Fight Back Against FDA Tyranny

Life Extension is now coordinating with other health freedom groups to stop Big Pharma from further monopolizing consumer access to affordable dietary supplements and conventional healthcare. We need the support of everyone reading this article to win this battle.

For those who think it’s not worth the effort, consider the consequences of failing to take action. Innovation in the natural ingredient marketplace will be stifled while pharmaceutical companies grab dietary supplements and gain FDA protection to sell them as prescription drugs.

Many retired seniors will have to take jobs to afford their medications. Those working full-time may have to find additional part-time work to pay the high premiums and many out-of-pocket expenses no longer covered by medical insurance.

These problems can be partially resolved if free-market competition is allowed in the generic drug and dietary supplement marketplaces.

Life Extension is mobilizing a grass roots campaign to overwhelm the lobbyists that have dominated Congress and federal agencies.

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How Much More Abuse Can Americans Tolerate?

The extortionist cost of generic drugs is rendering Americans insolvent.

Regulation of drug prices is not the solution.

The problem of generic drug price gouging will disappear if the Food, Drug and Cosmetic Act is amended to allow greater competition in the generic marketplace.

If enacted, generic prices will plummet to levels so low that consumers won't even worry about the percentage their insurance company will pay.

When generic drug prices drop this much, it will push down many name brand prices because there are often generic substitutes that work almost as well as newer branded drugs.

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Big Pharma Trying to Restrict Consumer Access to Better Drugs

On April 16, 2013, the FDA was subpoenaed to appear before Congress to account for over fifty deaths from contaminated drugs. According to the House Committee investigative report, the unscrupulous manufacturer was allowed to inflict this carnage because the FDA failed to do its job.

But instead of punishing the FDA for its failure to protect the public, the Senate has introduced a bill giving the FDA more power to take away bioidentical hormones and other drugs that are safely made at compounding pharmacies.

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Cancer Patients Should Have Access to Potentially Life-Saving Therapies

Scientists have identified novel ways of treating cancer and other illnesses, but too little of this new technology is being used in clinical practice. When new discoveries are made, drug companies spend years seeking a patent, and then more years carrying it through the cumbersome bureaucratic approval process. A major reason so many cancer patients die today is an antiquated regulatory system that causes effective therapies to be delayed (or suppressed altogether).

This system must be changed, if the 1,500 American cancer patients who perish each day are to have a realistic chance of being saved. Our long-standing proposal has been to change the law so that anyone can opt out of the FDA's umbrella of "protection." This approach will allow companies to sell drugs that have demonstrated safety and a reasonable likelihood of effectiveness, which are clearly labeled "Not Approved by the FDA." Patients who wish can still use only FDA- approved drugs, while those willing to take a risk, in consultation with their doctors, will be allowed to try drugs shown to be safe that are still not approved.

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Please ask your Legislators to Co-Sponsor the Free Speech about Science Act

A bill has been introduced in the US House of Representatives that would give consumers greater access to truthful, non- misleading health information.

Please contact Congress and ask your legislators to co-sponsor HR1364, the Free Speech about Science Act. If it passes, this bill has the potential to transform the healthcare field by educating the public about the science behind natural health.

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Conventional Medicine Wants FDA to Take Away Most Dietary Supplements

An editorial in the January 25, 2012, issue of the New England Journal of Medicine strongly supports the Food and Drug Administration’s (FDA) proposed New Dietary Ingredient guidelines that would ban most of the effective nutrients you use today.

Ask your senators and  representative to make a one-minute floor speech opposing the FDA’s plan to sweep many supplements off the shelf. At the same time, you will be asking your members of Congress to write the FDA about the consumer revolt that is occurring in response to these draconian proposals to take away the most effective dietary supplements on the market today!

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Pharmocracy Uncovers Egregious FDA Incompetence – Take Action Today!

Governments collapse when ineptitude and corruption reach such egregious magnitudes that the citizenry has no choice but to revolt.

While Pharmocracy uncovers egregious FDA incompe­tence and abuse, Congress is the body of government that provides FDA with enabling laws that ultimately result in needless suffering and death ...while the nation descends into financial ruination.

Implementing the free-market approaches advocated in this book could spare Medicare and Medicaid from insol­vency, while significantly improving the health and pro­ductivity of the American public.

