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10,000 Americans Tell FDA: Withdraw the “NDI Draft Guidance”!!

By James J. Gormley

WE DID IT!

WASHINGTON, DC – On December 2nd, representatives from Citizens for Health (a non-profit health advocacy group with over 100,000 supporters) will deliver a petition to The United States House of Representatives, The United States Senate, the U.S. Food and Drug Administration (FDA) and President Barack Obama signed by 10,320 Americans, calling for the FDA’s outrageously anti-supplement and anti-consumer NDI Draft Guidance to be summarily withdrawn.

This history-making petition drive, one which generated well over 10,000 signatures in under 10 days, received support and inspiration from many sources, including New Zealand truth rapper and activist Jody Lloyd, aka “Trillion,” whose re-mastering of CFH’s “10,000 Signatures” video for YouTube helped inspire and activate thousands of health-freedom-conscious Americans to “Sign the Petition” (watch the video here: http://youtu.be/3knIwX09d9Y).

In July the FDA issued its “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (what is called the “NDI Draft Guidance”). The agency issued the guidance purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.

However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present. If this guidance is not withdrawn and its misinterpretation of law is backed by the FDA’s own policy, review and enforcement powers, it would cause major disruption in the dietary supplement market; force a significant number of products off the shelves; and, say estimates from Emory University, result in revenue losses of over a billion dollars and the unemployment of over 100,000 Americans.

Neither American consumers nor the dietary supplement industry will stand for this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.

That is why Citizens for Health supporters are calling on Congress and the President to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Citizens for Health and its army of supporters were aided by, and would like to thank, many liberty-loving people and organizations, including (but not limited to): Suzanne Somers (Actress); Michael Schoor and William Schoor (Essential Formulas); Bob Barrows, Jr. (Bluebonnet Nutrition); Charles Brown (Consumers for Dental Choice); Dr. Betty Martini (Mission Possible World Health International); Alliance for Natural Health; Living Naturally; Gary Null; “The Power Hour With Joyce Riley”; “Tunies Friday Health Line Show”; Michael Ostrolenk (The Liberty Coalition and Campaign for Liberty); Bill Sardi; Martie Whittekin (Healthy By Nature radio show); Wayne Gorsek; and Mary F. Christopher.

 To read the petition go to: http://tinyurl.com/ndi-petition.

END – ###

About Citizens for Health: Citizens for Health, one of the nation’s oldest and most respected consumer action groups. Citizens for Health is a non-profit organization that provides over 100,000 supporters with consumer news, action alerts, and ways to demand access to healthy food, non-toxic products, and truthful, non-misleading health information.  More information is available at www.citizens.org.

Sign the Petition! Time to Knock It Out of the Park!

By James J. Gormley

After a brief technical snafu, our PETITION is once again operational…….our apologies to all who tried to add their name but could not since midnight. But it is working again, so please try again to sign if you tried last night!!

CLICK HERE to add your name to the petition!

WE NOW BROKE 9,OOOPETITION SIGNATURES!!!  We’re now at 9,808 signatures!!

A few days ago it seemed like a far-fetched, impossible goal: 10,000 petition signatures in 10 days! What organization could possibly do that!? Well, Citizens for Health supporters are on the road to doing JUST that!

For those who have asked, here is additional information as to WHY this New Dietary Ingredients (NDI) Draft Guidance is so bad.

As of this writing, 1:51 PM EST on November 30th we have 9,808 signatures and counting!! Thank you to all who signed the petition!!!

That being said, we’re at 98% of our goal and we have  ONE AND ONE-HALF DAYS LEFT to make history.

Click here to add your name!

We need to take it to the streets. To our e-mail address books. To our Facebook friends. To our LinkedIn connections. To our Twitter followers as well!

So…………to make that even easier, here is the link to “SIGN THE PETITION.”

…and here is the link to the video.

Now is the time for righteous indignation, so let’s express that indignation by sending in a massive boatload of petition signatures this week!

