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Book Trailer for "Health at Gunpoint: The FDA's Silent War Against Health Freedom"

Health at Gunpoint: The FDA's Silent War Against Health-Freedom

By James J. Gormley

What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?

These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.

The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.

In Health at Gunpoint, I present a history of both the natural foods movement and of this over-reaching Federal agency and examine how the agency has changed over the years. I then look at the FDA's most controversial decisions and the troubling reasons behind them.

Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?

Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint not only sheds light on what is happening, but also explains what you can do about it.

In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.

Health at Gunpoint will help prepare you for the coming fight.

Children Are Not Little Adults

By James J. Gormley
Courtesy of the SupplySide Community

One of my back-to-school memories in the late-1960s and early 1970s was going to the five-and-dime with my mother and choosing brand-new marble “composition pads” and #2 pencils. 

A 1970s-era ad ... the thinking has changed since then.

Although I preferred Jules Verne to geometry --- and really “digged” my summer vacations --- I was still psyched at the beginning of each new school year. I think it had something to do with the seemingly infinite possibilities for learning and success, fun and friendship. A clean slate (or blackboard).

Today, not every child has it as seemingly worry-free as that, unfortunately. In 2007, 5.4 million American children aged four to 17 were reported to have attention deficit hyperactivity disorder (ADHD) and, of these, over half of that number were being medicated for this disorder. In addition to that, autism afflicts more than 2 million people, the incidence of which increased 172 percent in the 1990s.

Artificial additives are linked to ADHD and, in addition, one of many contributing factors to this developmental disability is believed to be mercury exposure, including the historical use of thimerosal in vaccines.

According to Robert F. Kennedy, Jr., in a 2005 Rolling Stone article, “The FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen.” In 2012, thimerosal is still being used in vaccines.

Kennedy added: “If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children [with thimerosal], their actions arguably constitute one of the biggest scandals in the annals of American medicine.”

And as if things were not challenging enough for children without even considering exposure to toxins, the Federal Interagency Forum on Child and Family Statistics noted that the percentage of overweight children aged six to 17 years between 1976-1980 and 2003-2004 has gone from 5.7 to nearly 17 percent; in addition, 2 million adolescents (or 1 in 6 overweight adolescents) aged 12 to 19 have pre-diabetes, according to the American Diabetes Association.

There are, however, some indications of improvement in the lives of American kids. The percentage of children living in households classified as “food insecure” has gone down and educational attainment in high school is improving, noted the Forum.

One thing much better today for kids is the variety of dietary supplement options, from multivitamins to immune-boosters to omega-3s and more. Not only is the selection better in health-food stores but so is the manufacturers’ focus on including natural-source ingredients and excluding what I would have called “yucky” but my kids would probably call “nasty” artificial colors, flavors, binders, excipients and preservatives.

As customers visit retailers looking for healthy snacks, yogurt smoothies and kids’ vitamins, retailers can serve as an island refuge in a sometimes scary ocean of supermarkets and mass market behemoths.

Armed with good information, high-quality products and trustworthy guidance, you can help your end-user customers genuinely help their children.

In the meantime, the kids can get back to perhaps avoiding geometry and reading Jules Verne’s Journey to the Centre of the Earth, er … or would that be The Hunger Games?

Note: The title for this piece came from an ad I found (manufacturer name and ad copy cropped out) from July 23rd, 1978, subtitled: “Because Children Are Little Adults.” Of course, kids have different metabolisms and nutritional needs over and above the fact that they may be 25 to 50% less heavy than an adult, but this was the thinking in the late-1970s!

Hershey Will Offer Certified Chocolate Following Consumer-Driven Campaign

Company announces new commitment to buying Rainforest Alliance certified cocoa after hearing from over 100,000 consumers; takes first step to addressing child labor

WASHINGTON, D.C.///February 1, 2012/// The Hershey Company announced yesterday that it will make its first commitment to sourcing independently certified cocoa for its Bliss line by the end of 2012. The announcement was made days before International Labor Right Forum was scheduled to run a Super Bowl ad highlighting Hershey’s use of child labor and follows a multi-year campaign that generated over 100,000 letters to Hershey, including from 50,000 supporters on Change.org asking Hershey to improve its cocoa sourcing practices.

