Nation’s Cosmetics Industry Calls for Greater FDA Role in Oversight of Ingredients in Personal Care Products

Press Release from The Personal Care Products Council:

Groundbreaking Initiative from Personal Care Products Council Would Establish an Additional Layer of Federal Oversight & Enhance Existing Consumer Safeguards

WASHINGTON, July 15 /PRNewswire/ — In a groundbreaking initiative intended to enhance existing protections for millions of American consumers, the nation’s cosmetics industry today announced plans to support legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the U.S. Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.

The proposal represents the culmination of more than three years of planning and research by the Personal Care Products Council (the Council), the cosmetics industry’s trade group, which has consistently advocated for more FDA funding to support additional regulatory oversight. The Council detailed its proposal in a letter to key health policy leaders in Congress. The proposal would enhance current FDA and industry safety initiatives.

The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of the public and stakeholder groups and to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel. No such FDA processes currently exist.

“For decades, the industry has had an impeccable safety record under the existing requirements implemented by FDA under the Federal Food, Drug, and Cosmetic Act. Our products remain among the safest in the marketplace,” said Lezlee Westine, the Council’s president and chief executive officer. “Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role. In fact, for the last 30 years, we have aggressively implemented numerous safety initiatives and processes to strengthen industry safety practices. Our consumers deserve multiple layers of protection and transparency.”

Westine emphasized the proactive nature of today’s announcement, which is being made in the absence of any specific public health risk or legislative mandate involving personal care products, which remain safe to use. Rather, the industry is responding to American consumers who are requesting and deserving more transparency from government and industry while ensuring their ability to keep pace with continued demand for innovative products.

“From Wall Street to the Gulf of Mexico, we have seen what can happen when there is a breakdown in the relationship between government and the private sector,” said Westine. “Our initiative recognizes the need to establish a more collaborative and constructive relationship with federal regulators.”

Toward that end, the Council’s five-point plan includes mandatory industry reporting and mandatory Good Manufacturing Practices, two provisions currently in HR 759, the Food and Drug Administration Globalization Act of 2009, introduced by Congressman John Dingell (D-MI), and three additional provisions that industry is seeking.

The Council plan includes:

(1) Enhanced FDA Registration. It requires that personal care products manufacturers who market their products in the United States comply with the following:

* Register with FDA all facilities where those products are manufactured.
* File with FDA product ingredient reports disclosing all of the ingredients used in those products; and
* Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) New Process to Set Safety Levels for Trace Constituents. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products;

(3) New FDA Ingredient Review Process. Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable;

(4) New FDA Oversight of CIR Findings. FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review (CIR) Expert Panel and determine if these findings are correct. If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products;

(5) FDA-Issued Good Manufacturing Practices. FDA would establish industry-wide “Good Manufacturing Practices” requirements.

“The current process has served the public well for decades, but the time has come for us to advocate for additional safeguards as science and technology evolve. Today’s consumers have even higher expectations for the products they choose for themselves and the companies that provide them,” said Westine. “Our companies commend Rep. Dingell for his ongoing work to better protect consumers and increase transparency. We look forward to working with the current and next Congress to ensure these changes are meaningful and attain the full force of federal law.”

For more information about cosmetic and personal care products, visit www.cosmeticsinfo.org.

Based in Washington, D.C., the Personal Care Products Council is the leading national trade

association representing the global cosmetic and personal care products industry. Founded in 1894, the Council’s more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on every day, from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance, personal care products companies are global leaders committed to product safety, quality and innovation.

SOURCE: Personal Care Products Council


More about the author:  Kristin is the founder & CEO of The Grapeseed Company ~ botanical beauty from the byproduct of wine. She creates handmade skincare with organic and local ingredients in Santa Barbara, CA. Kristin blogs at GreenSkinCareBlog.com Read more from this author


Related posts:

  1. Personal Care Products Council Statement on Campaign for Safe Cosmetics’ “Market Shift” Report: Industry Safety Initiatives Have Produced Tangible Results
  2. Statement by Lezlee Westine President and CEO of the Personal Care Products Council
  3. Statement By Lezlee Westine President And CEO Of The Personal Care Products Council In Response To The Safe Cosmetics Act of 2011
  • JCC

    I have to say, I'm not thrilled with this proposal by “our” industry group. As a contract manufacturer, the reason we have chosen not to register with the FDA (which is currently voluntary) is because the paperwork would be overwhelming for us. We literally make about 800 completely different formulas in a year for 800 different products. We do not have “stock” products that we sell to everyone. (And this is not even counting the thousands of R&D samples we make in a year…and I'm not exaggerating). And that changes every single year, depending on what our customers order. So reporting all of the ingredients (which may or may not require MSDS sheets or CofA's for each ingredient, which would be a truckload of paperwork) would just be ridiculously time consuming. We would literally have to hire another person to do it, because it's my department, and I don't have the time (I'm overworked as it is!).

    In addition, testing for trace constituents could be extremely costly for some chemicals, and most reputable raw ingredient manufacturers already do this testing. The finished products manufacturers shouldn't be required to recheck them. We would have to completely change the way that we order raw materials, in order to keep testing costs down (each test can be about $150-350, depending on the chemical).

