Cosmeceuticals: Cosmetics or Drugs? Or In-between?

Holly C. Young looks at the definitions and regulations surrounding this high-growth sector, and explains why this prompts a wake-up call for our industry.

Written by Holly C. Young

AUTHOR BIO: Holly C. Young is president of H+Y Regulatory Graphics Consultants. She has worked in the cosmetics packaging industry for almost 40 years, and is the recipient of numerous awards.

First and foremost when using the word “cosmeceutical” on your beauty packaging or in your promotion, it is vital that you understand what this means and how this is viewed by officials who have a say in how you market and package your products.

Here is what Wikipedia has to say about the subject:

“Cosmeceuticals represent the marriage of cosmetics and pharmaceuticals. Examples of products typically labeled as cosmeceuticals include anti-aging creams and moisturizers. …However, despite the reports of benefits from some cosmeceutical products, the term cosmeceutical remains a marketing term, as there are no requirements to prove that the products actually live up to their claims. Therefore, it is up to the consumer to decide whether these claims are valid and worth the cost.”

As a note, these last two statements in Wikipedia are false. All products, whether cosmetic or drug, must live up to their claims.

And this is what the FDA has to say about the term “cosmeceutical”:

“The Food, Drug & 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.

“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)].

“Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses.

“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.”

And to the North, this is what Health Canada has to say about the term:

"Cosmeceutical" is a term used in the cosmetic industry for cosmetic products that have drug-like qualities. The definitions under the Food and Drug Act do not allow a product to be both a cosmetic and a drug. Therefore, "cosmeceuticals" fall under either cosmetics or drugs, depending on the ingredients and claims made.

“It is important to note that the rejection of a product as a cosmetic does not necessarily ensure its acceptance as a drug since safety and efficacy must be demonstrated.”

As you can see here, two large regulatory agencies (FDA & Health Canada) agree that “cosmeceutical” is only a marketing term but if a claim is made that is a drug-type claim, the product is then a drug and MUST be labeled as such. Always keeping in mind the governing regulations of “safe and effective” and that all statements about the product MUST be “truthful and NOT misleading.”

There is nothing wrong with the use of the term “cosmeceutical” as long as any and all claims are substantiated, the product is safe and effective, and the labeling is done correctly.

One last note: There was an Import Alert (Import Alert #66-38, 4/1/2010, Alert Name: “Skin Care Products Labeled as Anti-Aging Creams”) sent out by the FDA to Customs and posted on the Internet to watch out for products with “cosmeceutical” type claims. A list of offending products and companies was included in this document. To me, this is a wake-up call to our industry that we must all be cautious about how far we are pushing the envelope on our claims and our labeling.

EDITOR’S NOTE: For more on cosmeceuticals, please see the July/August 2010 issue of Beauty Packaging, in print and online.