TENNESSEE
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, packaged to 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.”
In a statement, Jumet said the company had already ceased its over-the-counter drug manufacturing operations before the order was issued. She added that the company had been preemptively and voluntarily making needed changes to comply with regulations before being notified by the DOJ since she and Menke took over management in 2015.
In an interview with OTC magazine, Jumet talked about the company’s roots:
“The company traces its roots back to 1924 when it was originally founded by Joseph and Hilda Menke. It was later incorporated in 1926. Keystone has always been a true family-oriented company from its inception. Joseph and Hilda saw an unmet need in the African American community; a large wave of consumerism had swept across America and Keystone was one of the first businesses to provide African American clientele with a diverse line of cosmetics, hoodoo conjure supplies, as well as various medicines, all of which were popular at the time.”