Although this is coveted as a wonderful bill that is needed in the US so that drugs and medical devices can be fast tracked, if you read the nearly 1000 pages it is clear this is dangerous bill that is has the best interests of the Pharmaceutical industry at heart, NOT its consumers.
The following is reprinted with the permission of McClatchyDC
Dental group defends mercury fillings amid mounting evidence of risks
The association has lobbied the Food and Drug Administration to ensure the fillings, which contain one of the world’s most menacing toxins, receive a government seal of safety and wouldn’t be tightly regulated.
For years, the ADA also resisted Environmental Protection Agency rules that would force dentists to stop dumping tons of mercury debris down public sewer lines, even as the United States and 128 other nations negotiated a treaty to curb mercury’s global spread.
But now, evidence is emerging of the potential consequences of the U.S. dental industry’s longtime reliance on mercury and its chief advocacy group’s determined crusade to fend off any and all challenges.
New scientific research has found that the fillings may indeed harm millions of people, especially men and boys. Further, the lax controls over dental clinic discharges have allowed the chemical to spread into rivers and streams, into the air through sludge incineration and even onto cropland as fertilizer.
The new research, by a team based at the University of Washington, concluded that low-level releases of mercury from fillings present long-term risks of brain damage for people with certain genetic variants. The findings are based on data underpinning one of the same two pivotal clinical studies of American and Portuguese children that the dental association has cited as proof the compounds are safe.
In 2006, after results of the initial studies were published, several of the researchers decided to re-evaluate data from 330 Portuguese students to identify those with subtle genetic impairments and see if they were more vulnerable to mercury inhalation in annual tests of their memory, concentration and other neurological activities. Kids with mercury fillings performed significantly worse on the tests than those who got mercury-free treatments.
The results, in four papers published in scientific journals from 2011 to 2014, have escaped public attention, although the authors say up to 40 percent of the population has at least one of the genetic traits and could be affected.
Diana Echeverria, a scientist who collaborated with University of Washington toxicologist James Woods and others in the reassessment, said the susceptible groups face “a lifetime risk” of neurological damage.
“We’re not talking about a small risk,” said Echeverria, who works for the Seattle-based Battelle Centers for Public Health Research and Evaluation.
“Twenty-five percent to 50 percent of people have these (genetic variants). There were these deficits that were accounted for by having them. . . . We reasoned that we would see these if we would simply genotype these children. That is indeed what we saw.” Former University of Washington toxicologist James Woods
The Food and Drug Administration has staunchly defended the safety of the mercury-laden dental products, known in the trade as amalgams. But the University of Washington’s findings prompted a European Union scientific panel to urge dentists to explore alternatives, such as popular tooth-colored plastic resins.
Behind the scenes, FDA officials also have shown deepening concern about mercury fillings, especially since two scientific advisory panels, in 2006 and 2010, criticized the agency’s analysis of science on the issue and its failure to protect vulnerable groups.
In July, McClatchy reported that the FDA drafted a safety communication that urged dentists to avoid using mercury fillings, where possible, and advised them not to use them in susceptible groups, including pregnant women and small children.
But officials of the Department of Health and Human Services blocked the warning on grounds that the cost of pricier alternatives might lead low-income patients to let decayed teeth go untreated, an argument often sounded by the American Dental Association.
The 157,000-member dental association and its state and local chapters have long been potent — and successful — advocates for dentists. Again and again, they have prevailed in impeding or weakening efforts to control mercury in dentistry.
Over the years, the ADA has:
— Argued against FDA safety warnings about mercury fillings for pregnant women and small children.
— Imposed a gag rule barring member dentists, including those specializing in the safe removal of mercury fillings, from telling patients the compounds could harm their health.
— Lobbied to ensure that the international treaty signed by 129 countries would call for a phase-down of mercury uses worldwide, not a phase-out that eventually would ban dentists’ use of mercury fillings.
— Cut a deal in the final days of George W. Bush’s presidency that put off the issuance of regulations requiring dentists to install mercury “separators,” so they can properly dispose of their mercury debris, in favor of a voluntary approach.
“They (the dental association leaders) are powerful, and they are very scared of good science, because if it comes out on the wrong side of their goal of using amalgam, then they have to rethink and retool their practice. . . . These people should be more open-minded and more scientifically driven — evidence-based, rather than protecting their turf.” Diana Echeverria, researcher into mercury’s effects
The dental association declined to make any senior officials available for an interview, but its president, Maxine Feinberg, recently wrote McClatchy: “No properly designed, peer-reviewed scientific study links dental amalgam to any neurological or systemic disease, and that’s the scientifically sound bottom line.”
In written responses to questions, the association said it supported the international treaty, the Minamata Convention, which ultimately set no deadlines for nations to meet its goals and gave them great leeway in how to do so.
