We call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will…
DSHEA Under Fire
By James J. Gormley The ballroom was packed at the Natural Health Research Institute (NHRI) 6th Annual Scientific Symposium in Schaumburg, Illinois on October 28th, as well it should have been not only considering the event title, which was “Cutting Healthcare Costs Through Prevention: Measuring the Efficacy, Safety, and Cost Savings of Dietary Supplements,” but also given the stellar lineup…
Click here to submit yours now! October 6, 2011 Division of Dockets Management (HFA-305) U.S. Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” Dear Commissioner Hamburg: Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft…
September 20, 2011 FOR IMMEDIATE RELEASE Contact: James J. Gormley, VP and Senior Policy Advisor, Citizens for Health Phone: 202.695.2027; email: jamesgormley01@gmail.com Washington, D.C. – Citizens for Health (CFH) today launched an action campaign to join with our 100,000 supporters and the rest of the health freedom movement in opposing the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary…
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…
By James J. Gormley In our August 23rd post, we alerted you to a U.S. Food and Drug Administration (FDA) draft guidance on “new” dietary ingredients. We recommended that our 100,000+ members ask the FDA to withdraw the guidance and to not adopt the policies underpinning the interpretation behind this “guidance” in its review and enforcement activities. In the meantime,…
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…
July 19, 2011 Washington, D.C. – At the end of June, just before the sleepy holiday weekend news cycle, Senator Dick Durbin (D-IL) introduced S. 1310, the Dietary Supplement Labeling Act of 2011. The bill is a response to recent marketing tactics by unscrupulous food companies intended to circumvent Food and Drug Administration (FDA) standards. The most familiar example, and,…
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…
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.