The “Raise the Bar, Hershey! Coalition”, a group of responsible cocoa advocates led by Global Exchange, Green America, and International Labor Rights Forum, started the campaign after identifying Hershey as behind its competitors on addressing child labor, forced labor, and other abuses in the cocoa industry.

"We are heartened to see Hershey's taking this first step towards accountability in their supply chain and we will continue to dialogue with them about how to ensure they no longer depend on forced child labor," said Judy Gearhart, executive director of the International Labor Rights Forum. "The threat of a Super Bowl ad forced the announcement, but Hershey’s new moves are really the result of thousands of consumers, students, church congregations and community groups writing to them over the past two years.”

The Raise the Bar, Hershey Coalition has been increasing pressure on Hershey, including launching a petition on Change.org, creating “brand-jamming” photos and videos of Hershey products, blanketing the company’s Facebook wall in messages, organizing rallies at Hershey flagship stores, and delivering more than 100,000 letters from concerned consumers to Hershey’s corporate headquarters on Halloween.

“The Raise the Bar, Hershey! Coalition is excited to see Hershey listening to consumer demand for ethically sourced cocoa,” said Elizabeth O’Connell, fair trade campaigns director for Green America, “but we also recognize there is much more work to be done to fight child labor and other abuses in the cocoa industry, and we will continue to encourage Hershey to develop ethical sourcing practices.”

“The growth and ultimate success of Raise the Bar, Hershey’s petition on Change.org is incredible,” said Change.org Director of Organizing Amanda Kloer. “Hershey responded to consumer pressure with a significant improvement in cocoa sourcing transparency. It has been empowering to watch this group of concerned organizations and individuals use Change.org’s tools to fight for changes at the Hershey Company.”  

In response to Hershey’s announcement, eighth grader Jasper Perry-Anderson has created a follow-up campaign on Change.org asking the Hershey Trust to ensure the Hershey Company expands its commitment to certified cocoa to all its products in the future.

Journalists interested in contacting Hershey’s public relations staff should try:

Andy McCormick, Vice President, Public Affairs
717-534-5739
anccormick@hersheys.com

Kirk Saville, Spokesperson
800-468-1714
ksaville@hersheys.com

The Raise the Bar, Hershey! Coalition is led by the following organizations:

GREEN AMERICA is the nation’s leading green economy organization. Founded in 1982, Green America (formerly Co-op America) provides the economic strategies, organizing power and practical tools for businesses and individuals to solve today's social and environmental problems. http://www.GreenAmerica.org

GLOBAL EXCHANGE is a membership-based international human rights organization dedicated to promoting social, economic and environmental justice around the world.http://www.GlobalExchange.org

INTERNATIONAL LABOR RIGHTS FORUM is an advocacy organization dedicated to achieving just and humane treatment for workers worldwide.http://www.LaborRights.org

ABOUT CHANGE.ORG

Change.org is the world’s fastest-growing platform for social change — growing by more than 500,000 new members a month, and empowering millions of people to start, join, and win campaigns for social change in their community, city and country. For more information on Change.org, please visit: http://www.change.org/about

Jarrow Formulas Challenges FDA on NDIs With 128-Item Freedom of Informatio​n Request

By Stephen Daniells

From Nutraingredients-USA.

California-based Jarrow Formulas has submitted a 128-item Freedom of Information [Act] Request to the U.S. FDA with questions it deems "vital" to any comments it seeks to file in response to the New Dietary Ingredient (NDI) draft guidance.

The Freedom of Information [Act] Request (FOIA) seeks clarification on the potential impact of the draft guidance on a number of topics, including economic, business and public health, the costs of testing and costs of actual notifications, safety issues and probiotics.