The association also said it generally supports the EPA’s proposed rule to require safe disposal of mercury waste but hopes the agency will accept its “simple suggestions” for easing burdens on its members, such as by relaxing from 99 percent to 95 percent requirements for the separators’ efficiency to reduce the devices’ estimated average $1,300 one-time cost — plus a few hundred dollars each year to operate them.
The dental industry’s long-held position that mercury fillings are the safest, most durable solution for restoring decayed teeth, however, appears to have produced a troubling legacy.
Not only have America’s dentists placed compounds that continuously release toxins into the mouths of an estimated 181 million people, but they also have washed hundreds of tons of mercury-tainted debris into public sewer lines — and ultimately the environment — over the last several decades.
Washington attorney James Turner, who has represented consumers in a 23-year campaign to ban mercury fillings, believes the dental association’s advocacy on these issues has been motivated at least in part by an unspoken economic interest: to “avoid enormously costly product liability suits” by patients sickened from mercury exposure.
“The ADA owes no legal duty of care to protect the public from allegedly dangerous products used by dentists. The ADA did not manufacture, design, supply or install the mercury-containing amalgams. . . . Dissemination of information related to the practice of dentistry does not create a duty of care to protect the public from potential injury.” American Dental Association response to a patient lawsuit
For decades, the dental association contended the alloys, comprising about 50 percent elemental mercury and a blend of metals that usually includes tin, copper and silver, were inert once placed in teeth.
However, the discussion took a turn in the 1980s when new instrumentation showed microscopic amounts of mercury coming off the compounds’ surfaces, especially during chewing.
The World Health Organization says inhaling or ingesting mercury, “even in small amounts . . . may cause serious health problems,” including depression, tremors, memory loss, cognitive and motor dysfunction, as well as damage to the lungs, kidneys and digestive and immune systems.
Courtesy of Randall Moore, director/producer of the documentary Evidence of Harm
That hasn’t dissuaded the dental association, which has continued to challenge any implication that mercury fillings might cause harm.
The association’s Model Code of Ethics bars members from even suggesting to a patient that mercury fillings can be injurious, and dentists who have done so have risked their careers.
Numerous state dental boards, including those in Georgia, Iowa, North Carolina and Pennsylvania, have adopted similar prohibitions and enforced them by revoking or threatening to revoke the licenses of dozens of dentists specializing in the safe removal of mercury fillings, charging they made false advertising claims in describing the compounds as hazardous. Some dentists lost their licenses.
In 2008, as the FDA considered whether mercury fillings were devices warranting tighter controls, the dental association went so far as to argue that no safety warnings should be issued, not even for pregnant women and children under 6, because research had yet to prove the fillings to be dangerous.
The FDA posted such a warning on its website for about a year as part of a settlement with consumer lawyers but removed it in 2009, when the agency upheld the mercury products’ safety.
Nonetheless, growing numbers of dentists have abandoned mercury fillings, in part because patients prefer more cosmetically appealing alternatives.
The number of mercury compounds placed in Americans’ teeth has fallen steadily, from 157 million in 1979 to 96 million in 1990 and perhaps to under 20 million in 2015, according to claims data from Delta Dental, the nation’s largest dental insurer, with 68 million members and a 34 percent share of the market.
The trend has been aided by a narrowing price gap between mercury and resin fillings, whose durability also has improved. Composites cost about 25 percent to 28 percent more than mercury fillings, said Bill Kohn, chief science officer for Delta Dental. However, safety concerns also have arisen about some resin products.
Even a ban on mercury fillings — like bans already imposed in Sweden, Denmark, Norway, Finland and Japan — wouldn’t eradicate the potential health risks in the United States anytime soon.
According to the last U.S. government estimate, in 2004, 181 million Americans carried 1.46 billion mercury restorations in their teeth.
Much of that mercury, once estimated by the EPA to total 1,200 tons, could add to the environmental harm if there were to be continuing increases in the percentage of people opting to have their bodies cremated when they die. By 2025, incineration of corpses could send as much as 12 tons of mercury per year into the air, according to an analysis by the Vermont-based Mercury Policy Project, an environmental group.
The University of Washington’s followup study of genetic variants, known as polymorphisms, in children at the Casa Pia School in Lisbon, Portugal, could help solve the mystery of why some people seem to suffer serious effects from mercury fillings and others do not.
“We’ve clearly demonstrated at least a dozen very common genetic polymorphisms make worse the effects of mercury on some behavioral processes in children,” Woods, a recently retired University of Washington toxicologist who helped lead the research, said in a phone interview.
