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The FDA: A Warning Letter From American Taxpayers

By James J. Gormley

From American Chronicle

In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.”

Vasilos Frankos, Ph.D, outgoing director of the FDA’s Division of Dietary Supplement Programs, told health-food industry magazine, Nutritional Outlook, that the FDA is looking to greatly increase the number of inspections it performs.

If companies are inspected by FDA and receive a Form 483 letter (List of Inspectional Observations) noting noncompliance, Frankos said that they should respond to FDA quickly, preferably within 15 days. Form 483 letters are used by the FDA to document and communicate concerns discovered during these inspections. According to the FDA, these letters:

“…list observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”

As of April 29th, reported Nutritional Outlook, FDA had performed 66 dietary supplement GMP inspections. “Ultimately, the agency may aim to perform as many as 191 inspections or more by the end of this year [2011],” the trade publication noted. “By contrast, FDA performed 84 total inspections in 2010.”

With reports noting that 25 percent of supplement companies did not pass their FDA GMP inspections, the “FDA is due to assist industry overcome these and other issues by producing a compliance program for dietary supplements that is in the clearance phase and is due to be published imminently,” FDA senior advisor, Carl Reynolds, told attendees at a recent industry conference.

But will it assist companies? And, more importantly, what’s really at stake here?

It’s hard to comply with every requirement when the FDA holds all of the cards and provides guidance that is either surfacey in many cases or nearly impossible to carry out in others. With the agency’s surfeit of discretionary authority, the FDA can decide what is adequate documentation and what constitutes satisfactory compliance—and what is or does not—with many well-meaning companies left bewitched and bewildered by the unexpected 483 letter or warning letter they receive.

According to Jonathan Emord, one of the lead architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA admits that cGMPs:

  • may result in the elimination of over 100 dietary supplement companies;
  • will likely increase the cost of dietary supplements; and
  • will likely decrease demand for dietary supplements.

“These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes,” noted Emord.

Knowing this, Emord and his colleagues commissioned Dr. Steve Hanke, former senior economist on President Reagan’s Council of Economic Advisers, to evaluate the economic impact of the cGMP regulations and he predicts the burden will be approximately 10 times higher than the FDA has predicted.

What if the FDA says a company’s paperwork is not in compliance? Failure to comply with the regulations is considered “adulteration,” and the agency does not need any proof that products produced by the company “present an actual risk of illness or injury to the public.”

Emord and the consumer health group, ANH-USA, and others challenged this in federal court and sued the FDA over GMPs. “Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling ‘adulterated’ products, with the same jail sentence,” noted ANH-USA.

“We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.” The judge in this case ultimately sided with the FDA.

Gormley Take-Away: The way the FDA is going about implementing the cGMPs is misguided, at best, and malign, at worst. No consumer, health food store or legitimate manufacturer has a problem with the concept and practice of Good Manufacturing Practices. However, we all should have a problem with supplement companies being set up for failure by a combination of flimsy guidance and cut-throat enforcement tactics. Companies deserve to have clear guidance and to not be buried in administrative recordkeeping and paperwork requirements. These same companies also deserve to be treated fairly and respectfully, for example to be given a heads up about something that needs correction instead of immediately being slapped with an FDA Warning Letter. While the FDA will be gunning for supplement companies in the second half of 2011, all of us need to be closely watching how our tax dollars-funded agency is conducting itself as well. Because it is high time that the agency receive a warning notice of its own from the American people that we will not tolerate continued tax dollars being spent on malicious witch hunts against companies that produce wholesome food products that help us live better and healthier.

Quality: Giving It A Chance

If a U.S. finished product manufacturer vigilantly quarantines ingredient shipments and vigorously tests everything that comes in (from qualified suppliers), if retailers stop stocking those “sexy” but probably spiked products, and if consumers are educated as to how dangerous (and dumb) it is to seek out “too good to be true” products……then we have a chance.

The Food Safety Law: The Way Forward!

Passage of this bill won’t change much unless the bill is funded. In this economic environment, it will be difficult to get the $1.4 billion required to implement this bill without some revenue generator, which this bill does not include. There has already been talk from Republicans in the House that they will not fund the bill. The government is currently under a continuing resolution (CR) which expires on March 4. So one of the first challenges for the new Congress is how they handle the Fiscal Year 2011 budget. Therefore, it is unlikely that anyone will get an increase in this environment. Some lobbying from states is also anticipated since they’ll be able to seek a variance from the produce safety standards as long as they can show that they have procedures in place to reach the same goals.

