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The FDA recently announced that they have issued a new draft guidance on good manufacturing practices for cosmetic products.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
On March 21st, 2013, Rep Jan Schakowsky (D-IL) introduced the Safe Cosmetics and Personal Care Products Act of 2103. The text is now available at govtrack.us. It has been referred to to the House Energy and Commerce Committee and the Committee on Education and the Workforce. This bill does contain provisions that will affect handcrafters and small businesses when it … Read More
On February 4, 2013, the FDA announced a final rule amending the criteria for administrative detention to prevent potentially unsafe food from reaching the marketplace. While this doesn’t apply to soap, cosmetics, forestry or small woodland ownership (my usual blog topics), there were some issues in that I just had to comment on.
Three bills have been introduced this session that affect cosmetics – especially small soap and cosmetic manufacturers. They are: HR 2359 – Safe Cosmetics Act of 2011 HR 4262 – Cosmetics Safety Enhancement Act of 2012 HR 4395 – Cosmetic Safety Amendments Act of 2012 All are trying to address “cosmetic safety” in different ways. There are some similarities between … Read More
The Safe Cosmetics Act of 2011 was introduced June 24th. I’ve reviewed the bill and have been following all the discussions. Unfortunately, it seems to have somewhat polarized the handcrafted soap community – surprising since we all want essentially the same things … to be able to run our businesses, make safe soaps and cosmetics and not be overly regulated … Read More