Last month the President released his FY 2016 Budget. Similar to last year, the budget includes a call for cosmetics user fees. This makes the fourth consecutive year that the Obama administration has proposed a cosmetics user fee program to support the activities of the Office of Cosmetics and Colors (OCAC ) within the Food & Drug Administration (FDA).
The FY 2016 budget request increased from $19 million in 2015 to $19.9 million. The FDA reported that the increased amount would be “derived from user fees and will promote greater safety and understanding of cosmetic products.”
Cosmetics User Fees– A Checklist
- Proposed cosmetics user fees would support 42 full-time cosmetics employees at OCAC, plus 18 for field operations and three in FDA’s headquarters.
- $12.7 million of the $19.9 million would be allocated to the OCAC overhead, $4.6 million would go toward cosmetic field operations, and the remainder would be applied to cosmetics activities at FDA headquarters and for overhead.
- 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.”
- Enable the FDA “to meaningfully participate in international harmonization efforts for cosmetic standards” as a member of the International Cooperation on Cosmetics Regulation, a group that works to promote regulatory harmonization and facilitate trade across member countries.
- 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, the FDA will be better positioned to fulfill its public health mission.”
- Extend the existing Voluntary Cosmetic Registration Program that currently “provide[s]the FDA with the best information available about cosmetic products and ingredients, their frequency of use and businesses engaged in their manufacture and distribution.”
- The program would require all domestic and international cosmetics firms marketing products in the U.S. to register their establishments and products with the FDA.
- The “FDA will provide information gathered from the complete listing of marketed cosmetic products and their ingredients to the industry to assist it in its safety evaluations and product modifications.”
Interesting Fast Facts
The budget justification document also includes interesting data provided by the FDA regarding their field work. Here are a few worth noting-
- The FDA conducted 103 unique domestic inspections on cosmetics establishments and 4 foreign inspections in FY 2014.
- Cosmetics field personnel performed 6,809 import field exams/tests and analyzed 448 import lab samples in FY 2014 and made 2.6 million import line decisions.
- For FY 2015 and FY 2016, the FDA estimates it will undertake 100 domestic cosmetic inspections each year and no foreign inspections.
- The FDA also projects it will conduct 1,600 import field exams/tests and analyze 500 import lab samples each year.
- The agency is actively participating in international trade negotiations such as the Transatlantic Trade Investment Partnership.
Looking Forward, Legislation Is Needed
In order for the FDA to collect user fees from manufactures legislation would need to be enacted before the user-free program can be implemented. A number of cosmetics bills have been introduced in previous years dating back to 2010 and at one point targeted $20.2 million in additional funds. The user fee portion of the bill has been an ongoing area of debate primarily between smaller independent manufactures vs. larger corporate brands. Currently, Sen. Dianne Feinstein (D-FL) is working with both NGO’s and cosmetics industry trade groups in drafting legislation to overhaul the FDA’s oversight of the cosmetics industry.