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Media May Kill Vitamins

Submitted as a guest editorial by Suzanne Jenkins, November 20, 2011

What happened to the media that investigates and reports both sides of the story? The practice of denigrating dietary supplements and raising public concern over “safety” has been elevated to an art form by the media. Sound bites and articles with such titles as, “Vitamins May Kill Elderly Americans,” ignore the number of documented deaths caused by prescription drugs. Without both sides of the story, media is playing with half a deck – when this happens in oppressed countries, we call it propaganda.

The current rant over the safety of dietary supplements is really not about safety. Lack of “safety” is being touted as the main reason supplements are under siege. However, ignored by the media is the Adverse Events Reporting System (AERS) of the Food and Drug Administration (FDA), which contains over 4 million adverse events reported from 1969 to the present for FDA approved drugs. From 2000 to 2009, the FDA AERS received 370,056 reports of deaths and 2,345,066 reports of serious patient outcomes from FDA approved drugs, NOT from dietary supplements. Eleven years ago on July 26, 2000, the Journal of the American Medical Association (JAMA) reported that behind heart disease and cancer, ­­­­American medicine was the 3rd leading cause of death.

The study inspiring the media to create confusion, “Dietary Supplements and Mortality Rate in Older Women: The Iowa Women’s Health Study,” was observational and not the double-blind placebo gold standard with controls on every test component. Doctors and scientists know that an observational study based on a self-reporting questionnaire does not prove cause and effect – but the reader wouldn’t know that from a flamboyant title that indicates sensationalism is more important than substance. Studies like these look for clues that should then lead to further research. They are not designed to be used to guide clinical medicine or public health recommendations.

The value of using dietary supplements to improve the health of the elderly, as well as the health of other sectors of the population, has been confirmed in published studies. The Lewin Group is a health care consulting firm that does policy research and data analysis on Medicare, etc. In their study, “A Study of the Cost Effects of Daily Multivitamins on Older Adults,” the Lewin Group summarized that “given the available evidence, we conclude that daily multivitamins can be beneficial for older adults. Because suboptimal nutrient intake has been linked to chronic disease, the risk from not taking a multivitamin outweighs the minimal risks of taking one.”

Various think tanks have determined that a significant number of older Americans are deficient in vitamins and trace elements and could benefit from taking a multivitamin. A study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction,” commissioned by the Dietary Supplement Education Alliance and updated in 2007, found that taking four specific supplements could reduce health care cost by over $24 billion.

Reviews supporting the use of nutritional supplements have appeared in both JAMA and The New England Journal of Medicine. Some people, due to age, genetic predisposition, environmental insult, lifestyle choices, disability, or disease, have a heightened requirement for dietary supplements.

Media cannot fulfill its obligation to the public when the only source of information considered originates from government, corporations that represent conventional medicine, or sectors that serve both. Media shapes public opinion about dietary supplements with information coming from entities representing only the conventional standard of care model. The Feds, pharmaceutical industry, and media make interesting bedfellows. What we have is mainstream corporate journalism devoted to official positions.

The purpose of thorough and unbiased investigational reporting is to empower the public to deal intelligently with information.  Besides knowing where and when a medical study took place, reporters need to ask critical questions and provide the people they serve with answers to the following:

  • Who funded the study?
  • What was the original purpose of the study?
  • What substances were tested (types and dosages)?
  • Did the research involve combinations of nutrients?
  • Was the research on isolated components only?
  • In the case of hormones, were they synthetic or compounded bio-identical hormones?
  • What type of study was it (observational or double-blind placebo)?
  • What was the outcome of the study?
  • Whose health stands to benefit from the outcome?
  • Who stands to profit monetarily from the outcome?
  • Were physician/researchers from ACAM (American College for   Advancement in Medicine) or other scientists without financial ties asked to comment on the study?

