FDA AND DRUG-LIKE ANTI-AGING COSMETIC CLAIMS

ImageDo you believe your skin product is “anti-aging”? If it works then it should be a drug with extensive research and FDA approval. If it doesn’t work then it falls into the category of a cosmetic and the anti-aging promotion may be fraudulent.

As I have been reporting through seven editions of my Consumer’s Dictionary of Cosmetic Ingredients, the definition of cosmetic according to the Food, Drug and Cosmetic Act is that a cosmetic improves appearance, whereas a drug diagnoses, relieves or cures a disease.

Drugs are subjected to an intensive review and approval process by the FDA while cosmetics are not. Drugs also have to reveal side-effects and cosmetics do not.

The FDA has recently issued an alert to importers about “Skin Care Products Labeled as Anti-Aging Creams”. The first alert was issued between April 17 and June 17, 1987. Regulatory letters were sent to manufacturers that stated:“Any products found to be substantial violation of the new drug and misbranding of the act may be subject to regulatory action without prior notice.There are numerous skin care products on the market with exaggerated claims which cause the products to be unapproved new drugs. Examples of such claims are that the products ‘counteract,’ ‘retard’ or ‘control’ the aging process. Claims that their product will ‘rejuvenate,’ ‘repair,’ or ‘restructure’ the skin may also be drug claims. A claim such as ‘molecules absorb and expand, exerting upward pressure to lift wrinkles upward’ is a claim for an inner structural change which would usually cause a product to be a drug.”

There is an international list of firms and their products subject to intensified surveillance by the FDA. Among them are some of the best known companies such as Avon, Estee Lauder, Elizabeth Arden Chesebrough-Ponds USA, Claris, Revlon, Yves Rocher, and La Prairie.

La Prairie, for example, is a company I have cited a number of times for its hype and costs. Nordstrom,( department stores) sells La Prairies Skin Caviar Liquid Lift for $500 for 1.7 ounces. Nordstrom’s ads say: Reflecting the heritage of our Skin Caviar beads, the very essence of lifting, this modern-day next-generation formula contains scientific advancements that create a lifting phenomenon. Past damage recedes as existing cells are rejuvenated, and new ones are super-charged, nourished and protected. Skin appears lifted and taut. Skin Caviar Liquid Lift epitomizes science and luxury, the true nature of the Skin Caviar collection.

  • Benefits:

–          Lifts and firms the skin structure.

–          Protects and restores epidermal stem cell function.

–          Prevents the appearance and deepening of lines and wrinkles.

–          Hydrates, nourishes and protects

La Prairie’s own promotion says: “ascent to skin treatment based on La Prairie’s exclusive cellular complex only found in La Prairies age-fighting appearance of skin.”

Both Nordstrom and La Prairie have inserted the word “appearance” because after the first round of warnings in the 1980’s companies used “appearance” rather than “change” to get around the potential problems with the drug-cosmetic definition. Do the buyers, however, really absorb the word “appearance” or do they pay $500 for a tiny vial they believe will change their skins to make their faces more youthful?

The two companies cited above are certainly not alone in their anti-aging hype today.

Does Estee-Lauder follow the FDA drug-cosmetic rule?

Estee-Lauder’s Perfectionist Wrinkle Lifting/Firming Serum is selling at $100 for 1.7 liquid ounces at Neiman Marcus, Nordstrom and Saks Fifth Avenue. The cost might be worth it if the serum fulfilled the claims for it such as: “This powerful wrinkle lifting/firming serum supercharges your skin to dramatically reduce the look of lines and wrinkles. Breakthrough CPR-75 Technology is proven to double skin’s natural collagen building power (in vitro testing after 1 week). Instantly lines and wrinkles are plumped and smoothed. Skin feels smooth, looks fresher and younger. In just 4 weeks, skin reclaims a youthful firmness and suppleness.”

Is the serum a cosmetic or a drug? Does it really work?

The FDA, in its current warnings, lists lash enhancer cosmetics NeuLash, Rapid Lash and NeaveauBrow. The producers were first warned in 2011 because their lash products contained a synthetic prostaglandin analog in the same class of compounds as the active ingredient in an FDA-approved drug that lowers pressure in the eyes due to glaucoma. The FDA determined these”cosmetic” lash enhancers were drugs. In  my opinion, maybe it wasn’t just the FDA warning that made the companies recently remove the prostaglandin from the lash products but rather the threat of a lawsuit from Allergan, the company who markets the  prescription prostaglandin-containing eye lash enhancer, Latisse, approved by the FDA in 2008. Allergan found by serendipity their glaucoma drug increased eyelash growth and thus Latisse was born.

You can buy the cosmetic NeuLash from Amazon today in a mascara-sized container for $95 and from many other  places including NeimanMarcus which sells a Neulash product for $150 at this writing. The new version contains myristoyl and peptides-17. In  A Consumer’s Dictionary of Cosmetic Ingredients, I wrote “myristyol is derived from fats—either vegetable or animal” —and “peptides are pieces of protein”. Both ingredients have been declared safe by the CIR, the Expert Panel formed by the cosmetic and toiletries trade group which reports its findings to The International Journal of Toxicology.

The new magic ingredient in these cosmetic eyelash products, by the way, is reportedly pumpkin seed extract which the sellers say” helps lashes look more voluminous than ever. When lashes reach their full potential, a look of volume, length, curl and luster is revealed”.

And what’s in your anti-aging product? Stay tuned.

6 Comments Add yours

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