the gormley files

09 May: The FDA’s DMAA Gamble

By James J. Gormley Courtesy of the SupplySide Community On April 24th, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 companies cautioning them, in the strictest possible terms, that their DMAA (1,3 Dimethylamylamine)-containing products may be considered new dietary ingredients for which notifications have not been submitted and, so, would be adulterated products in violation of…

13 Sep: The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun

September 13, 2011 By James J. Gormley, Vice President and Senior Policy Advisor, Citizens for Health According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies. U.S. Medicare spending is…

23 Aug: What’s old is new again? The FDA takes aim at modern science and innovation

By James Gormley, Senior Policy Advisor, Citizens for Health On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186…

16 Jun: The FDA: A Warning Letter From American Taxpayers

By James J. Gormley From American Chronicle In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to Nutraingredients-usa.com, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.” Vasilos Frankos, Ph.D, outgoing director of the FDA’s Division of…

18 May: Quality: Giving It A Chance

If a U.S. finished product manufacturer vigilantly quarantines ingredient shipments and vigorously tests everything that comes in (from qualified suppliers), if retailers stop stocking those “sexy” but probably spiked products, and if consumers are educated as to how dangerous (and dumb) it is to seek out “too good to be true” products……then we have a chance.