Men and boys are likely more susceptible, the researchers found, because girls in the study generally excreted more mercury in their urine, suggesting their immune and hormonal systems were better able to protect them from the toxin.
Echeverria, the Battelle researcher, said that while the observed effects were subtle, children in the study with genetic variants were increasingly impaired as their mercury exposures rose.
“If you have mercury in your fillings, you’re exposed to it for your entire life,” Woods said. “It gets to the point where it can override your ability to excrete mercury. The rest of it backs up and can bio-accumulate, especially in your brain.”
The American Dental Association has sought to play down the genetic findings.
Its science division rated the University of Washington team’s work “of medium quality” and said research on the subject has produced inconsistent results.
However, in a letter to consumer lawyers in January 2015, the FDA described the study as “well conducted” and said it offers evidence people with genetic abnormalities “may be at a higher risk for adverse health effects” from mercury fillings. The evidence isn’t yet strong enough to justify banning the compounds, the agency said.
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks wasn’t so tentative. It advised dentists in the European Union’s 28 member countries to consider alternatives, because patients’ “genetic variants appear to impart increased susceptibility to mercury toxicity.”
James Love, a Tulsa, Oklahoma, consumer lawyer also fighting for a mercury ban, called the FDA’s inaction “a clear dereliction of duty” that fuels beliefs the agency “is the puppet of industry and has abdicated its role as the protector of the public.”
Dentists’ discharges of mercury-tainted debris first drew attention around 2002, when analyses concluded their offices were producing about half of the toxin in public waste streams.
In 2005, a study funded by the dental association concluded that U.S. dentists were using about 35 tons of mercury each year, of which about 6.5 tons was channeled into sewer systems. The EPA now puts that figure at 4.4 tons.
As a naturally occurring element, mercury cannot be destroyed, so its disposal poses a daunting challenge.
At wastewater treatment plants, most of the mercury settles into tons of sewage sludge, portions of which are incinerated, dumped into landfills or spread as fertilizer over cropland, a method environmentalists say puts the toxin in the food chain.
“Mercury is like a hot potato,” said Michael Bender, director of the Mercury Policy Project. “The dentists don’t want it, so they dump it down the drain. The sewage sludge facilities can’t handle it, so they allow it to be dumped into the sludge, and the community incinerators pick up the tab. It’s not costing the lazy wastewater utilities. It’s an externalized cost of dentistry.”
“They say the solution to pollution is dilution. But you can’t dilute mercury. It never goes away. Scientists say it ping pongs from the atmosphere, into the water and back into the air. These folks with the smoke and mirrors, they’d like you to think the mercury disappears.” Michael Bender, director of the Mercury Policy Project
Many dental clinics’ current efforts to collect mercury waste get low grades.
About half of dentists use dry vacuums to suction large chunks of mercury from patients’ mouths and deposit them into tanks, one former dental industry figure said.
But a valve at the bottom of many of the tanks is set up to automatically open at day’s end, when the dental staff turns off the vacuum lines, said this person, who spoke on condition of anonymity to avoid damaging relationships. If a dentist failed to first empty his tank into hazardous waste receptacles, the toxic brew goes into sewer lines. Asked about this allegation, two EPA officials did not dispute it.
The American Dental Association has walked a narrow line between publicly supporting efforts to contain dental mercury waste and quietly seeking to put off regulations.
In 2003, the association adopted “best practices” to guide its members’ handling of mercury waste. It did not include a recommendation that dentists install separators until 2007, after it became possible to recycle the mercury.
“We have worked with the EPA on a separator rule for years. We support the proposal in its essence and have offered only constructive comments.” American Dental Association
Curt McCormick, who worked for 20 years in the EPA’s Denver regional office, said he began in 2004 to advise communities with high mercury levels in their drinking water to require dentists to install separators. That brought an emailed rebuke from Jerry Bowman, then an assistant counsel for the dental association. At a meeting that December in Washington, Bowman complained about McCormick’s activities to Ben Grumbles, chief of the EPA’s Office of Water.
Weeks later, Bowman wrote Grumbles that the regional office had “not shifted its position one inch” and expressed frustration the agency wasn’t accepting a voluntary approach.
On Dec. 29, 2008, three weeks before Barack Obama was sworn in as president, the dental association and a seemingly unlikely ally, a trade group representing nearly 300 of the nation’s big-city wastewater treatment utilities, signed a deal with Grumbles, acting on behalf of departing President George W. Bush’s EPA. It gave dentists time to address the mercury pollution voluntarily.
Within a year, Obama’s EPA concluded the voluntary route wasn’t working.
Ken Rosenblood, a Los Angeles entrepreneur who for 20 years sold equipment to help dental offices remove toxins, said he experienced the problem firsthand. Hundreds of times, he said, he heard this refrain from dentists: “If the law doesn’t require it, I’m not going to do it.”
