This is ridiculous and seems to be politicians pandering to their supporters to drive small businesspeople out of the soap business :
http://legalinsurrection.com/2015/05/the-government-is-coming-for-your-handmade-soap/
They are now going to regulate our soap?
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This is ridiculous and seems to be politicians pandering to their supporters to drive small businesspeople out of the soap business :
http://legalinsurrection.com/2015/05/the-government-is-coming-for-your-handmade-soap/
This is typical bureaucracy. From the link; “protect consumers and streamline industry compliance by strengthening the Food and Drug Administration’s (FDA) authority to regulate the ingredients in personal care products."
Because certainly, this always serves the consumer and taxpayer best. I hope it fails big time or our small artisan shave soap makers could face a lot of paperwork and regulation.
Because certainly, this always serves the consumer and taxpayer best. I hope it fails big time or our small artisan shave soap makers could face a lot of paperwork and regulation.
No "seems to be" about it. Big companies are in favor of regs like this just to drive mom and pops out of business. It is not as if the artisans are any threat to P&G, etc.
Just depressing and mind boggling.
Just depressing and mind boggling.
This is ridiculous and seems to be politicians pandering to their supporters to drive small businesspeople out of the soap business :
http://legalinsurrection.com/2015/05/the-government-is-coming-for-your-handmade-soap/
I doubt a blog post on a website called "Legal Insurrection" is the best source for a balanced discussion on this matter. I wouldn't be inclined to dismiss the bill on the basis of a single hot-headed, biased and distorted opinion piece. (The author makes it sound like the Personal Care Counsel is against the bill, but the Counsel's CEO has issued a statement publicly supporting it.) Here's a less biased analysis of the basic aims of the bill.
Although I'm not a fan of pointless governmental regulation, I'm not convinced an updating of the FDA regulations on cosmetics is such a bad thing, given that the current regs date back to 1938. Under the current regulations, the FDA has no recall power, and companies aren't legally required to disclose adverse health effects reported by consumers. I don't think an overhaul is the worst thing in the world, and a bit of research reveals this bill covers a lot of ground beyond the narrow interests of wet shavers and artisanal cosmetics producers.
Legislation of this nature is so broad, it can be hard to fully understand all the pros and cons inherent in it. Personally, I haven't made up my mind on it. However, I don't think it serves anyone to have a knee-jerk reaction to it.
A couple other articles that may be of interest to those interested in learning about the bill:
New York Times
Slate
NB: The Slate piece is clearly biased in favor of the bill, but no more so than the Legal Insurrection piece is biased against it.
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I've read through the bill itself. I'm not adverse to the FDA regulating cosmetics in general.
I believe that the author of the Legal Insurrection article should have done some more fact checking prior to publishing. The author appears to have decided that soaps are cosmetics without looking into how the FDA defines soap.
I saw nothing in the bill that changed the definition of cosmetic to define soap. So the FDA isn't coming for handmade soap. Products labeled "shaving soap" may be ok as well. Traditional shaving "creams" intended to be used with a brush (which are normally alkali salts of fatty acids and water) might need to be re-labeled as "liquid shaving soap" or something similar to avoid regulation.
However, as I understand the bill, artisan aftershaves would fall squarely within the realm of what the FDA would be allowed to regulate.
Standard disclaimer: I am not a member of a bar in any jurisdiction. Please contact a member of your local bar for legal advice.
I believe that the author of the Legal Insurrection article should have done some more fact checking prior to publishing. The author appears to have decided that soaps are cosmetics without looking into how the FDA defines soap.
I saw nothing in the bill that changed the definition of cosmetic to define soap. So the FDA isn't coming for handmade soap. Products labeled "shaving soap" may be ok as well. Traditional shaving "creams" intended to be used with a brush (which are normally alkali salts of fatty acids and water) might need to be re-labeled as "liquid shaving soap" or something similar to avoid regulation.
However, as I understand the bill, artisan aftershaves would fall squarely within the realm of what the FDA would be allowed to regulate.
Standard disclaimer: I am not a member of a bar in any jurisdiction. Please contact a member of your local bar for legal advice.
I knew the FDA didn't regulate soap, but I missed this little bit of legal confusion:
Does that mean a scented soap, or a soap with added moisturizing ingredients, or both, qualifies as a cosmetic? Would a shaving soap be deemed as "intended...for other cosmetic uses," since it isn't intended primarily for cleansing?
