Updated Info on FDA site

The FDA recently updated several pages on their website that have to do with cosmetics. The regulations haven’t changed, but it appears that they are continuing in their trend to making them more understandable (although it is still a bit difficult to find things when you need them). Here’s a brief overview of some of the pages that have been updated:

“Trade Secret” Ingredients

The labeling regulations say that if you have an approved “trade secret” ingredient, you can omit the name from the ingredient declaration and just state “and other ingredients”.  Several people have asked me if it would be worthwhile to try to protect their formulas/ingredients by treating them as a trade secret.

In the last twenty years, only one ingredient has been granted “trade secret” status.

First of all, in order to leave off an ingredient and use “and other ingredients” in an ingredient declaration, the trade secret has to be approved by the FDA.  Their new page, “Trade Secret” Ingredients goes into exactly how that process works.  It’s written in plain english and pretty easy to understand.

In order to request trade secret status for an ingredient, you first must be enrolled in the Voluntary Cosmetic Registration Program (VCRP) and have submitted the cosmetic formulation or raw material composition statement using Form FDA 2512 (Cosmetic Product Ingredient Statement).  In other words, you must tell the FDA the details of what you want classed as a trade secret.  They are supposed to keep it confidential, of course, and it’s not subject to the Freedom of Information Act.

Part of what you need to tell them is how well the ingredient is known, inside and outside your company, what you’ve done to protect the ingredient details and how easily it could be duplicated AND the value of the identity of the ingredient to you or you competitors and the effort and expense that went into developing the ingredient.

There’s no cost for submitting a request for trade secret status. If you submit a request, the FDA will respond within 180 days (6 months) and the entire process can take up to a year.

So how likely are you to get approval on trade secret status for an ingredient?  Well, only ONE ingredient has been approved by the FDA in the last 20 years.  So, not too likely.

Product Testing

Another page recently updated by the FDA is their page on Product Testing. There aren’t any changes to the regulations, and I can’t tell exactly what was changed on the page, but it does give a nice overview of the responsibilities a cosmetic manufacturer has for product safety.

The FDA doesn’t approve cosmetics before they go on the market (except color additives), and they don’t have a list of tests that are required.  The responsibility for product safety falls to the manufacturer.

You can use available safety data to establish the safety of your product, including information from the ingredient supplier or information published in scientific journals.  Some ingredients have also been reviewed by the Cosmetic Ingredient Review (CIR) and information is available on their website.

According to the FDA, you may need to do additional testing in order to fill any gaps in the available information.  That is up to you, just so long as you fulfill your responsibility for ensuring the product is safe.

Shelf Life/Expiration Dating

This page hasn’t been updated (according to the dates on the page), but it does appear to have been moved, so the information is including under the “labeling” section (which I don’t think it was before). Much of it is written to the consumer, but the information is quite valid for a manufacturer.

The FDA doesn’t require expirations dates on the labels of cosmetics, but they are still responsible for the safety of the product.

[The] FDA believes that failure to [determine the shelf life for products] may cause a product to be adulterated or misbranded.

In other words, if you haven’t determined what the shelf life is, and made sure somehow that a consumer isn’t going to use a product past it’s self life, then the FDA might consider that you haven’t lived up to your product safety responsibilities and the product could be adulterated or misbranded.

How long should a product be good for?  One guideline (referenced on the page) say 18 – 24 months, another recommends 3 years. The EU Cosmetic Directive (1993) requires expiration dating only for products whose “minimum durability” is less than 30 months (2 1/2 years).

Keep in mind, though, that some products have short shelf lives, especially products with natural or botanical ingredients, natural or untested preservative systems.  Products for use around the eye should be considered to have a short shelf life due to the serious hazard should they become contaminated.

Summary

Again, the regulations have not changed, but the changes to the pages above will hopefully make those regulations a little more understandable.

 

Comments

  1. It looks like they’re making an effort to make the regulations easier to use – that’s awesome! Sounds like the “trade secret” attempt is a complete waste of time, though. I’m surprised they spend the time & money to evaluate requests if they’re not going to approve any of them!

    1. I just went through the inspection yesterday and it was brutal. I can tell you that there are things they look at that will blow your mind. They take photos of everything, take copies of everything and disect everything. He would not answer any of my quesitons either. He said he was not allowed. Just wondering do they give you a second chance to fix what is wrong? I mean I got called out for not having a ” humidity detector” in the fridge. It was crazy insane!

      1. Author

        Of course they just look for what’s wrong. You should get a letter (hopefully detailed) that lists everything that you should fix.

  2. This may be wishful thinking, but are there any lists of “safe” words to “identify” or describe a product?

    1. Author

      The identity of the product is what it is … soap, lotion, cream, scrub, etc.

      You can describe a product however you want, just keep in mind that your description is a major part of what determines the “intended use”. To be a soap, the intended use must be to cleanse (only). To be a cosmetic, the intended use must be to improve appearance or beautify (or cleanse). To be a drug the intended use is to cure, mitigate, treat or prevent disease or to alter the function or structure of the body. An addition clarification is that a cosmetic causes only a surface/visual change; a drug causes a deeper, physical change.

      There are no “safe” words … it just depends on what you want to say about your product and how your statements affect the intended use of the product.

  3. Hi there, I’m from Canada. I would like to purchase your book but am concerned its U.S. focused and may not completely apply. Would this book still be helpful?

    1. Author

      Much, but not all, of the book is applicable. Most of the basic regulations about what goes on a cosmetic label are the same (since there is an agreement between Canada, the EU and the US to keep the regulations similar). There are sections that are applicable to just the US, though – especially having to do with soap exempt from the definition of a cosmetics and the agencies that are responsible for enforcement.

      If nothing else, the book will give you a good idea, in plain English, of the basic label requirements. You can probably get the same information (although in not quite as friendly wording) from the Health Canada website.

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