Senate Health Committee Releases Cosmetics Reform Discussion Draft

The committee's discussion draft of cosmetics reform legislation combines elements of the proposed Personal Care Products Safety Act and FDA Cosmetic Safety and Modernization Act, but most closely aligns with the former. NGOs likely will be pleased; small businesses, perhaps not so much

A discussion draft bill from the Senate Health, Education, Labor and Pensions Committee lays out a comprehensive blueprint for cosmetics regulatory reform that is likely to meet with NGOs' approval, but may be a harder sell to the small business community.

Stakeholders are invited to comment on the discussion draft by March 15.

Released Feb. 23 as the "Modernization of Cosmetics Regulation Act of 2018," the legislation combines elements from the proposed Personal Care Products Safety Act, S. 1113, and FDA Cosmetic Safety and Modernization Act, S. 2003, though it most closely aligns with the former. Both bills currently reside with the Senate Health Committee.

The PCPSA is sponsored by Sens. Dianne Feinstein, D-Calif., and Susan Collins, R-Maine, while the FCSMA was introduced in October 2017 by Sen. Orrin Hatch, R-Utah. (Also see "Surprise Hatch Bill Lays Middle Ground For Cosmetic Regulatory Reform" - HBW Insight, 26 Oct, 2017.)

Collins is a Senate Health member, as is Hatch, who chaired the committee previously. He announced in January his intention to retire at the end of his term this year.

 

According to a recent agenda statement, the Senate Health Committee aims to mark up cosmetics reform legislation in mid-April.

 

Like the formally introduced measures, the Modernization of Cosmetics Regulation Act would require cosmetics manufacturers to register facilities and report serious adverse events.

Companies also would have to submit ingredient lists to FDA for every product they manufacture and attest to meeting a reasonable-certainty-of-no-harm safety standard, consistent with provisions in the PCPSA. (Also see "PCPSA's 'No Harm' Standard Would Set High Bar For FDA Ingredient Review" - HBW Insight, 13 Apr, 2016.)

FDA would be tasked with developing good manufacturing practices, which companies eventually would have to comply with. (Also see "Supplement Industry Offers Cautionary Tale For Mandatory Cosmetic GMPs" - HBW Insight, 14 Apr, 2015.)

The agency also would review the safety of cosmetic ingredients, compiling an initial list of at least 10 ingredients or nonfunctional constituents targeted for assessment and tackling them in accordance with timeline and process specifications, including opportunities for public comment.

The discussion draft takes a page out of Hatch's bill, providing for ingredient evaluations by accredited entities, which would be taken into consideration by FDA in its own safety review work.

Notably, eligible parties for accreditation must not be "owned, managed or controlled by a responsible person, manufacturer, processor, supplier, or vendor of articles regulated under this section" or have a "material organizational or financial affiliation (including a consultative affiliation) with such entities."

It's unclear how those terms would bear on the Cosmetic Ingredient Review. CIR is funded by industry, but its expert panel consists of individuals who "meet the same conflict of interest standards as are applicable under federal law to special government employees," according to the organization's procedures.  

To date, FDA has put considerable stock in ingredient assessments conducted by CIR's independent experts. The panel includes an FDA representative as a non-voting liaison member.

The Personal Care Products Council has been advocating for an accreditation system for third-party ingredient review as part of cosmetics oversight reform, so the Senate Health Committee's proposed framework presumably would allow CIR participation if the trade group had a hand in shaping it. (Also see "PCPC Hatching Proposal For CIR Role In FDA Ingredient Review" - HBW Insight, 7 Mar, 2017.)

PCPC President and CEO Lezlee Westine said in an email that “while we recognize there are additional steps in the legislative process, and that the discussion draft may change based on public comments, we are very pleased to see the HELP Committee's leadership in taking this important step forward."

She added, "We look forward to reviewing the discussion draft and providing our comments to the Committee. We recognize this is a process where various stakeholders are working together toward a compromise piece of legislation, and we support a compromise bill that creates a more modernized regulatory system for the personal care products sector – a system that advances innovation, safety and consumer confidence.”

Mandatory Recall Authority, User Fees Left Out

The Modernization of Cosmetics Regulation Act would not authorize FDA to order product recalls, as the PCPSA would (much to the NGO community's liking), though it would empower the agency to suspend ingredient listings and/or facilities in cases where there is a "reasonable probability" that products or wider lines are linked to serious adverse health consequences. The PCPSA includes similar provisions.

Further, the Senate Health proposal would require companies to grant FDA access to records if/when serious health concerns arise, another piece that mirrors the PCPSA and represents a marked departure from the status quo. (Also see "Think FDA Inspections Are Painful Now? These Could Be The Good Old Days" - HBW Insight, 24 May, 2017.)

The discussion draft contains limited exemptions for small businesses. Companies with average annual sales of less than $1m for three years running would not have to register with FDA, comply with GMPs or meet certain labeling requirements.

In previous cosmetics regulatory reform discussions, a $1m exemption threshold for companies subject to registration duties and other burdens has been viewed by many microbusinesses as too low. (Also see "Handcrafted Cosmetics Sector Says Exemptions In Reform Bills Are Insufficient" - HBW Insight, 5 Oct, 2016.)

Meanwhile, the Independent Cosmetic Manufacturers and Distributors (ICMAD) has been stalwartly opposed to the scope of the PCPSA, characterizing the legislation as overkill compared with the regulatory update that it believes is warranted and manageable for small companies. (Also see "ICMAD Stands By House Cosmetics Bill, But May Be Ready To Negotiate" - HBW Insight, 31 Oct, 2017.)

ICMAD President Pam Busiek said the group is reviewing the Senate Health draft legislation.

A strong preemption component to ensure national uniformity amid a growing patchwork of state requirements could help sweeten such legislation in the eyes of small business advocates.

The Modernization of Cosmetics Regulation Act includes a placeholder for preemption, noting, "HELP Committee staff believe that a uniform federal standard for cosmetics regulation is an important component to this reform proposal. HELP Committee staff also recognize that work done by States to date warrants consideration. Staff would especially appreciate feedback from stakeholders regarding the best approach to federal preemption that works appropriately with the framework presented in this discussion draft."

Importantly, the committee's discussion draft does not include a user fee schedule to fund increased FDA oversight activities, something that many experts see as essential to passing cosmetics reform legislation. The PCPSA proposes a framework that would provide FDA with around $20.6m initially.

Instead, Senate Health proposes an unspecified amount of additional FDA funding via federal appropriations, a provision President Donald Trump may well balk at, despite what appears to be a loosening of the purse strings in the White House when it comes to supporting FDA's public safety mission. (Also see "Trump's Budget Surprise: FDA Gets 13% Increase" - HBW Insight, 21 Feb, 2018.)

Stakeholders can provide feedback on the discussion draft to [email protected]. A section-by-section summary is available here.

In a notice to Senate Health members, the office of Chairman Lamar Alexander, R-Tenn., noted, "The goal of the Modernization of Cosmetics Regulation Act of 2018 is to help ensure greater safety and transparency for consumers who use cosmetic products. Committee staff is requesting feedback from the public to inform the committee’s process for developing a consensus product."

According to a recent agenda statement from Alexander and Ranking Member Patty Murray, D-Wash., the Senate Health Committee aims to mark up cosmetics reform legislation in mid-April. (Also see "Senate Health Committee To Move On Cosmetics; News In Brief" - HBW Insight, 11 Feb, 2018.)