FDA interprets the term "soap" to apply only when the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold, and represented solely as soap [21 CFR 701.20]
Scented soap seems ok, since the bulk of the nonvolatile matter is still an alkali salt of fatty acids. I'd have to do additional research to get to the heart of the question. I'm going to go poke around and see if I can find a better answer.
Nice job guys! Good reading all around.
The Federal Food Drug & Cosmetic Act (FD&C Act) doesn't define Soap.
http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-sec701-20.pdf
21 CFR 720.4 (4)(c)(11)
Shaving Preparations, which include "shaving soap", is its own category of cosmetic. 21 CFR 720.4 seems to be the precursor to the new bill. So, it seems the FDA would likely interpret the new bill to include shaving soaps, creams, aftershaves, pre-shave oils and everything else.
So soap soap is fine. Scented soap is ok. However, shaving soap appears to be a cosmetic. Shaving soap that advertises that it has moisturizing properties is very likely a cosmetic, because it isn't represented solely as soap.
My advice is to call/ write / e-mail your U.S. Congresspersons and address concerns you might have about this bill. I'll be letting mine know that I support artisan American small businesses and that I'm concerned about additional regulatory hurdles. I'm also concerned that it may be more difficult to obtain Arko or other foreign shaving supplies because of the additional regulatory burdens.
http://www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol7/pdf/CFR-2011-title21-vol7-sec701-20.pdf
21 CFR 720.4 (4)(c)(11)
Shaving Preparations, which include "shaving soap", is its own category of cosmetic. 21 CFR 720.4 seems to be the precursor to the new bill. So, it seems the FDA would likely interpret the new bill to include shaving soaps, creams, aftershaves, pre-shave oils and everything else.
So soap soap is fine. Scented soap is ok. However, shaving soap appears to be a cosmetic. Shaving soap that advertises that it has moisturizing properties is very likely a cosmetic, because it isn't represented solely as soap.
My advice is to call/ write / e-mail your U.S. Congresspersons and address concerns you might have about this bill. I'll be letting mine know that I support artisan American small businesses and that I'm concerned about additional regulatory hurdles. I'm also concerned that it may be more difficult to obtain Arko or other foreign shaving supplies because of the additional regulatory burdens.
Correct, but as you showed earlier, the CFR (which is distinct from the FD&C Act) does list the criteria for how soap is defined for the purposes of determining FDA jurisdiction. The FDA website gives a "plain language" interpretation of the definition in 21 CFR 701.2:
[Emphasis added.]
It's the third criterion that I think might snag a lot of the products we like to use. That would seem to be based on 21 CFR 701.20(a)(2). Based on that, I'm not convinced scented soap is totally in the clear, depending on how it's marketed. If the new legislation doesn't change the definition of soap, then the old FDA conditions would still apply.
Sorry to nitpick, but that should actually be 21 CFR 720.4(c)(11). You'll notice the first subsection begins with a letter, not a number.
i don't think that Dove, or Irish Spring, or Dial are considered cosmetic or drugs? Are they? I can't tell from their websites. They moisturize, make you smell better and kill germs.
Interesting. Maybe as long it is labelled as a soap that does those things it is considered a soap?
Interesting. Maybe as long it is labelled as a soap that does those things it is considered a soap?
With the information so far presented in this thread, we're left to speculate. I suspect these issues may have already been settled, but I don't know in what way.
But in the spirit of speculating, I will note that original Irish Spring is labeled right on the package as a "deodorant soap," and the website touts that it imparts "12-hour deodorant protection." Based on the FDA's definition, it would seem Irish Spring qualifies as a cosmetic.
Likewise, Dove's advertising copy states, "The secret to beautiful skin is every-day moisture, and no other bar hydrates skin better than Dove. With ¼ moisturizing cream, Dove Beauty Bar helps skin feel more firm and elastic when compared to ordinary soap." That marketing definitely purports that Dove does more than merely cleanse the skin; it is intended for some other cosmetic use. Accordingly, I believe it would also qualify as a cosmetic.
A trickier issue would be something like T&H Trafalgar bath soap. It's just labeled as soap, and it isn't purported to do more than what regular soap does. However, it is part of a larger fragrance line, and the ad copy does say, "Only the finest quality ingredients are used ensuring a rich lather and long-lasting fragrance." One could infer that the soap is intended to make the user smell good, and therefore qualifies as a cosmetic. Granted, T&H is already subject to EU regulation, but the way the FDA defines it definitely has a bearing on scented soaps made by US artisans.
