Legislative proposals that would require cosmetics companies to report adverse events to FDA and register their manufacturing facilities were the focus of discussion among panelists testifying on Capitol Hill May 14 on a draft version of the Food and Drug Administration Globalization Act of 2008.

The Energy and Commerce Committee's Subcommittee on Health convened for its third hearing on the bill and specifically addressed provisions relating to cosmetics, which include a requirement to register any facility engaged in manufacturing, processing, packaging or holding cosmetics in the U.S. or for import into the U.S.

The legislation, spearheaded by Committee Chairman John Dingell, D-Mich., would require the HHS secretary to establish an adverse event registry and good manufacturing practices for the cosmetics industry within 18 months of enactment. Companies would be required to register their facilities and pay a $2,000 registration fee within the first six months (¹ Also see "Beauty Firms Face Adverse Event Reporting, GMP Requirements Under Bill" - HBW Insight, 21 April, 2008., p. 4).

The adverse event reporting (AER) and registration requirements were welcomed by Jane Houlihan, VP-research at the Environmental Working Group, who held that the current regulatory scheme does not provide FDA with enough information about the types of products on the market or the risks they may pose.

Houlihan was critical of the industry-funded but independent Cosmetic Ingredient Review process in which an expert panel of physicians and scientists assesses safety data and makes usage recommendations for cosmetic ingredients.

"One shortcoming of the CIR process is that it is dominated by dermatologists who are primarily interested in allergic reactions and irritations in the ingredients, and that makes a huge wealth of impacts that don't get proper consideration from the panel," Houlihan said.

This "is one reason, in addition to many others, that we feel the authority for assessing ingredients needs to belong with the FDA."

Houlihan cited the voluntary AER system currently in place for the cosmetics industry as one of seven "major gaps" in cosmetic safety. She believes the bill's provisions requiring an AER system and registration of facilities would be "a great first step to get FDA that very basic data it needs to determine the range of unsafe products that might be on the market."

Pamela Bailey, president and CEO of the Personal Care Products Council, maintained that "adverse events are very rare with [personal-care] products because they are inherently safe."

She noted that some cosmetics containing active ingredients - such as antiperspirants, toothpastes and sunscreens -are regulated by FDA as over-the-counter drugs; accordingly, adverse event reactions associated with their use must be reported to FDA's drug office.

Adverse events stemming from use of other cosmetic products do not have to be reported. Voluntary reporting practices in the industry produce about 200 AERs every year, Bailey said.

Rep. Jane Schakowsky, D-Ill., was skeptical. "Do you believe that's really the extent of adverse effects?" she asked. "I really would caution against using that number. ... Even when there are adverse events, so few people end up reporting at all."

Houlihan agreed, maintaining the number was "an absolute understatement."

"The companies that experience the most adverse events from their products may be disinclined to report voluntarily. Until we have mandatory reporting, we won't see the full scope," she said.

"For example, fragrance is considered one of the top allergens in the world, and we're certainly not seeing all allergic reactions to fragrance recorded to FDA's database."

Parabens, Phthalates And Long-Term Safety

Another "major gap" in cosmetic safety is evident in that personal-care goods may be the "primary exposure route for many chemicals that raise significant health concerns," Houlihan said.

In written testimony, she points to reports from the Centers for Disease Control and Prevention (CDC) that have documented the presence of ingredients from personal-care products in the tissues and blood of most Americans, including children. "Many of these chemicals present serious health risks, and most have not been evaluated by the CIR or any authoritative body," she asserts.

Such chemicals include parabens found in breast tumor tissue and urine, as well as fragrance components like musk xylene found in human fat and breast milk. Sixty percent of all products contain estrogenic chemicals that can cause hormone problems, according to Houlihan.

The CIR expert panel reviewed research on breast cancer cells in June 2006 and determined parabens safe as used in cosmetic products (² Also see "Parabens “Safe As Used” In Cosmetics, CIR Concludes" - HBW Insight, 19 June, 2006., p. 7).

Also, Houlihan said, industrial plasiticizers called phthalates that are used in products like shampoos have been found in urine samples and linked to birth defects in baby boys, reproductive problems in men, abdominal obesity and thyroid problems.

Phthalates were reaffirmed as safe by CIR in September 2005 after the panel reviewed safety data related to the substances' effect on male reproductive development (³ Also see "CIR Requests Parabens Exposure Data, Reaffirms Phthalates Safety" - HBW Insight, 19 September, 2005., p. 3).