In California’s Sacramento County, dentists have accounted for 42 percent of the annual 40 to 67 pounds of mercury in sewage since 2010, county officials said. Over the last two years, the county sent circulars beckoning about 800 dentists to join a program to install separators voluntarily. Ten dentists signed up.
McCormick said many cities use testing methods not powerful enough to detect traces of mercury, so they don’t know how much is in their waste streams.
It was September 2014 before the EPA formally proposed a rule requiring the nation’s 110,000 dental offices to buy mercury separators and submit to waste disposal policing by public utilities. The agency estimates that about 40 percent, or 44,000 of the nation’s dental offices, have dealt with their mercury problems, most located in 13 states that have lurched ahead of the EPA and now require separators.
The dental association’s newfound ally, the National Association of Clean Water Agencies and its members, rained negative comments onto the EPA’s rule-making docket, complaining that they would be saddled with a huge administrative burden and that the EPA’s $49 million cost projection “greatly underestimates the cost of the rule.”
The association told McClatchy that separators “primarily shift the point of capture from a treatment plant to the office. In either case, the amalgam is captured.” It did not explain how this occurs, since tons of mercury wind up in sewage sludge.
EPA spokeswoman Monica Lee declined to say whether the agency, which has imposed tough curbs on hundreds of coal-fired power plants to cap emissions of greenhouse gases and mercury, will act by next June to compel dentists to limit mercury discharges, leaving enough time for the rule to take effect before Obama leaves office.
The dental association says it supports the Minamata treaty, which directs each country to choose at least two of nine options for phasing down mercury fillings.
But in 2011, as the treaty negotiations heated up, Raymond Gist, then the president of the dental association, sent a letter urging the State Department to make the Food and Drug Administration, not the EPA, the lead U.S. negotiator over the environmental pact. FDA officials not only had defended mercury fillings, but they also never required manufacturers of dental fillings to file statements assessing the environmental impacts of their products.
The next year, an outside lobbyist hired by the association reported he had been paid $40,000 to “oppose” the treaty.
A couple of weeks after its 2013 signing, Charles Norman III, then the dental association president, issued a statement praising the treaty, emphasizing first that it “upholds the use of dental amalgam, a durable, safe, effective cavity-filling material.”
“Monsanto’s Dream Bill” – also known as the Safe and Accurate Food Labeling Act, HR 1599, and the “DARK Act” – standing for the Deny Americans the Right to Know Act would ban states from passing legislation to label food and products containing GMOs (genetically modified organisms), undoing years of hard-won progress at the states level made by food labeling advocates like Citizens for Health and Food and Water Watch.
Now there is a renewed sense of urgency stemming from testimony at a Senate Agriculture Committee hearing held yesterday. The Biotechnology Industry Organization (BIO) and food manufacturers were out in force to protect their interests by confusing the debate with repeated assertions about the safety of GMOs. It didn’t help that Ag Committee Chair, Senator Pat Roberts (R-KS), and Ranking Member Debbie Stabenow (D-MI), demonstrated they have drunk the industry Kool-Aid when they wasted spectators’ time making the same claims about GMOs’ safety.
The issue is not one of safety, even though there is compelling evidence that we should be concerned about the prevalence of GMOs. As Consumers Union director of food policy initiatives, Jean Halloran has noted, “Safety is not the point. Almost all the labels required on food—such as ingredients and fat content—are informational. So is GMO labeling. The debate over GMO labeling is about consumers’ right to know what they are eating.”
A joint letter from a bi-partisan group of state lawmakers urging Congress to oppose HR 1599 also points out that a District Court in April affirmed that states have a constitutional right to pass GMO labeling laws. Whether everyone agrees they are safe – or not.
Senator Stabenow called for “a bipartisan bill that can pass the Senate by the end of this year.”
Don’t let the biotech industry and food manufacturers hide behind questionable claims about the safety of GMOs as they trample over the US Constitution and your right to know.
Proposed Warnings Have Been Kept Secret for More Than Three Years
WASHINGTON – For the first time the Food and Drug Administration has proposed curbing dentists’ use of mercury in treating Americans’ decayed teeth. This would be a major step forward in protecting Americans from one of the planet’s nastiest toxins.
It would be – if senior U.S. health officials hadn’t put the kibosh on the proposal after a cost-benefit analysis by officials at the Department of Health and Human Services.
The proposal, which was approved by FDA officials in late 2011 and kept under wraps ever since, would have advised dentists not use mercury fillings when treating cavities in pregnant women, nursing moms, children under 6 and people with mercury allergies, kidney diseases or neurological problems. It even went so far as to urge dentists that when considering using mercury fillings, the best course of action is simply not to – ever.
