Recently, the FDA (U.S. Food and Drug Administration) announced that it was considering legislation to strengthen food, drug and cosmetic safety (see the Draft Discussion here). While I sincerely believe that the FDA and all that testified on behalf of the legislation have the consumers’ best interests at heart, I am deeply concerned about the unintended consequences of this action. I am so concerned about the ramifications of this legislation that I will be heading to Washington DC next week to speak on behalf of Bramble Berry’s customer base and add my voice to all of you who have worked hard to turn this hobby into a business. Joining me will be three amazing women: Donna Maria Coles Johnson from the Indie Beauty Network, Lela Barker from Belle Lucce, Jamila White from jBlossom.com and Kayla Fioravanti from Essential Wholesale. We will be meeting with staff of the House Energy & Commerce Committee (under whom this discussion framework is moving forward), Senator Kerry (Senator Kerry chairs the Senate Committee on Small Business & Entrepreneurship) and the Deputy Press Secretary for Congressman Jesse Jackson Jr. Rep. Jackson serves on the Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies.
In a nutshell, the FDA Globalization Act of 2008, is designed to impose stringent monitoring, manufacturing and reporting requirements on all products under FDA purview. The “Cosmetics” portion of the bill is actually very small (1/64th of the entire bill) in relation to the “Food” portion. None the less, the implications for small, home based crafters and cosmetic manufacturers, is concerning.
This legislation is coming at a time when cosmetics and personal care consumers have never had more choice, nor have the products they have to choose from ever been more safe. Just look at these quotes from experts:
Pamela Bailey, President of the Personal Care Products Councill (formerly CFTA), stated in her April 12th testimony to the Energy & Commerce Committee, “Cosmetics and Personal Care Products are the safest category regulated by the FDA.”
Additionally, Stephen F. Sundolff of the Center for Food Safety and Applied Nutrition stated, “The FDA’s oversight has ensured that the Nation’s cosmetics are among the safest in the world.”
The experts quoted above believe the system is already working and we here at Bramble Berry are pleased to help you make some of the most useful, safe and innovative products in the country.
Consumer safety is important to me. I am a strong advocate of proper ingredients labeling, best manufacturing practices and education. As Bramble Berry’s founder and CEO, I am consistently impressed with your commitment to the safety and purity of your products. This is why I am so concerned about this legislation.
With this potential legislation at our doorstep, it imperative that you review all of your products, formulations and manufacturing practices to ensure that you are within full compliance of all current laws for home crafters and cosmetic manufacturers. This new proposed legislation will do nothing to strengthen the cosmetics industry safety. Rather it will just be a bigger burden which could force some small producers out of the market.
The areas in the current discussion framework which I find particularly disturbing are:
• Requirements that you register all of your formulations with the FDA – Cosmetic manufacturers select from a list of approved ingredients generally regarded as safe by the FDA. This rule would add another unnecessary burdensome reporting requirement onto small businesses. Who exactly of the 18 people currently employed by the FDA to oversee Cosmetics is going to look at the formulations? If there were 100,000 large and small manufacturers, each with 25 formulations … well, that’s a lot of paperwork to go through! Not to mention, as a small business owner, you’re already doing enough, stressed to the max and now you’re going to need to fill out forms rather than work on bettering your business? Yikes. Talk about tying your hands with red tape. Consider also the stifling effect such a reporting requirement will have on new product innovation, or even minor improvements made to old products.
• Requirements that you report all “Potential Adverse Reactions” to the FDA – Again, through self-regulation (GRAS list, The Cosmetic Ingredient Review (CIR) and Cosmetic Ingredient Dictionary) there is a comprehensive list of approved (and not approved) ingredients to use. Who is to say what a “potential adverse reaction” might be? I might have an adverse reaction to the foundation I just made … if I put it directly on my eye. No one can legislate or know what consumers do with our end products. Why would the government want us to even try? According to the Personal Care Council, every year, out of 11 BILLION personal care products sold, there are less than 150 adverse reactions. That’s a safety factor of .00000000136%. There is no evidence that the current laws and regulations are not working. In fact, the excellent safety record of the Cosmetics Industry proves the contrary.
• Fees, fees and more fees will jeopardize businesses all over America. In uncertain economic times, it is imperative that Americans have choices about how they earn their money. At the minimum, this act would require a registration fee of between $2000 up to $12,000 per year, no exceptions. 95% of Bramble Berry’s extensive customer base would not be able to bear this burden. In fact, only 40% of our customer base grosses over $250 in sales per month. Yet, it is from this very customer base that the next Mary Kay or Estee Lauder may arise.
Just think of how these three points might affect YOUR business. The time to act is now. This law has many unintended consequences. Rather than strengthening the cosmetics industry, it will force thousands of small producers out of the market. And, where there is less choice, there is always a higher price in the end.
If you haven’t yet signed the petition, there is still time. Head to Indie Beauty Network’s site here. Be sure to sign your name, business name and city and state.
I’ll be in DC next week – let me know what you think is important for the committee to hear. What would you tell them? I’d love to meet you at the Indie’s In the City meet-up after our busy day of meetings on the Hill. Learn more about that meet-up and RSVP here.
