If you’re a cosmetics producer in the United States, this should definitely be a major stop for you: the FDA Cosmetics Lableing manual which has been around since 1991.
Summary of Regulatory Requirements for Labeling of CosmeticsMarketed in the United States.
Of particular significance lately is this:
“Products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., “fluoride” toothpastes), hormone creams, suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.
Most currently marketed cosmetics which are also drugs are over-the-counter drugs. Several are new drugs for which safety and effectiveness had to be proved to the agency before they could be marketed. A new drug is a drug which is not generally recognized by experts as safe and effective under the conditions of intended use or which has become so recognized but has not been used to a material extent or for a material time under such conditions.
The regulatory requirements for drugs are more extensive than the requirements applicable to cosmetics. For example, the FD&C Act requires that drug manufacturers register every year with the FDA and update their lists of all manufactured drugs twice annually. Additionally, drugs must be manufactured in accordance with current good manufacturing practice regulations as codified at 21 CFR 210 and 211.”
It doesn’t matter if this is topical. It doesn’t matter if it says “reputed to.” Any implication AT ALL your cosmetic can treat a malady will get it classified as a new drug.
From here, we’ll be talking about ingredient declarations. But for right now - even if it really does fix dandruff, you can’t tell your customers that without some serious testing.
Tags: fda_regulations
