The NGO community has yet to weigh in on the Cosmetics Safety Modernization Act, but it's fairly safe to expect a cold reception, if not a more vehement backlash, from the sector.

A representative from the Breast Cancer Fund, which leads the Campaign for Safe Cosmetics, said in a Nov. 24 email that the group did not have a statement to offer at the moment.

The Environmental Working Group did not respond to requests for comment.

However, historical precedent and the organizations' recent positions on competing legislation would suggest that support from the NGO camps likely is not in the cards for H.R. 4075 ([A#02151130001]).

The draft House bill includes a sweeping federal preemption component and would allow for limited structure/function claims on cosmetics while largely omitting elements in other bills intended to address NGOs' foremost concerns.

Introduced Nov. 18 by Rep. Pete Sessions, R-Texas, the draft bill includes some provisions of which public safety watchdogs are liable to approve.

Specifically, the program would require domestic and foreign manufacturers of cosmetic products sold in the US to register their facilities with FDA and provide the agency with contact information, as well as product statements for every cosmetic they market that include ingredient lists.

Small businesses, including makers of handcrafted soaps or other homemade cosmetics and companies with less than $1m in annual sales, would be exempt from such requirements.

In addition, the legislation would mandate that companies report serious adverse events to FDA within 15 days of being notified themselves.

NGO stakeholders could be disposed to embrace those provisions, though the registration exemption hoists the sales threshold from $500,000 in the Personal Care Products Safety Act, S. 1014, which EWG helped to develop and supported when it was introduced in the Senate with bipartisan sponsorship in April Also see "Sen. Feinstein’s Cosmetics Safety Bill Launches With GOP Cosponsor" - HBW Insight, 21 April, 2015..

But that may be where their support leaves off. Because while the Cosmetics Safety Modernization Act touches on some other areas where the CSC and similarly focused NGOs have called for reform, its language lacks the actionable weight seen in alternative bills to date, S. 1014 included.

For example, the Safe Cosmetics Modernization Act is crafted so that FDA "may" establish GMPs for cosmetic manufacturers. However, the agency is not directed to do so or given any timeframe for taking action.

The Personal Care Products Safety Act, on the other hand, would require from FDA a proposed rule on GMPs not later than 18 months after the bill is enacted, and a final rule would be expected within three years. In addition to EWG, the CSC also has praised the spirit and bulk of that legislation.

Similarly, the draft House bill would require FDA to establish "a program within the center of the [agency] with primary responsibility for regulating cosmetics to evaluate and make determinations, by regulation, on the safe use of cosmetics and ingredients and nonfunctional constituents thereof."

But again, there's no detail on how ingredients would be selected for safety assessments or any timetable for such reviews, representing a stark contrast to the Personal Care Products Safety Act. The latter would mandate FDA's review of five cosmetic ingredients or nonfunctional constituents each year, specifying the first handful and providing for the creation of a dedicated advisory committee to assist in related activities.

Importantly, the Senate bill also would establish user fees to fund FDA's increased regulatory activities to the tune of roughly $20 million. According to some industry experts, a funding mechanism is crucial for any cosmetics legislation with the potential to tax FDA's already strained resources.

Small-Biz Proposal Less Give Than Take?

The Independent Cosmetic Manufacturers and Distributors, the small-business trade association behind the House bill's conception, has suggested that the Safe Cosmetics Modernization Act's compact digestibility is in large part what makes it promising ([A#02151130006]).

What it omits, however, are many of the elements in the Personal Care Products Safety Act that appealed to NGOs – mandatory recall authority for FDA, for example – in addition to provisions the CSC believed were missing from that proposal ([A#02150427008]).

Meanwhile, it adds provisions that would bar states from implementing or continuing their own programs to regulate cosmetic ingredient use, as well as state-level labeling requirements for cosmetics that differ from federal regulations, rubber-stamp vast swaths of ingredients as safe for cosmetic use and amend the "cosmetic" definition under federal food and drug law to allow for limited structure/function claims.

While such changes would represent decided triumphs for industry, NGOs are likely to contest such measures fiercely, particularly in the context of a bill that addresses few of their leading concerns.

Even without dissecting the Cosmetics Safety Modernization Act, it's recognized that the proposed bill is to great extent a reprise of the Cosmetic Safety Amendments Act of 2012, which CSC lambasted as a "Trojan Horse" that essentially would keep the existing regulatory system in place Also see "Rep. Lance, Council Work To Generate Support For Cosmetics Bill" - HBW Insight, 7 May, 2012..

With the House bill's introduction, ICMAD has answered its members' concerns about the Personal Care Products Safety Act, which has at least limited support from both big business and the NGO sector. Small companies, however, fear its added burdens and costs could put them out of business Also see "Feinstein Bill Lacks ‘Crucial’ National Uniformity Assurance – ICMAD" - HBW Insight, 23 April, 2015..

Now the Personal Care Products Council seems to be distancing itself somewhat from the Cosmetics Safety Modernization Act, perhaps anticipating an NGO response that could call into question industry's willingness to embrace meaningful regulatory reform.

In a Nov. 20 statement, PCPC says it is "very sensitive to the concerns of small businesses" and notes some of the Cosmetics Safety Modernization Act's merits and similarities to the Personal Care Products Safety Act, while also pointing out the "important differences in [their] approach."

ICMAD is optimistic about the House bill's prospects, anticipating that up to a dozen cosponsors could sign on from both sides of the aisle before the end of the year.

It remains to be seen how the picture changes when the NGO piece falls into place.

NGOs Mum On House Cosmetics Bill, But Likely Not Giving Thanks

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