To connect the dots, the media has to recognize itself as a significant part of the health care problem in the U.S. Since the media shapes public opinion, special interest groups will continue to use the media to discredit dietary supplements and ultimately make them ineffective or unavailable to the public in the over-the-counter manner we enjoy now. Does the media want conventional medicine, with its heavy reliance on expensive physician-dispensed prescription drugs, to be the only game in town? Media must not offer a Trojan horse to a public that relies on it to be impartial and knowledgeable enough to report both sides of the story.

10,000 Signatures in 10 Days; We Can Do It!

By James J. Gormley

With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI (New Dietary Ingredient) Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petition signatures in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.

To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!

Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!

Petition Demanding that the FDA Withdraws the NDI Draft Guidance!!

We call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

That’s why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:

“I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA.”

Will you sign this petition? Click below:

Sign the petition now!

Thanks!

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.

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NHRI Chicago Symposium Heralds A New Era for Dietary Supplements

By James J. Gormley

The ballroom was packed at the Natural Health  Research Institute (NHRI) 6th Annual Scientific Symposium in Schaumburg, Illinois on October 28th, as well it should have been not only considering the event title, which was “Cutting Healthcare Costs Through Prevention: Measuring the Efficacy, Safety, and Cost Savings of Dietary Supplements,” but also given the stellar lineup of world-class experts.

The speakers were:
Meg Jordan, PhD, RN, Department Chair and Professor of Integrative Health Studies at the California Institute of Integral Studies, and Director of Integrative Practice at the Health Medicine Institute;
Mark Blumenthal, Founder and Executive Director of the American Botanical Council (ABC) and Founding Member of the American Herbal Products Association (AHPA)
Allen Dobson, PhD, Health Economist and President of Dobson DaVanzo and Associates;
Artemis Simopoulos, MD, Founder and President of the Center for Genetics, Nutrition and Health; and
Russell Jaffe, MD, PhD, Fellow of the Health Studies Collegium and Founder of PERQUE.

Dr. Jordan, whose presentation was entitled “Let Sanity Reign: The Undeniable Health-Wealth Connection for a Happier, Healthier Society,” electrified the audience with what could have been an indictment of how unhealthy the U.S. is but, instead, pointed the ways we can build a well-being society that takes into account: spirituality, nutrition-food, physical health, social belonging, intimacy and love, financial well-being and occupation-livelihood.

Mark Blumenthal’s talk was entitled: “Review of Safety and Benefits of Numerous Herns and Phytomedicinal Dietary Supplements as Demonstrated by Systematic Reviews and Meta-Analyses of Controlled Clinical Trials.” Mr. Blumenthal stunned many attendees with the statement that over a 3-year period, the annual number of herbal medicine papers rose from 739 in 1977 to 6,364 in 2007, most of which were scientific reviews and randomized controlled trials. He compared thenumber of studies with the imbalanced, typicaly negative coverage of herbal studies by the mainstream press, especially noticeable in journals that have the highest ratio of pharmaceutical ads, and reviewed the worldwide research on a wide range of medicinal plants.

Dr. Dobson’s presentation, “Discussion of Methods Used to Study the Reduction in Health Care Cost Through Dietary Supplements,” reviewed the billions of dollars in healthcare savings that could be achieved by widespread public-health promotion of a number of nutrients (including: calcium with vitamin D; folic acid; omega-3 fats; and lutein with zeaxanthin). Of great interest to many in attendance, he punched a number of holes in the recent multivitamin and vitamin E studies that have achieved such infamy.

Dr. Simopoulos’ talk was entitled: “Economic and Health Implications of Changing America’s Oil: The Omega-3 Opportunity.” She outlines the many downsides of the dramatic decrease in omega-3 fat consumption over the past 150 years due to agribusiness and food processing and the reasons why it is utterly imperative that we, as a society, significantly increase our consumption of omega-3 fats and decrease our intake of omega-6 fats.

