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.
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.
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