Tuesday, February 03, 2009

The FDA Globalization Act of 2009 HR 759 is cause for alarm to all artisan businesspeople

What the FDAGA 2009 will do to the American artisan food of cosmetic businessperson

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.


We will NOT be able to survive this government red tape - it will strangle our businesses.

We are planning to seek relief in the form of an exemption for small artisan businesses. Join us!

United we stand, divided we fall.

17 comments:

  1. Thank you for this information Anya. Please continue to keep us posted and let me know at anytime what i can do to help.

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  2. Hey Anya,

    I hope this post finds you doing well. Actually, the time it takes to register your company and products is not that consuming. My company, Cactus & Ivy, participates in the VCRP and the process has been very easy.

    You said, "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".

    If a company is listing their ingredients on their website and on the product, then they are already providing their information. When you register your ingredients, it is nothing more than listing your ingredients in descending order, as you would on the product label. The form does not ask for the percentages used. Anyone can go to a competitors site or purchase a product and then do reverse engineering to try and replicate a product.

    As for the GMP, according to HR759, the requirements to comply with current GMP guidelines are not in this new legislation.

    I believe the legislators need to be made aware of our industry and the many hats we wear so they can better understand our concerns as a whole, however, I don't believe the registration process is detrimental to the business owner.

    Have a great day!

    Lisa M. Rodgers
    Cactus & Ivy

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  3. Hi Beth - will do, and don't forget to spread the word, especially to foodie artisans. They're the ones that will really be hurt by this.

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  4. Hi Lisa:

    I'm aware of all the points you make regarding registration and listing of products in descending order. I have a different viewpoint, and I really would like to come to a stop until we get everyone on board.

    Why? The EU-generated regs that are behind this. The burden on the artisan is enormous, the bureaucracy overwhelming, and this Act is the foot in the door.

    Reverse engineering will always be with us, but I believe proprietary secrets are best kept that -secret.

    I have two advisors re-looking at the GMP issue, and I'll post about that in a few days.

    It IS very imporant that legislators become aware of our business needs, but registration, GMP compliance, REACH compliance, IFRA regs and the other stuff I know is in the pipeline behind this needs to be stopped. Otherwise, we'll be red-taped and paperworked out of business.

    Besides, trusting the FDA to "protect the public's interest" is rather a quaint idea, given the number of approved drug-related deaths each year, the tomato and peanut salmonella scandals, etc. I think we can go better as a self-regulating industry.

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  5. Hey Anya,

    Are you a member of the Indie Beauty Network? Having points of view of varying degrees is what's needed and even though we all are different, we are still in the same boat.

    Thanks for your opinion on the issue. Have a great day!

    Lisa

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  6. Hi Lisa:
    No, I'm not a member of IBN, but I did contact dM back in early June about the 2008 Act - and she took the ball and ran with it via the video, etc.

    When she and I formed a Coalition together with some others this summer, I did offer reciprocal membership with the Natural Perfumers Guild, which I head, but dM declined, as she told me it's not part of her business plan.

    Differences of opinion, and different ways of interpreting laws (as we have here) are necessary and expected. Everyone moving forward to bring the greatest opportunities to the small business artisan with the least amount of government constraints is, I'm sure, the goal we're all aiming towards.

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  7. Hi Anya, it's me Donna Maria at the Indie Beauty Network. Maybe I'm reading your post incorrectly, but just in case not, I wanted to point out a few things that might interest you. I'm only speaking about cosmetics here because I am not advocating with regard to drugs, food or drug devices which are also covered by the bill.

    1. Your post is incorrect if it means to state that the FDA Globalization Act of 2009 requires cosmetics companies to "adhere to the FDA Good Manufacturing Practices." In fact, the bill specifically recognizes that some cosmetics companies will not comply with GMP, and non-compliance is not made illegal under the bill as it now stands. This is clearly stated on pages 122and 123.