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FDA views your supplements in the same light as synthetic food preservatives

According to the FDA's New Dietary Ingredient guidelines issued on July 1, 2011, the FDA believes that “new dietary supplements” must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives. This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives.

The FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.

Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems...

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FDA Says Walnuts Are Illegal Drugs

Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’s website.

According to the FDA, these walnuts were classified as “drugs” and the “unauthorized health claims” cause them to become “misbranded,” thus subjecting them to government “seizure or injunction.” Diamond Foods capitulated and removed statements about the health benefits of walnuts from its website.

Passage of the Free Speech About Science Act will stop federal agencies from squandering tax dollars censoring what you are allowed to learn about health-promoting foods. Our Legislative Action Website provides you direct contact with your Representative to let them know that you want H.R. 1364 (Free Speech About Science Act) enacted into law.

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Senate Wants Food Makers Jailed for Ten Years

We Must Stop This Bill from Passing in the House

Despite protests from health freedom activists, the Senate passed a bill that enables the FDA to put food makers in jail for ten years!

If enacted by the House of Representatives, this bill would empower the FDA to imprison food makers if they quote findings from peer-reviewed published scientific studies on their websites.

This draconian proposal is concealed in a bill titled the Food Safety Accountability Act (S.216). This bill passed the Senate because it inflicts harsh jail sentences against anyone who knowingly contaminates food for sale. But there already are strong laws to punish anyone who commits this crime, so this bill instead serves the purpose of enriching pharmaceutical interests by censoring what healthy food makers can say about their products.

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Walnut Grower Capitulates to FDA Censorship

Life Extension® has published 57 articles that describe the health benefits of walnuts.

Some of this same scientific data was featured on the website of Diamond Foods, Inc., a distributor of packaged walnuts.

Last year the FDA determined that walnuts sold by Diamond Foods cannot be legally marketed because the walnuts “are not generally recognized as safe and effective” for the medical conditions referenced on Diamond Foods’ website.

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FDA Delay of One Drug Causes 82,000 Lost Life-Years

In 2004, I wrote an article describing how Americans die needlessly because of the FDA’s delay in approving lifesaving drugs.

One example of a delayed therapy I cited was Provenge®, which in the year 2002 had demonstrated improved survival in prostate cancer patients.

In 2007, Dr. Stephen Strum and I co-authored an article showing how enormous numbers of lives could be spared if scientists were liberated from oppressive FDA over-regulation. We described several cancer drugs that should have been approved including Provenge®, which by the year 2007 had extended survival in several clinical studies.

In 2010, the FDA finally approved Provenge®. This was after still another FDA-mandated clinical trial documented the efficacy of this therapy.

As you’re about to read, the FDA’s eight-year delay in approving Provenge® has resulted in a horrific number of prostate cancer victims prematurely dying!

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Waxman’s Anti-Supplement Measure Excluded From Senate “Wall St. Reform” Bill! But Fight Is Not Over

On Thursday, May 19, the Senate held their final vote on the Wall Street “Reform” Act. We are pleased to report that the anti-supplement provision drafted by Congressman Henry A. Waxman (D-CA), and included in the House bill, which would have expanded the authority of the Federal Trade Commission (FTC), was not included in the final version of the Senate bill — the provision had suddenly become “too controversial”!

This victory was largely due to you, our supporters, who flooded Senate offices with thousands of e-mails and phone calls. Thank you! This is proof once again that when you make your voice clearly heard, legislators listen.

But the fight isn’t over yet.

Now’s the time to let your senators and congressional representatives know that you want them to tell the conference committee to remove the FTC powers expansion language currently in the House version of the bill from the final version of the Wall Street Reform and Consumer Protection Act. As we noted earlier, this could be a devastating piece of legislation for anyone who uses dietary supplements. We’ve made so much progress – we need to redouble our efforts now!

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Another attempt on Capitol Hill to take away our Vitamins

The threat of a regulatory stranglehold over dietary supplements has intensified.

The urgent issue we face today is language U.S. Representative Henry Waxman inserted into the Wall Street Reform Bill (H.R. 4173). This bill has been passed in the House of Representatives and Waxman hopes the Senate will pass the bill with language that gives FTC bureaucrats arbitrary authority to impose crippling requirements that will drive up the costs of supplements or remove them from the market entirely.

