The Personal Care Products Council has effected an initiative through which the U.S. Food and Drug Administration (FDA) would have a greater role in assessing ingredient safety for personal care products sold in the United States.
The Council spent nearly three years planning the five-point plan, which it finds will increase consumer protection. This initiative was submitted in a letter to key health policy leaders in the U.S. Congress. The industry group is seeking to create formal processes for the FDA to review ingredients for safety at the request of the public and stakeholder groups and to review all safety determinations made by the Cosmetic Ingredient Review (CIR) Expert Panel. No such FDA processes currently exist.
The Council’s five-point plan includes: mandatory industry reporting and mandatory Good Manufacturing Practices (GMP); two provisions currently in HR 759, the FDA Globalization Act of 2009, introduced by Congressman John Dingell (D-MI); and three additional provisions that industry is seeking. The five points are described below.
Enhanced FDA Registration
Under the Council's call for more FDA regulation, it requires personal care product manufacturers to register all facilities where those products are manufactured with the FDA. In addition, it requires those manufacturers to file product ingredient reports disclosing all of the ingredients used in those products with the FDA. Finally, the manufacturer should report any serious unexpected adverse event with a personal care product experienced by consumers to the FDA.
New Process to Set Safety Levels for Trace Constituents
As part of the initiative, the FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products.
New FDA Ingredient Review Process
Once a request has been made, or FDA unilaterally determines action is warranted, the agency would be required to review the safety of any ingredient intended for use in a personal care product and set safety use levels for such ingredient on a specified timetable
New FDA Oversight of CIR Findings
FDA would be required to review current and future findings on the safety of cosmetic ingredients by the CIR Expert Panel and determine if these findings are correct. If there are instances in which it determines a CIR finding is not correct, FDA would determine by guidance or regulations if, or under what conditions, the ingredient can be used safely in personal care products.
FDA-issued Good Manufacturing Practices
FDA would establish industry-wide GMP requirements.
According to the Council, the initiative is being enacted in the absence of any specific public health risk or legislative mandate. The Council maintains that personal care products are safe; however, it is seeking better collaboration between the cosmetic industry and federal regulators.
"We believe it is time to develop a more contemporary approach that includes a greater federal regulatory role. In fact, for the past 30 years, we have aggressively implemented numerous safety initiatives and processes to strengthen industry safety practices. Our consumers deserve multiple layers of protection and transparency,” said Lezlee Westine, the Council’s president and chief executive officer, in a group press release.