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We Will Make Our Voices Heard in 2011!

Just as with voting, being an informed, active and participatory citizen is essential to protecting and advancing democracy. As Mr. Buckley sagely noted, we must be obtrusive, we must be committed and we must be assured in claiming our rights. By being knowledgeable and informed about the issues, we do not need to worry about our message or our cause being construed as ambiguous. We must question “Authority” since authority is merely power lent to agencies and officials to carry out the public will and to fulfill the public good.

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Top Ten Lies About S. 510, The FDA Food Safety Modernization Act

Wednesday, December 01, 2010 – by Mike Adams, NaturalNews Editor

The Food Safety Modernization Act looks like it’s headed to become law. It’s being hailed as a “breakthrough” achievement in food safety, and it would hand vast new powers and funding to the FDA so that it can clean up the food supply and protect all Americans from food-borne pathogens.

There’s just one problem with all this: It’s all a big lie.

Here are the ten biggest lies that have been promoted about S.510 by the U.S. Congress, the food industry giants and the mainstream media:

Lie #1 – Most deaths from food poisoning are caused by fresh produce.

Here’s a whopper the mainstream media won’t dare report: Out of the 1,809 people who die in America every year from food-borne pathogens (CDC estimate), only a fraction die from the manufacturer’s contamination of fresh produce. By far the majority of food poisoning is caused by the consumption of spoiled processed foods, dead foods and animal-human transmission of pathogens.

For example, one of the largest food-borne killers according to the CDC is Toxoplasma gondii, a disease that people acquire from cat feces coming into contact with their food, which can happen right in their own homes (…). Salmonella poisoning accounts for 553 deaths a year. As a reference for relative risk, over 42,000 people die each year from road accidents in the USA, meaning driving a car has a roughly 7600% higher chance of killing you than eating fresh produce. (…)

In terms of food-borne illness, many of the deaths come from things like spoiled tomato sauce, spoiled canned foods and spoiled pasteurized milk. S 510, of course, does absolutely nothing to address these food contamination deaths, since those foods are considered “sterilized” at the time of sale.

Lie #2 – Under S.510, the FDA would only recall products it knows to be contaminated.

Not true. S.510 merely requires the FDA to have “reason to believe” a food is contaminated. So right there, that means all raw milk will be targeted by the FDA because even without conducting any scientific tests at all, the FDA can say it has “reason to believe” the milk is contaminated merely because it is raw.

In other words, the FDA no longer needs science to outlaw a food product. It merely needs an opinion.

Is this “reason to believe” section really true? Yep, and here’s how it was amended:

23 (a) IN GENERAL. – Section 304(h)(1)(A) (21 U.S.C.24 334(h)(1)(A)) is amended by
(1) striking ”credible evidence or information indicating” and inserting ”reason to believe”;

In other words, in negotiating this bill, the U.S. Senate removed the requirement that the FDA needed “credible evidence” in order to recall a product and, instead, replaced that with the FDA only needing “reason to believe.”

It is utterly amazing that the U.S. Congress would give the FDA to conduct large-scale product recalls and even imprison people based entirely on what the agency “has reason to believe.”

Last time I checked, the FDA held some pretty bizarre (if not downright moronic) beliefs, including this jaw-dropping whopper: The FDA literally believes that there is no food, no herb, no vitamin or supplement that has any ability to prevent disease of any kind. They don’t even believe limes can prevent scurvy, and you’d have to nutritionally illiterate to believe that.

The FDA believes foods are inert and that all the amazing phytonutrients in those foods (carotenoids, antioxidants, therapeutic fats like omega-3 and so on) are utterly useless for human biology.

This belief, held by the FDA that has now been put in charge of the food supply, is the belief system of an insane government agency that has completely lost touch with reality while abandoning nutritional science.

Lie #3 – They didn’t tell you that nearly 70% of grocery store chickens are contaminated with salmonella every day.

