Monday, August 11, 2008

FDA Globalization Act

If you're offended by swearing, please read no further.

Have you heard of it? If you're a work-at-home mom or small business owner who manufactures "cosmetics" (soap, lip balm, salves, lotions, etc.), you should have. I read the 69 page draft. Of particular interest, Section 301, Registration of cosmetic facilities, on page 7 informs us that, "Section 301 requires the Secretary, by regulation, to require any facility engaged in manufacturing, processing, packing, or holding of cosmetics to register annually. These facilities will be subject to a $2,000 registration fee. The Secretary shall, by regulation, require cosmetic manufacturing facilities to report all anticipated and unanticipated serious adverse events. The Secretary shall also, by regulation, require that cosmetic facilities comply with good manufacturing practices."

Of course I agree that manufacturers of cosmetics should comply with good mfg practices, and that every product should have its entire ingredient list, inci names included, provided either on the package or an insert. Canada has "Cosmetic Regulations" which require mandatory ingredient labelling on all cosmetic products sold there, and I think the US should do the same. The International Cosmetic Ingredient (ICI) Dictionary and Handbook "presents, in detail, the bulk of INCI names juxtaposed with their corresponding empirical chemical formulas, technical/trade names, Chemical Abstracts System numbers (CAS No.), or alternate numbers" (from Health Canada). What more could you ask for? Don't answer that.

There is a copious amount of information about the FDA's mandatory rules and regulations concerning the manufacture of cosmetics listed in their Compliance Guidelines. They have the right to inspect any manufacturer without notice, but they can't afford all the extra leg and paperwork the new legistlation will require. If there were only 10 WAHM's or other small home businesses in every state paying the fee the FDA would generate an extra $1 million annually (remember, it's not a one-time fee) in revenue. You can do the math from there. Business as usual. I read on an FDA Law Blog in April that, "There are fees for registration, reregistration, reinspection, certification, certifying agent accreditation, laboratory accreditation, export certification, and importer registration. The Energy and Commerce Committee predicts that the food registration fees alone will generate approximately $600 million for food safety activities at FDA. In addition, the bill provides for the levying of substantial fines for violations of the new requirements. The proposed fees in this bill mirror the efforts seen in FDAAA to increase user fees as a means of generating revenue for FDA."

One of the reasons this makes me so mad is because I read at the federaltimes.com that the FDA has performed inspections at just 1,500 of the nation’s *5,000* drug manufacturers since 2002. I find this infuriating and think they need to - once again - take a good long look their big ducks before they start eyeballing the ducklings. But the big ducks have government lobbyists and a team of expensive lawyers in every corner, don't they? Did you see the piece on CNN this morning about Gardasil? It's been linked (coincidentally, of course) to over 9,000 "adverse events" and 21 deaths. Please don't tell me the FDA is actually going to show up in Flat Rock to inspect my lip balm when they are already *3500 drug manufacturers* behind. The annual $2000 fee is a crock of shit. I don't think neglecting to monitor big pharma is any excuse to let small biz mfg companies slide. But I do think the fee is another way for them to make more money and that it won't change a thing, except for putting small time businesses, including work-at-home mom's who already barely pay their taxes and won't have the extra time or energy for all of the additional paperwork (and trust me, I am already struggling under a mountain) which will come with the legislation, out of business. They aren't going to effectively regulate WAHM production any more than they do Merck or Mary Kay. I was a bookkeeper and tax preparer for a struggling small business for eleven years and I know exactly how the government deals with the "little guy". If I stay in business for 10 years under this ammendment I will have paid $20,000.00 to Uncle Sam and have filled out literal mountains of paperwork. Surely there is an easier way to ensure public safety from my plantain salve. They don't give a hoot about your ethics or the quality of your products, they just want your money and a little extra insurance to cover their own asses. If they're going to charge us no matter what we say, they should at least do so based on our annual sales. Not that I really believe that would be a good alternative. I didn't even MAKE $2000 in my first year of business.

I support consumer safety 100%, and I follow every single guideline set forth by the FDA concerning cosmetics mfg. I wouldn't even mind paying a one time $2000 fee (even though I would have to borrow it ) to cover the additional paperwork it will take to establish ingredient safety materials for consumers. I do, however, respectfully decline the annual poke-in-the-rear, thank you very much.

If you support small businesses who provide quality handcrafted bath and body products, please sign the "Stop the FDA Globalization Act of 2008" petition.

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4 comments:

Cindy said...

Wow, I found this very interesting and kind of scary too considering I have been toying with the idea of an herbal based home business for about a year now. How would a WAHM be able to comply with those sort of standards. It actually makes me rather angry the more I think about it. Thank you for calling attention to it.

Leanne said...

Thank you, Cindy. It truly is an alarming prospect. I haven't been selling herbal products for very long but I am certain if the legislation is passed it will put me and many, many others out of business, and make it almost impossible for newcomers like yourself to make a good start. Like you said, it scares *and* angers me. Hopefully enough concerned citizens will speak up to do something about it.

CatHerder said...

In our town, you cant even make soap at home...ridiculous...but we have people in single family homes with 50 people from their "country" living there while they get their citizenship. Thats one of the reasons i did not pursue my crafting of soaps, i wound up making jewelry..which is regulated as well.

Leanne said...

Catherder, it's hard to believe you can't even make soap at home. That is truly ridiculous. None of this really suprises me, though. The government has been dying to get their greedy little mitts into the herb and herbal product market for a very long time. I'm afraid the best we can do is hold them off for as long as possible. It sickens me.