FDA Overreach Threatens New Dietary Ingredients and Supplements

FDA Overreach Threatens New Dietary Ingredients and Supplements

******* Action Alerts For This Campaign ********
stopTell the Congress and the FDA: The Draft Guidance on NDIs is Bad for Consumers
On July 1, the US Food and Drug Administration issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols required by the Dietary Supplement Health and Education Act (DSHEA)—seventeen years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.
Read More>>

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.
Please write to the Committee, thank them for writing the letter, and ask them to encourage their colleagues to raise their voices in agreement.
Read More>>

Read More About Threats to NDI and Supplements:

Will FDA’s “Grandfathered” Ingredients Rule Mean No More Real Vitamin E?
Herbal supplementsOctober 29, 2012Supplements not on an FDA “approved” list could disappear.
Read More>>

Government Releases Report to Justify FDA Pre-Approval of Supplement Claims
supplement labelOctober 9, 2012
They say “stakeholders” have raised concerns about these claims. Could those “stakeholders” possibly be members of the pharmaceutical industry?
Read More>>

ANH-USA and Trade Groups Meet with FDA on New Supplement Guidance
iStock_000000676381XSmallAugust 7, 2012
Agency begins its promised rewrite after a massive grassroots letter-writing campaign.
Read More>>

FDA Breaks Promise on Proposed New Supplement Rules
Vitamin-Herbal-SupplementsMay 1, 2012FDA promised not to enforce the NDI guidance until it was final. Last Friday, they broke that promise.
Read More>>

The “Wild West” of Supplement Safety
DatelineMarch 20, 2012This week, Dateline NBC ran a “shocking exposé” of “dangerous supplements.” We separate fact from fiction.
Read More>>

FDA Isn’t Listening—Time to Turn Up the Heat!
Sign_HereFebruary 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!
Read More>>

FDA Says No to the Senators Who Drafted DSHEA
fdalogodhhsFebruary 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.
Read More>>

Senators Give Supplements a Lifeline
LifelineJanuary 3, 2012
Will it be enough to rein in FDA’s outrageous power grab?
Read More>>

“FDA is Violating Federal Law”–Emord
Respect_for_Law-low-resDecember 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!
Read More>>

A New NDI Bill: It’s a Step in the Right Direction, but There’s Still a Long Way to Go
long-roadNovember 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.
Read More>>

NDI Supplement Guidance is Just a Bait-and-Switch—and Time Is Running Out to Stop It!
FDA LogoOctober 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.
Read More>>

The Threat to Dietary Supplements We Couldn’t Tell You About Last Year
capitolOctober 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.
Read More>>

Details on Our September 8 Call-in Lobby Day
call in lobby dayAugust 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!
Read More>>

ANH-USA Files Emord-Drafted Analysis with FDA that Reveals Cockeyed Assumptions Behind Proposed New Supplement Guidance
bad-economicsAugust 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.
Read More>>

NDI Draft Guidance is a Big, Fat Gift to Big Pharma
iStock_000015707906XSmallAugust 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.
Read More>>

FDA Copies the European Union and Slips In One of its Deadliest Weapons
EU and USJuly 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.
Read More>>

FDA Guidelines a Perversion of Congressional Intent
iStock_000006788919XSmallJuly 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!
Read More>>

They say “stakeholders” have raised concerns about these claims. Could those “stakeholders” possibly be members of the pharmaceutical industry?

Leave a Reply

Your email address will not be published. Required fields are marked *