Personal Care Products Council Urges Congress To Modernize Cosmetics Laws; Strengthen FDA Regulatory Authority

Citing the need to enhance existing protections for American consumers, the nation’s cosmetic and personal care products industry today urged Congress to support legislation to modernize existing regulations, provide greater transparency and equip the U.S. Food and Drug Administration (FDA) with an oversight framework for the 21st century.

“While cosmetic products remain among the safest in commerce, the existing system for regulating our industry is overdue for a makeover,” said Lezlee Westine, President and CEO of the Personal Care Products Council (the Council), which for several years has been advocating for reform.  “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.”

The Council is seeking to create formal processes for FDA to review ingredients for safety at the request of all public and stakeholder groups and to review all safety determinations made by the independent Cosmetic Ingredient Review (CIR) Expert Panel.  CIR was established in 1976 with the support of the FDA and the Consumer Federation of America. While companies do assess the safety of products and ingredients prior to marketing, creating these new processes will provide the added transparency that consumers are seeking.

The Council’s science and legal experts advocated for these and other changes at today’s hearing of the Health Subcommittee of the House Committee on Energy and Commerce.  

“The basic statutory provisions that govern FDA regulatory authority over cosmetics today were put in place in 1938,” testified Peter Barton Hutt, the former chief counsel for the FDA and longtime Harvard law lecturer on the current legal and regulatory system.  “Since then, FDA and the cosmetic industry have worked together to keep pace with changing technology by the promulgation of creative regulations and the establishment of new regulatory programs.”

Despite the fact the FDA has repeatedly stated that cosmetics are the safest products they regulate, Hutt said that the increasing global nature of the industry, a desire for more transparency from consumers and other factors suggest “it is time to bring FDA’s statutory authority up to date.”

Dr. Halyna Breslawec, the Council’s chief scientist agreed with Hutt, recommending that FDA incorporate the CIR findings into its product regulatory process.  

“FDA should formally recognize the findings of the CIR Expert Panel as part of the regulatory regime for cosmetics,” Breslawec said. “Science and safety are the foundation of the cosmetics industry and collectively we must remain steadfast in our commitment to safety.  Acceptance and reliance on CIR findings will reaffirm that commitment.”

Breslawec urged Congress to ensure a workable system that allows small businesses to thrive, especially those created by women.

“A regulatory structure should be comprehensive and robust, but should not be so overly burdensome that it stifles or prevents companies from delivering innovative products to the marketplace,” she testified. “The cosmetics industry plays a unique role in the lives of American women, and not just as women consumers. We are dedicated to ensuring women have advantages and opportunities for both their professional and personal success.”

Through its experts, the Council offered the following specific provisions for Congress to consider which would bolster FDA’s oversight:

  1.  Enacting into law the existing FDA voluntary programs for registration of manufacturing establishments and listing of cosmetic products and their ingredients.
  2.  Requiring submission of reports on adverse reactions that are serious and unexpected.
  3.  Mandating FDA regulations establishing Good Manufacturing Practices (GMPs) for cosmetics.
  4.  Establishing programs to require FDA to review and determine the safety of cosmetic ingredients and constituents along with strong FDA enforcement.
  5.  Requiring FDA review of all CIR determinations on cosmetic ingredient safety and either accept or reject those determinations.
  6.  FDA establishment of a national cosmetic regulatory databank for use by other state authorities and the public.
  7.  An unambiguous Congressional determination that, as modernized, the revised statute will apply uniformly across the country.

“Our industry supports these important reforms and encourages Congress to act on them,” said Lezlee Westine, Council President and CEO. “We are requesting comprehensive, mandatory regulation and our rationale for that is simple: it is in the best interest of regulators, manufacturers and consumers – all of whom will greatly benefit for years to come.”

For the complete text of the Council’s expert testimony, please click http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9394.

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Cosmetic Ingredient Review (CIR) Expert Panel Reaffirms the Safety of Parabens Used in Cosmetics and Personal Care Products- Preservatives Vital to Product Integrity

The Cosmetic Ingredient Review (CIR), an independent panel of scientific and medical experts, reaffirmed this week at their public meeting that parabens, a family of preservatives used in cosmetics and personal care products, are safe.

“The cosmetic industry formally requested that CIR re-examine the safety of parabens as they are used in cosmetics, and we are gratified that the panel has done so and confirmed the safety of these ingredients,” said Halyna Breslawec, chief scientist for the Personal Care Products Council (the Council).

