California Firm Agrees to Stop Production of Adulterated and Misbranded Dietary Supplements and Unapproved New Drugs
As a result of a lawsuit filed by the United States, a federal court in California has issued an injunction shutting down Health One Pharmaceuticals Inc., a City of Industry, California, based manufacturer of dietary supplements and unapproved new drugs. The firm and its president, Richard S. Yeh, agreed to shut down and resolve the lawsuit as part of a consent decree. The Justice Department filed the injunction action in the Central District of California at the request of the U.S. Food and Drug Administration (FDA).
The consent decree forbids the company from operating unless and until it takes a number of steps to improve its compliance with federal law. The defendants have represented to the court that they have already ceased operations.
“Protecting the health of American consumers is some of the most important work we do,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division. “We have an unwavering commitment to ensuring that the dietary supplements in this country are safe and have been manufactured in accordance with federal law.”
Based on the results of FDA inspections, the complaint alleged that the defendants violated the Federal Food, Drug and Cosmetic Act by delivering, or causing to be delivered for introduction into interstate commerce, dietary supplements that have been prepared, packed or held under conditions that do not meet current good manufacturing practice regulations. Among other things, the complaint alleged that the defendants failed to meet current good manufacturing practices for dietary supplements by failing to conduct at least one appropriate test or examination to verify the identity of every dietary ingredient prior to using the ingredient. Furthermore, the complaint alleged that the defendants’ dietary supplements were misbranded because their labels do not include all the information required by federal law.
The complaint further alleged that some of the defendants’ products were unapproved new drugs—and therefore cannot be lawfully distributed under federal law—because they were articles intended for use in the cure, mitigation, treatment or prevention of disease and, among other things, are not generally recognized as safe and effective for their intended uses and were not the subjects of new drug applications approved by FDA. Furthermore, the complaint alleged that these drugs were misbranded because it is impossible to provide “adequate directions for use” for an unapproved new drug.
The FDA referred this matter to the Department of Justice. The Civil Division’s Consumer Protection Branch, together with the U.S. Attorney’s Office for the Central District of California, filed this case on behalf of the United States.
The claims alleged in the complaint are allegations only and there has been no determination of liability.