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A Defining Moment for the Dietary Supplement Industry

By James J. Gormley

The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent  the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”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 potencis 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, an 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=8252) and to FDA Dockets here (https://secure3.convio.net/aahf/site/Advocacy?cmd=display&page=UserAction&id=833),
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.

Written by

Vice President and Senior Policy Advisor of Citizens for Health and a principal of Gormley NPI Consulting, James Gormley served as the Editor-in-Chief of "Better Nutrition" magazine and Editorial Director of the Vitamin Retailer Magazine group. He also served as the Scientific and Regulatory Affairs officer for Nutrition 21 and attended Codex Alimentarius meetings in Paris and Rome. An award-winning blogger and author of six books, including "Health at Gunpoint: The FDA’s Silent War Against Health Freedom," Gormley has been a leading consumer health advocate for nearly 20 years.

15 Responses to “A Defining Moment for the Dietary Supplement Industry”

By edward kenneth - 12 November 2011 Reply

FDA stay away from my whole milk

By Candace Slade - 15 November 2011 Reply

In July, your Agency issued the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” ostensibly to help industry regarding requirements for filing new dietary ingredient (NDI) submissions. I believe the guidance should be summarily withdrawn.

The guidance document makes it clear that your Agency is willfully and grossly misinterpreting the law, especially the Dietary Supplement Health and Education Act of 1994 (DSHEA), with regard to re-defining NDIs and filing submissions for them. Your Agency’s attempt to create new regulatory requirements using a guidance document is also in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law.

Your Agency is attempting to drastically change the law by saying that finished product manufacturers must provide a new submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present.

Furthermore, your Agency is disregarding the law (Section 413 [21 USC §350b] of DSHEA), which says an NDI submission is not required if “there is a history of use or other evidence of safety” supporting its inclusion, use and marketing prior to 1994. Instead your Agency is making NDI submissions product-specific rather than ingredient-specific, which contravenes the spirit and the letter of the law.

For your Agency to claim that newer technologies and improved processing and extraction methods render ingredients as NDIs since these methods were not known prior to 1994 is akin to saying that meat-packing plants should observe the filthy and unhygienic practices that led to today’s modern food-safety system because these antiquated methods were approved and these new processes are different.

The guidance can be expected to cause a major disruption in the dietary supplement market, which will force a significant number of products off the market, result in revenue losses of over a billion dollars and cause the unemployment of over 100,000 Americans, according to some estimates.

Innovation will suffer as well.

The policies behind this guidance would result in “dumbed down” formulations that exclude innovative natural ingredients that may have received objection notices from the FDA. Whole swaths of products could be eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. Further harm would result as a consequence of companies rolling back their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.

The massive impact to the dietary supplement industry and consumers implicit in this document requires, at the very least, an extension of the comment period to July 2012. Ultimately, this guidance should be withdrawn.

American consumers and the dietary supplement industry are not going to quietly accept this unconscionable attempt by your Agency to effectively re-write DSHEA, maim the health-food industry and drastically limit consumers’ options for maintaining their health and wellness.

With respect, I stand with Citizens for Health in calling for you to withdraw this guidance. I further ask you to officially state, for the record, that you will no longer attempt to deviate from the plain and intended meaning of DSHEA.

By Michael - 15 November 2011 Reply

fda should stay out of our business.

By Thomas - 16 November 2011 Reply

The involvement of the government in my right to choose what foods, minerals, herbs or any other dietary supplementg product is not their business. There has been no credible evidence that the health food formulas and ingredients currently being consumed has been anything but helpful to the general public. Stay out of my health care choices. You allow genetic modification of the foods we consume without any concern to the long term effects this has on the worlds health. But when it comes to our right to choose regarding NATUAL SUPPLEMENT choices you play God by trying to dictate what the nation should consume. It appears you are not concerned as to what we eat, but to appeasing those who feed you. Leave our nation alone. My desire to choose what I feel is best for me to consume is part of my right to “pursue happiness” in the way I feel is best for me without effecting the rights or health ot others. Please do the same for me.

