Teach Soap

Hey, all,

I read with great interest last year about the FDA Globalization Act, which would call for tighter restrictions and regulations for the bath and beauty industry. (And thank you, Anne-Marie, for going to D.C. to speak to the committee!) I was concerned about what this Act would do to small business owners, especially after I saw the headaches that the 2008 CPSIA (Consumer Product Safety Improvement Act) caused for small business owners (like those on Etsy) who make products geared toward children. Some of them just closed shop.

I've been looking up stuff on the FDA Globalization Act and don't see much action beyond January or February of 2009. Does anyone know if the Act is off the table, or is it still under consideration? The only recent thing I saw was a webpage last updated Jan. 5, 2010 seemingly indicating that, so far, this bill has been referred to committee, the first step of the legislative process. It goes on to say that the majority of bills never make it out of committee.
http://www.govtrack.us/congress/bill.xpd?bill=h111-759

Is this Act DOA? Or is it still a threat?

Who would be affected by this Act? Would soapers be affected, or is that outside of FDA regulation? Surely folks that make lotions, lip balms, cosmetics, perfumes, etc. would be affected. Is there a small business exemption? It would break my heart if small businesses and sole proprietors are regulated out of business.

I realize that these sorts of bills are usually introduced with good intentions -- in this case, to protect consumers. But most of us are lovingly handcrafting small batches of products we care deeply about in an effort to offer a superior product. Overregulating and restricting such a thing seems silly.

Anyway, just wondering what is going on with this Act since I don't see much on it recently.

Thanks, everybody, for any info!

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- Jenny -
My soapy blog:
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It's been put on hold, but it's not dead yet. Lots of folks would be affected if this gets passed. It would also put some people out of business the way it's written now.

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Irena
Closed minds are like faulty parachutes; they refuse to open.

Hi, Soapbuddy, and thanks for the response. Sorry I've been absent from the forum for the past few days.

I'm trying to learn as much as I can about the FDAGA, but I'm sure there are gaps in my knowledge. The 2009 draft seems to be an improvement over the 2008 draft. The 2008 version was downright horrifying. I read that the 2009 draft does away with 2008's annual fee of anywhere from $2,000 - $12,000, which is good. That alone would do lots of folks in -- some of us don't make $2,000 in an entire year and can't afford to put up that kind of money just for the privilege of being in business.

I'm a bit confused about what the 2009 draft says about Good Manufacturing Practice adherence (http://www.fda.gov/Cosmetics/GuidanceCo ... efault.htm). I've read that it is not mandated, but I don't know if that's correct. I've also read that the door may be open for GMP regulations in the future. It would be good if special GMP consideration was given to small businesses. Good manufacturing practice sounds like a good thing, and a lot of it is. GMP includes some common-sense kind of stuff that most of us already do anyway -- keep your work area clean, keep "filth" out of your product, store supplies properly, etc. But what home-based, sole proprietor business could possibly comply with the testing guidelines outlined under "Raw Materials" and "Laboratory Controls"?

The main concern, it seems, is that Congress has no idea how small businesses are run (particularly tiny home-based ones like a lot of us have) and may strangle these businesses with burdensome albeit well-intentioned red tape. Even if fees are dropped and GMP guidelines are relaxed, registering your business annually, submitting ingredients lists for everything, and reporting and this, that, and the other creates a bureaucratic quicksand that could suffocate small businesses. The paperwork pile is big enough as it is, and this just adds to it. A small business would be too busy juggling all of its paperwork to find the time to actually produce its products!

What about folks that just make soap? Will they be affected? The FDA does not regulate soap so long as it is strictly soap and makes no therapeutic claims, correct? Say your soap is “moisturizing” or clears up acne, or has some sort of aromatherapeutic benefit, though, and now you’re treading into FDA territory and would be subject to the FDAGA, if I'm not mistaken. Even though I make only soap, I am still concerned about this bill because there are so many wonderful folks that make and sell lotions and lip balms and all other kinds of good stuff and it makes me ill to think that they might get regulated out of business. My fear is that someday only giant corporations will be able to afford to stay in business.

