Proposed U.S. legislation to ban animal-tested cosmetics potentially would have greater industry support if manufacturers felt more assured that alternative testing methods were acceptable to FDA.

Industry maintains that cosmetic animal testing is rarely conducted today except in instances where it's required by government bodies or necessary to evaluate new ingredients in the absence of viable alternative strategies.

In a July 23 interview, John Bailey, senior advisor for colors and cosmetics with EAS Consulting, said currently available alternative methods "by all appearances are valid, but it's just impossible to get FDA to say, 'Yes, we think it's valid.'"

Without a clearer position from the agency on use of alternative tests to substantiate cosmetic product safety, firms may be hesitant to renounce animal testing altogether in favor of alternative methods that may or may not have FDA's endorsement.

While the Federal Food, Drug and Cosmetics Act does not require that specific testing be conducted or submitted to FDA to demonstrate cosmetic product safety prior to market launch, companies are liable and "FDA has consistently advised manufacturers to use whatever testing is necessary to ensure the safety of their products and ingredients," according to the agency's website.

FDA says product safety can be adequately substantiated via:

reliance on already available toxicological test data on individual ingredients and on product formulations that are similar in composition to the particular cosmetic; and
performance of any additional toxicological and other tests that are appropriate in light of such existing data and information.

The agency's position offers companies flexibility, but with a proposed cosmetic animal-testing ban on the table before Congress, some industry members seek an assurance that alternative methods developed and validated – in many cases with the help of industry funding – would suffice to meet FDA's expectations for manufacturers.

The Humane Cosmetics Act, H.R. 2858, would prohibit use of animals to test cosmetics and cosmetic ingredients in the U.S. one year after its enactment, and bar companies from selling cosmetic products tested on animals two years later. Introduced June 23 with bipartisan support, the bill now has 52 cosponsors ([A#02150629009]).

Composed of five short sections and less than 400 words in total, the proposal has raised questions concerning its aim and scope.

"To me [the bill] seems awfully vague," said Bailey, who directed FDA's Office of Cosmetics and Colors for nearly a decade in the 1990s and early 2000s. "If it's going to be enacted, I think it may require some additional attention to ensure that it's clearly written and that it accomplishes what's intended."

No Defined U.S. Pathway For Regulatory Acceptance

Specifically, the bill could include provisions for regulatory acceptance of animal-testing alternatives, he suggested, noting that Europe has a "robust" process for alternatives acceptance that is lacking in the U.S.

FDA is one of 13 federal agencies that make up the Interagency Coordinating Committee on the Validation of Alternative Methods, which serves to advance the development, validation and acceptance of alternative test methods to refine, reduce and replace animal use.

There has been criticism leveled at ICCVAM, part of the National Toxicology Program, for what some stakeholders perceive as underperformance compared with the similarly tasked European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM).

ICCVAM representatives have been quick to point out the differences between the two in terms of size and funding, championing ICCVAM's work particularly in light of its limited resources Also see "NICEATM Readies 5-Year Plan For Congress; Director Stokes Discusses" - HBW Insight, 17 September, 2007..

There also is less of a defined pathway in the U.S. for validated alternatives to gain regulatory acceptance. In the EU, the Cosmetics Regulation spells out a protocol for advancing non-animal alternative methods that are validated at community level or approved as being scientifically validated by ECVAM.

"After consulting the [Scientific Committee on Consumer Safety] as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognized as being applicable to such ingredients," the regulation states.

ECVAM also works to promote adoption of alternative methods by the Organization for Economic Cooperation and Development as OECD test guidelines, which represent "internationally agreed test methods used by government, industry and independent laboratories," according to the international forum's website.

On the U.S. side, FDA participates in the International Cooperation on Cosmetics Regulation, which has addressed animal testing and viable alternatives in its work toward aligning regulatory approaches and lowering trade barriers in the participants' markets.

At ICCR's 2013 meeting, members – regulators from the U.S., the EU, Japan and Canada – accepted a report listing validated alternative methods that have associated OECD test guidelines Also see "ICCR Addresses Lead Limit, Endocrine Disruptors At 7th Meeting" - HBW Insight, 29 July, 2013.. However, FDA has not formally embraced the tests as appropriate for use in cosmetic manufacturers' safety substantiation efforts.

"I'm not sure the ball gets handed off [from ICCVAM] to FDA and FDA then gives it a stamp of approval or endorsement, and therefore there's a great deal of uncertainty and confusion on the part of companies," Bailey said. The Humane Cosmetics Act "perhaps would be better if it said FDA should more proactively participate in the development and regulatory acceptance of alternative methods."

More Active FDA Could Help Mitigate Manufacturer Liability

In the current regulatory and political landscape, most companies don't want to do animal testing, and given a choice would rather use an internationally validated method, according to Bailey. But uncertainty as to FDA's position on alternatives gives companies pause, he said.

Formerly chief scientist at the Personal Care Products Council, Bailey has been emphasizing for years that regulatory acceptance of alternative methods is as important as their validation.

At ICCVAM's 10-year anniversary symposium in 2008, he called for more active communication between the committee and FDA, noting that "at the end of the day it's important to keep in mind we're enabling regulatory decision-making, and that's what this is all about."

In the July 23 interview, he suggested that another option would be to give ICCVAM the authority for declaring alternative tests acceptable for industry use in the context of safety substantiation, rather than merely providing recommendations.

Even if procedural changes weren't legislated, a more vocal FDA as to the suitability of alternative methods for addressing targeted safety endpoints would benefit industry, as the agency "certainly has a huge influence that carries a lot of weight in the manufacturing world," Bailey said.

And having FDA or another agency's endorsement could help protect companies in the event of adverse health reactions in the postmarket, he added, citing concern about the liability risks to which companies are exposed without animal tests to verify safety.

PCPC's John Hurson, executive VP for government affairs, expressed similar concerns in a July 1 statement addressing legislative movement in the U.S. to ban cosmetic animal testing.

"Our industry has long advocated for government recognition and acceptance of alternative testing methods. Unfortunately, the [FDA] has not recognized many alternative tests. We hope removing this obstacle will emerge as a key provision of H.R. 2858," he said.

The exec noted that industry has invested "hundreds of millions of dollars over the past several decades to develop scientifically valid alternative safety testing methods."

Bailey also pointed to inconsistencies in U.S. and European regulations as a factor compounding challenges for industry when adapting to animal-testing prohibitions.

For example, certain OTC drugs that may require safety substantiation via animal testing in the U.S. – such as sunscreen and toothpaste – are considered cosmetics under European regulations, and thus are subject to the EU's marketing ban on animal-tested cosmetics implemented fully in 2013.

Humane Cosmetics Act Lacks FDA Assurance Regarding Alternative Methods

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