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 drug).
The issue came up again recently on a newly updated FDA webpage, Cosmetic Export Certificates. On that page, which is essentially a FAQ about how to get a cosmetic export certificate, lip balm was mentioned in one of the questions, “Is my product really a cosmetic under the law?” Continue reading
The FDA recently announced that they have issued a new draft guidance on good manufacturing practices for cosmetic products.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 lately have asked me about using the term “organic” when it comes to cosmetics. Can cosmetics be claimed to be “organic? What about using the term “organic” in a product or company name?
I did some research, and what I discovered was a little bit surprising. Seems that the FDA and the USDA don’t actually see eye-to-eye on the subject.
Noni – is it a drug?
The FDA continues to cite claims for ingredients and claims in referenced publications as claims for the product itself as noted in my earlier post, FDA Cracking Down on Cosmetic Product Claims.
A warning letter issued May 16th, to Matrix Health Products, is a good case in point. While the products are nutritional supplements, not cosmetics, what’s interesting is what the FDA referenced as the claims made for the products.
In the letter, the FDA stated that several of the products offered by the company were “unapproved drugs” because the materials stated that the products were used for the “cure, mitigation, treatment or prevention of disease”. Drug claims in several different forms were cited.
Not one to rest on my laurels, I’ve produced another book for soapmakers (also for cosmetic makers, even though that’s not in the name). The Soapmaker’s Handy Reference Guide was released at the Handcrafted Soap & Cosmetic Guild’s 2013 Annual Conference last week and was very well received.
This little book contains the formulas, facts and stats that come in super handy when you’re in the middle of making product. And it’s printed on water-proof, oil-proof paper, so you can pick it up and use it when you’re deep in the middle of work.
There has been considerable discussion over the years on how botanicals should be listed in the ingredient declaration for cosmetics. Based on some fairly recently posted information on the FDA website, it is now clear that common names are required, and when used as a secondary listing, Latin names are accepted.
Although the “INCI name” (which usually means the Latin name) is commonly thought to be required, it isn’t – it’s optional.
Important Note: This information applies to soap and cosmetic regulations in the United States. Most other countries require that the Latin name for botanicals is used in the ingredient declaration.
Life isn’t ALL about regulations and legislation and good manufacturing practices (or preparing for presentations at the HSCG Annual Conference). Sometimes you have to step back and take time to smell the roses — or in my case, plant the garden.
We’ve been gradually working on it for years, and this spring – especially in the last few weeks – have made major headway into getting it (or at least part of it) the way we want. Even with everything else going on, and the HSCG Conference just 12 days away, it’s been nice spending a couple of hours a day taking advantage of garden therapy to relax.
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 “No!” The regulations for what you can (and cannot) claim about cosmetics are clear. Putting a disclaimer that the statements “aren’t evaluated by the FDA” doesn’t exempt you from the regulations.
So when ARE these disclaimer statements used?
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 comes to labeling, reporting and websites selling cosmetics.