FDA Overreach Threatens New Dietary Ingredients and Supplements
|******* Action Alerts For This Campaign ********|
|Tell the Congress and the FDA: The Draft Guidance on NDIs is Bad for Consumers|
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols required by the Dietary Supplement Health and Education Act (DSHEA)—seventeen years late.
The biggest problem is that this guidance will turn a notification system into an approval system—a terrible precedent that will utterly cut off the supply of nutritional supplements. It will also create such huge barriers for supplement manufacturers that it will be much more difficult and expensive to produce them. But of course, that means consumers would either have to pay much more for nutritional supplements, or else risk not being able to buy them at all if the manufacturer deems them too expensive to produce.
Thank House Committee Members for Taking a Stance on NDI!
Fourteen members of Congress—all of them members of the House Energy and Commerce Committee—wrote to the FDA, raising their concerns about the NDI guidance which threatens our access to supplements. In their letter, they highlighted many of our major concerns about the guidance.
|Read More About Threats to NDI and Supplements:|
|Will FDA’s “Grandfathered” Ingredients Rule Mean No More Real Vitamin E?|
|October 29, 2012Supplements not on an FDA “approved” list could disappear.|
|Government Releases Report to Justify FDA Pre-Approval of Supplement Claims|
|October 9, 2012|
They say “stakeholders” have raised concerns about these claims. Could those “stakeholders” possibly be members of the pharmaceutical industry?
|ANH-USA and Trade Groups Meet with FDA on New Supplement Guidance|
|August 7, 2012|
Agency begins its promised rewrite after a massive grassroots letter-writing campaign.
|FDA Breaks Promise on Proposed New Supplement Rules|
|May 1, 2012FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.|
|The “Wild West” of Supplement Safety|
|March 20, 2012This week, Dateline NBC ran a “shocking exposé” of “dangerous supplements.” We separate fact from fiction.|
|FDA Isn’t Listening—Time to Turn Up the Heat!|
|February 14, 2012|
A champion of supplements in the House sends a warning to FDA. Persuade others in Congress to join him with our Action Alert!
|FDA Says No to the Senators Who Drafted DSHEA|
|February 7, 2012|
According to our sources, the rogue agency is digging in its heels on the NDI draft guidance that threatens so many supplements, refusing to listen to Congress or follow the intent of the law.
|Senators Give Supplements a Lifeline|
|January 3, 2012|
Will it be enough to rein in FDA’s outrageous power grab?
|“FDA is Violating Federal Law”–Emord|
|December 6, 2011|
Bolstered by a massive outpouring of support from you, we are asking the agency to withdraw its New Dietary Ingredient (NDI) draft guidance completely!
|A New NDI Bill: It’s a Step in the Right Direction, but There’s Still a Long Way to Go|
|November 14, 2011|
FDA’s disastrous supplement guidance, which threatens thousands of supplements, would be greatly improved by a new bill in the House. But it isn’t enough.
|NDI Supplement Guidance is Just a Bait-and-Switch—and Time Is Running Out to Stop It!|
|October 25, 2011|
Only 38 more days to tell FDA and Congress that the proposed rules for supplements could lead to the elimination of thousands of supplements and make the surviving ones much more expensive.
|The Threat to Dietary Supplements We Couldn’t Tell You About Last Year|
|October 4, 2011|
ANH-USA is always working behind the scenes in Washington on your behalf. But sometimes we can’t shout it from the rooftops.
|Details on Our September 8 Call-in Lobby Day|
|August 30, 2011|
We need to ask Congress to review the FDA’s absurd claims and carefully watch over the FDA’s draft NDI (supplement) guidance process. Please join us in this nationwide campaign!
|ANH-USA Files Emord-Drafted Analysis with FDA that Reveals Cockeyed Assumptions Behind Proposed New Supplement Guidance|
|August 23, 2011|
The FDA says all new supplements since 1994 must be approved, but this will result in only 55 new applications. Huh? Experts predict as many as 125,000, and sale of these supplements will be illegal while the FDA decides what to do with them all.
|NDI Draft Guidance is a Big, Fat Gift to Big Pharma|
|August 2, 2011|
Want to let the drug industry take your favorite supplements off the market, patent them, and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now? A follow-up to our recent Action Alert.
|FDA Copies the European Union and Slips In One of its Deadliest Weapons|
|July 26, 2011|
Are the NDI guidelines the ultimate FDA tool to freeze dietary supplement innovation? A special report by Robert Verkerk, PhD, ANH-USA Scientific Director and ANH-Europe Executive and Scientific Director.
|FDA Guidelines a Perversion of Congressional Intent|
|July 12, 2011|
The FDA is trying to turn a simple notification system for new supplements into a totally arbitrary approval system. Let’s tell the FDA that supplements are not drugs and ask Congress for help!