This is the first of my new blog post series, Monday Mailbag, in which I’ll answer soap or cosmetic labeling or GMP related questions that have been sent to me. We’re starting out with an eclectic mix this week – from patenting soap to how to list hydrogenated oils in the ingredient declaration. If you have a question that you … Read More
Updated September 25, 2017 Several people have asked me recently about soaps and cosmetics that repel insects. What are the regulations and how do they get labeled? Once there’s a “pesticide” claim (i.e. that the product repels insects), the product falls under the jurisdiction of the EPA, under the authority of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). The … Read More
The FDA recently updated the Cosmetic section of their website and added some new pages that clarify regulations, particularly for small manufacturers of soap and cosmetics. Some of the most commonly asked questions are very clearly answered in FAQ format.
The Code of Federal Regulations specifies where to find the names by which cosmetic ingredients should be identified in the ingredient declaration on a cosmetic. First are any names “established by the Commissioner” (there are a few) and then the CTFA Cosmetic Ingredient Dictionary, Second Ed., 1977. After some searching, I was finally able to locate a copy of this … Read More
Last year I wrote a post, “Drug Claims and Lip Balm” which discussed the use of the phrase “lip balm” as the identity of a product. Unlike “lipstick” or “lip gloss,” the specific term “lip balm” is cited in the over-the-counter drug monograph for “skin protectants” as one of the approved ways to identify a skin protectant (which is a … Read More
The FDA recently announced that they have issued a new draft guidance on good manufacturing practices for cosmetic products. This new draft is an update to the existing “Cosmetic Good Manufacturing Guidelines/Inspection Checklist“. According to the Introduction: “This document provides guidance to industry and other stakeholders on the FDA’s current thinking concerning what constitutes Good Manufacturing Practices (GMPs) for cosmetics.”
In a nutshell, no, testing is not required. What IS required is that you make sure your products are SAFE. Actually, the FDA (and most state) regulations require that you ensure that your product is not “adulterated or misbranded”. So what does that mean, exactly?
Several people have asked me about FDA disclaimers they see on packaging, websites and promotional materials that say: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.” I’ve been asked if the same disclaimer can be used for claims made about cosmetics. The answer is … Read More