If this legislation is passed, our fear is that many supplements will disappear or that Americans will be unable to afford their supplements and will succumb to a host of deficiency-related diseases.

Email your Senator to demand that Rep. Waxman's drug company-favoring language not be added to the Senate version of the so- called Wall Street Reform Act and not be included in any later House/Senate version of the bill.

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Ask your Representative to cosponsor the Free Speech about Science Act (H.R. 4913)

On March 23, 2010, a bipartisan bill was introduced into the House of Representatives called the Free Speech about Science Act (H.R. 4913). This landmark legislation protects basic free speech rights, ends censorship of science, and enables the natural health products community to share peer-reviewed scientific findings with the public.

The Free Speech about Science Act has the potential to transform medical practice by educating the public about the real science behind natural health. For this very reason, the bill will have opposition. It will be opposed by the FDA since it restricts their ability to censor the dissemination of published scientific data. It will be opposed by drug companies fearing competition from natural health approaches based on diet, dietary supplements, and lifestyle.

The public, on the other hand, wants access to credible information they can use to make wise dietary choices. Please don’t let special interests stop this bill.

Passage of the Free Speech about Science Act will stop federal agencies from squandering tax dollars censoring what you are allowed to learn about health-promoting foods.

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Oppose the Dietary Supplement Safety Act of 2010 bill

Senator John McCain has introduced a bill that if passed, will drive up the cost of dietary supplements and restrict your access to them. The bill being spearheaded by Senators John McCain and Byron Dorgan supposedly originates from the controversy surrounding the use of steroids by Major League Baseball players. Since some unethical companies illegally sold steroid drugs as “dietary supplements,” certain members of Senate appear to have been deceived into believing that the FDA needs to be given additional power to ban dietary supplements across the board.

In order to mislead the public about the true nature of this bill, it has been named the Dietary Supplement Safety Act of 2010 (DSSA). Despite nutritional supplements’ safety record, McCain’s bill would give the FDA authority to draw up a list of allowed and disallowed supplements (and supplement potencies). This bill would cause any dietary supplement to be classified as “adulterated” if it is “manufactured, packaged, held, distributed, labeled or licensed by a dietary supplement company not registered with the Secretary.” The “Secretary” in this case is the Secretary of Health and Human Services, the department of the federal government that oversees the FDA.

The FDA already requires manufacturers to maintain records of serious adverse reaction reports. This bill would require that all “non-serious adverse events” be submitted to the federal government. The problem is that when a large group of people take any product, there are always coincidental “adverse reactions”. This means that for any given product, the FDA can arbitrarily take the list of adverse reports submitted to it and use it as a basis to remove the product, even if there was not a single valid adverse reaction! Pharmaceutical companies would be able, under the Freedom of Information Act, to gain access to these reports, and petition the FDA to remove the supplement from the market. If McCain’s bill is passed, it will make it far easier for pharmaceutical companies to file use patents on what are now inexpensive dietary supplements and convert them into outrageously priced “drugs.”

Please alert your two Senators and Representatives about this oppressive legislation that should not be co-sponsored and should instead be vigorously opposed.

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Take action now on FDA failure, deception and abuse!

Hunter Lewis and Gretchen Dubeau run an organization called the Alliance for Natural Health-USA (ANH-USA). (The name reflects a merger of the American Association for Health Freedom (AAHF) and the Alliance for Natural Health in the UK.) The merged organization will redouble its efforts to radically reform the FDA.

Hunter and others compiled a collection of articles written by William Faloon over the years concerning the United States Food and Drug Administration. The book, entitled FDA: Failure, Deception, Abuse represents a compilation of FDA atrocities that have never appeared together in one publication. The objective is to disseminate this book, published by Praktikos Books (praktikosinstitute.org/praktikos-books), far and wide in order to enlighten this country about the urgent need for radical FDA reform. Order this book from Life Extension

Life Extension encourages its customers to obtain a copy of FDA: Failure, Deception, Abuse for themselves and to loan it out to others. There may be no more efficient way to initiate a revolution against FDA tyranny while unshackling legitimate scientists whose discoveries could save countless numbers of human lives.