District Court Orders Tennessee Personal Care Products Manufacturer to Comply With Drug Safety Requirements

A federal court permanently enjoined a Memphis, Tennessee company from distributing misbranded drugs and drugs manufactured under insanitary conditions, the Department of Justice announced today.

In a complaint filed September 25, 2018, at the request of the U.S. Food and Drug Administration, the United States alleged that Keystone Laboratories, Inc., the company’s owner, Melinda Menke, and its operator, Elizabeth Jumet, violated the Federal Food, Drug, and Cosmetic Act by distributing hair care and skin care products that were not manufactured, processed, packaged, or held subject to current good manufacturing practices for drugs. The complaint alleged that FDA inspections of Keystone’s facilities and products revealed numerous problems, including an instance in which the company released a batch of hair product despite test results that suggested contamination by the potentially harmful bacteria Staphylococcus aureus (S. aureus). The defendants agreed to be bound by a consent decree filed with the complaint in U.S. District Court for the Western District of Tennessee.

“The Department of Justice is committed to ensuring that manufacturers and sellers of over-the-counter drugs follow safety laws that protect consumers,” said Assistant Attorney General Joseph H. Hunt for the Department of Justice’s Civil Division. “We will continue to work with the FDA to ensure that over-the-counter drugs are manufactured under safe conditions and are properly labeled.”

“Ensuring that consumers are protected from adulterated and contaminated over-the-counter drugs and products is a concern in this district. We will continue to partner with the Department of Justice Civil Division and the FDA to pursue these cases in an effort to protect consumers,” said U.S. Attorney D. Michael Dunavant for the Western District of Tennessee.

The consent decree entered by the court permanently enjoins the defendants from violating the Food, Drug, and Cosmetic Act. As part of the settlement, the defendants may not manufacture or distribute their over-the-counter drug products from any facility owned or operated by the defendants unless they comply with specific remedial measures set forth in the injunction. The order also provides safeguards in the event that the defendants contract with third parties to manufacture similar products.

Trial attorney Claude Scott of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Stuart J. Canale of the U.S. Attorney’s Office for the Western District of Tennessee represented the United States, along with the assistance of Associate Chief Counsel for Litigation Rosselle Oberstein of the FDA’s Office of the General Counsel.