A Congressional proposal to formalize the Cosmetic Ingredient Review's work through a public-private partnership could lend added credibility to the program's safety assessments and strengthen consumer confidence in the safety of cosmetic products.

In reports supporting draft fiscal 2016 spending bills for FDA and related agencies, both House and Senate appropriations committees direct FDA to explore options with industry for recognizing CIR's role through a public-private partnership similar to that in place between the agency and the U.S. Pharmacopeial Convention.

Frustration with perceived shortcomings in FDA's cosmetics oversight program seem to be at the root of the proposal. Both chambers point to FDA's failure to address a more than four-year-old industry petition asking the agency to set a maximum limit on trace lead in cosmetic products.

The issue of lead contamination in lipsticks and other cosmetics has been cited by NGOs for over a decade as evidence of inadequate industry regulation, though FDA maintains that lead levels found in marketed lipstick products do not pose safety concerns to consumers, based on its own analysis published in 2009 Also see "FDA Releases New Lipstick Lead Data, Putting Names To Numbers" - HBW Insight, 9 November, 2009..

Regardless, concerns about trace amounts of lead in cosmetics – often due to use of approved color additives and present at levels deemed safe by FDA – continue to drive NGO action and negative PR for industry, which could be tempered by an official position from the agency on permissible lead content.

According to the Obama Administration's fiscal 2016 budget request released in February, FDA said it was evaluating data from studies and other information regarding trace lead in cosmetics, with the intention of responding to industry's petition in March 2015 Also see "FDA Will Respond To Lipstick Lead-Limit Petition In March" - HBW Insight, 4 February, 2015..

Following the missed deadline, a spokeswoman said the agency was still reviewing the matter Also see "In Brief: FDA, EPA Sharing Data; Industry Lead-In-Cosmetics Petition Goes Unanswered; More" - HBW Insight, 2 April, 2015..

According to Senate appropriators, FDA's promised response "has not occurred, and this unacceptable delay is indicative of longstanding issues with FDA’s review of cosmetics."

The House committee directs FDA to respond to the petition by Dec. 31 of this year.

In the context of the lead-in-cosmetics discussion, both committees note the part CIR plays in industry's safety-assurance work since its creation in 1976, and FDA's role as a nonvoting liaison to the CIR Expert Panel of independent scientists.

Almost 40 years after its inception, "given the breadth and volume of ingredients reviewed and the scientific expertise applied to its process, it is the Committee’s belief CIR should be recognized and formalized as a public-private program," the House report states.

House appropriators direct FDA to cooperate with industry to transfer CIR to the U.S. Pharmacopeia Convention, which they characterize as "a widely respected independent scientific organization whose drug standards are explicitly incorporated under the Federal Food, Drug and Cosmetic Act."

USP notes on its website that it has worked with FDA for more than a century to protect public health and promote the quality and safety of drugs, dietary supplements and foods. USP develops standards for naming/identity, quality, purity and strength of medicines and ingredients used in the sectors, and FDA enforces those that are incorporated into federal law, the nonprofit organization says.

In a statement, a USP rep said the organization "was unaware of this legislative activity, but we would be pleased to serve as a resource to the Congress and others." While USP's involvement, as proposed by the Congressional committees, falls outside the scope of the nonprofit's current standard-setting activities, USP would welcome the opportunity to offer its scientific assistance, she indicated.

The House report recommends that CIR be transferred to "some other appropriate third body," if not USP.

On the Senate side, appropriators similarly direct FDA to study the possibility of transitioning CIR to a formal public-private partnership such as the USP arrangement "if appropriate and beneficial for consumers."

Both reports bid the agency to report back to the appropriations committees on their efforts, with the House setting a Jan. 15 deadline and requesting "a framework and a detailed plan."

Promoting FDA Acceptance Of CIR Findings

The partnership envisioned by lawmakers could reinforce the authority of CIR Expert Panel assessments, which NGOs have been known to question along with the objectivity of panel members, given that CIR is funded by industry.

In an email to "The Rose Sheet," a Personal Care Products Council rep said the trade group supports the concept of a CIR public-private partnership and "believes this is one of several options for modifying the way the Expert Panel works in order to have FDA accept their findings."

The agency should rely on CIR's objectivity and expertise, PCPC said, adding that collaboration between the two could help strengthen FDA's oversight program and add new levels of assurance to ingredient safety efforts.

"We understand the perceptual challenges of a program funded by industry, and while we believe that scientists and experts working within CIR approach their mission with diligence and impartiality, we support any move that will help further legitimize their work, complement FDA’s role as the regulatory authority over our industry and further ensure public confidence in our products," according to the PCPC spokesperson.

The trade group says USP is one of several groups with whom it is exploring options for a public-private partnership. PCPC has reached out to FDA on the matter, the rep said.

Currently, compliance with restrictions and other use recommendations in CIR safety assessments is voluntary, under PCPC's Consumer Commitment Code for example. Launched in early 2007, the code requires participating member companies to observe CIR recommendations or use only ingredients that are otherwise substantiated as safe by data maintained in company files available to FDA upon request.

Were FDA to formally recognize, vet or accept CIR safety determinations through a public-private partnership, they could be folded into agency guidance, which is generally followed by manufacturers but not legally binding, or new regulations, which would make industry compliance mandatory.

Alternatively, the partnership could serve as the basis for increased FDA ingredient review in cosmetics legislation seeking more active industry oversight. The Personal Care Products Safety Act, introduced in the Senate in April, would require the agency to review five cosmetic ingredients for safety annually ([A#02150427003]).

OCAC Funding Offer Flat

Funding in the appropriations bills for the Office of Cosmetics and Colors for fiscal 2016 falls considerably short of the President's budget request.

The Obama Administration asked for $19.9 million for OCAC, to be derived from user fees, which would require implementing legislation.

The proposed Personal Care Products Safety Act, for example, includes user-fee provisions aimed at generating $20.6 million in funds. Under the bill, manufacturers would have to register their facilities and pay a fee if their average gross sales across facilities were greater than $500,000 annually for the preceding three-year period ([A#02150504002]).

According to the President's request, which also proposed making the FDA's Voluntary Cosmetic Registration Program mandatory, user-fee resources would support the agency in its work to “refine inspection and sampling of imported products and apply risk-based approaches to postmarket monitoring of domestic and imported products, inspection and other enforcement activities" Also see "Fourth Time’s A Charm? President’s FY 2016 Budget Includes Cosmetic Fees" - HBW Insight, 4 February, 2015..

The White House's target for OCAC represented a 4.7% increase over its request for fiscal 2015. However, such requests in recent years have not been met by Congress.

Last year, the Senate appropriations bill earmarked $11.7 million at minimum for cosmetics activities in fiscal 2015, including at least $7.2 million specifically for the OCAC "for direct support of the operation, staffing, compliance, research and international activities performed by this office" Also see "Congressional Appropriators Urge FDA Action On Cosmetic Lead Limits" - HBW Insight, 3 June, 2014..

For fiscal 2016, the Senate's Agriculture, Rural Development, FDA and Related Agencies appropriations bill includes the same amount for OCAC, while the House bill directs FDA to "spend no less than the fiscal year 2015 level for cosmetics activities as well as for the Office of Colors and Cosmetics."

The Senate panel wants to give FDA as a whole $2.637 billion in the fiscal year beginning Oct. 1, a figure that does not include industry user fees. The amount is around $10 million more than the House’s offer, but still $106 million below the President’s total funding request of $2.74 billion for the agency.

Congress Proposes Public-Private Partnership For CIR

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