US Enters Consent Decree with Dietary Supplement Manufacturer

The company entered the consent decree due to its repeated failure to follow current good manufacturing practices, according to FDA.

The United States has entered a consent decree with Triceutical, Inc., a dietary supplement manufacturer based in New York, according to a report from the U.S. Food and Drug Administration. The company's repeated failure to follow good manufacturing practices prompted government action, and the company's president has agreed to stop production and distribution of products due to its violations of the Current Good Manufacturing Practice (cGMP) requirements. The consent decree was officially entered by U.S. District Judge Leonard D. Wexler of the Eastern District on July 8.

FDA will be supervising the company's subsequent recall and destruction of all dietary supplements that were manufactured, prepared, packed, repacked, labeled, held, and distributed since Feb. 6, 2012. The company must bring its manufacturing, packing, repacking, and labeling procedures into compliance with FDA laws and regulations before it can resume production and distribution.

FDA initially issued a warning letter to the company on Nov. 8, 2012. It cited various violations, such as the company's failure to perform tests to verify the identity of dietary ingredients used to manufacture the dietary supplements. FDA's follow-up inspections showed the company failed to take adequate corrective action, rendering the company's products "adulterated under the Federal Food, Drug, and Cosmetic Act," according to FDA.

"When a company violates good manufacturing practice requirements, they put consumers at risk," said Melinda K. Plaisier, FDA's associate commissioner for regulatory affairs. "Our goal at the FDA is to ensure that the dietary supplements consumers have access to meet federal standards for safety, effectiveness and quality."

Product Showcase

  • The MGC Simple Plus

    The MGC Simple Plus

    The MGC Simple Plus is a simple-to-use, portable multi-gas detector that runs continuously for three years without needing to be recharged or routinely calibrated after its initial charge and calibration during manufacturing. The detector reliably tests a worksite’s atmosphere for hydrogen sulfide, carbon monoxide, oxygen and combustible gases (LEL). Additionally, it is durable enough to withstand the harshest treatment and environments, which is why it has an IP 68 rating. The MGC Simple Plus is also compatible with a variety of accessories, such as Gas Clip Technologies’ new GCT External Pump. Visit gascliptech.com for more information. 3

  • Magellan X Pte Ltd

    Hesitate No More with SOL-X Connected Worker Health & Safety Solution

    According to the National Safety Council, work-related medically consulted injuries total 4.26 million in 2021 in USA alone. SOL-X solution prevents “human factors” safety issues by anticipating incidents and improving compliance workflows. Leverages digital technologies (IIoT, AI and analytics) to predict patterns from occurring and make informed decisions. Control Of Work - gets rid of tedious paperwork and experience digital workflows. Crew Protect - maximises safety and situational awareness with health trackers and situational indicators. Award-winning Intrinsically Safe SmartWatch – innovative features that enable near real-time visibility and connected well-being. Works well with major connectivity protocols like Wi-Fi, Bluetooth, and Long-Range Bluetooth! 3

Featured