Yep, it’s true: Amid all the fear-mongering over salmonella, everybody forgot to notice that the vast majority of fresh chickens sold at grocery stores every single day are widely contaminated with salmonella (…). Yet S 510 does absolutely nothing to address this. It’s not even mentioned in the bill.

In fact, it is these contaminated chickens that end up cross-contaminating the fresh produce in many kitchens across America. So the so-called “food poisoning” that’s often blamed on spinach or onions often originates with the contaminated chicken meat people bring home and slice on their kitchen cutting boards.

Lie #4 – S.510 will exclude and protect small farmers.

The Tester Amendment, which was finally included in S.510, excludes farmers who sell less than $500,000 worth of food each year from the more onerous paperwork and compliance burdens described in the bill. But this dollar amount is not indexed to inflation, meaning that as the U.S. dollar continues to lose value due to the Federal Reserve counterfeiting machine running at full speed (more “quantitative easing,” anyone?), food prices will continue to skyrocket — and this will shift even small family farms into the $500,000 sales range within just a few years.

In fact, a single-family farm with just four people could easily sell $500,000 worth of fresh produce a year right now, even before inflation. Remember, $500,000 is not their profit, but rather the gross sales amount. The profits on that might be only $50,000 or even less.

Furthermore, this $500,000 threshold means that small, successful farms that are doing well and would like to expand will refuse to hire more people or expand their operations. To avoid the tyranny of S 510, small farms will try to stay small, and that means avoiding the kind of business expansion that would create new jobs.

Lie #5 – The FDA needs more power to enforce food safety.

The FDA already has the power to effectively recall foods by publicly announcing a product has been found to be contaminated. The FDA already has the power to confiscate “misbranded” products, too, and it could easily use this power to halt the sale of contaminated food items.

But the FDA simply refuses to enforce the laws already on the books and, instead, has sought to expand its power by hyping up the e.coli food scares. The ploy apparently worked: Now in a reaction to the food scare-mongering, the FDA is being handed not just new powers, but more funding, too! And you can bet it will find creative new ways to put this power to work suppressing the health freedoms and food freedoms of the American people.

Lie #6 – Fresh produce is contaminated because of a lack of paperwork.

There is no evidence that requiring farms to fill out more paperwork will make their food safer. The real cause of produce contamination is the existence of factory animal farms whose effluent output (huge rivers of cow feces, basically), end up in the water supply, soils and equipment that comes into contact with fresh produce.

The food contamination problem is an UPSTREAM problem where you’ve got to reform the factory animal operations that now dominate the American meat industry. S.510, however, does absolutely nothing to address this. Factory animal farms aren’t even addressed in the bill!

Lie #7 – The American people are dying in droves from unsafe fresh food.

The truth is that Americans are dying from processed food laced with toxic chemical additives, not from fresh, raw produce. Partially-hydrogenated oils, white sugar, aspartame, MSG and artificial food colors almost certainly kill far more people than bacterial contaminations.

The American public is also dying from pharmaceuticals — anywhere from 100,000 to 240,000 people a year are killed by FDA-approved drugs (, most of which have been approved under the guise of blatantly fraudulent science and drug company trickery. The FDA doesn’t seem to mind. In fact, it has been a willful co-conspirator in the scientific fraud carried out by Big Pharma in the name of “medicine.” (…)

To think that the FDA — the very same agency responsible for the Big Pharma death machine — is now going to “save us” by controlling food safety is highly irrational.

Lie #8 – The FDA just wants to make food “safer”.

Actually, the FDA wants to make the food more DEAD. Both the FDA and the USDA are vocal opponents of live food. They think that the only safe food is sterilized food, which is why they’ve supported the fumigation, pasteurization and irradiation efforts that have been pushed over the last few years.

California almond growers, for example, must now either chemically fumigate or pasteurize their almonds before selling them ( This has destroyed the incomes of U.S. almond farmers and forced U.S. food companies to buy raw almonds from Spain and other countries.

Lie #9 – Food smuggling is a huge problem in America.

One of the main sections of S.510 addresses “food smuggling.” Yep — people smuggling food across the country. If you’ve never heard of this problem that’s because it’s not actually a problem.

Not yet anyway.

But there’s a reason why they put this into the bill: Because they’re probably planning on criminalizing fresh produce and then arresting people for transporting broccoli with the “intent to distribute.”

