Archive for the FDA Category

can you sign the petition, please?

Posted in FDA, news, Uncategorized with tags on June 26, 2008 by scentedwench

If you haven’t already.

I posted about the FDA Globalization Act of 2008 previously.

Here’s your chance to get active, eh.

In a nutshell, the current draft of the Act spells business closures for most small businesses who move under a certain volume, annually. It is in essence an income stream for an agency that has proven time and again to not serve the public interest, to not protect the consumer, and to be in big pharma’s back pocket. The Act is about monopoly. In this case, the companies that small businesses like myself laughingly refer to as “the Big Boys” will wind up being the winners.

Anyway, Donna Maria runs an org I belong to, the Indie Beauty Network. And she put a petition up on the blog for the org. She used to be a corporate attorney, but is now in the business of helping small businesses get ahead and stay ahead, and just follow their bliss and live creative lives that are lucrative.

If you’re so inclined, I’d strongly suggest you sign the petition. And if you blog as well, and think it’d be a good exercise to post about the topic there, go ahead and permalink her blog link. She’s got a video up that addresses the Act as well, and is hoping to get 100,000 signatures (you are welcomed to embed and link to the video from your site; I cannot figure out how to do this at the moment, so I’ve only got the petition URL linked right now).

Link and petition, here.

Thanks for reading.

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so, because the FDA isn’t stretched enough already

Posted in business, FDA, regulatory agencies with tags , , , , on June 9, 2008 by scentedwench

There’s word on the wind about the Food and Drug Administration Globalization Act of 2008.

A lot of us small businesses are quaking in our boots abut it. With good reason, because many won’t be able to afford the reg fees that’ll be required for us to remain in business.

And, you can tell in spades that it is ALL about making up for lost funding more than it is about doing the right thing and protecting consumers. Look at this passage and tell me that they’re not just looking for another income stream,

“The legislation is aimed at giving the FDA authority to promulgate new regulations that are supposed to protect consumers and also provide the funding the agency needs to enforce existing laws in a global market…”

It’s the line about the funding, in particular. (I am quoting from the Indie Beauty Network forum, there).

It isn’t enough for all of us to go crazy capitalist style and spend money we don’t have in order to stimulate the economy, no, we have to balance a federal agency on our backs now, too.

If you’re interested in reading more, here’s a few links worth perusing:

http://www.fda.gov/ola/2008/devices051408.html

http://www.personalcarecouncil.org/Template.cfm?Section=News_Room&template=/ContentManagement/ContentDisplay.cfm&ContentID=5976

http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf

(I hope the people in the Soap Guild who were actively lobbying for this kind of micromanaging dreck, before they were ousted from the leadership, are happy now. In the end, it’s not worth getting rid of your competition by any means necessary, if it negatively impacts the ability of your contracted soapers to make your products for you. Meow. Hiss. Spit.)

So, is this FDA act worth worrying about? Yes, it is. I really do think that some regulation is going to be necessary for as long as rebels without a clue pick up a stickblender one week and start selling their wares the next week. And for as long as would-be ‘perfumers’ decide to bottle some fragrance oil they bought for scenting something else and call it ‘perfume’. In those instances, it is really going to separate the chaff from the grain. And don’t get me started on the learn-as-you-go manufacturing of aqueous solutions like lotions and gels.

BUT… self-regulation is nothing to sneeze at. I dare anyone to join a soaping bulletin board and post some seemingly innocuous questions like, “I just made my first batch of soap! How do I go about selling it?” or, “I made some lotion and it grew hair! What do I tell my customers?” See, people will be on your case so fast you’ll learn in a hurry that there’s a careful way to go about doing things, and a very careless way. We’re all in this together.

But I also see what the FDA is proposing on a par with what happened when RLI decided to screw most of its handcrafting customers and tell them they’d no longer be insured unless they were making just enough money to warrant a tax audit rather than enough to sustain and enable them to grow their businesses. And to that end, I’d ask what the greater goal is here.

Everyone in business has to start someplace, so why would you cut off your nose to spite your face by effectively shutting down scads of small businesses before they even get a chance to take off and expand to where they can afford the fees?