Cosmetics and personal care products currently fall under the regulation of the FDA and the application of the Food, Drug & Cosmetic Act. However, the trade body is proposing additional responsibilities for the regulatory agency in what it refers to as a ‘more contemporary approach’.
“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,” said CEO of the Council Lezlee Westine.
“Nonetheless, we believe it is time to develop a more contemporary approach that includes a greater federal regulatory role".
Enhanced registration procedures
PCPC is suggesting that manufacturers systematically submit product ingredient reports to FDA, with lists of all ingredients used in each product, as well as registering all manufacturing facilities.
In addition, the trade association is proposing that manufacturers report any serious, unexpected adverse effects experienced by consumers to the regulatory body.
Currently, cosmetics have to be substantiated for safety before they are marketed and cannot contain any prohibited substances, but existing regulations do not require the submission of comprehensive ingredients lists nor facilities registration.
From CIR to FDA
The Council is also proposing changes to how the safety profiles of ingredients are investigated and who is involved in this process.
At present it is the Cosmetics Ingredients Review (CIR) Expert Panel (an independent panel of experts publicly nominated by consumer and scientific groups as well as industry bodies) that reviews cosmetics ingredients for safety.
PCPC is proposing that FDA in turn reviews all the CIR safety assessments, including those already completed, to determine if these findings are correct. If the findings of the CIR Expert Panel are deemed to be lacking FDA will have to determine under what conditions the ingredient can be used.
Trace contaminants and new ingredients of concern have also been highlighted in the Council’s proposals, which suggest the FDA should undertake a review of such substances if requested by an outside party of if the regulatory body itself feels there is a need.
According to the trade body, this move is the result of consumer concern over the presence of some substances in minute amounts that are not intentionally added.
PCPC is quick to add that there have been no valid scientific studies that link the use of any cosmetics products with adverse health effects, rather that this action results from its willingness to address any consumers concerns.