Yep, farmers bringing fresh produce to sell at the weekend farmer’s market could soon be arrested and imprisoned as if they were drug smugglers. Hence the need for the “food smuggling” provisions of S.510.

Soon, we will all have to meet in secret locations just to trade carrots for cash.

Lie #10 – S.510 will make America’s food supply the safest in the world.

Actually, even with S.510 in place, America’s food supply is among the most chemically contaminated in the world, second only to China. You can find mercury in the seafood, BPA in the canned soup, yeast extract (MSG) in the “natural” potato chips, and artificial petrochemical coloring agents in children’s foods.

Eating the “Standard American Diet” is probably the single most harmful thing a person can do for their health. It’s the fastest way to get cancer, diabetes and heart disease. Every nation in the world that begins to consume the American diet starts to show record rates of degenerative disease within one generation. This is the “safe food” that the U.S. Senate is now pushing on everyone.

Remember, with S.510, SAFE = DEAD. And the FDA says it wants to keep everybody safe.

Special thanks to Mike Adams and NaturalNews for this contribution.
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Senators Voting for S. 510, The FDA Food Safety Modernization Act

Wednesday, December 01, 2010 – Unfortunately, today the Senate passed S. 510, The FDA Food Safety Modernization Act. If signed into law it would significantly expand FDA authority, especially over small farms and local food producers. The result: elimination of competition for big Agribusiness and limitations on what you choose to eat and drink.

We intend to fight final passage of the bill in the House and every step of the way to the President. If signed into law, we will mobilize the public to oppose its implementation.

Meanwhile, here are the Senators who voted to pass S. 510, and let’s make it clear that we will not forget the way they voted when they come up for re-election:

Akaka (D-HI)
Alexander (R-TN)
Baucus (D-MT)
Bayh (D-IN)
Begich (D-AK)
Bennet (D-CO)
Bingaman (D-NM)
Boxer (D-CA)
Brown (D-OH)
Brown (R-MA)
Burr (R-NC)
Cantwell (D-WA)
Cardin (D-MD)
Carper (D-DE)
Casey (D-PA)
Collins (R-ME)
Conrad (D-ND)
Coons (D-DE)
Dodd (D-CT)
Dorgan (D-ND)
Durbin (D-IL)
Enzi (R-WY)
Feingold (D-WI)
Feinstein (D-CA)
Franken (D-MN)
Gillibrand (D-NY)
Grassley (R-IA)
Gregg (R-NH)
Hagan (D-NC)
Harkin (D-IA)
Inouye (D-HI)
Johanns (R-NE)
Johnson (D-SD)
Kerry (D-MA)
Kirk (R-IL)
Klobuchar (D-MN)
Kohl (D-WI)
Landrieu (D-LA)
Lautenberg (D-NJ)
LeMieux (R-FL)
Leahy (D-VT)
Levin (D-MI)
Lieberman (ID-CT)
Lincoln (D-AR)
Lugar (R-IN)
Manchin (D-WV)
McCaskill (D-MO)
Menendez (D-NJ)
Merkley (D-OR)
Mikulski (D-MD)
Murkowski (R-AK)
Murray (D-WA)
Nelson (D-FL)
Nelson (D-NE)
Pryor (D-AR)
Reed (D-RI)
Reid (D-NV)
Rockefeller (D-WV)
Sanders (I-VT)
Schumer (D-NY)
Shaheen (D-NH)
Snowe (R-ME)
Specter (D-PA)
Stabenow (D-MI)
Tester (D-MT)
Udall (D-CO)
Udall (D-NM)
Vitter (R-LA)
Voinovich (R-OH)
Warner (D-VA)
Webb (D-VA)
Whitehouse (D-RI)
Wyden (D-OR)

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Industry Bought Congressional Votes to Pass S. 510 Food Safety Bill

Wednesday, December 01, 2010 – by Jonathan Benson, NaturalNews staff writer

Despite an incredible outpouring of public opposition to the U.S. Food and Drug Administration (FDA) “Food Safety Modernization Act”, or S. 510, the Senate voted 73 to 25 to pass the bill anyway. And data presented by, a nonprofit, nonpartisan research organization, shows that big industry groups and large food producers spent millions of dollars buying off Congressmen to garner support for it.

