped short and unpainted, and never leaves for work with more than a few swipes of eyeliner on her face each morning. She’s unmoved by the beauty products most women her age can’t seem to live without—except for a $15 drugstore anti-aging cream that she has used every night for as long as I can remember.

Even my unfailingly modest mother is reluctant to watch herself age, and like many others, she’s willing to pay to keep the wrinkles at bay. The cosmetics industry is happy to oblige. By 2015, the worldwide market for anti-aging cosmetics, including creams, serums, and salves, is expected to hit $114 billion, up from an estimated $1.15 billion in 2005, according to a report published by the European Molecular Biology Organization. Within the next 10 to 15 years, that number is projected to double.

Since most manufacturers aggressively guard their products with patents or laws that protect trade secrets, consumers have no way of knowing what is actually in the cosmeceuticals or how they were tested.

If these anti-aging creams and serums, or “cosmeceuticals,” actually do what they claim, 15 dollars, or even $100, or $350, would seem like a small price to pay. Most women swear by their favorite products, in spite of or unaware of the often-dubious science used by the companies who peddle them. More likely, though, the secret is in the marketing, not the science—lies told to placate those who have sagging skin and disposable incomes.

First coined by a prominent dermatologist in 1984, “cosmeceutical” is not an officially recognized term by the Food and Drug Administration. It has since been used to describe an ever-expanding range of over-the-counter topical skincare products with implied biological, drug-like capabilities. Euphemistic jargon abounds, with phrases like “therapeutic cosmetic” and “active treatment.” And yet, while the FDA aggressively investigates pharmaceuticals and medical devices before they hit the market, requiring extensive laboratory and clinical testing to demonstrate safety and efficacy, cosmetics (including cosmeceuticals) completely escape their regulatory purview.

The Food, Drug, and Cosmetic Act distinguishes between drugs and cosmetics purely based on the intended use as defined by the manufacturer; unfortunately, these rigid categorizations have remained constant for the better part of a century. As long as a product’s packaging and marketing materials don’t claim to mitigate, treat, or cure disease, or otherwise affect the structure and function of the body in any way, it is considered a cosmetic and therefore relieved from its burden of proof. In essence, cosmeceutical firms have exploited a semantic loophole to create an enormously profitable subcategory of quasi-drugs that circumvent all government oversight.

In the absence of meaningful regulation, anti-aging skincare products are now overrun with unproven or controversial “active” ingredients, at times even eschewing the FDA’s language restrictions with impunity. Most major manufacturers are careful to use tempered phrasing when advertising their products, guaranteeing only to “reduce the appearance” of wrinkles and sun damage, or, vaguely, to “promote” and “boost” the production of skin-firming collagen.

"Our patients are deluged with ads proclaiming the special qualities of moisturizers, night creams, eyelid renewers, and other magic rejuvenators of aging skin. Scientifically, this is all nonsense."

Bolder products claim to reverse and correct aging by actively repairing DNA damage or treat wrinkles so effectively that they are “Better than Botox.” (Never mind that Botox is a neurotoxin that has been FDA-approved as a wrinkle treatment.) The Federal Trade Commission, government watchdog for truth in advertising and partner to the FDA in policing health and fitness claims, has largely ignored the cosmetics industry, choosing instead to focus on the overwhelming number of fraudulent and sometimes dangerous weight loss foods and dietary supplements. When it comes to cosmeceuticals, in other words, consumers are on their own.

THIS IS NOT TO say that scientifically proven skin treatments do not exist—however, they typically require a prescription. These creams and gels are classified legally as drugs (including Retin-A, Renova, and Refissa) and have overcome the scientific hurdles imposed by the FDA on medications. They contain known wrinkle-reducing compounds like retinoic acid (retinoin) and alpha hydroxy acids. Newer active ingredients like peptides and antioxidants are still controversial, but are slowly gaining traction in independent and industry research. Some cosmeceuticals may feature these compounds or a less effective derivative, but always in much lower doses.

