The US Food and Drug Administration (FDA) has finalized its guidance to generic drug manufacturers on how to seek drug development information through the controlled correspondence process. The guidance incorporates changes that were part of the reauthorization of the...
To best follow regulations, foods and dietary supplements promoting protein content must document the quality of their protein sources. Comprised of various individual amino acids that define the precious molecule that enables life, proteins vary greatly in what they...
The FDA fired fresh consumer warning on tainted male sex enhancement and weight-loss products sold on Amazon and eBay showcases FDA’s ongoing frustrations with undeclared ingredients, including pharmaceuticals. Despite a long list of warnings over the years about...
The U.S. Supreme Court has settled its fate and denied a petition for a writ of certiorari filed by a supplement manufacturer Hi-Tech Pharmaceuticals and its owner, Jared Wheat. The nation’s highest court has rejected a request to review a case involving the legality...
The owner of a North Carolina-based sports supplement company Musclegen pleaded guilty to selling unapproved drugs and agreed to forfeit the money earned from the illegal business. Selective androgen receptor modulators (SARMs) are drugs under development for...
As COVID-19 drives continued demand for immune booster dietary supplements, new disruptions in the supply chain emphasize the need for quality assurance. The COVID-19 pandemic has been an accelerator for the dietary supplement industry, with sales at record-breaking...
