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Petition Demanding that the FDA Withdraws the NDI Draft Guidance!!

We call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the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in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA.”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The Federal Register states that the New Dietary Ingredient (NDI) Draft Guidance, “when finalized, will represent  the Agency’s current thinking on NDIs and dietary supplements that contain NDIs.”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.

The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun

September 13, 2011

By James J. Gormley,
Vice President and Senior Policy Advisor, Citizens for Health

According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), 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.

I am sure that the FDA 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.

Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.

It is baffling as to why the FDA 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,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.

Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.

Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.

The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being 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. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.

Neither American consumers nor the dietary supplement industry are going to take 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 sitting down.

In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:

I invite all of you to join with and support the critical work being done and about to be rolled out over the coming weeks.

While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.

While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.

Our defining health-freedom battle of the first century of this new millennium has begun.

FDA Must Withdraw NDI Guidance or Extend Comment Period to July 2012

By James J. Gormley

In our August 23rd post, we alerted you to a U.S. Food and Drug Administration (FDA) draft guidance on “new” dietary ingredients. We recommended that our 100,000+ members ask the FDA to withdraw the guidance and to not adopt the policies underpinning the interpretation behind this “guidance” in its review and enforcement activities.

In the meantime, Attorney P. Scott Polisky and Susan Brienza — on behalf of Jarrow Formulas, many members of the natural products industry and consumers who value innovation in their dietary supplements — are asking the FDA to at least extend the comment period for this guidance until July 5th, 2012.

Short of an immediate withdrawal of the guidance, Citizens for Health agrees with Attorney P. Scott Polisky and also with Hyman, Phelps and McNamara, which, in its July 26, 2011 request letter, said that “a one-year comment period is further justified given that there is no apparent and certainly no urgent public health need for a shorter period.”

Indeed, the draft guidance itself ignores the stellar record of supplement safety (vis-à-vis drugs and other FDA-regulated products).

As shown in FDA’s response to a 2006 Freedom of Information Act Request (FOIA) by JFI, in stark contrast to the more than 400,000 annual Adverse Event Reports (AERs) for drugs, there were only 129 non-Ephedra serious AERs for supplements in over 12 years — and six deaths that the FDA, in its 2006 response, found to be “biologically plausible” but not caused by the supplements.

Clearly, as many have noted, dietary supplements are safer than tap water, table salt, aspirin and even food, and it is unlikely that the newly proposed guidelines will make them any safer. Finally, when needed, the FDA has numerous regulatory and enforcement mechanisms (supplement GMPs, import alerts, Physicians Advisories, inspections, mandatory MedWatch reports for serious AERs, etc.) with which to monitor and ensure supplement safety.

Let’s ask the FDA to withdraw the guidance and to assure American consumers that it will not be heading down the road of trying to re-classify hundreds, if not thousands, of safe, historically used ingredients as “new dietary ingredients,” as this could serve as a fatal blow to the dietary supplement industry, especially those companies which feature innovative processes and formulations!

In the meantime, we can buy time by asking them to extend the comment period to July 2012.

What’s old is new again? The FDA takes aim at modern science and innovation

By James Gormley, Senior Policy Advisor, Citizens for Health

On January 4th, 2011, the Food Safety Modernization Act (FSMA) was signed into law. It included a number of requirements, including one that the FDA issue industry guidance as to when companies need to submit New Dietary Ingredient (NDI) notifications to the agency and when they do not, and about 186 calendar days after that, on July 1st, the FDA issued a draft guidance on new dietary ingredients.

What is all this about old and new dietary ingredients? Old dietary ingredients (ODIs) are nutritional ingredients ? herbal extracts and nutrients ? that were sold prior to 1994 and were considered to be “grandfathered in,” and “generally recognized as safe” when NDI submissions were first required, so manufacturers did not need to worry about ingredients that were always in the food supply in foods or food-based supplements.

NDIs, on the other hand, were supposed to be completely new compounds – often hybrids of nutrients – never before seen in nature in exactly that form. Notwithstanding, this itself was always considered a strange requirement, however, since many safe nutrients are often combined with other safe, natural substances that help the mineral or vitamin’s absorption, so how could these benign compounds be considered “new” when compared to products of genetically engineered bacterial fermentation, for example.

So, many companies were advised by legal and industry experts to not submit NDI notifications since the products in question were exempt from the requirements since the individual parts of the compound were considered safe anyway. On top of that, the FDA was rejecting so many NDI submissions on administrative grounds alone that companies understandably began to see the NDI process and non-objection threshold as impenetrable, indeed.

Fast forward to this guidance, which was actually originally mandated in our main dietary supplement law, the Dietary Supplement Health and Education Act of 1994 (or DSHEA), but it has somehow taken the FDA 17 years to get around to it.

The FDA and its apologists are saying that this is no big surprise and has been a long time in the making. Be that as it may, natural products industry organizations have raised a number of important objections to the dangers to innovation posed by this guidance and policy and procedures that may well follow from it.

“We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to DSHEA should remain on the market,” noted the Natural Products Association in a July 6th statement.

As the “decision tree” provided by the FDA with this guidance makes clear, if a new manufacturing process, extraction method or plant part is used, then it is a new dietary ingredient!

This is absurd! This means that if hexane or other harsh solvents were used in the past, and safer solvents are used today that better preserve the integrity of the ingredients (such as grain alcohol or glycerin), that these solvents now render the ingredients as NDIseven though the extracts are closer to what’s growing in the soil than how it was extracted in 1993!

As Steve Mister of the Council for Responsible Nutrition (CRN) said to Nutraingredients-usa.com, “They are trying to freeze industry in 1994 and lock us into extraction processed used 20 years ago.”