I agree, it seems a bit confusing. I emailed dial soap. When I hear back I will share what I learn.
Best Wishes,
Brian
If you get a straight answer from them on any question - especially one regarding legal classification of their product by the FDA - that will be worth reporting.
A couple other notes:
I just looked up the ingredients for Dove. It contains non-soap detergents, so it would be a cosmetic without even considering its intended uses.
Dial bar soap uses a soap base, but is marketed as an antibacterial deodorant soap; it contains triclocarban. The deodorant billing could make it a cosmetic, but the inclusion of triclocarban likely makes it a "drug" for FDA purposes.
Also, I'm curious to see if the proposed legislation will mandate disclosure of cosmetic ingredients online, either by the manufacturer or e-vendor. In an age of e-commerce, where it is often difficult or impossible to inspect physical packaging prior to purchase, it seems ridiculous to me that vendors can sell cosmetic products without listing the ingredients so customers can read them prior to purchase. (Although it would seem the EU doesn't require that, since there are plenty of UK and European manufacturers and vendors that don't list ingredients on their websites.)
I just looked up the ingredients for Dove. It contains non-soap detergents, so it would be a cosmetic without even considering its intended uses.
Dial bar soap uses a soap base, but is marketed as an antibacterial deodorant soap; it contains triclocarban. The deodorant billing could make it a cosmetic, but the inclusion of triclocarban likely makes it a "drug" for FDA purposes.
Also, I'm curious to see if the proposed legislation will mandate disclosure of cosmetic ingredients online, either by the manufacturer or e-vendor. In an age of e-commerce, where it is often difficult or impossible to inspect physical packaging prior to purchase, it seems ridiculous to me that vendors can sell cosmetic products without listing the ingredients so customers can read them prior to purchase. (Although it would seem the EU doesn't require that, since there are plenty of UK and European manufacturers and vendors that don't list ingredients on their websites.)
Got the following back from the dial soap contact link today.
Dear Mr. Hugo,
Thank you for taking time to contact us.
Regarding your concern Dial soap is just a regular soap it is not a cosmetic soap.
Sincerely,
Henkel Consumer Affairs
Dear Mr. Hugo,
Thank you for taking time to contact us.
Regarding your concern Dial soap is just a regular soap it is not a cosmetic soap.
Sincerely,
Henkel Consumer Affairs
Not sure if that settles much, but it looks to me like you can call it soap and get around being a cosmetic or drug to some extent.....not sure about dove or any others.
Honestly, I don't put much stock in that answer. We're talking about a legal distinction based on a close reading of a federal administrative rule, something the folks in their customer service department probably aren't qualified to answer, or don't want to answer. The answer may also depend on how you asked the question. If you asked if Dial is a "soap" or a "cosmetic," they may have answered from a layperson's perspective. If you asked them, "Pursuant to 21 CFR 701.20, is Dial considered a 'soap' or a 'cosmetic' for the purposes of FDA jurisdiction?" that might get a different answer. Or more likely, they would have ignored you.
It's an academic question anyway. Most grooming-products companies, including artisinal makers, put out products that fall under FDA jurisdiction, even if their soaps do not. Liquid body washes and face cleansers*, shaving soaps and creams, aftershaves and balms, moisturizers, etc., all are cosmetics. Even if such companies produce soaps that are exempt from FDA regulation, they will still have to jump through the procedural hoops required by the new legislation (assuming it passes) for every other product they make. The only grooming-related companies that will not be affected by the new rules are ones that only produce soaps that fit within the narrow FDA definition, and as such are not subject to FDA regulation. Off the top of my head, I can't think of any of the regular favorites here that qualify.
* Most liquid body washes and face cleansers are detergent based, and therefore are not soaps, although there are actual liquid soaps on the market that probably would be exempt (e.g., Dr. Bronner's).
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I see your point.
I did ask whether their soap was regulated as a soap, cosmetic or a drug, and in those exact words.
It's too bad artisans will probably have more red tape.....
I did ask whether their soap was regulated as a soap, cosmetic or a drug, and in those exact words.
It's too bad artisans will probably have more red tape.....