For your convenience, we have attached the FDA’s recommendations here – please share far and wide: FDA 2012 Safety Communication Mercury
Note: Following information is from College Pharmacy, a fully licensed compounding pharmacy.
Why Is The FDAs MOU A Threat To Your Access To Compounding Pharmacies and Compounded Medications?
The FDA Memorandum of Understanding (MOU) is a guidance document that was created by the FDA to explain the regulatory framework that it plans to use in enforcing the Drug Quality and Security Act that was passed in November 2013.
In the current draft form, the MOU would regulate the interstate filling of compounded prescriptions by 503(a) compounding pharmacies. As the majority of compounding pharmacies in the U.S. are 503(a) compounding facilities, the impact would be one felt throughout the nation by patient and practitioner alike.
IMPORTANT Deadline: July 20, 2015 at 11:59pm
Unprecedented Expansion of FDA Oversight
The intent of the original MOU was to prevent compounding pharmacies from becoming manufacturers and limited office use prescriptions. The FDA has since taken that intent and expanded it into unprecedented areas of oversight and regulation to include interstate commerce.
The current draft MOU would restrict compounding pharmacies to no more than 5% of interstate sales per month unless their respective state agrees to enter into a MOU agreement with the FDA. If the state agrees to bear the burden for any adverse events or quality issues, then those pharmacies may increase their interstate sales to 30%.
This is supposed to translate into patient safety. So, 5% interstate sales per month is safe. 30% interstate sales per month is only safe if a state bears the burden of adverse events. 35% of interstate sales is not safe and shall not be allowed. The proposed regulation of interstate commerce has no scientific or evidence basis. These are arbitrary numbers with no tie to patient safety.
The MOU would leave state boards of pharmacy with an unfunded mandate to investigate and report pharmacies in violation of the FDA’s interpretation of federal law. It would place significant economic burdens on a state without providing appropriate funds for required reporting activities. There is no benefit to the state to enter into the MOU.
The MOU would reduce patient access to medically necessary treatments, restrict interstate commerce, and punish successful pharmacies that already adhere to all existing state and federal regulations.
We take exception to the FDA’s expansion of oversight, not because we are a compounding pharmacy that ships throughout the U.S., but because as citizens we believe in the right of choice and access and that the following points should be part of the discussion now before the MOU is adopted:
- The Right to Choose: Every patient and practitioner should have the right to choose the compounding pharmacy of their choice.Compounding pharmacies are not interchangeable. Patients should have the right to easily access compounded medications from a compounding pharmacy in another state. They currently do. And the DRAFT MOU does not lend itself to an increase in patient safety by regulating interstate commerce.
- As mentioned above, compounding pharmacies are not interchangeable. The MOU would severely restrict patient access to and choice of compounding pharmacies offering the services that they require. While most compounding pharmacies can produce capsules and topical preparations, specialty dosage forms and sterile compounds often come from pharmacies throughout the U.S. that are expertly trained to meet the compounding needs of specific patient groups. For instance: Are you a current patient or practitioner that uses our sublingual tablets or fused pellet implants? If you are outside of Colorado, your access will be severely limited.
- Doors will close. If a compounding pharmacy is currently shipping out more than 30% of monthly sales through interstate channels, it does not mean they are participating in illegal manufacturing practices. It means that patient and practitioner alike have chosen to do business with them because of expertise, because of specialty compounding services, because of exclusive formulations…because it is a free-market and they have the right to do so. It is the law abiding, experienced, comprehensive compounding pharmacies that will feel the brunt of the MOU if it is adopted in the current form. Why? Supply and demand. While there is a demand nationwide that keeps our doors open, that same demand does not exist in a single state.
IMPORTANT Deadline: July 20, 2015 at 11:59pm
We put patient safety above all else. The MOU fails to increase patient safety and would severely regulate compounding pharmacies to the point of scaling back services and closing doors.
There should be no limit to the interstate shipping of prescriptions as long as 503(a) compounding pharmacies follow both state and federal regulations.
It is not just about keeping our doors open. It is about keeping an industry alive. It is about ensuring that patients and practitioners have access to the integral services that compounding pharmacies provide.
Read the entire message from CollegePharmacy.com
Courtesy of our allies at Alliance for Natural Health
This time it’s been slipped into a defense bill. Major Action Alert – Send Your Letter Now!
We suspected it would only be a matter of time before Sen. Dick Durbin (D-IL) launched his next broadside against supplements. Once again, Durbin and his allies, including Sen. Richard Blumenthal (D-CT), are pouncing on must-pass legislation and attaching last-minute amendments that would threaten Americans’ access to supplements.