    And while I don't really oppose GMPs, I worry that the FDA would make them almost impossible for some small companies to comply with, and put them out of business. My company had to get out of the OTC drug business, because it was going to cost us hundreds of thousands of dollars to get in compliance, and it wasn't financially feasible. (The FDA Inspectors said it costs a company about $1 million to get in compliance for OTCs.) In our local area, at least three other OTC drug manufacturers (for personal care, like sunscreens and acne products) have gone out of business for the same reason just recently, because the FDA came down on all of us at the same time.

    It’s just frustrating to have to spend mountains of money on unnecessary measures just to appease an under-educated and untrusting public. And a loud-mouthed NGO (Obviously, I mean the EWG) that is out to get everyone, it seems. Sigh.

  • http://greenskincareblog.com/ Kristin Fraser Cotte

    Great points JCC. My company and Lisa's company have both participated in the FDA Voluntary Cosmetic Registration Program (VCRP) and went through registering our formulas. It does take quite a bit of time and neither of us have 800+ formulas to register. Personally, my company has stayed away from manufacturing some products our customers request such as moisturizers with SPF and acne treatments due to the same reasons you mention… we cannot afford to.You make some terrific points that I hope will be taken into consideration when it comes to drafting legislation. Otherwise we will ALL see huge increases in the cost of personal care and cosmetics from raw ingredients to finished product consumers pick up off the shelf. There needs to be an equal balance between understanding what's safe and frivolous, unnecessary spending.

  • Dene Godfrey

    I understand your frustration, JCC, but I have to ask why you think the public should trust you (ie. the industry)? Your company may be ethical, but not all are, and self-regulation is only as good as the least ethical company. I share your views (and then some!) on the EWG, but see this as a way to take a lot of the wind out of the EWG's sails. Much of what they claim is based on the currently perceived lack of regulation – they will have far less reason to complain once the regulations are tightened up. It works in the EU, despite the extra burden of paperwork. At least that burden is common to all manufacturers, so it should not place any one manufacturer at a competitive disadvantage. In fact, the larger you are (and your company sounds quite large) the more efficient this will be.

  • http://www.sterlingminerals.com/ Katherine

    Dene quick question, does the EU require pre market testing on all manufacturers finished products? I located where on ingredients no animal testing but the safety of the product falls on the manufacturer, but can't locate in what detail and isn't this costly if they do, so how do the small indie companies launch?

    Okay more than a quick question, but the information you provide would be great!

  • Dene Godfrey

    Katherine – even quick questions often require lengthy answers! lol

    I am by no means an expert on the regulatory side of the industry but, as far as I am aware, there is no requirement in the EU for “pre-market testing” per se. A Product Information Pack (PIP) must be provided to the authorities for each product placed on the market. This must contain detailed information on the ingredients and a toxicological assessment by a qualified person. I would also expect preservative efficacy test data to be included. It makes sense for all companies to ensure that their products are physically stable, but I am not sure if this information is a legal requirement in the EU. There is certainly NO animal testing whatsoever on either ingredients, or on finished products. If a product is likely to be used in a manner that may potentially cause skin irritation, most responsible manufacturers would conduct, or contract, human studies and provide the information in the PIP, I would guess, and any label claims would have to have supporting documentation included in the PIP. Maybe one of the PCT followers with a more detailed knowledge might like to come in on this one to help me out!

  • http://www.sterlingminerals.com/ Katherine

    Thanks Dene, do you know the cost of the qualified person to assess this?

  • Dene Godfrey

    Sorry Katherine, I don't, as I never get involved in this side of the industry. All I do know is that there is a huge variation in charges between the various consultants that offer this service in the UK, from comments I have picked up from formulators.

  • http://www.wingsets.com Annrn @ Wingsets

    Interestingly enough, I was following your discussion/debate with Stacy Malkan the other day on her blog and posted a comment about how in the world the FDA could possibly pull this off – out of all the comments on that blog article, mine says “comment awaiting moderation” – hmmmm. I must have hit a sore spot. Of course, you have to wonder what other comments she's disallowing. Here's what I said on July 28th at 8:57 pm:

    “Wonderful exchange of ideas and opinions. One of the issues that seems to be overlooked or purposely avoided is how in the world could the FDA even carry out something of this magnitude? I would imagine they’re thinking that themselves. They’re so understaffed now that our food supply is dangerous and people on Capital Hill now want to add on the burden of additional cosmetic regulations and testing? This is how the new health care reform got passed – it got slammed down our throats and that is what this bill (I can’t call is safe cosmetics bill – sorry) is looking like. Where do you think the money is going to come from? Yep, not only will it put me, a small manufacturer quickly out of business, but it will raise my taxes – again. Somewhere, somehow, our friends in government and their friends didn’t learn the basics principles of problem solving skills. Yes, there are issues and questions about the safety of ingredients, but this entire bill has not been thought through to the ramifications of implementing said bill. Thank you Lauren for your very well thought out discussion about some of these. Truthfully, at this point, I’m wondering if the “science” is academic at this juncture and someone needs to take a good close look at how this could possibly be implemented regardless of whether it’s right or wrong.”

  • Acne Treatments That Work

    This is cool! And so interested! Are u have more posts like this? Plese tell me, thanks

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