Dr. Jaffe closed out the presentations with a talk entitled, “Evidence of Savings Through Application of Supplements to Treat Dietary Deficiencies.” He explained how by our correcting essential nutrient deficits relating to diabetes alone could save $135 billion each year, and that supplements for other health areas can save America an additional $50-100 billion annually, all while improving quality of life.

With the event having been organized by the NHRI and the American Nutrition Association, the NHRI is an independent, non-profit organization that supports science-based research on natural health and wellness. It is “committed to informing consumers, scientists, the media, policymakers and legislators about scientific evidence on the efficacy and cost-effectiveness of diet, supplements and a healthy lifestyle in order to improve health and wellness, and reduce disease, around the world.”

Millions of American Consumers are Food Identity Theft Victims

 Food Packaging Deceptions Threaten National Food Integrity

 

FOR IMMEDIATE RELEASE

Primary Media Contact:
Kevin Sanchez                                                          
Hollenbeck Associates                                              
(415) 227-1150 ext. 10                                                   
kevin@hollenbeckassociates.com

 

WASHINGTON, DC – Even as more American families are trying to make healthier diet choices, many duplicitous food makers are contributing to the spread of Food Identity Theft.  Despite government safeguards and restrictions, dozens of food producers are misleading consumers with deceptive packaging or attempting to conceal questionable ingredients on labels.

While some of the deceptions are subtle, others are much more serious. Some make claims that are simply untrue, while others are in direct violation of Food & Drug Administration policies. Food Identity Theft issues include:

  • High Fructose Corn Syrup trying to change its name to “corn sugar” in order to conceal itself from consumers;
  • “Blueberry” muffin mixes, breakfast cereals and pastry products that have absolutely no blueberries in them;
  • Spaghetti sauces “Made from California Vine-ripened Tomatoes” that are made using industrial tomato concentrate (tomato paste and water).

“These companies are knowingly trying to pull a con on American families,” said Jim Turner, who chairs the non-profit consumer protection group, Citizens for Health. “We have the right to know what’s in the products we’re buying, and that means clear, accurate, and truthful package labeling.”

Citizens for Health has launched a new website, www.FoodIdentityTheft.com, to alert consumers about these deceptive practices. With important information, links to the latest news stories, videos, and regulatory updates, site visitors will be aware of the most flagrant Food Identity Theft culprits.

Numerous consumer action groups, including the National Consumer League, the Consumer Federation of America, and the Center for Food Safety, have all publicly denounced Food Identity Theft deceptions.  Many businesses, including Whole Foods Markets, Jason’s Deli and Stonyfield Farm, actively support truth in food labeling practices.

“Americans who want to eat healthier need to know that companies like Betty Crocker, Smucker’s, Kellogg’s, Contadina and General Mills, and trade groups like the Corn Refiners Association, are attempting to mislead them on food package labels,” said Linda Bonvie, Senior Editor at FoodIdentityTheft.com.

About Citizens for Health

Funded by concerned consumers, non-profit partners, food growers, and businesses, Citizens for Health is a non-profit organization that provides over 100,000 supporters with consumer news, action alerts, and ways to demand access to healthy food, non-toxic products, and truthful, non-misleading health information.  More information is available at www.citizens.org.

For more information, or to arrange an interview with a representative from Citizens for Health, please contact Kevin Sanchez of Hollenbeck Associates at 415-227-1150 ext 110 or kevin@hollenbeckassociates.com.

 

CFH Submits Its NDI Comments to the FDA

Click here to submit yours now!

October 6, 2011

Division of Dockets Management
(HFA-305)
U.S. Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

Re: Docket No. FDA-2011-D-0376, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

Dear Commissioner Hamburg:

Citizens for Health (CFH) is hereby submitting its organizational comments on the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”

CFH and its over 100,000 supporters call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit and letter of DSHEA.

BACKGROUND

According to a July 7, 2011 report from your Agency, Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.

U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.

With this as a backdrop, we are certain that your Agency is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone – calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) – could reduce healthcare costs by over $24 billion.

These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on – it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.