It’s important to realize that the skin is an incredibly effective natural barrier, and not just against dangerous pathogens. Even natural compounds found throughout the body, like collagen, aren’t given a free pass. For this reason, prescription creams are developed (and tested) to ensure that active ingredients penetrate the skin in high enough doses to have a physiological effect and produce true, wrinkle-reducing results on a cellular level.

While a small number of active ingredients have been validated experimentally, cosmeceutical products as a whole are never subjected to the rigorous process of peer review. They may brand themselves as “clinically proven” or “dermatologist recommended,” but these terms have no industry standard definition. And since most manufacturers aggressively guard their products with patents or laws that protect trade secrets, consumers have no way of knowing what is actually in the cosmeceuticals or how they were tested.

In order to lend itself legitimacy in the absence of real information, the cosmeceutical industry has cleverly courted dermatologist-entrepreneurs, credentialed medical doctors who partner with beauty industry giants as paid consultants or clinical researchers. Some even create namesake product lines like Murad and Perricone MD. It’s an egregious conflict of interest, at odds with every medical code of ethics, as some within the field will attest.

A decades-long debate rages between a burgeoning population of physician-businessmen and less profit-minded practitioners regarding the ethicality of anti-aging product endorsement, in-office dispensing (re-labeling drugstore skincare products to be sold out of a dermatologist’s office at a 300 to 600 percent mark-up), and the inception of the medical spa.

In a letter entitled “Are We Consultants or Peddlers?” published in the Journal of the American Medical Association Dermatology, dermatologist Ernst Epstein makes his opinions clear: “There is a price paid by the dermatologist who sell cosmetics.... It is our integrity. ... Our patients are deluged with ads proclaiming the special qualities of moisturizers, night creams, eyelid renewers, and other magic rejuvenators of aging skin. Scientifically, this is all nonsense; we know that while some of the ‘cosmeceuticals’ may temporarily plump up the skin a bit more than others, the differences are trivial and temporary.”

More likely than not, “dermatologist recommended” and “tested” products were distributed by a dermatologist to a few patients, and no overtly adverse reactions were observed. In the same vein, “dermatologist created” products may well have been developed with the advice of a dermatologist under consideration, but such cosmeceuticals are no safer or more effective than any other, as the marketing is clearly intended to imply.

These are more than just benign overstatements. In 2010, market research firm The Benchmarking Company estimated that 35 percent of women choose skincare products based on “dermatologist recommended” branding, and that over 50 percent of women believe “dermatologist tested” products are guaranteed to work.

Officially, the American Academy of Dermatology does not endorse products and prohibits dispensing or promoting products that have no beneficial effect. In fact, the AAD states unequivocally that the two most effective anti-aging products consumers can purchase are moisturizers and broad-spectrum sunscreens, and that the secret ingredient in most anti-aging creams is actually a well-formulated moisturizer, sometimes enriched with sun-blocking agents.

IS IT POSSIBLE THAT these products do work, and that cosmetic companies simply don’t provide scientific evidence because they’re not required to? Recent events would suggest otherwise.

With cosmeceutical prices quickly skyrocketing—department store brands easily run between $450 to $700 for a few ounces—the FDA and FTC finally have taken notice of the potential for manufacturers to defraud the public. Since 2010, the FDA and FTC have issued 10 warning letters to cosmetics companies for making drug-like statements in their anti-aging creams’ marketing materials, including L’Oreal, Avon, Nivea, and L’Occitane.

L’Oreal is the world’s largest cosmetics group, amassing nearly $30 billion annually in sales. In a half-year financial report filed with the SEC in June 2014, L’Oreal reported spending around $450 million on research and development, but over $4 billion on advertising and promotions. Apparently, spending nearly $1 billion annually on research can generate enough evidence to assure consumers their cosmeceuticals work, but not quite enough to meet the FDA’s standards of proof.

The advertisements in question described their products as having the ability to, for example, change gene expression in the skin to induce collagen production and block the process of aging, or even promote weight loss. Under threat of legal action, manufacturers were ordered to produce scientific evidence to substantiate their claims and have products evaluated through the FDA’s New Drug Approval process, or cease making such statements altogether.

All of the firms chose the latter.