Following eight months of negotiations, industry and FDA have arrived at a tentative framework for a bill to update cosmetics regulation in the U.S., including a possible provision that would preempt state-level cosmetics legislation, according to John Hurson, the Personal Care Product Council’s executive VP of government affairs.

Presenting during a July 15 legislative update at the Cosmoprof North America trade show in Las Vegas, Hurson provided an overview of the effort and the nascent legislative proposal, reflecting optimism but noting that “we have a long, long way to go.”

According to the exec, PCPC, the Professional Beauty Association and other industry representatives have had roughly a dozen meetings with FDA since December 2012, focused on enhancing federal regulations for cosmetic products, which have not been updated since passage of the Food, Drug and Cosmetics Act in 1938.

A perceived lack of oversight in the sector has rendered the cosmetics industry a target for public health watchdogs and environmental NGOs.

“A lot of consumer groups are making a lot of claims about the lack of regulation of cosmetics that are basically true,” Hurson acknowledged. “Cosmetics are the least regulated products” under FDA’s authority, he noted.

Industry is set on securing preemption of state legislation, and “we are doing better with it than expected, but there are some big holes in what FDA has agreed to on preemption that we are still trying to close,” Hurson said.

Currently, in the absence of a premarket approval system for cosmetics, manufacturers are responsible for substantiating the safety of their products. If a cosmetic product is deemed hazardous, FDA may request a voluntary recall or pursue seizure action, a court-issued restraining order or criminal litigation.

Otherwise, regulatory controls are limited. Companies are not required to register with FDA, report their ingredient use or bring adverse events to the agency’s attention.

“And those are all things that consumers are throwing at industry in a negative kind of way,” Hurson said.

Proposed federal legislation has emerged in recent years aimed at tightening cosmetics oversight, typically backed by NGOs such as the Environmental Working Group, the Breast Cancer Fund and other members of the Campaign for Safe Cosmetics.

In March, Reps. Edward J. Markey, D-Mass., and Jan Schakowsky, D-Ill., reintroduced their proposal for closing alleged loopholes in food and drug law that allow consumers to be exposed to carcinogens and other hazardous substances in cosmetics products Also see "Safe Cosmetics Act Launches, Aimed At “Regulatory Black Hole”" - HBW Insight, 25 March, 2013.. The Safe Cosmetics and Personal Care Products Act, H.R. 1385, currently resides with the House Energy and Commerce Subcommittee on Health.

That bill and others of its ilk, which would impose significant costs and burdens on industry and FDA alike, have prompted industry work on its own proposal for modernizing cosmetics regulations. However, it’s legislation increasingly cropping up at the state level that has lit a fire under industry’s effort.

“The only reason we would [willingly] assume federal legislation is that it would preempt state laws,” Hurson told session attendees.

At PCPC’s annual meeting in February, the exec said the group was already tracking around 100 state bills with potential impact on the personal-care industry and expected the number to climb toward 200 by year-end ([A#02130311005]).

At Cosmoprof, he cited a bill that passed in Minnesota in May, HF 458, which bans the use of formaldehyde and formaldehyde-releasing preservatives, such as 1,4-dioxane, in products intended for children under the age of eight, including personal-care items like shampoo and bubble baths.

Such laws create an uneven regulatory environment across the U.S., making compliance for national personal-care manufacturers a moving target with considerable costs to business.

Industry’s bill-in-progress ideally would address this situation, according to Hurson.

“What we are seeking in this legislation is what we call preemption of state laws,” he said.

Opportune Climate For Industry Bill

With state bills sprouting around the nation, time is of the essence for a federal bill that would quash those measures and even nullify certain existing state laws governing cosmetics. And according to Hurson, the current political environment lends itself to industry-friendly legislation, with the House under Republican control.

For industry, moving ahead with a proposal means hammering out the specifics with FDA.

“Both the Republican and Democratic leadership in Congress have told us that we have to negotiate a deal with FDA,” Hurson explained.

He went on: “Most legislation that passes Congress that deals with FDA-regulated products is the product of an agreement between industry and FDA, so the normal way these things are worked out is that the policymakers tell industry, ‘Go work it out with FDA and then come back to us.’ So that is essentially what we have been doing.”

After months of work, a legislative framework has taken shape that would include manufacturer, facility and brand registration and ingredient filing with FDA in line with measures taken now by manufacturers that participate in the agency’s Voluntary Cosmetic Registration Program.

Under the developing proposal, FDA would enforce formal Good Manufacturing Practices in the cosmetics sector, whereas currently the agency recommends best practices in manufacturing under nonbinding guidance Also see "ICCR Ushers Forth Updated Cosmetic GMP Guidelines From FDA" - HBW Insight, 1 July, 2013.. The agency also would be given the authority to order product recalls.

Mandatory adverse-event reporting also is on the table, though industry and FDA continue to haggle over the logistics of such a provision.

Hurson explained: “FDA is looking for a lot more info on adverse events than we are really comfortable with, so we are having continued discussions on adverse events.”

Any bill that emerges likely will also include “defined safety substantiation for cosmetic products,” according to the exec. In addition to solidifying existing requirements, the bill would establish a system that recognizes ingredient safety findings from independent experts under industry’s Cosmetic Ingredient Review program, so that “if you are relying on the findings of CIR or other authoritative findings, then that is presumed to be satisfactory and adequate for safety substantiation of products for FDA,” he said.

At the same time, the agency has “flatly refused” to entertain proposals for a system in which it vets all CIR safety determinations. “They simply will not do it. Realistically they don’t have the resources to do it,” Hurson said.

However, certain high-priority ingredients recommended by industry would be subject to FDA review. According to the exec, industry would have to draw up a separate agreement with FDA to secure ingredient-review commitments.

“We want them to agree to review at least five ingredients a year. We would actually want more than that. And we want them to add a certain number of ingredients to the list every year,” he said.

If the plan goes through as envisioned, it would ensure that FDA has the final word on ingredient safety. “State findings on the safety of ingredients, non-functional constituents or trace contaminants would be overruled by an FDA finding,” Hurson said.

He emphasized that the preemption component is still being negotiated on all fronts.

“We are doing better with it than expected, but there are some big holes in what FDA has agreed to on preemption that we are still trying to close,” Hurson said.

To carry out its new duties FDA would require additional resources and funding, which would require industry user fees, he noted. The details for such a program would have to be worked out between the agency and industry as well.

“A Question Mark”

Hurson made no bones about the fact that much work remains to be done and the final legislative proposal could be very different from that which is beginning to crystallize.

“This is a question mark,” he said. “There are many questions that remain even though we have reached a relatively tentative agreement,” as of June 21.

Next, bill language must be drafted, “and it’s going to take a long time given the differences we have with FDA,” Hurson said.

PCPC, FDA Negotiate Oversight Bill With Possible State-Law Preemption

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