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Norman R. Farnsworth, Renowned Medicinal Plant Researcher, Dies at 81

From American Botanical Council

Renowned pharmacognosist and internationally-respected medicinal plant research expert, Norman R. Farnsworth, PhD, died on September 10 at a Chicago hospital. He was 81 and had been in declining health for months, suffering from long-term congestive heart failure and type 2 diabetes.

Dr. Farnsworth was born on March 23, 1930 in Massachusetts. Norman Farnsworth was a veteran of the Korean War, drafted in the US Army at age 18 in 1949. PFC Farnsworth served in the Third Infantry Division, Seventh Regimental Combat Team. Although he was seriously wounded in the winter of 1950, Farnsworth survived. Corporal Farnsworth was awarded the Korean Ribbon with Four Battle Stars, the Combat Medical Badge, and Bronze Star with a "V" device.

He received his degree in pharmacy from the Massachusetts College of Pharmacy in 1953 and his PhD in pharmacognosy, the study of drugs from natural origins (including medicinal plants, microbes, marine organisms, and fungi), from the University of Pittsburgh in 1959. At Pitt, he helped to institute a pharmacognosy PhD program at the university and was the first to chair it.
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FDA Extends NDI Draft Guidance Comment Period by 60 Days

Adapted from Natural Products INSIDER

FDA extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA to extend the comment period by 45 days.


NPA, along with the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) , the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) requested a 45-day extension for comments, asking for a deadline of Nov. 17, 2011.

Last week, Jarrow Formulas, a dietary supplement company, requested FDA extend the comment period by one year; however, FDA chose to extend the comment period by an additional two months.

The original 90-day deadline for comments regarding FDA’s “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was Oct. 3, 2011.
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Trade Associations: 45-Day NDI Draft Guidance Extension Request Reasonable

From Nutraingredients-USA

By Stephen Daniells

Spokespeople from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA) were responding to requests from other quarters of the industry to extend the comment period from 90 days to one year.

Last week, supplement manufacturer Jarrow Formulas added its voice to those of an initial request on July 26, 2011 by law firm Hyman, Phelps and McNamara, P.C. to extend the comment [period] until July 5, 2012.
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Capitol Comments: Dissecting FDA’s NDI Guidance

From Nutraceuticals World

By Todd Harrison

On July 1, 2011, FDA published its long-awaited Draft Guidance on New Dietary Ingredient (NDI) Notifications. The notice of availability of the Draft Guidance was published in the Federal Register on July 5, 2011. While comments on the guidance may be submitted to the agency at any time, to ensure consideration by the agency, comments should be submitted by October 2, 2011.


First and foremost, the positions articulated by FDA in the Draft Guidance can be expected to have a significant impact on all those who manufacture or distribute dietary supplement products. As such, the Draft Guidance must be evaluated very carefully to determine the effects it may have on your company.
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Associations Oppose Supplement Labeling Bill

From Nutraceuticals World

The Natural Products Association (NPA), Washington, D.C., has launched a grassroots campaign to oppose the “Dietary Supplement Labeling Act” recently introduced in Congress by Senator Richard Durbin (D-IL). NPA is urging its more than 1900 members to ask their legislators to oppose the bill by sending them a letter. Among other provisions, the bill would direct the Department of Health and Human Services (and presumably FDA) to create a list of ingredients and proprietary blends of ingredients that “could cause potentially serious adverse events.” According to NPA, this overly broad language (e.g., no definition is offered of “could cause”) takes the regulation of supplements well beyond the current, effective rules governing the industry.
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Jarrow Formulas Calls for 1-Year NDI Draft Comment Extension

From NutraIngredients-USA

By Stephen Daniells

California's Jarrow Formulas has called for an extension of the comment period on the FDA's NDI draft guidance to one year. Citing the scope of the draft guidance, its complexity, and its potential impact, a letter on behalf of Jarrow Formulas Inc. (JFI) said that the current 90-day comment period is insufficient, and that it is "respectfully requesting" an extensio to July 5, 2012.
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Rising Up Against Durbin’s Bill

From Natural Products INSIDER

By Steve Myers

Once again, the Natural Products Association (NPA) is seeding a grassroots campaign to fight Congressional opposition to the dietary supplement industry and DSHEA. In the wake of Illinois Sen. Dick Durbin’s latest bill, this one proposing mandatory dietary supplement company registration and an FDA/IOM-compiled list of potentially dangerous ingredients, NPA is urging its 1,900-plus members to send letters to their legislators asking them to oppose Durbin’s bill, the Dietary Supplement Labeling Act.

