The FDA Globalization Act of 2009 HR 759 is cause for alarm to all artisan businesspeople
Do you make any body care or foodie product in the artisan manner? Artisan soap, artisan bread, artisan cheese, artisan perfume, etc? Don't let your guard down over the new "improved" Food and Drug Administration Act of 2009 (FDAGA2009). Please bookmark the links I'm providing here, you'll need them if you are an artisan. Also subscribe to this blog and others who are updating our efforts to understand (and in my case, fight) the FDAGA2009.
A big sigh of relief went out from many who had opposed the horrifying fees proposed in the Food and Drug Administration Act of 2008 were eliminated from the Food and Drug Administration Act of 2009. I agree, dropping the fee was a great act. I called Donna Maria of the Indie Beauty Network in early June of 2008, alarmed. I had blogged about it the month before, and knew it was trouble, but couldn't figure out just what the trouble was. Donna Maria asked me a lot of questions, such as "what committee is overseeing it, etc." but heck if I knew.
I just knew I had been warning about Globalization for two years and it was bad. I hadn't gotten my hands on the Act, but Donna Maria called me a few days later and by then she had gotten her hands on it and was alarmed. Folks went to Washington, I spoke with several key legislators, and I formed alliances with others who are taking a broader view and including food artisans, not just cosmetics folks. We'll announce our website soon, and in the meantime we have a great team of volunteers who are working with us.
If you're a foodie artisan reading this, please join our effort. Subscribe to this blog or write to me via my website and we'll get you on our outreach list. We have some volunteers who will be researching all the foodie organizations, guilds and associations we can find asap and reaching out to y'all.
Sure, the fees were waived for the cosmetics folks like myself who made a stink - but you foodies had no representatives who protested, so you'll still be hit with the fees, in addition to the stuff listed below. Your fee? $2,000 to $12,000 per year!
Basically, we believe the new, revised FDAGA2009 is a false, misleading and deceptive act. There are provisions written in FDAGA2009 that will prove a great burden on small artisan business, perhaps drowning them in paperwork at the very least, and putting them right out of business in the worst scenario.
Wake up, people, please - this is a Trojan Horse.
Don't roll over and accept the kumbaya - or you'll live to regret it. I'll be blogging about this frequently, and I urge others who are blogging on the FDAGA2009 to link up with me.
Look, I am the first to admit I am a dummy when it comes to really understanding legislative acts. They're boring to read, contain a lot of language I'm not familiar with, and relate back to other legislation - it's like following a hazy, crazy paper trail. But follow it you must. I have some savvy folks assisting me, one who has served on a lot of committees and another who has written legislation.
Ok, deep breath, let's plunge into the murky waters of FDAGA 2009:
1. The act requires registration, every year. Why be against registration, you ask? Isn't it responsible and something we should do if we are in business?
If you register, you must supply a list of your products, a list of the ingredients, and if you change an ingredient, you must inform them via update within 60 days. This means all your formulas will be public record, out there for an competitor to copy. (Technically, the law says it won't be available, but I'm skeptical.) The paperwork burden is tremendous. We're just small businesses. We've operated for decades, actually, hundreds of years without major incidents of public injury. Why the rush to get us all on the public record? American businesses have operated quite well so far, why fix what's not broken?
2. You'll have to adhere to the FDA Good Manufacturing Practices.
The GMP is written for companies the size and nature of pharmaceutical companies. The requirements are so stringent no indie artisan small business person I know can meet them.
You have to have your ingredients sussed out before use, and then after incorporation in a product. You have to have a paperwork trail of lot, batch and control number. Do you have any idea what this entails? Do you have any idea of the software and technical help needed to track this?
This costs a LOT of money - do you have it?
You know what this really means? You'll have to go to contract manufacturing. Contract manufacturing facilities have large minimums. Can you afford that? What if you produce organic or "all natural" products?
Make artisan cheese and can't meet the GMP requirements and have to send your milk and cultures to a big foodie contract manufacturer? That is what the GMP will cause.
Artisan chocolate maker? Good luck keeping your product up to your standards if it's in that hopper.