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NDIs—Is everything old new again?

By Loren Israelsen, President, UNPA

On August 11, 2016, the FDA published its latest revised Draft NDI Guidance, which the agency notes is an expanded and clarified version of its 2011 Draft NDI Guidance. The FDA also notes that the dietary supplement industry’s comments and objections have been considered and taken into account.

But, in fact, we have been presented a document that envisions a dietary supplement world quite different from the one we currently live in.

How did we get here? Let’s set the stage for the 22-year saga of NDIs. It is summer 1994. The Dietary Supplement Health and Education Act (DSHEA) has exploded into a heated public and congressional debate. The House and Senate negotiators (senior staff of the Hatch, Harkin, Kennedy, Dingell, Waxman and Richardson offices), together with a small group of industry leaders, are grinding out a final set of issues in hopes of reaching a compromise bill capable of passage by late October.

The stickiest of sticking points was the question of safety, and rightly so. What standard should apply, and would it apply to all dietary ingredients and dietary supplements, or just some? CONTINUE →


Michael Specter  

Tough Talk

By Loren Israelsen, President, UNPA

On the third day of the 2015 NBJ Summit, one featured speaker opened his remarks with something like this: “DSHEA is a stupid law. It should never have passed. It has not helped you, and in fact you blew the one chance you had to show you can be trusted as an industry.” 

Then it went downhill from there.

The Q&A that followed his talk was a painful exercise in watching audience members flame out in attempts to defend DSHEA, defend the industry and to correct the record. No one came away from their turn at the mic unscathed. Despite being factually or historically correct, in that moment it didn’t matter. There would be no prisoners. This had become a simple matter of black and white—You are wrong. You don’t get it. And until you do, it’s only going to get worse for you. CONTINUE →

N.Y. Attorney General Eric Schneiderman

Our O-Ring Opportunity

By Loren Israelsen, President, UNPA

The recent furor over the New York Attorney General (NYAG) investigation of herbal dietary supplements has ignited a public (and private) debate over the regulation of supplements. On time, and as expected, the critics called for changes to DSHEA. The supplement industry protested that the test used by the NYAG was bogus. The bully pulpit power of the establishment press, i.e., the New York Times, was on display, as was the farcical and lobotomized regurgitation of the original NYT story via social media.

Amidst this, many asked, “Where is the FDA?” Nowhere, it seems. The NYAG did not consult FDA in advance of its investigation, and it appears that the agency was content to let all of this play out. This changed with the publication of Dr. Pieter Cohen’s article on BMPEA, which quickly resulted in the issuance of 14 warning letters to companies selling BMPEA. This, in turn, led to the filing of a $200 million defamation lawsuit against the study’s authors by one seller of BMPEA. Along the way, 14 other state’s AGs joined the New York AG in a letter to Congress urging a re-think of DSHEA and recommended other policy changes that even Sen. Durbin has not suggested. Meanwhile, yet other Attorneys General decided to look into this BMPEA matter and confronted major retailers who, in turn, took steps to remove BMPEA from their shelves. CONTINUE →

In Search of Responsible Media

By Frank Lampe, VP, Communications & Industry Relations, UNPA

It’s no secret that the dietary supplement industry continues to be the subject of seemingly endless mainstream media reports about “unregulated” industry; references to “snake oil salesmen”; and “ineffective,” “adulterated” and “unsafe” products, among a host of other transgressions, real or imagined.

You almost can’t open up your email without finding a new negative article, often from supposedly responsible, respected media outlets.

It is clear that the industry, which had to go to Congress to force the Food and Drug Administration to finally create GMPs more than 13 years after passage of the Dietary Supplement Health and Education Act, has issues to resolve in the eyes of legislators, FDA and since February, a pool of state regulators led by New York Attorney General Eric Schneiderman.

UNPA remains resolute in its position that the law isn’t the problem; the problem is a lack of resources and resolve at FDA to enforce the law. But will certain members of Congress stop complaining about industry long enough to champion—and pass—legislation to provide FDA with the funds needed to do its job and weed out irresponsible players? Don’t hold your breath waiting for that one.  CONTINUE →

UNPA releases Arizona State Economic Report

The Grand Canyon State is an emerging powerhouse in the natural health products industry, and sales are expected to reach $3.72 billion by 2020. A downloadable fact sheet is now available!



UNPA is currently updating its Utah Dietary Supplement Directory, a fact-filled resource for anyone interested in the DS industry in Utah, widely considered the epicenter of DS manufacturing. Available Fall 2016.

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