District Court Enters Permanent Injunction Against Chicago Companies to Stop Distribution of Adulterated and Misbranded Dietary Supplements and Unapproved and Misbranded Drugs
The U.S. District Court for the Northern District of Illinois has entered a permanent injunction against three related Chicago companies — Global Marketing Enterprises, Inc., Lifeline Nutrients, Corp., and Pronto Foods Company — as well as their owner Eduardo S. Chua, and their operations manager Haidee V. Dawis. The injunction prevents the defendants from manufacturing, selling, and distributing adulterated and misbranded dietary supplements and unapproved and misbranded drugs, the Department of Justice announced today.
The Department filed a complaint on July 26, 2018, alleging that defendants manufacture, package, label, and distribute numerous products in violation of the Federal Food, Drug and Cosmetic Act (FDCA). The complaint further alleges that defendants’ dietary supplements were adulterated because they were not manufactured, prepared, packed, labeled or held in compliance with federal current good manufacturing practice (CGMP) regulations. FDA inspections of defendants’ plant in 2015 and 2017 revealed numerous failures to comply with CGMP regulations, including the failure to establish specifications for the identity, strength, composition and purity of their products and the failure to establish and follow written sanitation procedures. The complaint also alleges that many of the labels on defendants’ supplements were deficient, and caused the products to be misbranded under the FDCA.
Additionally, defendants marketed numerous products as drugs, according to the complaint, by making claims that these products could help treat or prevent a host of serious diseases, including Alzheimer’s disease, diabetes, HIV/AIDS, and Parkinson’s disease. Defendants sold these products to the public using these claims despite not having the required FDA approval.
The complaint alleges that defendants’ disease-related treatment claims were unsupported by any well-controlled clinical studies or other credible scientific substantiation. Additionally, defendants’ products did not contain adequate directions for such uses. The complaint asserts that directions for use, including dosages, warnings, and side effects, must be premised on clinical data derived from scientifically controlled investigation, and since defendants made disease-related treatment claims about their products in the absence of any such clinical data, the products were misbranded.
The defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction. The consent decree requires that if the defendants wish to resume manufacturing and distributing dietary supplements in the future, they must implement the remedial measures set forth in the consent decree, notify the FDA of the measure they have taken, and obtain written approval from the FDA that they appear to be in compliance with both the terms of the consent decree and the provisions of the FDCA.
“Consumers must be able to trust that the products they buy are safe and the claims on the product's label can be relied on,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Justice Department will continue to work with FDA to take action against manufacturers that employ substandard practices, so that the public can rely on the safety and integrity of the products they buy.”
“Marketing medical products that were not manufactured in compliance with FDA regulations and making unsubstantiated claims about those products can lead to serious consequences for unsuspecting buyers,” said U.S. Attorney John R. Lausch Jr. for the Northern District of Illinois. “This case reflects our office’s ongoing commitment to safeguard consumers.”
“Companies that market dietary supplements with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “The FDA will take the enforcement actions necessary to protect consumers from this undue risk.”
This matter was handled by Trial Attorney James Harlow of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Donald Lorenzen of the U.S. Attorney’s Office for the Northern District of Illinois, with the assistance of Associate Chief Counsel Julie Lovas of the FDA’s Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Northern District of Illinois, visit its website at www.justice.gov/usao-ndil.