    2. On the ingredient issue, again only with respect to cosmetics, your post says that "All your formulas will be public record, out there for a competitor to copy." This is not true. The bill does not require anyone to register formulas. It only requires registration of the information that is already required by existing law to be included on the label anyway. While that's a paperwork issue for sure (!!), it's not a formula issue. Current cosmetics law requires you to label ingredients in descending order of prominence in the cosmetic product, and that's what the bill require. The difference is that the bill requires you to take what's already on your label and repeat it in a registration filing. Again, it's a paperwork issue to have to update it if you change it, and this is an issue. But it's not a formula issue.

    I have not had a chance to read through your entire post more than once, but these few things really jumped out at me.

    I hope this information is helpful somehow.

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  8. Hi Donna Maria:

    Are you working from the Act link provided by Marie Gale on Jan 27th? That's what we're working off of.

    From Page 122 of FDAGA 2009 (Marie Gale's copy)


    19 SEC. 304. GOOD MANUFACTURING PRACTICES FOR COS

    20 METICS.

    21 Section 601 is amended by adding at the end the fol-

    22 lowing:

    23 ‘‘(f) If the methods used in, or the facilities or con-

    24 trols used for, its manufacture, processing, packaging,

    25 storage, or holding do not conform to current good manu-


    >From Page 123 of FDAGA 2009 (Marie Gale's copy)


    1 facturing practice, as prescribed by the Secretary in regu-

    2 lations, to ensure that the cosmetic is safe and otherwise

    3 in compliance with this Act.’’.

    As this is such a crucial issue for all, and as the FDAGA bill identifies each line of the document with a number.

    dM, could you be so kind as to provide us with the EXACT line numbers from pages 122-123 for the wording that you says is clearly stated in the FDAGA on those pages. I, for one, would truly LOVE to see
    this exclusion be a reality, and I would also love for us all to have the correct language of the bill asap to refer to for our future
    reference.

    Yes, as you point out, the two GMP outlines have some differences, however, in regard to our member's concerns, the multiple testing requirements under numbers 4, 5, 6, 7 and 8 of the GMP outline for raw
    materials AND water AND repeated testing of finished products would be
    extraordinarily burdensome. I do not believe that it is possible for the vast majority of small artisan craft companies to meet all of these requirements as outlined at:

    http://www.cfsan.fda.gov/~dms/cos-gmp.html

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  9. Anya, add my email to your list for your updates. I am not a fan in anyway of the bill, registration or not, and would like to see a complete opt out of this requirement. I've posted my sentiment elsewhere as well and will continue to do so. I think we should have a grandfather clause or a signed exemption (i.e. my company will not receive your benefits and I will not comply with your organization). BTW- I think they are purported and not actual benefits of this bill.

    Sincerely,
    Amy Mattingly
    mikamy@mikamymeadows.com

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  10. Anya,

    I think I may have dashed my comment off hoping that I could convey a thought in a few words when more may have been necessary. It’s kind of a difficult point to make in response to this particular blog post because the post mixes food, drugs, cosmetics and a lot of other different issues together when they are actually treated quite differently in HR-759.

    All I meant to say is that last year’s draft bill said this: The Secretary shall by regulation require that the methods used in, and the facilities and controls used for the manufacture, process, packing, or holding of a cosmetic conform to good manufacturing practices as prescribed in such regulations. We vehemently opposed this provision and were happy to see that our position was not only heard but also well received, because the current draft of HR-759does not contain this language. What is does say is that if FDA does promulgate GMP, then if a cosmetic company does not follow it, then the cosmetic made may be deemed adulterated. That’s very different from a Congressional mandate requiring GMP, which is what I read your post to say HR-759was.

    That was my only point. I apologize if I did not state it eloquently, or if I’m not doing so now.

    Thanks,
    dM

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  11. Hi,

    Marie Gale of the Handcrafted Soap Makers Guild here. Donna Maria and I have written our letter in response to HR 759 (The FDA Globalization Act of 2009). There's a link to it in my HSMG blog post about it (http://www.soapguild.org/blog/2009/02/fda-act-2009-letter-to-congress/.