The guidance also states that synthetic versions of natural ingredients are also NDIs. What!? Virtually every product sold today includes synthesized, exactly bio-identical versions of what is found in a plant, nut, seed, fruit or soil. We are not talking artificial ingredients here; think vitamin C, as that’s what we’re talking about. If this is followed by FDA, most supplement ingredients and supplements containing them could eventually get their manufacturers slammed with notices of failure to submit a 75-day pre-market NDI notification, likely since most companies have been selling these ingredients and products for 17 years!

Attorney Marc Ullman, of Ullman, Shapiro & Ullman, told Nutraingredients-usa.com that this position on so-called synthetic nutrients is “preposterous, absolute nonsense” and with “no basis in science.”

In addition, the safety testing requirements recommended for NDIs go way beyond anything that could be reasonably required for herbal ingredients and nutrients. These over-the-top standards would be similar to what is required of food additives. It would not provide more safety; it would merely force companies to spend millions on unnecessary tests on ingredients that have been in the food supply for 10,000 years.

According to Ullman in Natural Products Insider, the guidance shows that FDA is taking an “incredibly narrow view of what can be considered a dietary ingredient and an incredibly overbroad view of what would require the submission of an NDI notification.”

What do consumers and retailers need to be aware of regarding this guidance? It is not law, not regulation and not binding . . . however, and this is a biggie . . . it gives a very clear picture of the intent of the FDA to use these side-door and back-door routes to undermine and effectively dismantle DSHEA, the law that protects our right to safe and effective dietary supplements.

If FDA were allowed to interpret the law in this way, it would endanger thousands of products and scores of categories of supplements, extracts and tinctures. The ones that survived would be locked into pre-1994-era processing and manufacturing standards, and innovation would be almost totally blocked, since any new advances used with existing ingredients would require participation in the draconian NDI notification process.

Gormley Take-Away: What do we all need to do? We need to file a comment with the FDA telling them to withdraw this notification as it is an outrageous, and unacceptable, approach to re-classifying hundreds, if not thousands, of safe dietary supplement ingredients. If you agree, let the FDA know that you will not stand for this egregious attempt to roll back the clock on innovation by nearly 20 years, to grievously harm the health food industry and to set the stage for far less choice and for virtually no more cutting edge products going forward.

Dietary Supplement Labeling Bill is No Solution

July 19, 2011

Washington, D.C. – At the end of June, just before the sleepy holiday weekend news cycle, Senator Dick Durbin (D-IL) introduced S. 1310, the Dietary Supplement Labeling Act of 2011. The bill is a response to recent marketing tactics by unscrupulous food companies intended to circumvent Food and Drug Administration (FDA) standards.

The most familiar example, and, apparently the specific reason for the legislation, is the brownies product called Lazy Cakes. Concerned parents made the story national news due to concerns that their children were consuming the brownies while they were unaware that they contained melatonin. The makers of Lazy Cakes, afraid that their profit margin would take a serious blow if they had to add a warning to the product label, decided to re-brand the brownies as “dietary supplements”.

Citizens for Health understands and shares the concern that makers of treats like Lazy Cakes or the plethora of “energy drinks” that have exploded on the market in the last decade are exploiting our system of consumer safety regulations and unethically targeting children with their duplicitous marketing. However, the answer is not directing more scrutiny and placing a greater financial burden on dietary supplement companies whose products have a long-standing, demonstrated track record of safety.

Supplements are not drugs, and therefore, deserve their own system of regulation – and that’s the point. Such a system already exists thanks to the Dietary Supplement Health and Education Act of 1994 (DSHEA), and it has done a more than adequate job protecting consumers largely due to supplement companies’ compliance with, and support of, that system.

S. 1310 grants the FDA and the Institute of Medicine the power to compile a list of dietary ingredients that pose a potential threat. And there’s the rub. What are the measures by which an ingredient will be deemed to pose such a threat? And why give the FDA, an agency that has shown an anti-supplement bias in the past, the power to arbitrarily amass a list of “potentially dangerous” dietary ingredients, especially when there is already a system in place to ensure the safety of supplements?

Besides, the FDA is already overburdened and understaffed, and has enough trouble keeping up with its existing responsibilities for policing pharmaceutical companies in their rush to receive permission to sell their hastily tested, potentially dangerous drugs. Now food companies are resorting to underhanded tactics and masquerading some of their products as supplements as a way of avoiding the FDA regulations intended for them, placing even more pressure on the FDA to do their job. The solution isn’t to investigate supplements and dietary ingredients – it should be to investigate the food companies exploiting the system!

Put simply: At best, S. 1310 is a bad bill, albeit with good intentions. At worst, it uses parents’ fear about what their children are consuming as an excuse to take another crack at imposing unnecessary and redundant regulations on the dietary supplement industry, which has demonstrated time and again its ability to ensure the safety of its products.

More than 150 million Americans use some form of dietary supplement on a daily basis, and this should come as no surprise. Supplements are among the safest products available and are rooted in a wellness-based approach to health. The misguided scrutiny proposed in S. 1301 is better reserved for food companies trying to “play the system” – like the makers of Lazy Cakes – and for pharmaceutical companies whose products are employed as part of a sickness-based approach to health. After all the data demonstrating the potential negative impacts of pharmaceuticals increases daily. Senator Durbin has shown in the past his willingness to preserve our ability to safely access products, like dietary supplements, that contribute to maintaining our health and wellness. We must take this opportunity to respectfully alert him to his error in sponsoring S. 1301 and help him resume his role as a champion of the natural health consumer.

You can stop this bill before it ever has a chance – click here to send a message to your Senators NOW!