New Hope 360 Blog

Herbalife suggests refreshing compromise on NDI guidance

RSS

Comments on the NDI Draft Guidance filed by multilevel marketing giant Herbalife suggest some compromises that could make the NDI process smoother, clearer and fairer.

FDA’s issuance of the NDI Draft Guidance document has been a watershed moment for the dietary supplements and functional foods industry, and has occasioned more hand wringing than at any time since before the passage of DSHEA.  In this emotionally charged atmosphere, there have been personal attacks on FDA personnel (yes, I’m talking about Dr. Daniel Fabricant here) and allegations that FDA is trying to subvert the will of Congress.

But cooler heads are coming to the fore, and one of them is John Venardos, vice president, worldwide regulatory and government affairs for multilevel marketing giant Herbalife. Venardos recently submitted comments to FDA on the NDI guidance on behalf of his company. Rather than taking issue with the substance of FDA’s stance, the comments are structured as suggestions for ways in which the guidance could be altered to make the NDI process smoother, clearer and more fair.

“We’re trying to support ways to make the guidance more effective and efficient,” Venardos said.  “We’re not trying to throw the baby out with the bathwater. We want to try to make this guidance to be as good as it can be.”

The comments suggest ways to streamline the NDI filing process, to protect companies’ intellectual property, and advocate a way to create an agreed-upon master list of Old Dietary Ingredients. 

The comments outline a “master file” that could be set up for NDI filings by suppliers. The suppliers could then allow their customers using their new ingredients access to these files containing safety information that has already been vetted by FDA, thus streamlining the process for NDI filings on new products containing NDIs. It’s not mentioned in comments but I’m inferring that such a procedure could significantly cut the cost for those add-on filings. The IP housed in those master files could also be protected via confidentiality agreements.

The comments also suggest further defining the procedure for the actual filings. According the comments, the current procedure is somewhat ambiguous as it relates to when FDA considers a filing complete and the 75-day countdown for the agency’s response begins.

As far as the issue of Old Dietary Ingredients is concerned, the comments envision setting up an 18-month window in which companies could submit documentation on what was being sold in October 1994 so that a master list—agreed upon by both FDA and industry—could be compiled.

All in all, the comments are a refreshing, constructive departure from the tenor of some recent rhetoric. They are in the spirit of recent remarks by Michael McGuffin, president and CEO of the American Herbal Products Association, who has reminded industry on several occasions that FDA has a track record of working with industry to hone the language of guidance documents into something both industry and the agency can live with. The calls for wholesale rewriting of the guidance document and for significant retrenchment on some of its basic assumptions seem doomed to fall upon deaf ears. An attempt to propose a reasonable compromise seems far more promising. Ending up on opposite sides of a negotiating table seems preferable to ending up in court.

Discuss this Blog Entry 5

on Nov 10, 2011

Herbalife's position should be no surprise to anyone. After all, the original author of the NDI Guidance document, Bill Frankos, departed FDA to work for Herbalife. http://www.wholefoodsmagazineonline.com/news/main-news/bill-frankos-reti...

on Nov 11, 2011

The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”

Although this same notice observes that the Guidance is not binding, the U.S. Food and Drug Administration’s (FDA) new dietary supplements’ director and erstwhile industry representative, Daniel Fabricant, PhD, made it clear that the FDA believes that the guidance contains “no surprises” (It, in fact, contains many) and merely provides “clarity” (Yes and no: it makes it clear that the FDA is willfully re-interpreting DSHEA is several key areas but is fuzzy on specifics).

And while Dr. Fabricant and his new employer may persist in believing that the Guidance contains no rabbits pulled out of a proverbial hat, a chief architect and co-author of DSHEA, Sen. Orrin Hatch (R-Utah) is alarmed by the Guidance.

Recently, at least one industry opinion leader has suggested that playing nice with the FDA on the Guidance would be the way out of the NDI quagmire since the FDA supposedly has such a stellar track record of working collaboratively with industry.

Nothing could be further from the truth. Every major victory won by the natural products industry has been always bloody, sometimes ugly and never cordial.

War seldom is.

In 1966, the FDA announced plans that it was going to ban nutrient potencies over the RDAs by reclassifying them as drugs, along with labeling restrictions that would have forbidden the inclusion of any useful information about supplements.

When this, the health-food industry’s, first defining conflict was waged in the late 1960s and 1970s, the battle cry that the great, and recently departed, Max Huberman rallied the industry and consumers around was, “No surrender! No retreat!”

The battle cry was not “Let’s play nice,” of that I can assure you.

In the early 1990s, when the industry and consumers were fed up with FDA raids on health-food stores and efforts by the agency to use food additive provisions of existing law to go after supplements and companies for which the agency bore a deep-seated animus, a dramatic response was needed, and aggressive, coordinated grassroots action was with what consumers and the industry fought back: black, funereal fabric was used to cover dietary supplements in health food stores, a major public service announcement was aired and millions of Americans demanded the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

And we won.

Offering an olive branch to the FDA at the time would have led to the destruction or gutting of the dietary supplements industry before many of us were even a part of it.

So for our industry to offer concessions on the Guidance while the battle has just begun is diametrically opposed to what the greatest debaters have known since the time of Cicero: being unattached to the outcome. Master negotiator Herb Cohen said this often: “I care, I really do … but not that much.”

Modern-day Cicero, Jeff Schneider explains this to mean that whichever party has the greater need to get the deal done is the party that is at a competitive disadvantage. He says that the moment we start making concessions prematurely is the moment we lose our leverage.

“It is unwise to assume that the person [or Agency] you are negotiating with maintains the same commitment to Win-Win outcomes that you have,” writes Schneider. He advises negotiators to “establish your line in the sand. […] You must vow not to cross the established line in the sand for any reason.”

Do those industry experts and pundits applauding accomodationist approaches to the NDI Draft Guidance know that the FDA is not our industry’s friend, and that the agency bears an institutional resentment (some might say hatred) against our marketplace and its products and has shown this since the 1960s with raids, illegal wiretaps, improper seizures and a boatload of adversarial rulings and decisions?

Do those self-appointed savants know that the legal duty of any agency is to solely regulate and enforce according to the law given to it by the American people through Congress, and agencies do not have the power to devise policy and are not allowed to issue regulations or enforce one millimeter outside of the express letter of the law?

They should.

When any agency, in this case the FDA, violates the law by re-interpreting the plain and intended letter and meaning of it, in this case DSHEA, it must be called on it.

We must not stand for side-door efforts to cripple or maim our industry, and we have no obligation to give one inch on this, especially when dealing with an out-of-control agency that is, through stated intent, itself violating the law with which it was entrusted by the American people to uphold.

For those who have not yet taken action on the issue, there are only about 20 days left to so, given the current deadline of December 2nd. Please write to Congress here (http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY...) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserActio...), and circulate these links via all of your consumer, customer and retailer lists.

Let no one in our industry fall victim to the romance of “having a seat at the table” as a representative of the regulated industry.

Because that plate in front of them might well be empty.

on Nov 11, 2011

BTW, that link to Alliance for Natural Health's action on the NDI is here: https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserActio...

on Nov 11, 2011

Excellent response James. It called back a time when the industry came together and initiated a wave, felt so immensely in Washington, that even the "deaf ears" were awakened. Hence, DSHEA was born. I'd love to see Hank Schultz interview James for the counterpoint to this blog article.

on Nov 12, 2011

Please or Register to post comments.

What's New Hope 360 Blog?

Your home for commentary from around the healthy lifestyle industry

Blog Archive