The U.S. government says that the company, doing business as Enzyme Process International, violated the Federal Food, Drug and Cosmetic Act on multiple occasions and must now come into compliance with the law.
“Dietary supplement makers must abide by federal health and safety requirements,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will work with FDA to vigorously enforce laws meant to protect consumers.”
Company owner Steven D. Roderick and corporate secretary Gorica Blagojevic were also named as defendants in the indictment and agreed to settle the suit and be bound by a consent decree of permanent injunction.
According to the complaint, filed in the U.S. District Court for the District of Arizona, the Food and Drug Administration (FDA) inspected the Global Vitality facility repeatedly – in 2012, 2014, 2016, 2019 and most recently in June and July 2021.
Despite the defendant’s recurring promises to correct deficiencies and a warning letter of non-compliance, the complaint alleged continued violations of current good manufacturing practices (CGMP), relevant food safety standards and hazard prevention measures.
During its visits, the FDA said it observed “dietary supplement CGMP deviations the same or similar to previous observations”, identified “claims indicating products were intended to be used to cure, mitigate, treat or prevent diseases”, and found that “products failed to comply with the labeling requirements for dietary supplements”. The complaint also alleged that a quality control failure at Global Vitality led to a positive test for the bacteria E. coli in one of its products.
Founded in 1988, Global Vitality’s Enzyme Process website offers branded products, custom manufacturing and private labeling at its 25,000-square-foot, FDA registered and inspected, CGMP certified facility, complete with full analytical laboratory, in Chandler, AZ.
In its inspections, the FDA identified multiple violations across products, citing close to 30 products as misbranded for either failing to declare ingredients, bear warning statements, identify parts of plants used, meet nutrition information presentation requirements, list correct serving sizes, identify species of shellfish or include domestic contact information on label.
The FDA also said that Global Vitality crossed the line with disease claims on its supplements Infla-Life 90, Pancreas 523, Candida Stop, Colloidal Silver, Chewable Bovine Colostrum for Kids, Lidtke Medical brand L-Glutamine Gastrointestinal Formula, Pro-Enzymes and Probio-Zyme-YST.
“Protecting the American public’s access to safe and quality-made products is a core function of the FDA’s public health work,” Judith McMeekin, the FDA’s associate commissioner for regulatory affairs, said in a statement issued by the Department of Justice.
She added that the agency will continue to use all regulatory tools available and work with federal law enforcement partners at the Department of Justice to ensure firms meet acceptable regulatory requirements for quality.
Commenting on the injunction, Marc Ullman, of counsel at Rivkin Radler, noted the severity of the good manufacturing practice violations, as well as the E. Coli contamination directly linked to these failures.
“It’s pathetically typical that this is what FDA allows to go on,” he told NutraIngredients-USA. “It’s inexcusable. This kind of regulatory and enforcement neglect harms the industry and creates a public health risk. FDA can have all the rhetoric it wants. The proof is in their allowing this company to operate in violation for years and years."
Path to compliance
To comply with the consent decree, Global Vitality is required to meet a series of reporting and notification requirements within specific time frames. It must also hire independent CMGP and labeling auditors to carry out annual inspections to be submitted to the FDA.
"The decree includes a 'cure' period for certain deviations and provides for prompt judicial review of agency determinations under the decree," Peter Arhangelsky, lead counsel from the Emord & Associates law firm representing Global Vitality, told NutraIngredients-USA. "Global Vitality has the option to petition for termination of the decree after five years of continuous compliance."
The company must also swiftly respond to correct any future compliance failures identified or propose specific alternative actions and timeframes in writing for achieving FDA's objectives. In addition, it must bear the cost of corrective actions, including the expenses associated with expert and FDA monitoring and implementation moving forward.
“It’s very difficult but not impossible for a company to come out of an injunction like this,” Ullman added.
Arhangelsky said that Global Vitality "has for decades operated lawfully as a leading manufacturer of dietary ingredients and dietary supplements" and "looks forward to working with the FDA under the terms of the decree, and it expects many more years of success in this industry."