Cosmetics & Toiletries - September 2008

regards to misbranding. To qualify as a cosmetic product, the labeling must not imply any physiological effect, must not suggest an impact on structure or function, must not contain ingredients that are commonly regarded as drugs, and must not contain unapproved color additives. If an ingredient is known by the public to have certain therapeutic effects, its use in a cosmetic product without drug claims would in fact violate the FDA misbranding rule. For

instance, incorporating acetaminophen^ainto a cosmetic product would instantly classify it as a drug by FDA standards, even if no drug claims are made. Therefore, incorporating drug claims on a cosmetic label deems the product to be misbranded, leading to FDA enforcement action.

In general, a cosmetic product is not allowed to contain ingredients

^a Acetaminophen is the active ingredient in Tylenol, a product of McNeil PPC, Inc.

that are commonly regarded as drugs, such as active ingredients recognized for therapeutic benefits. In addition, International Nomenclature of Cosmetic Ingredients (INCI) names should be listed on cosmetic labels instead of the chemicals names associated with therapeutic benefits.

For example, alpha-tocopherol should not be listed as vitamin E in the declaration of ingredients because listing it as such would imply a therapeutic effect. Other examples of ingredients well-known for therapeutic effects include hormones and hydrocortisone.

Any promotional material and statements including those appearing online, in product catalogs and in flyers are considered cosmetic product labeling in the United States.

The Global Situation: Cosmetics vs. Drugs

The definition of a therapeutic drug is quite similar around the world. Most countries agree that a drug is intended for the diagnosis, cure, mitigation, treatment or prevention of diseases via some means of physiological action. When it comes to cosmetics, however, differences exist in major world markets including Australia, the United States, Europe, Canada and Japan.

Australia: In Australia, a cosmetic is defined by the Therapeutic Goods Association (TGA) as:

A substance or preparation intended for placement in contact with any external part of the human body, including the mucous membrane of the oral cavity, and the teeth, with a view to altering the odors of the body; or changing its appearance; or cleansing it; or maintaining it in good condition; or perfuming it; or protecting it.