By Vanessa Hill - 16 November 2011 Reply

“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.”

Bravo!

By sharon hammersley - 17 November 2011 Reply

The government needs to stay out of the kitchen. Many of the members of congress,senate, etc should give up their daily drinks. We are grown ups, we do not need you telling us not to take a daily vitamin etc. WORK ON JOBS FOR THIS COUNTRY. YOU PEOPLE JUST WANT TO CONTROL LIVES.

By Max Riben - 18 November 2011 Reply

Nutritional supplements have been used safely forever with no deaths and hardly any adverse events reported. Prescription drugs and illegal drugs kill and hospitalize millions. Prescription drugs are dangerous drugs that, theoretically and hopefully, have positive effects, but even under the most strict conditions cause untold adverse side effects and deaths. Illegal drugs may be harmless or dangerous, but would better be treated medically rather than legally to reduce adverse effects through education and regulation rather than through legal enforcement which maximizes legal consequences and does nothing to minimize informed and regulated use. To reclassify nutritional supplements would only create new legal restrictions and increase prices, something that I expect has been stimulating the effort for new legislation, without producing and benefit to the consumer since it would primarily serve to restrict further access to what is already available.

By Ed LeBlanc - 19 November 2011 Reply

Keep the Federal Food Nazis away. All they do is find ways to make us stay ill, spend more money, create themselves more jobs, and harm the people. This is not what my taxes are being paid for. This is not for the common good of the people. Have you tasted the fresh squeezed apple cider before it’s been pasturized? There is a great difference.

If the FDA had its way all food and all supplements would be regulated, poisoned by processing, and all life healing energy removed. They do not want us healthy, they want us dead.

By arlene lyons - 19 November 2011 Reply

there is nothing wrong with whole milk! that choice should be mine! i grew up on it, and i am 70 years old now and with not one blessed drug in my body! had the whole milk been bad, i would be long gone by now i drank so much of it!

[…] reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary […]

By Sign the Petition! - 26 November 2011 Reply

[…] For those who have asked, here is additional information as to WHY this New Dietary Ingredients (NDI… […]

By Claire - 28 November 2011 Reply

Comments on Document ID FDA-2011-D-0376-0002
We do not need added regulation to the supplement industry when the DSHEA of 1994 provides adequate regulation for the supplement industry. Where are the statistics of deaths related to supplements?The death rate related to prescription medication grows every year and yet there is no investigation or legislation pending by the FDA or Congress to create better regulations for pharmaceutical safety. Analysis of CDC 2009 death statistics, the most recent available, showed for the first time ever in the US, more people were killed by legally prescribed drugs than motor vehicle accidents! The public does not want additional regulation of supplements! As a health care professional, I use supplements both personally and with clients who are seeking to improve their health. This new regulation is not needed and will deprive citizens of their legal right to choose their own healthcare. It is a waste of public taxpayer money which should be directed at a known cause of morbidity and mortality such a pharmaceutical drugs. I will be carefully watching the proceedings of this hearing.
Thank you.

By Charles Brown - 28 November 2011 Reply

The involvement of the government in my right to choose what foods, minerals, herbs or any other dietary supplementg product is not their business. There has been no credible evidence that the health food formulas and ingredients currently being consumed has been anything but helpful to the general public. Stay out of my health care choices.

By James Gormley - 29 November 2011 Reply

Dear Mr. Brown,
Thank you so much for your post.
Your health-freedom leadership and accomplishments are an example for us all.
If you could get the word out re the petition to all of your contacts and lists, that would be totally awesome!
Here is the link:
http://www.citizens.org/?p=2809
Thanks again, Mr. Brown!
Best,
James
(James Gormley for Citizens for Health)

[…] reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial reinterpretation of the laws governing dietary […]

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