Nail polish ingredient triphenyl phosphate (TPHP) has come under fire in a new study from the Environmental Working Group and Duke University, prompting Rep. Frank Pallone, D-N.J., to announce his intent to draft legislation for strengthening cosmetics regulations in the US.

Meanwhile, the Personal Care Products Council characterizes the study as "speculative, misleading" and lacking a foundation in sound science, maintaining that consumers who use nail polish should remain "confident" in the products' safety.

The biomonitoring study tested the urine of 26 women before and 10 to 14 hours after they painted their nails for diphenyl phosphate, a chemical created by the body when it metabolizes TPHP, a suspected endocrine disruptor and reprotoxin. Higher levels of DPHP were detected after polish was applied, which "represent[s] compelling evidence that TPHP … enters the human body via nail polish," the researchers say.

"Popular cosmetics and other personal-care products continue to be largely unregulated, despite the fact that they can be found in almost every drugstore and nail salon across the country. Today's report is another reminder that reforming our country’s cosmetics law is long overdue." – Rep. Frank Pallone, D-N.J.

TPHP is listed as an ingredient in more than 1,500 nail polishes, based on data from EWG's Skin Deep database, though researchers suggest its use is not disclosed on all product labels.

According to the PCPC's CosmeticsInfo.org, TPHP is used in very low concentrations, "primarily to increase the flexibility and durability of nail polish products and improve adhesion of the product to the nail plate."

Beth Lange, chief scientist at the Personal Care Products Council, says in an Oct. 19 statement that TPHP has been used safely in multiple industries worldwide, with extensive review by scientific experts – including evaluation of reproductive effects and fetal development – indicating that it does not pose human health concerns.

The Cosmetic Ingredient Review Expert Panel has not assessed TPHP's safety to date, but could prioritize the ingredient's review in response to the study and public concern.

Lange notes that federal cosmetics regulations require ingredients to be safe for their intended application, as demonstrated through appropriate in vitro, animal and/or human testing, and "the nation’s makers of nail polish take great pride in their products’ long history of safe use."

However, EWG and other NGOs have taken issue with the oversight framework for cosmetics, which places safety substantiation largely in manufacturers' hands, leaving FDA to enforce requirements, with its limited authority, on a postmarket basis.

In an Oct. 19 release, Pallone says he intends to work with his colleagues to develop bipartisan legislation in this Congress "that will finally allow FDA to ensure that cosmetics used every single day are not harmful."

He continues: "Every day, consumers carefully decide which brands to buy and which products their families use – they deserve to know that they are making safe choices.”

PCPC Rejects Long-Term TPHP Exposure Theory

EWG's study, titled "Nail polish as a source of exposure to triphenyl phosphate," has been accepted for publication in the January 2016 issue of the journal Environment International.

Led by Emma Mendelsohn, formerly of Duke University's Nicholas School of the Environment and now an environmental scientist at Integral Consulting, the study tested 10 polishes for the presence of TPHP, finding it in eight. Two of the eight did not list TPHP as an ingredient.

Researchers "decided not to make public the names of those two polishes or the six others that contained TPHP and disclosed it because the lab tested only 10 samples, not the manufacturers’ entire nail-product lines," according to an EWG analysis of the study. In addition, "the Duke team anticipated that some or all the manufacturers might update their product labels to disclose their TPHP use before the study could be published."

Concentrations of TPHP in the polishes ranged from 0.49% to 1.68%, with clear polishes generally containing more TPHP.

The study also included a biomonitoring component, with the urine of 26 women assessed before and after painting their nails.

Twenty-four of the 26 women had elevated levels of diphenyl phosphate, or DPHP, which forms when the body metabolizes TPHP, in their urine two to six hours after painting their nails. After 10 to 14 hours, DPHP levels in all of the subjects increased nearly sevenfold, "suggesting that more of the TPHP had entered their bodies and been metabolized into DPHP," according to EWG.

When participants wore gloves and applied polish to synthetic nails on the gloves, their urinary levels of DPHP diminished significantly, signaling that the route of exposure is likely dermal and not through inhalation.

EWG recognizes that other research has shown that most molecules are generally not absorbed through nails. But the Duke researchers "theorized that other polish ingredients such as solvents rendered nails more absorbent" and additionally "suspected that the network of capillaries in the cuticle that surrounds the nail might play a role in carrying the chemical into the body."

The NGO suggests that the study's results show that nail polish can be a contributor to short-term TPHP exposure.

"For frequent users of nail polish, exposure to TPHP may be a long-term hazard," EWG conjectures.

PCPC's Lange takes issue with the group's allegations, particularly the idea that nail polish may be a significant contributor to long-term TPHP exposure.

She points to EWG statements acknowledging that TPHP's use as a fire retardant in foam furniture and similar applications could be sources of exposure for consumers. Further, other biomonitoring studies have shown that TPHP is found in both men and women, she says, a finding that "contradicts" EWG’s conclusion that the ingredient's use in nail polish is an important contributor to TPHP exposure.

