Federal cosmetics legislation with the best chance at passing likely will be a compromise between the two reform bills currently pending on Capitol Hill, which likely will have to wait for the next Congress, according to Personal Care Products Council leadership.

The Personal Care Products Safety Act and Cosmetic Modernization Amendments of 2015, introduced last year in the Senate and House, respectively, "have many, many similarities," PCPC's Executive Vice President of Government Affairs John Hurson noted Feb. 29 at the trade group's annual meeting in Palm Beach, Fla., during the event's "Washington Report" session.

Both proposals would require companies to register their facilities with FDA, submit product/ingredient statements to the agency and report serious adverse events within 15 business days of receiving notice.

A more informed FDA would be better equipped to address perceived risks and react swiftly to safety issues in the marketplace. Mark Pollak, senior executive vice president and assistant secretary at PCPC, suggested during the session that having "a strong cop on the beat," in the form of an empowered FDA, "is the best way to maintain continued consumer confidence in our industry's products."

"I honestly don't think anything's going to happen this year because we're in the middle of an election," PCPC's John Hurson said, noting however that the next Congress will see renewed interest, legislation and potentially pivotal compromise efforts.

However, the two bills also are very different in other respects.

The PCPSA, supported by PCPC and a number of industry's biggest players, is generally the more demanding of the two bills in terms of its proposed industry requirements, and it grants FDA the added authority of being able to order product recalls. Further, FDA would be expected to develop a regulation establishing good manufacturing practices under the PCPSA, while the CMA would make that optional.

The PCPSA also would put ingredient-safety decisions in FDA's hands, tasking the agency with evaluating five cosmetic ingredients or non-functional constituents annually, whereas the CMA would rubber-stamp ingredients as safe if they have been favorably reviewed by the Cosmetic Ingredient Review Expert Panel or the Research Institute for Fragrance Materials' experts, among other scenarios.

CMA has backing from the Independent Cosmetic Manufacturers and Distributors trade group, which represents small businesses.

Importantly, the CMA lacks a user-fee structure to fund expanded FDA oversight activities. The PCPSA, on the other hand, proposes a tiered fee schedule that would generate $20.6m for FDA in its first year ([A#02150504002]).

Hurson doubts that either will pick up the momentum needed to pass in 2016. "I honestly don't think anything's going to happen this year because we're in the middle of an election," he said.

But interest in updating the cosmetics regulatory framework isn't going away, and legislation will be back in the next Congress, he said.

Hurson suggested that when that happens, the most likely prospect for passage will be a hybrid version of the PCPSA and CMA.

Preemption Will Be Key Issue

Negotiating a compromise between the two bills likely will focus heavily on an issue of high priority for big and small companies alike – federal preemption. Industry's goal is to foster legislation that would strengthen FDA responsibly while also providing companies with protection against state and local laws that conflict with or add to regulations imposed at the federal level, thereby achieving national uniformity.

However, the PCPSA and CMA differ in their proposed approaches to the issue and the measures of protection they seek.

Both would bar states from establishing new requirements concerning registration, good manufacturing practices and/or adverse-event reporting, but the latter also seeks to void related state requirements that already exist.

Similarly, the PCPSA has a lighter touch when it comes to preemption of state restrictions on cosmetic ingredient use. As drafted, it would prohibit states from establishing ingredient restrictions that conflict with final orders on ingredient use at the federal level, or that occur while FDA is in the process of reviewing a given ingredient. Existing state requirements pertaining to ingredient use would go largely unaffected ([A#02150427005]).

In contrast, the CMA would make ingredient restriction the exclusive prerogative of FDA and void any existing state ingredient mandates.

Overall, when it comes to ingredient regulation, the bills are similar enough in spirit, if not in their particulars.

"Our job is to try and get a national standard enacted on all these ingredients so we aren't fighting 50 different state regulations that make it impossible to formulate our products," Hurson said at the meeting.

"The Council's tried to be very mindful of the impact that any new legislation might have on smaller companies and take into account their views and concerns." – PCPC Senior Executive Vice President Mark Pollak

But the CMA's sweeping preemption provisions also seek to wipe out any state programs related to cosmetic labeling, which ostensibly would include cosmetic warning requirements under California's controversial Prop 65.

Preemption in the CMA likely is a major reason why it has no backing from NGOs, which haven't even deigned to comment on the proposed bill ([A#02151130010]). The PCPSA, on the other hand, has levels of support from the Environmental Working Group and the Campaign for Safe Cosmetics.

Small Business Not Out Of Mind

No personal-care company, whatever its size, would object to the preemption protections built into the draft CMA. The challenge is finding compromises for cosmetics legislation that don't lose NGO champions and, most importantly, congressional sponsors in the process.

Pollak acknowledged the concerns that small businesses have raised about legislative reform efforts and the PCPSA in particular.

"The Council's tried to be very mindful of this and the impact that any new legislation might have on smaller companies and take into account their views and concerns," he said, adding that the trade group sought to impress smaller companies' interests on sponsoring Sen. Dianne Feinstein, D-Calif., as the PCPSA came together.

Some larger players, including Mary Kay Inc., also oppose the PCPSA due to what they view as a weak preemption component in the bill ([A#02151130001]).

Pollak said all parties recognize the importance of addressing the concerns of small and medium-sized enterprises as the legislative process moves forward. According to the exec, PCPC will be meeting with CMA supporters in the near future "to discuss this common ground and a pragmatic legislative path forward."

At the same time, Pollak noted that industry must be realistic about the task at hand.

"Let's face it," he said, "compromises are always part of the legislative process, and no legislation that is ultimately enacted is going to make everyone happy."

Another House Bill On Tap?

The cosmetics industry potentially will have another cosmetics reform bill to consider this year.

In a March 1 interview at the conference, Hurson said Rep. Frank Pallone, D-N.J., and Rep. Leonard Lance, R-N.J., may look to introduce cosmetics legislation before the summer recess.

A rep from Pallone's office recently affirmed that the legislator is preparing a bill to update cosmetics regulations Also see "EWG Lobbyists Keep Eye On Prize: The Personal Care Products Safety Act" - HBW Insight, 26 February, 2016..

Hurson suggested that PCPC has served more of a consulting role in the legislation's development, compared with the trade group's heavy involvement in crafting the PCPSA, and has minimal insight into the bill's language.

According to the exec, PCPC has fielded numerous questions from Pallone's and Lance's offices regarding the differences and similarities of PCPSA and the CMA, and views their endeavor as an educational opportunity.

"That's essentially what we're doing – not pushing advocacy, we are simply answering questions," he said.

Pallone and Lance introduced separate cosmetics reform bills in 2012. The Lance bill garnered industry backing Also see "Council-Approved Cosmetics Safety Bill Launches" - HBW Insight, 23 April, 2012..

PCPC: Cosmetic Legislation A Long Shot In 2016, But Objectives Are Clear

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