    Our position is that while we are in agreement with most of the provisions of the Cosmetics portion, there are two sections in which we feel greater attention is needed for very small cosmetics businesses. Those are the filing of cosmetic ingredient statements (but not for the reasons you mention) and the possibility of future one-size-fits-all GMP requirements.

    Our proposal is to insert wording that specifically allows the Secretary (that would be the FDA) to take the circumstances of very small businesses into account during the process to promulgate regulations as mandated under the act.

    In other words, we just want to ensure that we don't end up with one-size-fits-all. By having the door open, we can work with the FDA to ensure that the capabilities, responsibilities, processes and activities of very small cosmetic businesses are taken into account.

    Truth is, we are moving into an age of more regulation for cosmetics. I don't honestly see that we will be able to stop that freight train. But we CAN make the differences of our small businesses knows and provisions for them included in the implementation of the regulation.

    Marie

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  12. Hi Amy

    Just sub to this blog and you'll get updates whenever I post anything.

    Thanks for voicing your comments, they are the words I'm hearing from many folks across America.

    Anya

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  13. Hi dM

    Please allow me a few days to get back to you on the GMP issue. Some of the folks I'm working with are unavailable and we're taking the slow response approach to this bill until we reach a concensus. The point I was trying to make, and yes, I may have been inarticulate too (not the first time!) also spills over into the requirement for testing.

    I'm led to believe that all raw materials will need to be tested. Finished product will need to be tested. Finished product will need to be kept on hand for further testing, if requested. Toxicology testing will need to be done.

    So, I, as an artisan, will have to GC and have tox testing done on every raw material? Even if it's just a tiny amount for a small run? Somebody like Burt's Bees can easily absorb that if they're manufacturing their typical large batches.

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  14. Hi Marie:

    Our goals aren't that much different from yours, but we're going beyond addressing the economies of scale, which as you point out, are off-kilter in this bill.

    We're also aligning ourselves with as many foodie groups as we can because they're our buddies at Farmers Markets, festivals, fairs, etc., and they have no idea what's coming, and they're still under the gun for the $2,000 - $12,000 yearly fees.

    Artisans need to be protected from government overregulation. The current hysteria about the salmonella in the peanut butter is a food issue, but it might as well be a cosmetics - or pharma - issue.

    The real problem is the monoculture of the huge industrial corporations. Their faults and problems are being translated to the artisan cosmetic and foodie people, and it's not fair.

    I don't believe that the freight train coming is inevitable: I believe it's important to stop it from powering up in the first place.

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  15. Anya,
    One of the many things I love about being an American is that we have the right to speak freely. I appreciate the passion behind your words and actions. I admire your desire to make something happen and the action you put behind it.

    As we talked before we vary some on our opinions but our overall goal is the same. We both want to see small businesses thrive in every industry. I am so glad that you have the connections to work with and help the people in the food industry. The fees levied on them are unjust and are bad for small businesses.

    I am thrilled to see the fees lifted for the cosmetic industry and I would love to see the same happen for the food industry. I am not opposed to registering our companies but would like to see some changes in the registering of products. I have used the system and it is very easy to navigate and use and only discloses as much as ingredient list discloses.

    We will both have to keep our ears to the ground and stay active in this fight for the long haul. I'd like to keep our lines of communication open as we work towards a common goal.

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  16. Marie, I forgot to ask earlier - simple question that's been at the back of my mind: why is the handmade soapmakers Guild involved since soap isn't labeled a cosmetic by the FDA and won't be affected by this Act? Is it because a lot of your members make products other than soaps? I think it's great you're involved, you have a good understanding of the issue. We need all the help we can get!

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  17. Hi Anya,

    The Handcrafted Soap Makers Guild is involved because soaps, while they CAN be exempted from the FDA if there are no claims, if a soap has any cosmetic claims ("moisturising", "soothing", etc) then it becomes a cosmetic, so the cosmetic regulations apply.

    Also, most soapmakers ALSO make some kind of cosmetics, which means that a majority of our membership will be affected by the bill.

    Marie

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