Should FDA Tighten Cosmetics Regulations?
The cosmetics industry has a solid reputation as far as safety, despite the fact products are not subject to the same scrutiny as drugs. Still, the Personal Care Products Council has asked the U.S. Food and Drug Administration to ratchet up the regulation of cosmetics sold in the U.S.
This comes at a time when a bill, the Safe Cosmetics Act of 2010, has been proposed to crack down on “toxins” in cosmetics. As Democrats proposed the bill, a video was released by the Campaign for Safe Cosmetics suggesting that the FDA doesn’t assess the safety record of the personal care products, which the group claims leads to “a minefield of toxic chemicals.” The PCPC reacted to the film, calling it an unscientific “ shockumentary–genre” video bearing no relationship to the “real” story of cosmetics.
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“It is repugnant to suggest that cosmetic companies would manufacture, and the U.S. Food and Drug Administration would allow them to market products that are dangerous or contain toxins that cause cancer or any other disease. It is absurd to suggest that the men and women in our industry would market products that could cause harm to themselves and their families,” said the PCPC. The association also bristled over the “cheap attack” on the philanthropic efforts of the industry to champion women’s causes.
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With this as a backdrop, the PCPC has put a plan in gear. “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, PCPC chief. “Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role.”
Even with high safety records, the beauty products don’t always go under the rigorous review of food or a drug. The PCPC is suggesting that manufacturers systematically submit product ingredient reports to the FDA, with lists of all ingredients used in each product, as well as registering all manufacturing facilities. In addition, the association wants manufacturers to report any serious, unexpected adverse effects experienced by consumers to the regulatory body. The Council is also proposing changes to how the safety profiles of ingredients are investigated and who is involved in this process. Now, the Cosmetics Ingredients Review Expert Panel reviews ingredients in beauty as far a safety. The PCPC is proposing that the FDA checks all the CIR safety assessments, including those already completed, to determine if these findings are correct. If the findings of the CIR Expert Panel are considered to be lacking, the FDA will have to determine under what conditions the ingredient can be used. The PCPC wants to zero in on trace contaminants which have emerged as a point of controversy of late.
The PCPC made the following statement about a proposed bill called the Safe Cosmetics Act of 2010:
“We appreciate the interest of Representatives Jan Schakowsky, Edward Markey and Tammy Baldwin in cosmetic regulation, and we share their desire to ensure that existing FDA regulatory oversight is enhanced to take into account evolving science, the continued growth of our industry, and the need to modernize the regulatory structure. Toward that end, our industry has lobbied for the last several years to obtain additional funding for FDA’s Office of Cosmetics and Colors. We also just last week proposed a number of new measures, including FDA ingredient reviews, that we believe would enhance FDA oversight and give the agency the information and flexibility it needs to continue to ensure consumer safety and safeguard public health.
“We are concerned that the Safe Cosmetics Act of 2010 as written is not based on credible and established scientific principles, would put an enormous if not impossible burden on FDA, and would create a mammoth new regulatory structure for cosmetics, parts of which would far exceed that of any other FDA-regulated product category including food or drugs. The measures the bill would mandate are likely un-achievable even with the addition of hundreds of additional FDA scientists and millions more in funding and would not make a meaningful contribution to product safety.
“We urge Congress to carefully consider our recently announced proposals to strengthen FDA cosmetics oversight, including FDA ingredient reviews, and encourage the passage of the FDA Globalization Act of 2009, sponsored by Rep. John Dingell, which also includes enhanced FDA regulations of cosmetics manufacturers. Our proposals and Rep. Dingell’s legislation constitute the strongest, most efficient and viable approach to modernizing the FDA regulation of cosmetics, increasing transparency, and enhancing existing consumer safeguards as science and technology evolve.
“Our plan includes the following five elements:
(1) Enhanced FDA Registration. It requires that personal care products manufacturers that 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 industrywide “Good Manufacturing Practices” requirements.
“Strong federal safety requirements already govern cosmetics and personal care products sold in the U.S. The safety of cosmetic and personal care products in the U.S. is overseen by the U.S. Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which requires that all cosmetics be substantiated for safety before they are marketed, contain no prohibited ingredients and that all labeling and packaging must be in compliance with U.S. regulations. Under the FD&C Act it is a crime to market an unsafe cosmetic product. Our proposed measures would further enhance the effectiveness of the FDA cosmetic regulatory structure.”
Does the industry need a tighter grip? Or, since these are beauty products and not something ingested, are the current safeguards enough? Is the video a cheap shot at the industry? Do we need this bill? Let us know your thoughts.
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A few words with Shakira as she prepares for her U.S. tour and the launch of her own fragrance from Puig.
WWDBeautyBiz: Why a fragrance and why now?
Shakira: I’ve always loved fragrance and how the notes of a fragrance are similar to writing music. I waited a long time to do it right and have found a company that allows me to have the fragrance of my dreams.
WWDBeautyBiz: Your fragrance will be launched at department, midtier and mass at the same time. Why?
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