Thursday, February 26, 2009

Perfume and fragrance and body care business owners - don't be caught asleep at the wheel with the FDAGA2009 HR 759

You can't move forward in fear. You must be motivated and feel you have some power, some ability to change things, or effect a different outcome. The following blog is meant to erase fear and replace it with a sense of being awake and aware at the forces that shape our artful industry.

What is all means to me: I don't want any more government regulations that can limit my ability to conduct a safe, environmentally-friendly small business. "If it ain't broke, don't fix it."

If you have a small USA-based business that manufactures perfume, aromatherapy or body care products such as lotions, body butters, soaps (soaps with a claim of moisturizing or some other attribute beyond cleaning) and related products, the Federal Drug Administration's Global Harmonization Act of 2009 (FDAGA2009), currently in committee, but fast moving towards a vote into law, can pose problematic to you continuing your business. The requirements for testing, paperwork and personnel are overwhelming, and that will be written about in future blogs.

In today's blog I will be addressing one portion of the FDAGA2009, and I urge you to keep yourself informed on each and every issue as they are blogged about here and elsewhere, to check the FDA paper trail yourself, and most importantly, get active in protecting your small business against more government regulations being imposed. I'll share a cautionary tale that I keep at the forefront of my thoughts when new regulations are promoted. After this intro, I'll get into the topic for this blog, just one tiny section of the Good Manufacturing Practices (GMP) that the FDA is attempting to convert from voluntary to mandatory via registration.

A few years ago, shortly after I first blogged on the International Fragrance Association (IFRA) "guidelines" that morphed into European Union (EU) laws that resulted in the reformulation of classic perfumes and severely limited the ingredients used in modern perfumes, I spoke with a retired perfumer, a card-carrying member of the American Society of Perfumers. He had seen the industry fall in step, timidly, not challenging the ever-increasing laws from the EU. It didn't matter if your perfume company was in the USA, or if your revenues topped $100 million dollars a year, you capitulated.

Perfumistas on internet forums bemoan the fact that the classic chypres perfumes have been reformulated to a former shadow of themselves (oakmoss now severely restricted in blends, ditto for bergamot re: IFRA.) Or that classic colognes have lost all their lively, beautiful citrus topnotes (again, IFRA.)

After a long discussion, wherein the perfumer related a chronological litany of the avalanche of regulations that brought us to the point that you can get more orange oil on your hand peeling an orange than is allowed in a modern perfume, I asked "How did you let this happen?"

His simple reply:

"We were asleep at the wheel."

I will never be asleep at the wheel, and I hope you won't, either.

I've been blogging about the IFRA/EU and Globalization threats to our small businesses for two years now. Robert Tisserand and Tony Burfield and I worked on a Primer about the IFRA amendments and a FAQ in February 2007. We devoted about two months of our lives to that project, at the expense of our businesses. We almost burned out. Why? We're not asleep. The word did get out, but it's amazing how few people here in the States know about the threat. Wake up, folks, it's coming at you like a runaway train, and the IFRA/EU Globalization is now taken up by our FDA.

Now to the first bit of bad news regarding the FDAGA2009 - and I'll blog about the others, but just one small bite at a time.

Bear in mind these GMP guidelines have been law for some time now. Enrollment was voluntary. The FDAGA2009 now wants to make enrollment (registration) mandatory.

There is one guideline that might be very problematic if you're a one-person small business. Anya's Garden Perfumes has grown so that I now have a part-time bookkeeper and a part-time assistant, and since I am math-challenged, I have them check *everything*, not just weighing and measuring of raw materials. But what if you don't have folks like this? Also, how does the FDA define this second person? Full time employee? Your kid in high school - can he or she fill the role? Your partner who is not affiliated with the business but wants to help? The nexus of the definition of that second person is one thing we're trying to dig out.

But that's not the real point of this blog, it only illustrates how unfriendly the FDA is to small businesses. Why can't a reasonable, responsible business person be allowed to run a sole proprietorship just that way - solely? Could you hire or otherwise have someone on hand to meet the FDA GMP on Sec. 5.d?

The team of savvy, concerned, engaged folks I'm working with right now are trying to rush (the FDAGA2009 is being rushed through committee, heading for a vote) while being deliberate and poring over all of the Act, the GMPs, and the root definitions of all the guidelines.

In the next few weeks we'll be contacting cosmetic and food associations with our White Paper on this critical issue. We'll have a draft letter in place for the associations to distribute to their members, along with a link to contact your congressional representative. I'll have all the links here soon, so please check back.

And don't be caught asleep at the wheel, you owe it to your business and your artisan indie community - we need to have reasonable government to allow us to thrive.

Anya McCoy

2 comments:

  1. Thank you for your vigilance and your hard work on this subject, Anya. I am watching eagerly on the Yahoo group and following this issue. When the time comes to stump up support -- signatures, phone calls, letters, whatever -- please keep us posted.

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  2. Thank you for this. I've already had to give up making herbal vinegars for the farmers' market (as they now in my state must be made in a certified kitchen, not a household one, and the fees to rent one are more than I make from the vinegars each year)---it sounds like the proposed $2000 yearly fee would apply to those too, so I guess I am truly out of the vinegar business?

    I would hate to see it get to the point that I can't sell lip balm because I am not married to a free employee to do my weighing for me.
    As to submittted lists of ingredients not being available online---one of the big ag surveys states on it it is voluntary and confidential and yet I've looked in on it online and seen nurserymen identified by name, address & id# , and there were their yearly income figures, by crop!

    For something as mutable as perfumes and soaps, balms and creams, the idea of having to register each new scent combination, or each time you decide to bump the % of cocoa butter to mango butter.....ack.

    I signed up for your newsletter, is there any other way to get more updates? (Apologies if this double posts, the captcha seems to have a bone stuck in its throat.)

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