U.S. District Court Enters Settlement Against Dietary Supplement Companies Ending Unapproved Drug Sales

The U.S. Attorney’s Office for the Northern District of Illinois in Chicago filed a complaint against Global Marketing Enterprises Inc., Lifeline Nutrients Corp. and Pronto Foods alleging that they violated the federal Food, Drug and Cosmetic Act.

This act regulates the production and sale of drugs and dietary supplements, including how they are prepared, packaged and labeled.

A settlement was reached on Aug. 3, 2018 against these three Chicago companies, which were accused of selling misbranded dietary supplements and unapproved and misbranded drugs.

The settlement was termed a consent decree of a permanent injunction, essentially a legal agreement between the federal government and the three companies.

In the lawsuit it was claimed that these companies violated federal law by choosing not to label their products as dietary supplements. It also claimed that the dietary supplements were prepared, packaged or stored under conditions that do not meet the Food and Drug Administration’s (FDA) current good manufacturing practice regulations for dietary supplements.

According to the complaint, the misbranded drugs included Berberine HCL Powder Extract plus milk thistle capsules, Berberine HCL Powder Extract and Ampalaya fruit bittermelon powder extract capsules.

The companies advertised the Berberine milk thistle capsules as treatment for Type II diabetes, while they marketed Berberine extract as being able to prevent the growth of certain cancerous tumor cells.

The companies claimed that Ampalaya bittermelon capsules could be used to treat diabetes, kill certain cancer cells and “slow the ability of HIV to injure its genes to human chromosomes.”

The government’s complaint argued that these companies’ claims are not supported by any scientific studies. The settlement reached prevents the companies from manufacturing, selling and distributing misbranded dietary supplements and unapproved and misbranded drugs. The settlement mandates that the companies hire an independent expert to ensure that the companies’ dietary supplements are produced, packaged and stored in compliance with regulations and judicial decree.

United States v. Global Marketing Enterprises Inc., et al., 18-CV-05104.

Kreisman Law Offices has been handling dietary supplement lawsuits, pharmaceutical product liability cases and medical negligence lawsuits for individuals, families and loved ones who have been injured, harmed or killed by the carelessness or negligence of another for more than 40 years, in and around Chicago, Cook County and its surrounding areas, including Schaumburg, Mount Prospect, Prospect Heights, Palatine, Palos Hills, Barrington, South Barrington, South Holland, Blue Island, Rosemont, Richton Park, Deerfield, University Park, Tinley Park, Warrenville, Bartlett, Bensenville, Chicago (Calumet Park, Fulton River District, Gold Coast, Humboldt Park, DePaul University, East Garfield Park, Bronzeville, Bucktown, Wrigleyville, Hyde Park, Back of the Yards, Beverly, Ashburn, Andersonville), Burbank, Justice, Bridgeview and Country Club Hills, Ill.

Kreisman Law Offices obtained a $2 million arbitration/mediation award in a dietary supplement lawsuit.