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Resources & Links referenced in the post:
Committee on Energy & Commerce: http://energycommerce.house.gov/FDAGlobalAct-08/index.shtml
Discussion Draft Legislation: http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf
Testimony of Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research http://www.fda.gov/ola/2008/fdaglobalact050108.html
Testimony of Stephen Sundolff for Center for Food Safety And Applied Nutrition http://www.fda.gov/ola/2008/devices051408.html
Testimony of Patricia Bailey of the Personal Care Products Council http://energycommerce.house.gov/cmte_mtgs/110-he-hrg.051408.DiscDraftCosmetics.shtml
Testimony of Center for Science in the Public Interest: http://www.cspinet.org/foodsafety/fdaglobalizationact.pdf
Anne-Marie, Thank you so much for all your hard work. Good luck and good blessings on your trip to DC…!
Victoria Sharpe
Victoria’s Natural Soap
Go get ’em! And thank you for spending your time and money doing this. It makes a difference to me and I notice who is going and taking an active role and who is not. That will help guide my buying decisions for supplies this upcoming Christmas (I’m just a hobbyist so only guy at Christmas).
Many thanks again, Anne-Marie! Where would we all be without you?!
I'll be thinking of you all day tomorrow! We are lucky that there are wonderful Indie Warriors like you and Donna Maria and all of the rest to speak on our behalf!
Have fun & go get 'em!
i know how you feel, we have those strict laws for cosmetics in europe too and therefore it is impossible for me to turn my hobby into a business.
i only give my soap as presents to friends and some friends buy soap from me. but in principle it’s even illegal to give homemade soap away as a gift unless you are a chemist, druggist or pharmacist. that is part of the cosmetics bill in austria. and if you’re produce soap for a business you will have to register every recipe, keep records of every ingredient and have every soap tested in an independent laboratory, which is very expensive.
I really appreciate all that you are doing on behalf of us little guys! Good luck in DC!
Hi Michelle –
My understanding is that soap would continue to have its exemption from the FDA under the current discussion framework. If I find out differently, I’ll certainly let you know. =)
The issue, of course, comes when a soaper is ready to branch out – either for creativity sake or for financial reasons to broaden their line – at that point, the potential new legislation would affect them.
Just got back into town and read that you’re getting ready to tackle DC. Thank you for sticking up for us little ones!!!
Jeannie
Hi:
My situation is similar to Michelle’s – I make soap and other body-care products and make NO claims about any of my products. I am fairly certain that I’m following correct labeling practices (but just ordered the Labeling book you have on your site to be 100% sure!).
I don’t plan on adding cosmetics to my product line at this time. How will this legislation (if passed – and let’s hope it doesn’t!!!) affect me?
I have a lot of confidence in you and know that we are all in good hands with you (representing this issue).
Kind Regards,
Erin
Thank you AM and to everyone who are going to Washington to speak on our behalf!
Sending good thoughts & positive vibes your way 🙂
Many thanks to you, Anne-Marie, Donna Maria and the others for speaking up for us. I am not dependent on my sporadic craft show and word of mouth sales to support myself, but have so many friends who depend on this income. The fees would wipe them out if the red tape didn’t.
I have several relations and friends who are very allergic and it is rare that they have any problem with my products. It is usually an eo or fo and if they have an irritation they don’t use it. (brilliant, and folks with sense can figure it out without regulation) The regulation will not prevent such reactions that are so individual. One highly allergic woman and her daughter rely on my products as they cannot find any commercial products that do not cause skin problems for them.
I hope and pray that your words will be heard. It looked like the petition has many, many signatures.
See you on the 17th in Lakewood!!!!
Great Job Anne-Marie! What a Leader!
Thanks, A-M, for your part in trying to ensure that small biz owners don’t get royally screwed (pardon my French).
THank You so Very much. I love your company/Blog. I use your products often, I cannot believe that all my work over the last 2 years will be for naught because of red tape. Here is to show that small business is worked against, not for in this government. People that are trying to produce honest products, with much opposition, can in no way succeed. Hopefully you can be a small voice in a sea of much lobbyist clamor.
Awesome post, A-M. Go get ’em!! See you next week! dM
Thank you for going and being a voice for all of us. I recently turned my hobby into another component of my business and it would be very upsetting to not be able to provide the products that I do. I love making soap and other bath and body products. For all of us that do, it has taken time, learning, energy, financial resources and more as an investment to this craft and I certainly would hate to see all of that go to waste for myself or anybody else.
Again, thank you for taking your time and resources to go and represent all of us. Good Luck
Anne-Marie,
I can’t thank you enough for what you are doing next week. I love what I do and don’t want it taken away from me. I’m among the 60% who don’t gross more than $250 in monthly sales, but it’s this very year that I’m finally beginning to break that barrier… what a tragic situation!
I have two chronic health conditions that would make working an “regular” job very, very difficult and painful, yet I don’t qualify for welfare or disability. If I lose my business, my lack of alternatives frightens me.
Here is my question: I make only soap, nothing else. I have no intention of ever making any cosmetics. Further, I make NO cosmetic claims on any of my products, written, verbally, or otherwise. I am aware of the FDA’s stance that my handcrafted lye soap is not therefore considered a cosmetic.
Thus, what happens to someone like me under these proposed regulations? Or do they plan to recategorize lye soap as a cosmetic?
Thank you for your time, and thank you in advance for your willingness to get these questions answered. Best of luck next week; I, like the rest of us, will be with you in spirit and appreciation.
Michelle Gilbert
Sarva Natural Artisan Soaps
Cleveland, Ohio
http://www.sarvasoap.com
http://soapleaves.wordpress.com