Call for a new federal legislation

Lezlee Westine, PCPC's President and CEO

Lezlee Westine, PCPC’s President and CEO

The Personal Care Products Council (PCP), the leading trade group representing the US cosmetics industry [1], has called for a new federal legislation that would strengthen and modernize regulatory oversight of the industry and create a greater role for the U.S. Food and Drug Administration (FDA) in assessing ingredient safety for personal care products.

The Council detailed its proposal in a letter to key health policy leaders in the Senate and House of Representatives. “The proposal represents the culmination of more than three years of planning and research,” said the Council in a release.

For decades, the industry has had an impeccable safety record under the existing requirements implemented by FDA under the Federal Food, Drug, and Cosmetic Act. Our products remain among the safest in the marketplace,” explained Lezlee Westine, the Council’s president and chief executive officer. “Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role.

Recurrent polemics

Westine emphasized the proactive nature of the PCPC’s announcement, which is being made in the absence of any specific public health risk or legislative mandate involving personal care products, which remain safe to use. “Rather, the industry is responding to American consumers who are requesting and deserving more transparency from government and industry while ensuring their ability to keep pace with continued demand for innovative products.

Indeed, the initiative is following recurrent polemics regarding the safety of cosmetics and their ingredients in the US. The introduction in Europe of regulatory provisions prohibiting carcinogenic, mutagenic and reprotoxic (CMR) substances in cosmetic products has also given arguments to several public action groups requiring a similar level of protection for US consumers. This even led to the adoption of a specific legislation in California [2] and several other legislative proposals in numerous other States.

Five-point plan

The Council is seeking to create formal processes for 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.

Toward that end, the PCPC has worked on a five-point plan that includes:

(1) Enhanced FDA Registration. Personal care products manufacturers who market their products in the United States would be required to:

- Register with FDA all facilities where those products are manufactured.
- File with FDA product ingredient reports disclosing all of the ingredients used in those products; and
- Report to FDA any serious unexpected adverse event with a personal care product experienced by consumers.

(2) Safety levels for trace constituents. When requested or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and finished products.

(3) 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. This initiative could dramatically increase the list of ingredients either prohibited or limited for use in cosmetics.

(4) New FDA oversight of CIR findings. The Council’s initiative would maintain the Cosmetic Ingredient Review (CIR) Expert Panel [3], which currently assesses the safety of cosmetic ingredients, but FDA would be required to review current and future CIR findings and determine if they 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.

(5) FDA-Issued Good Manufacturing Practices. There are currently no compulsory Good Manufacturing Practices (GMP) applicable to cosmetic products in the US, despite that numerous cosmetics manufacturers voluntary comply with the guidelines published by the Personal Care Products Council or other bodies. Under the Council’s plan, the FDA would establish industry-wide GMP requirements.

The Council and its member companies have been proactively working with legislators to materialise their plan in a bill: HR 759, the Food and Drug Administration Globalization Act of 2009, introduced by Congressman John Dingell (D-MI).

Our companies commend Rep. Dingell for his ongoing work to better protect consumers and increase transparency. We look forward to working with the current and next Congress to ensure these changes are meaningful and attain the full force of federal law,” said Westine.