Since 1980 lead acetate has been considered a safe color additive for use in cosmetics for hair coloring. In 2017, a color additive petition requesting repeal of regulation that allows for the use of lead acetate in cosmetics was submitted. After carefully reviewing the submission and other relevant information, FDA concluded that there is no reasonable certainty of no harm from this use of lead acetate. On October 30, 2018, FDA published a final rule banning the use of Lead Acetate in cosmetic products intended for hair coloring. The rule is effective from December 03, 2018 and the industry has 12 months to make the transition and reformulate their products. Such products must comply with the requirements of 21 CFR 73.2396, including the specifications, uses and restrictions, and labeling requirements.
Hair dye products containing Lead Acetate are required to bear such a warning statement:
CAUTION: Contains lead acetate. For external use only. Keep this product out of children’s reach. Do not use on cut or abraded scalp. If skin irritation develops, discontinue use. Do not use to color mustaches, eyelashes, eyebrows, or hair on parts of the body other than the scalp. Do not get in eyes. Follow instructions carefully and wash hands thoroughly after each use.
Manufacturers and labelers of cosmetic products must comply with FDA labeling requirements otherwise their products are considered misbranded and are subject to detention.
Liberty Management Group Ltd. can help companies with labeling compliance. Our label experts check your labels against current labeling regulations and help you avoid detention and import refusals.
Namrata
Regulatory Consultant
support@libertymanagement.us
Published on: September 25, 2019