Following an application by the US Department of Justice, a US court has issued a permanent injunction preventing three Chicago companies from selling unapproved and misbranded drugs.
In an announcement on 27 July, the DOJ said the US District Court for the Northern District of Illinois had blocked Lifeline Nutrients and Pronto Foods, their parent company Global Marketing Enterprises, and executives Eduardo Chua and Haidee Dawis from making or distributing “adulterated and misbranded dietary supplements and unapproved and misbranded drugs”
The injunction came a day after the DOJ filed a complaint with the court, citing FDA inspections of plants owned by the companies, which found that the dietary supplements were not manufactured, prepared, packed, labelled or held in compliance with federal current good manufacturing practice (CGMP) regulations.
The companies had failed to establish specifications for the “identity, strength, composition and purity” of their products, or to establish and follow written sanitation procedures, the DOJ said. The complaint further claimed that many of the labels on the supplements in question were “deficient”, causing the products to be misbranded under the FDCA.
In a warning letter sent to Chua on 15 March 2016, the FDA said that the companies had not conducted appropriate tests on its “Garcinia cambogia Powder Extracts” supplement, and that its “Caffeine Powder” product was misbranded as “the amount of [the product] claimed to be delivered using the included scoop” was “incompatible” with labelled dosage directions.
The DOJ complaint said the companies had marketed numerous products as drugs that did not have the required FDA approval, and had made “unsupported claims” that the products could help treat a wide range of serious diseases, including diabetes and HIV/AIDS.
The companies agreed to settle the litigation and be bound by a consent decree of permanent injunction, requiring them to implement remedial measures in order to resume manufacturing and distributing dietary supplements.
“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,” acting assistant attorney general Chad Readler of the DOJ’s Civil Division said in a statement, adding that the DOJ would continue to work with the FDA to “take action against manufacturers that employ substandard practices”.
US attorney John Lausch for the Northern District of Illinois reaffirmed the office’s “ongoing commitment to safeguard consumers”. Marketing non-FDA approved products and “making unsubstantiated claims about those products can lead to serious consequences for unsuspecting buyers,” he said.
“Companies that market dietary supplements with unproven health claims and also continue to violate manufacturing regulations put consumers’ health in jeopardy,” added Melinda Plaisier, FDA associate commissioner for regulatory affairs. “The FDA will take the enforcement actions necessary to protect consumers from this undue risk.”
The DOJ was represented by trial attorney James Harlow of the consumer protection branch of the Civil Division and assistant US attorney Donald Lorenzen of the US attorney’s office for the Northern District of Illinois. They were assisted by associate chief counsel Julie Lovas of the FDA’s Office of General Counsel, Department of Health and Human Services.