Senate Bill S.1014, the Personal Care Products Safety Act

LBussy said:

Things will become more expensive and the more likely impact would be "free" things diminish. Less people will be participating in the community, less people will be innovating, less people will be giving soaps to homeless shelters just because they can. All of these things because someone said "there ought to be a law" when Ms Feinstein was listening.

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I agree with what you are saying. Fortunately, giving to the poor will probably still be an option. Food that is illegal to sell is legal to donate without the fear of law suits. America is okay with poor people receiving items that may present a danger to health. I agree with not holding someone responsible for donating, and 1 out of 5 of American children are food insecure, but... As a side note, an old man in Florida was arrested about a year ago under a city ordinance that prohibited feeding the homeless -- true story. Being arrested for kindness... gad! :twisted::evil: A small window into the soul of our nation. When did we turn into a nation of selfish people who seem to be indifferent to the suffering of others? Sad, truly sad.

I did found this article.

Lawmakers want FDA to crack down on soap makers

Excerpts:

People who are trying to do good for their families and the planet by living a simple life based on traditional skills are facing yet another assault. Artisanal soap makers say new regulations, proposed by Senator Dianne Feinstein (D-California) and Senator Susan Collins (R-Maine), will put them out of business.

The view of Sen. Feinstein and her corporate backers (listed below) is that the Personal Care Products Safety Act (Senate Bill S.1014) will make the world a safer place by scrutinizing “everything from shampoo and hair dye to deodorant and lotion.” She says the Federal Food, Drug, and Cosmetic Act should be more progressive like laws in Europe rather than antiquated US regulations in effect since the 1930s.

If the industries that back this law are really so concerned about safety, why don’t they voluntarily make healthy products, like the small time producers already do?

Feinstein does not propose to ban these dangerous ingredients from soaps and cosmetics, just regulate them with tests and warning labels, fees, and recall authority. She thinks some of these products, though harmful to health, magically become “safe when used by professionals in a salon or spa setting.”

Companies and brands that support the bill:

Johnson & Johnson, brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson’s baby products.
Procter & Gamble, including Pantene, Head & Shoulders, Clairol, Herbal Essences, Secret, Dolce & Gabbana, Gucci, Ivory, CoverGirl, Olay, Sebastian Professional, Vidal Sassoon.
Revlon, brands include Revlon, Almay, Mitchum
Esteee Lauder, brands include Esteee Lauder, Clinique, Origins, Tommy Hilfiger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors.
Unilever, brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond’s, Suave, Sunsilk, Vaseline, Degree.
L’Oreeal, brands include L’Oreeal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl’s, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, The Body Shop, Redken.

biarine said:

I did found this article.

Lawmakers want FDA to crack down on soap makers

Excerpts:

People who are trying to do good for their families and the planet by living a simple life based on traditional skills are facing yet another assault. Artisanal soap makers say new regulations, proposed by Senator Dianne Feinstein (D-California) and Senator Susan Collins (R-Maine), will put them out of business.

The view of Sen. Feinstein and her corporate backers (listed below) is that the Personal Care Products Safety Act (Senate Bill S.1014) will make the world a safer place by scrutinizing “everything from shampoo and hair dye to deodorant and lotion.” She says the Federal Food, Drug, and Cosmetic Act should be more progressive like laws in Europe rather than antiquated US regulations in effect since the 1930s.

If the industries that back this law are really so concerned about safety, why don’t they voluntarily make healthy products, like the small time producers already do?

Feinstein does not propose to ban these dangerous ingredients from soaps and cosmetics, just regulate them with tests and warning labels, fees, and recall authority. She thinks some of these products, though harmful to health, magically become “safe when used by professionals in a salon or spa setting.”

Companies and brands that support the bill:

Johnson & Johnson, brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson’s baby products.
Procter & Gamble, including Pantene, Head & Shoulders, Clairol, Herbal Essences, Secret, Dolce & Gabbana, Gucci, Ivory, CoverGirl, Olay, Sebastian Professional, Vidal Sassoon.
Revlon, brands include Revlon, Almay, Mitchum
Esteee Lauder, brands include Esteee Lauder, Clinique, Origins, Tommy Hilfiger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors.
Unilever, brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond’s, Suave, Sunsilk, Vaseline, Degree.
L’Oreeal, brands include L’Oreeal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl’s, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, The Body Shop, Redken.

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This is what this whole thread is about from the start.

Yes, and it sad

This legislation requires every cosmetic manufacturer to register with the FDA. It also states in Sec 605.2.I (about registration) that "An assurance that the Food and Drug Administration will be permitted to inspect such facility at the times and in the manner permitted by this act". This means that the FDA can come into your home and inspect it whenever they feel like it! It is not just about the money or fees. They will be inspecting our homes! That will deny us our 4th Amendment Rights against illegal search. They will be searching for anything that does not comply with their mandate.

But your registration makes it legal, so it would not break the 4th amendment. It is also not "whenever they want" but within times stipulated by the legislation.

While I can understand people voting against this, let's at least keep the arguments against it valid and accurate.

