What are Cosmeceuticals?

I think of all the confusing terms/issues that are used by the cosmetic, beauty, and skincare industry one of the most confusing is the term cosmeceutical.  So what exactly is a cosmeceutical?  What does that term mean?  Is it even a legal term?


A Little History and an Explanation


The term cosmeceutical was coined in 1980 by the dermatologist Albert Kligman.  Dr. Kligman was a world-renowned dermatologist who made a lasting contribution to the world of skincare by discovering that topical retinoic acid (or tretinoin) could be used as both an acne and wrinkle treatment.  (Dr. Kligman’s research was, at times, very controversial, a fact I think should be noted).

The term cosmeceutical combines the words “cosmetic” and “pharmaceutical” together implying that any product labeled as such can actually change the appearance of the user’s skin for instance decrease wrinkles or fade sun spots.  BUT there is no actual medication in a cosmeceutical product because if there was the product would be labeled a drug and regulated by the FDA.  In essence a cosmeceutical is a blend of a beauty product and one or more active ingredients like peptides, antioxidants, or growth factors.  Now these active ingredients might have an affect on the skin, but they are not drugs so there is no guarantee that they will affect the skin in a positive (or negative) way.  As such cosmeceuticals fall under the same murky area as other cosmetic products on the market meaning companies can make all sorts of claims about their products and yet not offer a proof to those claims.


How the FDA Views Cosmeceuticals


According to the FDA (which regulates manufacture and approval of drugs in the US):

The legal difference between a cosmetic and a drug is determined by a product’s intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim, or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles 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” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpastes, and deodorants, as well as any material intended for use as a component of a cosmetic product.

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].

How can a product be both a cosmetic and a drug?

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

What about “cosmeceuticals”?

The FD&C Act does not recognize any such category as “cosmeceuticals.” A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law.

How is a product’s intended use established?

Intended use may be established in a number of ways. Among them are:

  • Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.
  • Consumer perception, which may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
  • Ingredients that may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.


 Where Does This Leave the Consumer?


In her excellent book Simple Skin Beauty Dr. Ellen Marmur makes an excellent point about cosmeceuticals (page 260):

When I read these labels [of anti-aging products] or beauty articles that explain how a cosmeceutical can reprogram cellular division, repair DNA, or extend the life span of cells, I have to wonder.  Think about it:  if these ingredients really did what they promise – namely, interact with cell function and the structure of the skin – they would certainly be considered drugs and thus regulated by the FDA.  If indeed some of these chemicals fundamentally impact the skin function in a significant way (rather than just the superficial appearance), we need to validate their safety as pharmaceuticals, with stronger FDA scrutiny.

 So when it comes to cosmeceuticals how can you make sure you aren’t being taken for a ride?


To read the rest of this post please visit my blog:  http://askanesthetician.wordpress.com


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