I hope there will be some sort of small business exemption, or at least language in the bill that recognizes the unique challenges of the small, often home-based, business.

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- Jenny -
My soapy blog:
Follow me on my

There is still a lot of confusion over this bill. The 2009 amendment is better than what it was, but it still has ways to go. I can see this bill opening up more stringent conditions on home based manufacturing from other agencies that would want a piece of the pie money wise. All of us should have good manufacturing practices in our businesses anyways. But I don't want the government over reaching the small guys like us and it wouldn't make a difference to the big guys. If they mess up, they just pay a fine and keep doing whatever they've been doing. As clean as my soapmaking area is, it wouldn't fly as I don't have a truly dedicated lab.

You are correct that the guys in Washington truly have no idea how many business like ours are all over the US. For the most of us, we aren't even a blip on their map. I'm not sure how this bill would affect those that make only soap and nothing else. I do understand that as long as you call it just soap and not "moisturizing" or "acne" or whatever and make no claims about your soap, you should be ok. I do not want to cross the line into the OTC drug category with any claims.

I can also see that some home based business would keep doing whatever they are doing now because there just isn't enough inspectors around to police the ones that are not compliant the way the FDA deems it to be. I have seen enough on Etsy that makes my head hurt.

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Irena
Closed minds are like faulty parachutes; they refuse to open.

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Irena
Closed minds are like faulty parachutes; they refuse to open.

Say what ...?

Soap is considered a cosmetic in Florida? Even soap that makes no claims to be anything other than soap? This is news to me. Why would a state have different criteria than a federal regulatory agency like the FDA?

And there's a proprosal to have the FDA define all soap as a cosmetic in this bill? This, too, is news to me.

My head hurts.

I agree with you, Soapbuddy, about how the little guys are the ones that get steamrolled, and that really frightens me. I would love to know what exactly this bill REALLY says, in layman's terms, because as it is right now, it's a massive bill written in legalese that hardly anyone, even those who are voting on it, can understand (like most bills, I suppose).

What bothers me most about all of this is the ever-increasing encroachment of government regulation. Politicians say that they're all for promoting and protecting small businesses, and yet they pass legislation that discourages new start-ups and systemically destroys existing businesses. Most of our beloved companies started out small and grew. Where will the next great company come from if it is smothered before it even gets going? And most of us aren’t doing what we do to get rich or to become the next Mary Kay. We do it because we love what we do, we believe in our products, and we want to share them with other people and make them happy.

I suppose the good news about this bill not being dead yet is that there is still time to write to our Congress representatives and have our voices heard!

_________________
- Jenny -
My soapy blog:
Follow me on my

That's what I was told by a person in Florida that I was wholesaling my soaps to. I haven't researched it. I just took her word for it.

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Irena
Closed minds are like faulty parachutes; they refuse to open.

Thanks for all of your input, Soapbuddy. I'm still trying to learn about this bill.

Although the 2009 version is way better than 2008's, it seems that there are still a couple of sticking points. The main two seem to be the requirement for all establishments to submit cosmetic ingredient statements for each product, and the possibility of across-the-board Good Manufacturing Practices requirements. The former could be extremely burdensome for very small businesses, and the latter could sink small and home-based business as they would be unable to comply.

It is encouraging, though, to know that the committee listened to the wonderful beauty industry folks who went to speak to them, and that they actually changed the language of the 2008 bill to exclude some of the more alarming sections. I know Congress is primarily thinking of large corporations when considering bills like these, but the little guy needs consideration, too, and I hope we get it. I do hope small businesses get some sort of waiver with some of the requirements still in the bill.

Sorry if I sounded ranty sometimes. I saw how the CPSIA crippled many small businesses, and it scares me to think that the bath and beauty industry could be next. The 2008 FDAGA draft would have killed so many small businesses. Thank goodness industry leaders went to speak on our behalf, and thank goodness the committee was willing to listen. That's a good sign for further negotiations.

_________________
- Jenny -
My soapy blog:
Follow me on my

I don't know anything about the acts involved here ... just to say that, in the EU, soap is considered a cosmetic and we have to abide by the same regs that the big boys do. However, there are tons of soapmakers out there still so it didn't kill the business.

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