Sen. Feinstein’s Cosmetics Safety Bill Launches With GOP Cosponsor

The Personal Care Products Safety Act would preempt duplicative state-level requirements for ingredient use and manufacturer responsibilities, addressing what has become one of the foremost banes of industry in recent years, while increasing FDA’s authority over the sector and giving it new responsibilities with regard to ingredient safety review. Additional compliance requirements for industry could prove challenging, but the positive PR likely to result from the legislation could help soften the blow.

The Personal Care Products Safety Act, introduced April 20 by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, would require cosmetics firms to comply with regulations establishing Good Manufacturing Practices, report serious adverse events to FDA and register with the agency annually, providing information on ingredients used in their products.

User fees to support FDA’s “cosmetic safety activities” would be collected from registrants on a tiered scale based on annual sales beginning in fiscal 2016, exempting small businesses that qualify under specified terms. The bill targets more than $20 million in user fees for fiscal 2016.

The Personal Care Products Safety Act also would increase FDA’s authority, empowering the agency to order recalls of cosmetics that pose hazards to consumer safety.

Further, the bill proposes that FDA be required to evaluate at least five cosmetic ingredients or nonfunctional constituents – e.g., trace contaminants – annually for safety.

The legislation identifies three preservatives – diazolidinyl urea, propyl paraben and quaternium-15 – as well as methylene glycol/methanediol/formaldehyde, as used in hair-straightening products, and color additive lead acetate, used in hair dyes, as the first set of chemicals that FDA would be directed to review.

The agency would establish a Cosmetics Safety Advisory Committee under the act to support its review activities and provide independent expert input.

While the bill’s proposed measures could pose challenges for industry, particularly small businesses, the legislation also could mean positive PR for the cosmetics industry, boosting the credibility of industry’s ingredient safety assurances and helping to defuse NGO campaigns that in recent years have painted the sector as an unregulated “wild west.”

Perhaps most importantly, the bill would preempt state-level legislation that conflicts with the proposed federal requirements, helping to ensure regulatory uniformity and a level playing field across the U.S.

In a release announcing the bill’s introduction, Sen. Collins notes that “by improving FDA oversight of the ingredients in cosmetics and personal-care products, this legislation aims to protect consumers while also providing regulatory certainty for manufacturers, enabling them to plan for the future.”

The legislation has been characterized by the Personal Care Products Council as a “compromise bill” developed through negotiations with Feinstein’s office and NGO stakeholders. The senators’ release cites the Environmental Working Group among consumer groups that support the proposal.

At its Annual Meeting in February, PCPC noted the difficulty of building consensus across industry when it comes to legislative proposals, but said its members’ voices were heard and represented in its advocacy work (Also see "GMPs, User Fees, Federal Preemption Provisions In ‘Compromise’ Feinstein Bill – PCPC" - HBW Insight, 26 Feb, 2015.).

The draft bill closely matches PCPC’s expectations for the legislation as outlined at the event.

PCPC President and CEO Lezlee Westine notes in a same-day statement: “For more than five years, the Personal Care Products Council and its member companies have worked collaboratively with members of Congress seeking to reform federal regulatory oversight for cosmetics and personal-care products. We support the creation of a national standard that maintains the continued safety of our products while providing the [FDA] with additional regulatory authority over our industry.”

Previous industry-backed bills included the Cosmetics Safety Amendments Act, introduced in the 112^th Congress by Rep. Leonard Lance, R-N.J. PCPC embraced the legislation as a more balanced alternative to the Safe Cosmetics Act from Rep. Jan Schakowsky, D-Ill., which was reintroduced in the 113th Congress to address what sponsors described as the “regulatory black hole” that is cosmetics oversight in the U.S. currently, but stalled in committee (Also see "Cosmetic User Fees, FDA Warnings, California: Top “Rose Sheet” Topics Of 2012" - HBW Insight, 24 Dec, 2012.).

In early 2014, industry’s efforts to develop a legislative proposal in cooperation with FDA came to naught when the agency threw in the towel, citing what amounted to irreconcilable differences in FDA’s eyes (Also see "FDA Abandons Negotiations With Cosmetics Industry On Legislative Plan" - HBW Insight, 7 Mar, 2014.).

“The Rose Sheet” reported in September 2014 that Sen. Feinstein was picking up the pieces, working with both industry representatives and NGOs on legislation to update FDA’s oversight program for cosmetics (Also see "Sen. Feinstein Plans Cosmetics Bill In Collaboration With Industry, NGOs" - HBW Insight, 30 Sep, 2014.).

ICMAD Opposes Bill, Citing Excessive Burden

While it pledges to continue working with PCPC and FDA to modernize cosmetics oversight in the U.S., trade group the Independent Cosmetic Manufacturers and Distributors has come out in opposition to the Feinstein bill, asserting in a same-day statement that it would place too large a burden on small business and stifle innovation.

There are protections built in the bill for small businesses, including room for extended deadlines and a registration-fee exemption for manufacturers with gross annual sales that average less than $500,000 over the three-year period immediately preceding the fiscal year for which fees are generated.

Additionally, federal preemption of state cosmetics requirements would benefit small businesses with limited resources to adapt their compliance efforts, ingredient use and product labeling across a patchwork of regulations nationwide.

However, provisions such as that mandating GMPs compliance could be particularly onerous for smaller industry players.

Rather than calling for guidance on the subject – which FDA already has drafted and would be nonbinding, providing flexibility in companies’ approach – the bill would require FDA to publish proposed and final GMP rules, taking into consideration national and international standards, 18 months and three years after the act’s enactment, respectively.

Large companies would then have 180 days from the rule’s effective date to come into compliance, while small businesses, as defined by specified industry standards, would be expected to conform within two years.

The dietary supplement sector’s tribulations in meeting GMP standards created through FDA rulemaking – with an industry noncompliance rate of nearly 70% reported roughly six years after a final rule published in 2007 – suggest that cosmetics manufacturers could be in for a similar ordeal (Also see "Supplement Industry Offers Cautionary Tale For Mandatory Cosmetic GMPs" - HBW Insight, 14 Apr, 2015.).

PCPC members that have instituted GMP programs based on ISO standards, per the trade group’s recommendations, likely would be in a better position than other companies, including many small concerns represented by ICMAD, which could face high costs and regulatory risks as they work toward compliance.

‘The Devil Is In The Details’

In an interview with “The Rose Sheet” a week before Feinstein’s bill launched, John Bailey, senior advisor for cosmetics and colors at EAS Consulting Group, weighed in on the legislation and its general provisions, as previewed by PCPC earlier this year.

Bailey views the bill as a promising opportunity for both the personal-care industry and FDA.

“It’s time to modernize the U.S. law for cosmetics and personal-care products,” he said, characterizing the legislation’s broad strokes as “pretty reasonable.”

At the same time, cosmetics enjoy a long history of safe use, so heavy oversight is not necessary, according to Bailey, who directed FDA’s Office of Cosmetics and Colors for nearly a decade and served as chief scientist at PCPC before moving to consulting.

“That theme needs to be captured” in any legislative proposal that advances “so we don’t end up with something that’s overly burdensome, stifles innovation or otherwise generates a lot of work with no particular gain to it,” he said, noting “the devil is in the details.”

Bailey identified elements that could prove problematic, including the GMPs provision, noting: “You don’t need a drug-like GMP structure where FDA can go in, do an inspection and find something that’s not exactly lined up and then shut down a company.”

The industry veteran suggested that further negotiations could be in industry’s interest.