Skin care claims

Executive Summary

Estee Lauder is seeking declaratory relief from FDA on skin care claims for five of the seven products cited by a 1987 regulatory letter for making unapproved new drug claims. Filed Sept. 23 in D.C. District Court, the suit is an attempt to prevent FDA from taking any further regulatory action against the company until the case has been heard. A hearing has not yet been set. Estee Lauder names as plaintiffs in the suit FDA Commissioner Young and Associate Commissioner for Regulatory Affairs John Taylor.