I still have not read the bill, so still just guessing here. If it works the way most do, someone who is exempt (domestic mftr grossing less than 100k) would not be required to register. Please correct me if I am wrong, you guys, or send me a link to the actual bill. I admit, I have been avoiding it b/c it will take so long to read.

I don't think it is a 4th Amendment violation, that really goes to search and seizure in homes *as* homes, not potential commercial facilities. If you are making enough soap/money to go over 100k, the lines get blurry and various other statutes will kick in. Plus, more than likely, the interstate commerce clause (applies to almost anything sold across state lines) will join the mix and it will become an entirely federal issue so state laws will be pre-empted/federal law will take priority.

The bill is confusing because it says that manufacturers earning less than $100,000 are exempt. At the same time, it says that ALL manufacturers need to register. All registered manufacturers of cosmetics can be subject to an inspection of their facility, in accordance with this legislation. (In my case, that would be a forced warrant-less inspection of my home).

Soaper12 said:

The bill is confusing because it says that manufacturers earning less than $100,000 are exempt. At the same time, it says that ALL manufacturers need to register. All registered manufacturers of cosmetics can be subject to an inspection of their facility, in accordance with this legislation. (In my case, that would be a forced warrant-less inspection of my home).

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Again, if you were to refuse, they would likely revoke your registration. If you wanted to stay registered you'd have to let them in, which then makes it unforced.

I've not read the bill as it doesn't apply to me, but if when it says that companies under 100k don't count, but all companies must register, is there something in there that defines a manufacturer as having more than 100k, so when it say 'manufacture' from that point on, it is only referring to those with 100k? Laws often have that so that they can clearly state what actually applies. For example, if it says 'all manufacturers will be subject to inspection by the FDA.....' I imagine it only means manufacturers of the products defined at the start of the bill, but once that term is defined in relation to this bill, they then just use the term itself to make things easier.

LBussy said:

Shave soap *is* a cosmetic - as are lotions and other B&B things.

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So I just looked at the FDA page where they explain the definition of soap.

Why do you think shave soap = cosmetic?

Regards-
Dave

Because the advertised purpose of shaving soap is not to clean you. You don't clean yourself with a shaving soap, rather you use it to protect the face during shaving, so then it is a cosmetic.

^^^ Exactly for this reason. Hense why it needs to be labeled as a cosmetic.

I skimmed the first half of the bill yesterday, TEG is right, if you are exempt the provisions of the bill will not apply to you (if my reading was correct.)

Soaper12 said:

The bill is confusing because it says that manufacturers earning less than $100,000 are exempt. At the same time, it says that ALL manufacturers need to register. All registered manufacturers of cosmetics can be subject to an inspection of their facility, in accordance with this legislation. (In my case, that would be a forced warrant-less inspection of my home).

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If you look at the bill, right upfront it gives you the definitions of a facility and responsible persons. It says in this section that domestic manufacturers that gross less that $100K are exempt. So anywhere there after it uses the terms 'facility' and 'responsible persons' it defaults back to the descriptions at the beginning of the bill.

Also, this won't effect you if all you make is soap, and never claims it does anything but clean.

But we all know soap is kind of a gateway drug. Most people who start soaping get into lotions, bath bombs, body scrubs, and all sorts of other bath and beauty products. And if you make a business out of this expanding your product line is usually not a bad idea.

My concerns about this are 2 fold.

1. It does not really address the problems the industry faces. Poor labeling and fantastic claims are the prime examples.

2. It will affect places we get some of our supplies from. I am sure Brambleberry and Nature's Garden and TKB Trading gross more than 100K a year. Even if they are not making lotion bases or M&P or their other kits themselves, they get it from places who also make more than that. All of these fee's are just going to roll down hill. I spend enough money on my hobby, thank you very much.

That is my view on why I think this is just a bad idea. And if nothing else, I think our culture is generally ignorant on how our government works, so getting people involved is never a bad thing. Even if this ends up not effecting us in any way - it will be a good learning experience for the next bad idea bill that comes across.

dosco said:

So I just looked at the FDA page where they explain the definition of soap.

Why do you think shave soap = cosmetic?

Regards-
Dave

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Because the FDA says it is? :razz: We had a bit of a go-around here some time back and new12soap decided to go to the source. I've attached the email received as an answer.

Although the reasoning would seemingly also make a razor a cosmetic, it's what they seem to be saying consistently. So, unless a person really wants to fight it, that's what we have.

View attachment FDA Info on Shaving Soap - SMF.pdf

The Efficacious Gentleman said:

Because the advertised purpose of shaving soap is not to clean you. You don't clean yourself with a shaving soap, rather you use it to protect the face during shaving, so then it is a cosmetic.

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From the FDA website:

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.

Note that the definition doesn't say "soap is something that is to be used to clean and/or remove dirt."

So I can see the argument where shave soap can fall on either side of the definition.