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On-Trend Products Defying Economic Downturn

From Nutraceuticals World

According to Netherlands-based Innova Market Insights, new food products with an ethical or premium positioning are on the rise despite the difficult economic situation. New data show that consumers, while pinching pennies elsewhere, are readily snatching up value-added products positioned on ethical platforms.


As a percentage of total U.S. launches, new food products with an ethical positioning grew from more than 3% in 2008 to 6% of introductions tracked in the first quarter of 2011. This paradigm shift comes as the wellness category is blurring to encompass new areas not typically considered as health and nutrition, such as “minimally processed,” “locally sourced” and “sustainable” and appealing to a more “responsible” American consumer increasingly concerned about the environment and sustainability.
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Negative EU Claims List Won’t Come Before Summer 2012

From Nutraceuticals World

The threat of an EU-wide ban on the use of article 13.1 claims on the European Commission’s negative register is not expected before next summer, according to international food policy consultancy EAS. Stefanie Geiser, EAS regulatory affairs manager, said as the European Commission has indicated it intends to present its proposal for an article 13.1 “Union list” of claims to the Standing Committee for discussion and potential adoption only by the end of 2011, it was unlikely that any ban on rejected claims would come into force before spring or summer 2012.
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NOW International Earns IL Export Award

From Natural Products INSIDER

Illinois Governor Pat Quinn presented NOW International with the Governor’s Export Award for Continuing Excellence in Exporting in the large company (more than 500 employees) category. NOW Foods president Al Powers said the award recognizes NOW’s teamwork and its mission to help people live healthier lives with natural products.


The award recognizes businesses that exemplify significant contributions to Illinois’ economic development in the fields of export and manufacturing, service and agribusiness. This was the second time the State of Illinois honored NOW International’s track record of growing exports; the company received a similar award for 2008. The company has also been recognized twice with the U.S. President’s “E" Award for Achievement in Export.
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New Durbin Bill Would Change DSHEA

From Natural Products INSIDER

A new bill from longtime DSHEA critic Sen. Dick Durbin (D-Ill.) would change the way supplements are regulated in very significant ways and add a lot of new burdens and costs to the industry. All supplement companies would be required to register every product with FDA, including ingredient lists and a copy of the label. There would also be required warning labels on certain ingredients as determined by FDA and the Institute of Medicine (IOM). Also, all products with "proprietary blends" would have to disclose the amount of each specific ingredient in the blend (so basically, no more proprietary blends). There is more, and it is not good. Needless to say, this is a bad bill for industry and consumers.

FDA’s New Take on Imports

From Natural Products INSIDER

FDA is stepping up enforcement on imported foods, supplements and ingredients with a new strategy designed to meet the regulatory challenges posed by the increased number of products imported to the United States. A report released by FDA, titled "Pathway to Global Product Safety and Quality," calls for coalitions of and increased data sharing among international regulators.

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Dietary Supplement Industry and the Park Doctrine

From Natural Products INSIDER

By Nadia A. Karim


The Park Doctrine, as decided by the U.S. Supreme Court in United States v. Park, could be a potential threat to the dietary supplement industry. Under Park, companies can be criminally sanctioned for non-compliance with cGMPs (current good manufacturing practices).

Firms already struggling with qualitative and quantitative testing (e.g., pre- and post- production), quality control (QC), validation and documentation stand to face potential criminal consequences irrespective of whether there was intent to disregard cGMP.

If a dietary supplement firm is struggling with compliance related to the necessary testing requirements, it naturally follows that the firm likely will not be able to provide proof that a product is safe for human consumption as required by the new rules.
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