In December 2011, the Council requested that CIR reexamine its review of parabens in light of two recent opinions by the European Commission’s Scientific Committee on Consumer Safety (SCCS).  SCCS concluded, among other things, that some parabens are safe at current use levels but recommended that levels of others used be reduced.

At its March 5-6, 2012 meeting, CIR carefully reviewed the SCCS opinions and concluded that there were little additional new data concerning parabens.  The panel voted to reaffirm its earlier conclusions that parabens are safe for use as cosmetic ingredients. CIR initially reviewed the safety of parabens in 1984, and since then has continually examined newly available data related to the safety of these ingredients. Its last comprehensive report was published in 2008.

A summary of the CIR Expert Panel findings for the March 5-6 meeting will be posted on the CIR Web site (http://www.cir-safety.org) within a few weeks.

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Personal Care Products Council Reaffirms Safety of Cosmetics, Says Silent Spring Study Flawed and Not Reflective of Sound Science

The Personal Care Products Council said a study by the Silent Spring Institute that claims to have found “harmful chemicals” in a wide range of household products again demonstrates the group’s lack of understanding of safety science.  Equating the mere presence of certain chemicals in products with potential harm is wrong and needlessly scares consumers about products formulated with ingredients that have a wealth of scientific data to support their safety.

The study, titled “Endocrine Disruptors and Asthma-Associated Chemicals in Consumer Products,” will be published today in the journal, Environmental Health Perspectives.  

“The results of this study are not new or surprising and should not alarm consumers.  The mere presence of those chemicals identified does not mean they are harmful,” said Linda Loretz, PhD, senior scientist and director of safety and regulatory toxicology for the Council.  “Cosmetics and personal care products companies formulate their products to ensure that the amounts of ingredients used are within safety limits that have been established by scientific and regulatory bodies around the world.”

The report contains several key flaws with the methodology, including: 1) no criteria for the list of chemicals identified as “endocrine disruptors” or “asthma-associated” is provided in the study; 2) products were inappropriately tested together in batches, so no conclusions can be drawn about the results for any specific product; and 3) the analysis also provides no consideration for the potency, dose or exposure levels of the ingredients.

Analysis of the study

“Endocrine disruption”:  Chemicals with endocrine activity are abundant in nature, and present in much of the food we eat such as soy, cabbage, cereals, pomegranates, and coffee.  The study’s findings that allege “endocrine disruption” are not based on relevant science and ignore the fact that these ingredients are used at levels found to be safe by scientific and regulatory bodies around the world.

“Asthma-associated”:  The authors do not define what is meant by “chemicals linked to asthma” and “asthma-associated chemicals.”  Instead, the study includes compounds that are reported to have effects in occupational settings, which have no relevance to the significantly lower exposures in cosmetics and personal care products.

Diethylphthalate (DEP):  The study itself notes, “DEP is not generally characterized as an endocrine active compound,” and cites numerous references in support of its lack of endocrine activity, yet the authors persisted in listing it among “endocrine disruptors.”

Sunscreens:  Sunscreens were cited as endocrine disruptors based on the results of screening assays with no proven relevance for humans.  High levels in products are cited, without acknowledgment that these are the FDA-approved, normal levels for use in sun protection products.  Despite the body of scientific evidence and the determination by regulatory authorities and professional medical societies that sunscreens play a critical role in protecting consumers from UV radiation and premature aging, the authors still assert that sunscreens are harmful to humans.   

Mixtures:  The finding of multiple fragrance materials in a fragranced product is considered a “mixture,” seems to overlook the fact that fragrances are mixtures by definition.  The paper reports as a significant finding that certain fragrance compounds are often detected together in the same product. Based upon how fragrances are developed, these are totally expected findings and raise no concern.

Consumer Safety Benefits of Personal Care Products Ingredients Reviewed

The ingredients examined in the Silent Spring study are important to the safety and functionality of personal care products. For example, parabens, which function as preservatives, are highly effective in preventing the growth of pathogenic fungi and bacteria, ensuring both the safety and quality of personal care products.

UV filters and antimicrobials are critical to maintaining public health as well. UV filters are used to absorb or reflect the UV rays and to protect against skin cancer and premature aging.

For more information on cosmetics 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.

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