“Clearly, there is no substance behind these alarming claims," says Lange. "The makers of nail polish stand behind their products and take pride in providing Americans with access to a wide variety of safe, high-quality and innovative products they trust and enjoy.”

The exec does not directly address the timeline component of EWG's study, but maintains that "TPHP is rapidly transformed in the body to the marker compound measured in their study (DPHP) and then rapidly eliminated from the body," which ensures that at least infrequent use of nail polishes poses no long-term exposure risk.

However, EWG cites an August 2014 survey from nail industry publication Nails Magazine, which found that 97% of American girls ages 12 to 14 used nail products, and 14% of all teens and tweens use nail products on a daily basis.

EWG and Duke investigators speculate on the rationale behind use of TPHP in nail polish.

“It is possible that TPHP is now being used in nail polish as a replacement for phthalates, which also have endocrine-disrupting properties and are toxic to the reproductive system,” says Heather Stapleton, associate professor at Duke University. “However, it’s not clear that TPHP is the better alternative. There is growing evidence suggesting that TPHP may affect hormone regulation, metabolism, reproduction and development.”

EWG has started a consumer petition to urge companies to discontinue use of TPHP in cosmetic products, and advises consumers to utilize its Skin Deep database to find nail polishes without the ingredient.

Revival Of Cosmetics Safety Enhancement Act?

In his response to the study, Pallone states: "Popular cosmetics and other personal-care products continue to be largely unregulated, despite the fact that they can be found in almost every drugstore and nail salon across the country."

From the congressman's point of view, FDA lacks the authority and resources to review and approve cosmetic chemicals "or even regulate cosmetic products until after they have already reached the marketplace." He adds, “Today’s report is another reminder that reforming our country’s cosmetics law is long overdue."

Pallone holds an influential position as ranking member of the Energy and Commerce Committee. Any bill impacting FDA's regulation of the cosmetics industry likely would need to pass through the committee before it could advance.

Pallone has had a hand before in developing legislative proposals for the cosmetics sector. In 2012, he introduced the Cosmetics Safety Enhancement Act of 2012 with now-retired House democrat John Dingell of Michigan Also see "Cosmetics Legislative Plans Vie In Congress" - HBW Insight, 2 April, 2012..

The draft bill was modeled after the Food Safety Modernization Act and would have required manufacturers to register facilities with FDA and pay associated fees to support the agency's regulatory activities.

Under the proposed framework, firms also would have been obligated to maintain safety files for their products and provide FDA with annual listings of products they market and detailed ingredient information while reporting any adverse-events related to their offerings' use.

Meanwhile, the bill sought to have FDA establish Good Manufacturing Practices for mandatory industry compliance and would have authorized the agency to mandate product recalls.

Similar in many respects to the Personal Care Products Safety Act under consideration in the current Congress, Pallone's proposal did not garner any additional sponsors and did not earn the support of industry or special interest groups.

The Personal Care Products Safety Act, introduced with bipartisan backing in the Senate in April, has picked up a few cosponsors since its debut, but neither industry nor the NGO community has embraced the legislation wholeheartedly.

Among industry's concerns are provisions that would impose significant burdens, particularly on smaller companies, without effectively ensuring national uniformity amid a growing patchwork of state legislation Also see "Feinstein Bill Lacks ‘Crucial’ National Uniformity Assurance – ICMAD" - HBW Insight, 23 April, 2015..

NGOs are encouraged by the bill but still critical of what they view as inadequate safety standards and a need for more robust FDA ingredient-review mechanisms ([A#02150427008]).

Pallone's Cosmetics Safety Enhancement Act did not propose making responsible persons at cosmetics firms attest to the safety of products, which would be required under the Personal Care Products Safety Act, raising potential liability concerns from industry's perspective.

That could help to garner industry support if his forthcoming draft is consistent along those lines, though his previous cosmetics oversight bill also did not seek to address the national uniformity issue.

Given the comparison between his 2012 legislation and the Personal Care Products Safety Act currently in play in the Senate, Pallone could take the lead in introducing the latter instrument on the House side rather than relaunching his own legislative plan.

Pallone holds an influential position as ranking member of the Energy and Commerce Committee. Any bill impacting FDA's regulation of the cosmetics industry likely would need to pass through the committee before it could advance.

The congressman also has been active in legislative movement to regulate use of plastic microbeads in cosmetics, introducing the Microbead-Free Waters Act of 2015 in March with Rep. Fred Upton, R-Mich. Also see "Regulatory News In Brief: House Microbeads Bill; Oregon Eyes Children’s Cosmetics; More" - HBW Insight, 9 March, 2015..

That bill – which has 36 co-sponsors and a Senate counterpart, but currently is stalled in committee – would prohibit the manufacture and sale of cosmetics and personal-care products containing synthetic plastic microbeads beginning Jan. 1, 2018.

Rep. Pallone Readying Cosmetics Bill Following EWG Nail Ingredient Study

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