For the fourth consecutive year, the Obama administration’s budget request for FDA includes user fees to support activities in the Office of Cosmetics and Colors, a funding base that would require legislation.

In its justification for the President’s proposed fiscal 2016 budget released Feb. 2, FDA says the $19.9 million for the cosmetics office would be derived from user fees and “will promote greater safety and understanding of cosmetic products” and enable the agency to establish and maintain a Cosmetic Registration Program.

Such an initiative would extend FDA’s existing Voluntary Cosmetic Registration Program, participation in which currently “provide[s] FDA with the best information available about cosmetic products and ingredients, their frequency of use and businesses engaged in their manufacture and distribution” Also see "VCRP Product Reporting To FDA Drops 25% In FY 2014" - HBW Insight, 8 December, 2014..

The mandatory program would require all domestic and international cosmetics firms marketing products in the U.S. to register their establishments and products with FDA.

“FDA will provide information gathered from the complete listing of marketed cosmetic products and their ingredients to industry to assist it in its safety evaluations and product modifications,” the agency says.

FDA says it would use funds derived from cosmetics user fees 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.”

Cosmetic user fees also would enable FDA “to meaningfully participate in international harmonization efforts for cosmetic standards,” according to the justification document.

FDA is a member of the International Cooperation on Cosmetics Regulation, which seeks to promote regulatory harmonization and facilitate trade across member countries. The group as a whole has accepted numerous reports aimed at aligning members’ regulatory positions on priority cosmetics issues, though FDA has been slow to adopt them for the U.S. Also see "ICCR Will Have Growing Role In Setting Global Policy – Industry Groups" - HBW Insight, 4 August, 2014..

With increased resources derived from user fees, FDA also would 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. As a result, FDA will be better positioned to fulfill its public health mission,” the agency says.

FDA acknowledges that legislation would be necessary to implement a cosmetic user-fee program. Members of the cosmetics industry and NGOs reportedly are working with Sen. Dianne Feinstein, D-Calif., to draft legislation that would overhaul FDA’s oversight of the cosmetics sector Also see "Sen. Feinstein Plans Cosmetics Bill In Collaboration With Industry, NGOs" - HBW Insight, 30 September, 2014..

Previous cosmetics bills proposed in the U.S., such as the Safe Cosmetics Act, have included provisions for user-fee collection. The legislative proposal that industry trade groups were developing with FDA – before the agency walked away from negotiations in March 2014 – also sought to institute a user-fee program for cosmetics, at one point targeting $20.2 million in additional funds ([A#02140310008]).

FDA’s user-fee justifications echo those in the White House’s fiscal 2015 budget request ([A#02141222001]).

Two Years, 200 Cosmetics Inspections

The budget request justification offers data on FDA’s field work, including inspections of cosmetics facilities. In FY 2014, FDA conducted 103 unique domestic inspections on cosmetics establishments, and four foreign inspections.

Cosmetics field personnel performed 6,809 import field exams/tests and analyzed 448 import lab samples in FY 2014. They also made 2.6 million import line decisions, examining 0.28% of import lines overall.

For FY 2015 and FY 2016, FDA estimates it will undertake 100 domestic cosmetic inspections each year, and no foreign inspections. FDA also projects it will conduct 1,600 import field exams/tests and analyze 500 import lab samples each year. Additionally, the agency expects to physically examine 0.08% of import lines both in FY 2015 and FY 2016.

The document does not specify where foreign inspections occurred or provide insight into the origin of imports targeted for inspection.

However, FDA notes that it has “established a collaborative relationship with Chinese regulators on cosmetic safety issues and continues to maintain an interactive dialogue,” with a bilateral forum planned for 2015.

Further, the agency notes that it is actively participating in international trade negotiations such as the Transatlantic Trade Investment Partnership.

Cosmetics Request Up 4.7%

The fiscal 2016 budget request for cosmetics is up approximately 4.7% from the $19 million request for fiscal 2015.

The proposed cosmetics user fees would support 42 full-time cosmetics employees at OCAC, plus 18 for field operations and three in FDA’s headquarters, for a total of 63 employees.

According to FDA’s justification, $12.7 million of the $19.9 million would be allocated to the cosmetics office, $4.6 million would go toward cosmetic field operations, and the remainder would be applied to cosmetics activities at headquarters and for overhead.

In response to appropriation committee inquiries, FDA says it intends to respond to a citizen petition seeking a 10-ppm limit on lead in cosmetic products by March Also see "FDA Will Respond To Lipstick Lead-Limit Petition In March" - HBW Insight, 4 February, 2015..

Overall, FDA is requesting a $4.9 billion appropriation for fiscal 2016, a 9% increase from its budget for fiscal 2015, which ends Sept. 30.

Of the $4.9 billion, $2.7 billion would be derived from direct appropriations – up 6% from last year – and $2.9 billion would come from user fees, representing an increase of 15%.

The White House’s fiscal 2015 request had more than 45.5% of FDA’s proposed funding coming from fees, while that level is about 44.4% in the fiscal 2016 request.

The fiscal 2016 budget request for FDA’s foods program totals $1.2 billion, up $252.9 million from that enacted for FY 2015. The Center for Food Safety and Applied Nutrition’s portion of the total foods request is $355 million, most of which would go toward implementation of the Food Safety Modernization Act.

FDA’s human drug oversight budget authority request includes $716,000 for evaluating OTC sunscreen ingredients, reflecting the agency’s increased workload relative to deadlines for deciding on time and extent applications following passage of the Sunscreen Innovation Act in November 2014 ([A#02150112004]).

FDA’s budget justification says the funding supports “activities related to reviewing the validity and outcome of new pharmacology and toxicology data, conducting searches of public literature and data, and writing summaries of relevant pharmacology and toxicology data.”

“The funds will enhance CDER’s ability to complete timely reviews of filed requests and determine the safety and efficacy of the sunscreen active ingredient or combination of ingredients,” FDA asserts.

Fourth Time’s A Charm? President’s FY 2016 Budget Includes Cosmetic Fees

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