FDA Sends More Warning Letters For Drug Claims In Skincare

FDA Is No Longer Being Complacent It Seems

FDA has sent out more warning letters to a small number of companies that specialize in skincare creams that correlate with Diabetes, since they are proclaiming a drug benefit when you use one of their topical treatments.  Although this is not a cosmetic company scenario, it still is something to underscore that FDA is keeping an eye out for those wanting to make medical claims that their skin cream will do more than just moisturize and help skin look and feel better.

Who Was Targeted This Time With An FDA Warning?

It was these medical skin care providers listed below:

• Health Care Products, Diabetes Division, concerning two of its Zostrix skin care products

• Anastasia Marie Laboratories for its Diapedic treatment

• The Magni Group for a number of medicated skin care products, to treat shingle-, diabetic- and other medical related skin care issues.

The FDA based their warning letters on the premise that some of the purported product claims offered by way of marketing and advertising, which is a violation of FTC regulations as well, also violated The Federal Food, Drug and Cosmetic Act, with specific reference to drug claims that might pertain to the diagnosis, cure, mitigation, treatment or prevention of disease.  In these cases, it revolved around those suffering from diabetes.

Although I have covered this in the past in many of my articles I feel they are worth repeating:

FDA is clear about a disease is any condition of the body such as wrinkles due to aging, dryness, skin damage due to sun exposure, acne, psoriasis, eczema etc.  Whereas a cosmetic is defined as a product intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

So most skincare creams or makeup products can clearly make us look and feel better including soothing skin and even improving its texture temporarily and / or skins appearance with cumulative effects.  However their descriptions, despite the ingredient profile of known benefits, especially when organic ingredients are used, cannot purport to be curative in any way of any disease, skin condition or otherwise.

I would love to proclaim historical and anecdotal evidence of how organic ingredients can truly react remarkably on skin, but without the actual clinical studies, no can do!  Only you can decide how your skin does or what you know has been improved after using a certain skincare product.

FDA Sent Out Warning Letters For Anti Aging Claims Last Year

Last Fall, the FDA notified some of the heavy hitters in our cosmetic and skincare industry and gave them a major smack down because they were making product claims relating to anti-aging benefits without actual FDA approved clinical trials.

Some of you may remember the companies that were targeted; Avon, L’Oreal (Lancome) and Janson Becket for example, making claims that their products can help treat or visibly repair wrinkles.  You can see the FDA list and who and what type of warning letters were issued to various cosmetic and skincare companies.

The FDA is especially keen to point out that many companies marketing anti-aging products avoid making claims that such treatments can have a physiological impact on the body or the appearance, which according to its definition of a cosmetic product, gives it a drug claim.  The term 'anti-aging' in and of itself could be determined also as a drug claim since it infers that it is reversing or preventing aging of our skin, which no product can do.  It can help skin look better and slow the process to a degree, but to prevent or reverse, this will not happen.

The FDA won't typically have a problem with a name of a product so much as a description based on its' intended use.  For instance you can call a product 'rejuvenate' or 'revitalize' as long as the name by definition doesn't broaden to a description that the skin will some how be completely transformed back to perfection before the wrinkles or damage.  However, in the other context, a product called 'acne buster' or 'acne complex' does create an inference within the name that it will do something for acne, such as cure or correct it without product description.  This would therefore fall under FDA scrutiny as a skincare product duping as a drug.

Claims that any skincare or cosmetic product will rejuvenate (restore to new), repair, or restructure the skin may also be a drug claim.  Another in particular that I have frowned on and know to be categorically false, are those that claim they can restore collagen simply by applying a collagen molecule to the skin.  Synthetic collagen is actually protein molecules, and they are too large to even penetrate skin, much less do anything to help restore our loss of natural collagen as we age.  

This also is something Lancome was claiming in their skincare products and this is tantamount to making a 'drug' claim.  So always be wary of those promising you the moon, stars and sun in a fountain of youth, physiologically speaking.  It simply cannot be done with a topical cream!