In the course of the discussion, Rep. Schakowsky asked whether any studies have been conducted to determine the potential effects of a lifetime's use of personal-care products.

Bailey replied that in substantiating the safety of their products prior to marketing, personal-care firms "take into account the knowledge that these products are used in combination with other products and may be used over a lifetime."

Battle Of The Bans

Rep. Schakowsky noted that the European Union has prohibited use of 11,000 ingredients due to concerns that they cause reproductive problems, birth defects and other health conditions. In comparison, however, only nine chemicals are banned from use in the U.S.

In accounting for the difference, Bailey said the list of chemicals banned in the EU includes many ingredients that are not in use in cosmetics in either the U.S. or Europe. She added that in both the U.S. and the EU, a company "must substantiate the safety of its product before it hits the market."

"If an ingredient has been proven ... to cause cancer or be a toxin or cannot be substantiated for safety, it cannot be included in a finished product," she said. "There is a substantial body of science in the U.S. behind every ingredient that is included in a finished product."

Houlihan pointed out that registration of cosmetic ingredients and manufacturing facilities with FDA is only voluntary. "Yes, there is a requirement in the law that ingredients and products be substantiated for safety, but there is no guidance that FDA has provided to industry for what that means," she said.

"We see one in five products contain ingredients with chemicals linked to cancer. ... Companies are making very different decisions about what is safe enough to sell because they don't have FDA guidance on the issue."

Houlihan also expressed concern that FDA does not know the number of cosmetic ingredients on the market. The agency has estimated the total at 12,500 cosmetic ingredients, while cosmetic industry officials claim the number is between 2,000 and 4,000 and EWG contends it is approximately 8,800.

If FDA's estimate is on target, only about 11 percent (1,400) of the 12,500 ingredients currently used in formulating personal-care items have been subjected to the CIR process, Houlihan said.

The pace at which ingredients are reviewed could be improved by requiring pre-market safety testing of cosmetic products before they reach the market, she suggested. "That testing could be done by manufacturers, it should be public [and] it should be reviewed by FDA," she said.

Bailey explained that the 12,500 ingredient figure reflects the number of discreet ingredient names included in the cosmetic dictionary published by the Council. Only 5,500 of those ingredients are commonly used in U.S. products, she said, and 3,000 are ingredients such as botanicals that do not reach the threshold of risk to warrant review.

Of the remaining 2,500 ingredients, Bailey said, 2,000 of the higher-risk chemicals will be reviewed by CIR by the end of the year.

"So that would leave some 500 that would be of lower risk, and CIR, as I understand, is now reviewing [what] the best way would be to review those ingredients," the CEO said.

Bailey suggested that another factor contributing to confusion about the number of ingredients used in personal care products in the U.S. is "the database problem that FDA has." The agency recorded its files on cosmetic ingredients on paper until 2005 and is still working to transfer the information to an electronic system, she said.

The final "major gap" in cosmetic safety, according to Houlihan, is that a consumer's "right to know" may be subverted by misleading labeling. For example, marketers can use the words "natural" and "hypoallergenic" to mean almost anything, she said.

Despite the concerns raised during the hearing, some committee members questioned whether cosmetics should be included in the bill at all. Rep. Michael C. Burgess, D-Tex., noted that while this year he has attended "hearing after hearing with regard to the resources, or lack thereof, of the FDA," he cannot recall any prior discussion or investigation of the cosmetics industry.

"I am sure that there are some reforms that need to be made in the Office of Cosmetics and Colors, but I would urge this committee to move methodically and deliberately; we shouldn't just be passing legislation because we happen to be here," he said.

Burgess and several other committee members also questioned whether the appropriate approach to reforming FDA would be through a bill like the Globalization Act that provides more authority or through the appropriations process.

Bailey was confident that additional funding would be the best approach. She noted that in 1974, FDA's budget for cosmetics was $2.7 million, which would translate to $14.5 million today.

"In reality, [the budget] was $3.5 million last year before we successfully lobbied for an additional $1 million," she said. "We are going to continue those efforts and urge the committee to support additional appropriations."

- Louisa Tavlas (L.Tavlas@elsevier.com)

House Subcommittee Hearing Explores Alleged Gaps In Cosmetic Safety

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