The bill this time is the National Defense Authorization Act (NDAA), an appropriations bill to fund the military for FY 2016. The House passed its version of the bill in May. Sen. John McCain (R-AZ) introduced what is called “an amendment in the nature of a substitute” to create a Senate version of the House-passed bill. The Blumenthal/Durbin amendments were introduced on top of the McCain legislation.
Because it is a defense bill, the Blumenthal/Durbin amendments pertain to the supplement use of the US armed forces.
There are three amendments.
The first amendment would require military electronic health records to include data regarding supplement adverse events experienced by servicemen and women. This type of information is already gathered by the FDA, which is much better situated to handle it than the Department of Defense. This additional data collection is redundant and cumbersome. In 2011, Sen. Durbin and Rep. Henry Waxman (D-CA) asked the Government Accounting Office to review supplement adverse event reports (AERs). In 2013 the GAO completed its report—which overwhelmingly demonstrated that supplements are safe! Why in the world is Durbin following the same tactic that embarrassed him so completely two years ago?
According to the resulting GAO report, there were a total of 6,307 AERs reported to the FDA between 2008 and 2011—an average of 1,575 a year. At the time, we pointed out that this was quite a low number, considering the fact that about half of Americans—157 million people—take supplements. This means that one-hundredth of one percent of all supplement users ever experience any problems at all.
If Sens. Waxman and Durbin had cared to search out where the real danger lies for the American consumer, they wouldn’t have had to look very hard. In 2008 alone, there were a whopping 526,527 AERs for FDA-approved drugs, with 275,421 considered serious. Of course, the astonishingly poor safety record of pharmaceutical drugs is irrelevant if you have a vendetta against supplements, as Sen. Durbin and his allies seem to have.
The second amendment would require the Department of Defense to establish minimum requirements for members of the armed forces to report on their supplement use. Service people would be ordered to report what vitamins and supplements they take—which means they could easily be ordered to stop taking them! It is simply Orwellian to have members of the military report on their supplement use. What business is it of the government if a service member is taking vitamin D, or B12? Big Brother shouldn’t be able to reach into your toiletries kit or control what you tell your doctor—even on a military base.
The third and most troubling of the amendments would extend a currently existing policy which regulates certain supplements on military bases to require all supplements that are to be sold to members of the military at exchange stores or commissaries to undergo a third-party review for “recognized public standards of identity, purity, strength, and composition, and adherence to related process standards.” This may sound innocent, but it is anything but.
First, supplements must already, by law, hold to current good manufacturing practices (CGMPs), which require that that they be processed in a consistent manner and meet quality standards. Second, supplement companies will likely be expected to pay huge sums for this review. Only the biggest companies, many of them owned by Big Pharma, will be able to comply. Yet another government-created monopoly will be handed over to big drug companies.
In addition, once this regime is established, it will be only a short step to expand it to all US consumers, not just the military. Then the pharmaceutical industry will have what it really wants: control over the supplement industry. Many supplements will become drugs and soar in price while their availability is restricted. As with any monopoly, quality will also decline, because regulations are never a substitute for real competition involving new and small as well as old and large companies.
Supplements are incredibly safe and already fully regulated by the FDA and FTC. These amendments are misguided attempts to limit access and hamper individual health freedom.
The truth of the matter is that the current regulatory regime governing dietary supplements is working—which is why supplements have such a sterling safety record. In fact, our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.
We’ve come to expect this sort of maneuver from Durbin and company: what can’t be accomplished through more conventional democratic means, they try to accomplish through sneaky, eleventh-hour maneuvering before the public can catch wind of it. This military appropriations bill has nearly 200 amendments attached to it, and not all of them will be discussed by the Senate. With your help, we hope to prevent the Blumenthal/Durbin amendments from ever being considered on the Senate floor. The natural health community has responded vigorously to defeat previous Durbin attacks against supplements: in one instance, our readers sent nearly 90,000 messages in less than twenty-four hours. The time has come again to make our voices heard on Capitol Hill to protect our access to quality dietary supplements!
Major Action Alert! Write or call your senators and urge them to stop the Blumenthal/Durbin amendments, which will take dangerous steps towards limiting consumers’ access to dietary supplements.
NEW BREAKTHROUGH BOOK EXPOSES THE FRAUDULENT FOUNDATION OF THE GE FOODS INDUSTRY –
LET’S MAKE IT A NATIONAL BESTSELLER
“Druker’s brilliant expose catches the promoters of GE food red-handed: falsifying data, corrupting regulators, lying to Congress. He thoroughly demonstrates how distortions and deceptions have been piled one on top of another, year after year, producing a global industry that teeters on a foundation of fraud and denial. This book is sure to send shockwaves around the world.” –Jeffrey Smith
*** IMPORTANT NOTE: If you buy more than one book, you need to do so in separate transactions in order to have maximal effect – because five books bought in a single transaction will only register as one purchase in the way the bestseller list is tabulated. Also note that you can have the e-book edition delivered to someone by providing their email address when you purchase.
Most of you are already concerned about the risks of genetically engineered (GE) foods, and should be. Regardless how much you know, or think you know, there is a new book is being released that demonstrates why everyone should be concerned:
How the Venture to Genetically Engineer Our Food Has Subverted Science, Corrupted Government, and Systematically Deceived the Public
It was written by public interest attorney Steven Druker, who initiated a lawsuit that forced the FDA to divulge its internal files on GE foods – thereby exposing how the agency had covered up the extensive warnings from its own scientists about their risks, lied about the facts, and then ushered them onto the market in blatant violation of U.S. food safety law.
But Steven’s book does far more than expose the FDA’s fraud. It reveals how the entire GE food venture has been chronically and crucially dependent on fraud – and how the key misrepresentations have been dispensed by eminent scientists and scientific institutions such as the U.S. National Academy of Sciences and the U.K. Royal Society.
Furthermore, the book’s factual and logical soundness – and its importance – have been recognized by several scientists who have unstintingly praised it. For instance, the world-famous (and well-beloved) primatologist Jane Goodall has written the foreword, in which she not only hails it as one of the most important books of the last 50 years but states: “I shall urge everyone I know who cares about life on earth, and the future of their children, and children’s children, to read it. It will go a long way toward dispelling the confusion and delusion that has been created regarding the genetic engineering process and the foods it produces. . . . Steven Druker is a hero. He deserves at least a Nobel Prize.”
Moreover, Dr. Goodall is not alone in urging people to read and heed this book. Dr. Joseph Mercola, creator of the world’s most popular natural health website, has posted two interviews with Steven and has strongly recommended that the book be purchased. He also declared: “Truly, Steven has given the world a phenomenal gift through this work, and his book is really an indispensable resource on the topic of GMOs.”
And Mike Adams, on his widely viewed Natural News website, has extolled the book as a global game-changer and called on people to buy it so it can become a New York Times bestseller.
We’re asking all of you to do the same – for several good reasons:
- First, by pushing this book to the NY Times bestseller list, we will be making people pay attention to it. Monsanto and its allies are desperately hoping that it will be ignored so that the fraudulent foundation of the GE food venture will stay hidden. But if it’s on the bestseller list, and remains there for many weeks, it can’t be ignored – and Steven will be increasingly interviewed by key media outlets, which will bring the startling revelations in his book to the attention of a large portion of the population and to influential individuals, disclosing how they’ve been systematically deceived by those whom they had a right to trust.
- Second, you owe it to yourself and your loved ones to become more fully informed about this vital issue, not only so you can protect yourself and them more effectively, but so you won’t be taken in by the misleading propaganda to which you’re regularly subjected.
- Third, by reading this book, you can intelligently push back against the false claims you routinely encounter from people who have been taken in by the propaganda. Moreover, we recommend that besides buying a book for yourself, you buy several to give to friends and relatives who regard you as unscientific or unreasonable for being concerned about GE foods. Ask them to read it and then have a discussion with you based on the actual facts. You will most likely find that their minds have been changed.
“A fascinating book: highly informative, eminently readable, and most enjoyable. It’s a real page-turner and an eye-opener.”
—Richard C. Jennings, PhD Department of History and Philosophy of Science, University of Cambridge
“This incisive and insightful book is truly outstanding. Not only is it well-reasoned and scientifically solid, it’s a pleasure to read – and a must-read. Through its masterful marshalling of facts, it dispels the cloud of disinformation that has misled people into believing that GE foods have been adequately tested and don’t entail abnormal risk.”
—David Schubert, PhD molecular biologist and Head of Cellular Neurobiology, Salk Institute for Biological Studies
“A great book. The evidence is comprehensive and irrefutable; the reasoning is clear and compelling. No one has documented other cases of irresponsible behavior by government regulators and the scientific establishment nearly as well as Druker documents this one. His book should be widely read and thoroughly heeded.”
—John Ikerd, PhD Professor Emeritus of Agricultural Economics, University of Missouri
“Steven Druker’s meticulously documented, well-crafted, and spellbinding narrative should serve as a clarion call to all of us. In particular, his chapter detailing the deadly epidemic of 1989-90 that was linked with a genetically engineered food supplement is especially significant. . . . Overall his discussion of this tragic event, as well as its ominous implications, is the most comprehensive, evenly-balanced and accurate account that I have read.”
—Stephen Naylor, PhD Professor of Biochemistry, Mayo Clinic (1991-2001)
“A landmark. It should be required reading in every university biology course.”
—Joseph Cummins, PhD Professor Emeritus of Genetics, Western University, Ontario
“Steven Druker has done a beautiful job of weaving a compelling scientific argument into an engaging narrative that often reads like a detective story, and he makes his points dramatically and clearly. The examination of genetic engineering from the standpoint of software engineering is especially insightful, exposing how the former is more like a ‘hackathon’ than a careful, systematic methodology for revising complex information systems. I will recommend this book to my friends.”
—Thomas J. McCabe Developer of the cyclomatic complexity software metric, a key analytic tool in computer programming employed throughout the world
“A remarkable work. If the numerous revelations it contains become widely known, the arguments being used to defend genetically engineered foods will be untenable.”
—Frederick Kirschenmann, PhD Distinguished Fellow, Leopold Center for Sustainable Agriculture, Iowa State University
So please act promptly. Your purchases will be part of an important process that can topple the entire GE food venture.
We’re gaining momentum in the fight to change the labeling of added sugar on nutrition labels. As you may know, more and more food manufacturers are leaving HFCS out of their foods.
Most recently, the FDA announced proposed changes to the nutritional information on product labels that would include information on how much added sugar a food contains. We at Citizens For Health applaud this move, but we need your help to encourage the FDA to do more.
Specifically: we’re asking the FDA to:
- Include “nutritive sweetener” after “Added Sugars”
- Identify the name of the added sugar
- Identify the percentage of fructose if the added sugar is high fructose corn syrup (HFCS)
We need your comments on the amendment, even if you already commented on the the original petition. More than 30,000 comments were received on our original petition; we want to increase that tenfold for the amendment.
Three years ago, our my friends John and Ocean Robbins began a modest summit that they hoped would help inspire people to learn more about healthy food. The information from that summit spread like wildfire and has inspired over 150,000 people from all over the world!
This year, they’ve stepped it up to a whole new level. There’s more urgency than EVER before… For you, your health, the health of your loved ones, as well as for our struggling planet. Joining John and Ocean Robbins are celebrities like Woody Harrelson, Jane Goodall, Alicia Silverstone, Amy Goodman, and MORE! These cultural persuaders are joining with expert doctors and food activists because they’ve realized that if we don’t do something now, we’re in trouble. They’ve chosen to use their platforms and names to inspire a critical mass where health becomes the norm.
Without a revolution, we are left in the hands of companies like Monsanto and Coca-Cola, who have spent tens of millions of dollars in recent years trying to stop anything that would interfere with their relentless pursuit of profits.
Think they care about our health? No way. Their bottom line is green, all right. But when healthy food is gone, you can’t eat money!
Find out all about how to join the revolution here, at no cost, where for a week you’ll be fully empowered with all the latest information and TRUTH about your food, how it’s grown, and what the heck is in it.
This is a major globally broadcast summit. John and Ocean Robbins, the hosts, have made it completely complimentary for you to participate.
You can listen in the comfort and convenience of your own home, from your computer or phone.
Plus, this is cool: When you register, you’ll get a copy of The Real Food Action Guide, which reveals medical breakthroughs the corporate food industry hopes you never discover, and gives your family the truth about GMOs.
Again, there’s no cost to attend the online Food Revolution Summit event, happening April 26 – May 4. Get your access details now. You’ll hear directly from Jane Goodall, Woody Harrelson, Alicia Silverstone, and 20 more brilliant speakers!
Our friends at the Fukushima Fallout Awareness Network (FFAN) have planned for an entire week of calling U.S. Representatives, Senators, and more to make them aware of the problems posed by the current guidelines regarding cesium contamination.
We urge you to join the FFAN and call your U.S. Representative and Senators to let them know that:
- The U.S. Food and Drug Administration’s current guidelines for radiation contamination are too lax, and
- In light of disasters like the 3/11/2011 nuclear catastrophe in Fukushima, we need to pay more attention to contaminated food, not less.
Guidelines set by the U.S. Food and Drug Administration (FDA) are some of the most lenient in the world, allowing levels of cesium in U.S. food that are banned in a wide variety of other countries, and that are twelve times higher than what is allowed in Japan.
In March of 2013, FFAN and its allies, including Citizens for Health, filed an official Citizen Petition with the FDA urging them to lower the amount of cesium allowed in U.S. food to 5 becquerels per kilogram, but the FDA has yet to offer a substantive response. Ask your Representative and Senators to urge the FDA to respond to the petition. (Regulations.gov: Cesium petition and its related documents).
Please take a few minutes and call your U.S. Representative and Senators. You can find their contact information here.
For more background, and to get you energized to take action, check out this post by fellow FFAN coalition member, Beyond Nuclear. Start your conversation with your members of Congress with this sample language.