Over-the-Counter Hair and Skin Drugs Manufacturer Consent Decree

On October 23, 2018, the Western District of Tennessee ordered Keystone Laboratories, Inc. of Memphis, Tennessee, the company’s owner, Melinda Menke, and its president, Elizabeth Jumet, to stop selling over-the-counter (OTC) drug products until the company complies with the Federal Food, Drug, and Cosmetic Act (FDCA) and other requirements listed in a consent decree. According to the complaint filed with the consent decree, Keystone manufactured and distributed OTC hair care and skin care products that violated federal law.


“Americans expect and deserve OTC drug products that are safe and effective and meet appropriate standards for quality. To ensure safe use by consumers, OTC drug products must also include specific information on product labels,” said the Director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, Donald D. Ashley, J.D. “Despite previous warnings, Keystone placed consumers at risk by manufacturing OTC drug products in violation of current good manufacturing practice (CGMP) requirements and failed to include adequate directions for use on its product labels. The FDA remains fully committed to taking enforcement action against companies and owners who place unsuspecting American consumers at risk.”


Keystone’s drug products were not manufactured, processed, packed, or held according to CGMP requirements. For example, Keystone failed to adequately investigate sources of contamination found in some of its products and failed to ensure its drug products met their specifications before releasing them to consumers. Some of Keystone’s drugs were also misbranded because the product labels did not include adequate directions for use or other label requirements for OTC drug products.


The consent decree required Keystone to cease operations until it completes corrective actions, including hiring a qualified independent expert to inspect its facility to ensure the company complies with the FDCA and its implementing regulations. Under the consent decree, Keystone may not resume operations until it establishes and implements a comprehensive quality control system and receives authorization from the FDA, among other requirements.


In March 2013, the FDA issued a warning letter to Keystone for similar violations as cited in the complaint. Following the warning letter, the FDA inspected the facility in February 2016 and November 2017 and observed repeat violations.


See the FDA Announcement


See also Medical Risk Law Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication