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Teach Soap • View topic - soap queen article re: FDA inspection

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PostPosted: Thu Mar 17, 2016 6:01 am 

Joined: Sat Jan 03, 2015 10:03 am
Posts: 4
Hi All,

As a fairly new soaper, I am going to open a small can of worms for comment here. I read the article and will also be reading the original site linked from it. Here's my thing. Once the references to healing and antibacterial properties is removed, the product goes back to being soap which is not under the perview of the FDA but rather the CPSC. This is by the FDA's own website. If what you make meets their legal definition of soap they have no authority. Since I make zero claims about my soap, I would tell the FDA inspector as such and ask him to vacate the premises. She caught their attention with claims made that could put her under FDA review. Unless their is additional info I have not seen yet she should not be subject to FDA inspection at all. OK off my soapbox. Feel free to comment while I go off to read as much other info about this inspection as I can find. I dislike feds overreaching their authority in case you can't tell. I will read all comments good, bad and ugly.

River city does however sell lip balm and lotion. I looked at the website. Beautiful stuff. Lip balm and lotion are cosmetics which are under FDA perview. That being said, I think the FDA can only dictate where it regards to her cosmetic stuff, not soap.

Note: I am not a lawyer, just an overworked federal employee for full disclosure. No I do not work for the FDA but rather another federal agency oft mentioned and always hated

Alice

ok paste directly from the FDA.gov website

What’s the regulatory definition of soap?

Whether a product is a “soap” in the traditional sense, or is really a synthetic detergent, helps determine how the product is regulated. So, let’s take a look at how “soap” is defined in FDA’s regulations;

To meet the definition of soap in FDA’s regulations, a product has to meet three conditions:
1.What it’s made of: To be regulated as “soap,” the product must be composed mainly of the “alkali salts of fatty acids,” that is, the material you get when you combine fats or oils with an alkali, such as lye.
2.What ingredients cause its cleaning action: To be regulated as “soap,” those “alkali salts of fatty acids” must be the only material that results in the product’s cleaning action. If the product contains synthetic detergents, it’s a cosmetic, not a soap. You still can use the word “soap” on the label.
3.How it's intended to be used: To be regulated as soap, it must be labeled and marketed only for use as soap. If it is intended for purposes such as moisturizing the skin, making the user smell nice, or deodorizing the user’s body, it’s a cosmetic. Or, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug. You still can use the word “soap” on the label.

You can read the entire regulation at 21 CFR 701.20.

How are different “soap” products regulated?
•If your product meets the regulatory definition of soap, it’s regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about requirements for these products to CPSC.


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