Toothpaste, mouthwash could get more FDA regulation

Jul 20, 2010

The U.S. cosmetics industry is supporting legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the FDA in assessing ingredient safety for personal care products, including toothpaste and mouthwash.

The proposal represents the culmination of more than three years of planning and research by the Personal Care Products Council, the council said. The council detailed its proposal in a letter to key health policy leaders in Congress.

The council 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, two provisions currently in HR 759, the Food and Drug Administration Globalization Act of 2009, introduced by Rep. John Dingell (D-MI), and three additional provisions that industry is seeking.

The council plan includes:

Enhanced FDA registration: Personal care products manufacturers who market their products in the U.S. would be required to comply with the following:
- Register all product manufacturing facilities with the FDA.
- File with the FDA product ingredient reports disclosing all ingredients.
- Report to the FDA any serious unexpected adverse event with a personal care product experienced by consumers.
New process to set safety levels for trace constituents: When requested or on its own 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 the 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: The FDA would be required to review current and future findings on the safety of cosmetic ingredients by the Cosmetic Ingredient Review Expert Panel and determine if these findings are correct. For 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: The FDA would establish industrywide Good Manufacturing Practices requirements.

Based in Washington, DC, the Personal Care Products Council is a national trade association representing the global cosmetic and personal care products industry. Founded in 1894, the council's more than 600 member companies manufacture, distribute, and supply the vast majority of finished personal care products marketed in the U.S.