Interestingly, LBussy's PDF states that shave soap is regulated as a cosmetic. I don't see anywhere in the email where that FDA employee is a lawyer, and if I had enough money I would hire a lawyer to challenge this in court. Why? Consider the following possibilities:

Possibility #1
I make soap from fats saponified into alkali salts of fatty acids (reqt #1), have only alkali salts of fatty acids as the ingredients (reqt #2), and label it as "soap" (reqt #3) ... and I now have made and marketed soap, per the FDA definition, that is outside of the regulatory framework. If the purchaser decides to use it for shaving, well, that's outside my control. Plenty of folks post on the various shaving forums about how great various bar soaps are for shaving (Ivory, Irish Spring, etc.).

Possibility #2
As soon as I take the soap from possibility #1 and I change the label and market it as "shave soap" it now falls into the regulatory framework and is (apparently) a cosmetic ... despite the fact that I haven't materially altered its composition. That's annoying.

Possibility #3
Now, if I and make the soap using HP and add shea butter after the saponification is largely complete, and then label the product as "moisturizing soap" I've now made a cosmetic that is subject to regulation.

Possibility #4
If I make it using HP, add the shea as a constituent fat, and then saponify (but have made it with superfat so that leftover shea is present) and label it as soap, I've again made a product that falls outside the regulatory framework.

Is there a trade association for soap artisans? (yes, I am ignorant).

Apologies if I'm rekindling an old debate.

Regards-
Dave

kchaystack said:

2. It will affect places we get some of our supplies from. I am sure Brambleberry and Nature's Garden and TKB Trading gross more than 100K a year. Even if they are not making lotion bases or M&P or their other kits themselves, they get it from places who also make more than that. All of these fee's are just going to roll down hill. I spend enough money on my hobby, thank you very much.

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Where are the various suppliers purchasing their raw materials for lotions, hair conditioners, etc.? My guess would be the various producers that also supply the same chemicals to the large manufacturers ... I agree that there will likely be some new costs that will be passed down to hobbyists, but how much of a price increase are we thinking of?

(yes, I'm ignorant)

-Dave

Dave if you do decide to take on city hall, let me know. Not so I can help mind you, I just want to watch.

In another pastime we have some of the same arguments regarding interpretation of regulations. The person giving you the interpretation need not be a lawyer, it's an official interpretation because they are selected/authorized to give you one. Regulations are not laws - they are regulations. Therefore the agency which creates the regulations are the arbiters of the interpretation. Yes you can fight it but you have to wait until you are cited - then you can hire a lawyer (and they will want a LOT of money up front) to fight it. In the meantime any actions they take against you like a cease and desist, seizure of inventory, etc., will stand.

It's just easier to put the right label on it.

LBussy said:

In another pastime we have some of the same arguments regarding interpretation of regulations.

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I currently work in this environment ... I generally agree with your position; however I avoided a large dissertation about Government, etc., for a number of reasons. Mostly because I don't feel like composing a dissertation.

Yes you can fight it but you have to wait until you are cited - then you can hire a lawyer (and they will want a LOT of money up front) to fight it.

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Yes. Like I said in my post, if I had a lot of money I would consider making a run on this. But I don't have a lot of money, so ... it's moot.

It's just easier to put the right label on it.

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So let's assume you make soap per "Possibility #1" that I presented ... which label would you put on your product?

-Dave

dosco said:

So let's assume you make soap per "Possibility #1" that I presented ... which label would you put on your product?

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Depends who my market is. If it's a mass market, take anyone that has money sort of thing then I guess I would sell a bar of soap and just call it soap. However a guy/gal would have to make darned sure NONE of the marketing included anything about shaving.

I like to consider myself a discerning consumer however, and I would not buy a bar of soap because "the masses" says it shaves great. You can find plenty of people to tell you the various M&P vendors make great shaving soap. We've had other conversations here (about dirt in soap for instance) where people say "my customers love it." Well, to paraphrase Groucho Marx, I would not want anyone as a customer that thought clay made a good shaving soap. I can afford that sort of snooty attitude (I admit it, it is snooty) because I do not sell my soaps. I think the people who DO say that Ivory soap makes a great shaving soap don't know their ***es from a hole in the ground. I tried it and it was "okay" surprisingly, but not a "good" shaving soap. I'd use it before Barbasol though. :-D

Therefore if I was going to go to the trouble to create a shaving soap (I did) I would want to market that soap for it's qualities, not as a bar of soap. I would want to share with my customers WHY it was a good shaving soap. Otherwise, what really distinguishes anyone these days? I think soapers here anyway are very proud of what they create as evidenced by the frustration that's often shared about the other soapers who do not care - pick any thread about the "other person at the farmer's market" as an example. I would want real discerning shavers as clients and then worry about them, as representatives in the community, to be the example others follow.

And as you know I correctly (I think) label the soap I give away anyway. I think the folks I give my soap to deserve no less information than those that buy soap. So again, I would not entertain #1 as a solution. I'd just do it right. Given the way things went for the last guy who got loose and frisky with the truth and shavers (I think you know what B&B thread I am talking about), why even chance it? As a matter of fact I think it behooves us to strive to provide customers/clients with as much information as possible whether we "have to" or not. If we do not then we run the risk of it being forced on us anyway. I have absolutely nothing to hide so I would not fail to share everything that is required of a cosmetic anyway.

All THAT being said, I hate the regulations and wish the gubmint would stick to things it does well like .. um ... gimme a second here, I'll think of something.