According to the site, Senators that ended up supporting the bill received nearly $10 million in political contributions from interest groups that also supported the bill. This amount was more than four times as much as groups opposed to the bill spent on overall contributions.

Some of the supporters of S. 510 that made these significant monetary contributions in order to buy support for the bill include Kraft Foods North America, the American Beverage Association, General Mills, the Center for Science in the Public Interest, the Grocery Manufacturers Association, and the Snack Food Association.

Interestingly, the top four receivers of contributions from groups that supported the bill actually voted against it, most likely because they are all Republicans and the bill was authored by Democrat Richard Durbin. Even so, these include Sens. Saxby Chambliss (R-GA) who received $503,700, Mitch McConnell (R-KY) who received $415,899, Jon Kyl (R-AZ) who received $335,377, and Richard Burr (R-NC) who received $317,086.

The top receivers of contributions from groups that supported the bill, and who ended up voting in favor of it, include Sens. Blanche Lincoln (D-AR) who received $301,776, Ben Nelson (D-NE) who received $245,906, Charles Schumer (D-NY) who received $179,435, and Amy Klobuchar (D-MN) who received $149,278.

Special thanks to NaturalNews for this contribution.

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Citizens for Health Announces New Initiative with Voice for HOPE

Dear Citizens for Health Community,

We’re very excited to introduce Voice for HOPE (Healers Of Planet Earth), our partner in our newest initiative.  This new initiative is an expansion of our Campaign for Better Health. Along with Voice for HOPE, we also want to introduce you to WisdomFilms™, a new resource that can support you both personally and in your efforts as an advocate for our world’s health and wellness.

Voice for HOPE was created to bring together consumers, practitioners and producers of complementary, alternative and integrative health and wellness modalities to advocate effectively for an expanded role for these approaches to improving personal, family and community health and well-being.  As the recently passed “health reforms” go through the next several years of refinements, regulatory implementation, re-evaluation and beyond, the potential value of these approaches needs to be, and is ready to be, recognized.

Voice for HOPE is a pro-active companion to Citizens for Health’s rapid and effective defense of dietary supplements, organic food, and other natural health approaches, mobilized when we’re faced with threats from industry and government.  With Voice for HOPE, we are calling on policy makers to pay attention to the value of natural healing modalities and approaches, and integrate them NOW into health policy at every level, rather than dismissing, rejecting or over-regulating them.

Millions of Americans are taking steps in their personal lives to improve their overall well-being, reduce stress and other risk factors, delay the onset of aging, and achieve better outcomes from conventional medical treatments.   Including natural health approaches in national, state and local health care policy could significantly improve outcomes and reduce costs across the country. This presents opportunities our country can no longer afford to ignore.

You can support the Voice for HOPE initiative and at the same time enjoy a personal healing experience.  WisdomFilms™ is a new genre of media, designed to evoke a contemplative, life-enhancing experience. It is a collection of 3-6 minute films explicitly created to reduce stress and restore balance to our minds, hearts, and souls.  The films feature spoken wisdom from some of today’s most acclaimed voices in self-help and spirituality (including Campaign for Better Health advisor and bestselling author Deepak Chopra, success coach Bob Proctor, and Buddhist teacher Thich Nhat Hanh), blended with inspiring original music and breathtaking imagery.

Thoughtful and beautiful at the same time, the films are designed to provide “a sanctuary of serenity” and “a connection to what matters most.”  Created by Emmy Award-winning composer Gary Malkin, these “media-tations” offer an antidote to fear and anxiety that can inspire, awaken, nourish and sustain. Leaders in healthcare and personal development, as well as research centers such as HeartMath, have found these films can provide a way to cultivate “coherence,” the integrative state that adds years to our lives.

Thomas Moore, admired author of Care of the Soul said, “These inspiring short films can help us connect our deepest selves to the vast world we live in.  No service could be more important. A multi-sensory feast for the senses!”

A free WisdomFilms™ sample, narrated by Deepak Chopra, is available for your viewing at  You’ll also find information there about how to purchase the 2-DVD set of the nine Wisdom Films.

As a vital Citizen for Health, I hope you find comfort and inspiration in these WisdomFilms™ and optimism about the possibilities for natural healing to play a more prominent role in American life as you learn more about Voice for HOPE.

With gratitude,

Jim Turner, and the Citizens for Health Team

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