PCPC Statement On Cosmetics Reform Legislation Hints At Potential Compromises
This article was originally published in The Rose Sheet
Executive Summary
The Personal Care Products Council outlines a list of “principles” that it believes should guide legislation to update cosmetics regulations. Many of its priorities could be seen as aligning more closely with reintroduced House legislation than the less industry-friendly Personal Care Products Safety Act in the previous Senate, signaling a possible change in strategic direction at PCPC under the new Administration.
The Personal Care Products Council continues to support legislative efforts to update cosmetics regulations in the US, committed to working “with all stakeholders” in the new Congress, according to a Jan. 18 statement.
It remains to be seen whether PCPC will adopt a new legislative strategy under the Trump Administration in line with the President’s anticipated pro-business, deregulation agenda, compared with the trade organization’s tack in the last session.
But the group’s statement may offer hints about a new direction under consideration that could unify big and small business and improve prospects for pushing reform legislation over the goal line.
The Personal Care Products Safety Act, sponsored by Sen. Dianne Feinstein, D-Calif., was the front-running proposal in the 114th Congress with backing from PCPC and a number of its biggest members, overshadowing the Cosmetic Modernization Amendments of 2015, introduced in the House by Rep. Pete Sessions, R-Texas, as an industry-friendlier alternative.
While the latter was championed by small business, led by the Independent Cosmetic Manufacturers and Distributors, NGOs rejected the proposal and large companies – outside of Mary Kay Inc. – seemed reluctant to put their weight behind it. (Also see "EWG’s Mary Kay Initiative For The PCPSA: Tactical Blitz Or Hail Mary?" - HBW Insight, 28 Jul, 2016.)
The Sessions bill was reintroduced Jan. 13 as the Safe Cosmetics Modernization Act, with new optimism at ICMAD regarding the legislation’s prospects. (Also see "House Cosmetics Bill Reintroduced; ICMAD Optimistic In New Political Climate" - HBW Insight, 13 Jan, 2017.)
Feinstein’s office told the Rose Sheet that the senator also intends to reintroduce the PCPSA this year.
It’s possible that PCPC is rethinking its stance on the ingredient safety assessment model delineated by the PCPSA in the last Congress, which not only omitted any reference to CIR but also proposed FDA review to a “reasonable certainty of no harm” standard, which differs from CIR’s approach and could be a high bar for industry to clear.
In its statement, PCPC does not address either bill specifically, but the group offers some insight into its mindset as the new Congress gets underway.
President and CEO Lezlee Westine maintains that cosmetics represent the safest product category regulated by FDA. However, “we also support modernizing cosmetics reform to ensure FDA has the appropriate resources and administrative authority to oversee our products for the 21st century,” she says.
Westine suggests that “well-crafted, science-based reforms will enhance our industry’s ability to innovate and further strengthen consumer confidence in the products they use and trust every day.”
The exec goes on to outline principles that PCPC believes should guide reform legislation. At the top of the list is national uniformity, or a strong national program for cosmetics that minimizes the burden on industry to conform to different requirements from one state to the next.
“The national regulatory program must preempt different or additional state and local laws that address cosmetics,” PCPC says.
The House SCMA’s preemption framework ostensibly is the surest means to this end. While the PCPSA would have provided some protection against conflicting mandates at the state level, the SCMA goes considerably further, proposing to bar states from regulating ingredient use and imposing or continuing labeling requirements (with implications under California’s Prop 65 that industry would no doubt embrace).
The PCPSA, in contrast, would not have affected state-level labeling requirements and would only have prohibited states from differently restricting use of cosmetic ingredients that FDA has assessed for safety, or from issuing rules on ingredients that the agency has scheduled for review.
CIR Could Get More Prominent Billing
There’s another key principle cited by PCPC that aligns more closely with the SCMA, namely that manufacturers should be required to “substantiate the safety of cosmetic products and ingredients, utilizing widely accepted scientific principles and established scientific ingredient reviews such as the Cosmetic Ingredient Review.”
The PCPSA of 2015 made no mention of CIR. Sessions’ SCMA, on the other hand, would recognize companies as compliant with safety substantiation requirements if they are using ingredients deemed safe by the CIR Expert Panel (or Research Institute for Fragrance Materials) at specified levels and conditions.
PCPC still lists FDA ingredient review as a component of high interest. At the same time, it notes that such a program should utilize “widely accepted scientific principles such as those reflected in the scientific reviews by the Cosmetic Ingredient Review Expert Panel.”
It’s possible that the trade group is rethinking its stance on the ingredient safety substantiation model delineated by the PCPSA in the last Congress, which not only omitted any reference to CIR but also proposed FDA review to a “reasonable certainty of no harm” standard, which differs from CIR’s approach and could be a more challenging bar for industry to clear. (Also see "PCPSA's 'No Harm' Standard Would Set High Bar For FDA Ingredient Review" - HBW Insight, 13 Apr, 2016.)
PCPC plans on providing a more detailed update on its legislative outlook for 2017 at the group’s annual meeting Feb. 26-March 1 in Palm Beach, Fla.
PCPC also suggests that legislation should include exemptions and other considerations for small businesses. ICMAD has maintained that Sessions’ SCMA provides for smaller players in ways that the PCPSA would not, ensuring their ability to stay afloat and compete against larger firms. (Also see "ICMAD Looks To Sway Legislators To Sessions Cosmetics Bill" - HBW Insight, 26 Oct, 2016.)
Additionally, PCPC believes legislation under consideration should “authorize” FDA to issue Good Manufacturing Practices for cosmetic products. Under the SCMA, FDA would be free to do that, while the PCPSA would have required the agency to draft cosmetic GMPs according to a specified rulemaking timeline.
Facility registration, ingredient statement submissions and mandatory serious adverse-event reporting – all proposed by both the SCMA and the previous session’s PCPSA – continue to be viewed by PCPC as reasonable requirements for cosmetics companies that would provide FDA with valuable information to support its regulatory mission.
PCPC says it plans on providing a more detailed update on its legislative outlook for 2017 at the group’s annual meeting Feb. 26-March 1 in Palm Beach, Fla.
Last year, the group predicted that negotiations in the 115th Congress could achieve the compromises needed to facilitate passage of cosmetics reform legislation. (Also see "PCPC: Cosmetic Legislation A Long Shot In 2016, But Objectives Are Clear" - HBW Insight, 2 Mar, 2016.)
For now, Westine states: “As different legislative approaches are considered, we look forward to working with members of Congress to create a more contemporary regulatory system for the cosmetics and personal-care sector, one that advances innovation, safety and consumer confidence in the context of these principles.”