THIS GUIDANCE DOCUMENT

Therefore, it is mystifying to us, and to many others, why your Agency would endeavor, 17 years after the passage of DSHEA, to re-interpret the laws governing dietary supplements as evident in this Draft Guidance.

It is likewise baffling as to why your Agency would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” and “what is a new dietary ingredient,” for example, as bases for what is obvious is your new and intended supplement and ingredient review and enforcement position.

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

Your Agency is in disregard of 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 proposing that NDI submissions be product-specific rather than ingredient-specific, which contravenes the spirit and the letter of the law.

For your Agency to assert that newer technologies and improved processing and extraction methods would 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 then and these new processes are different.

Review and enforcement based on the re-interpretation of DSHEA expressed in the guidance would be expected to cause major disruption in the dietary supplement market, forcing a significant number of products off the market, resulting, according to estimates by a leading economist cited by another commenter, in revenue losses of over $1 billion dollars and causing the unemployment of over 100,000 Americans.

In the area of innovation, the direct result of policies behind this guidance would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from your Agency.

The American people would be harmed by the market and access implications within this document.

The harm would come from whole swaths of products and categories (such as probiotics) being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, or even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already known to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994. The harm would come from reduced consumer health in America as innovative, high-quality dietary supplements are removed from shelves or never see the light of day.

Your Agency’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law on the basis of this alone.

CONCLUSION

Neither American consumers nor the dietary supplement industry are going to stand for this unconscionable attempt by your Agency to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice.

We call on your Agency to summarily withdraw this Draft Guidance and go on the record stating that the FDA will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in this document but, instead, will honor the law that the American people gave to your Agency to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

Sincerely,

James S. Turner, Esq.
Chair
Citizens for Health
jim@swankin-turner.com

James J. Gormley
Vice President and Sr. Policy Advisor
Citizens for Health
jamesgormley01@gmail.com

Citizens for Health Launches Campaign Against FDA’s NDI Guidance

September 20, 2011

FOR IMMEDIATE RELEASE

Contact: James J. Gormley, VP and Senior Policy Advisor, Citizens for Health
Phone: 202.695.2027; email: jamesgormley01@gmail.com

Washington, D.C. – Citizens for Health (CFH) today launched an action campaign to join with our 100,000 supporters and the rest of the health freedom movement in opposing the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”. The agency issued the guidance, mandated by the food “safety” law passed earlier this year, in July, purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.

However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present.

James Gormley, Vice President and Senior Policy Advisor for CFH, notes:

“Quite simply, the FDA is ignoring Section 413 [21 USC §350b] of the Dietary Supplement Health and Education Act of 1994 (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. Essentially, the FDA is making NDI submissions product-specific rather than ingredient-specific, which contravenes the spirit and the letter of DSHEA.”

Gormley adds:

“In addition, the FDA’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and is in violation of the law on the basis of this alone.”

While much has been written regarding the FDA’s guidance since its introduction, CFH made a strategic decision to “let the dust settle” and do a thorough analysis before adding its voice to the clamor for its withdrawal, given the massive impact to the dietary supplement industry implicit in the guidance. CFH is also calling for the comment period to be extended to July, 2012 so that more industry and policy experts, as well as the public, can be sufficiently heard on the issue. (Industry leaders have succeeded in pressuring the FDA to extend the comment period once already, until December of this year).

Click here to send a letter urging Congress to put pressure on the FDA to withdraw the guidance.

In the coming days and weeks CFH will offer further analysis and talking points on the guidance, as well as opportunities to take action. In fact, CFH will be conferring with consumer advocates and health-food industry leaders this Friday at the Natural Products Expo East trade show in a meeting sponsored by Jarrow Formulas, Inc.

CFH asks you to join them, industry leaders, the health freedom community and concerned Americans everywhere in the campaign to get the guidance withdrawn. Furthermore, ask Congress to rebuke the FDA and demand that the agency state, for the record, that they will no longer attempt to deviate from the plain and intended meaning of DSHEA.