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Senator McCain Files New Bill That Attacks Your Access to Supplements and Repeals Key Sections of the Dietary Supplement Health and Education Act

original link: The Delano Report

McCain’s bill is called The Dietary Supplement Safety Act (DSSA). It would repeal key sections of the Dietary Supplement Health and Education Act (DSHEA). DSHEA protects supplements if 1) they are food products that have been in the food supply and not chemically altered or 2) if they were sold as supplements prior to 1994, the year that DSHEA was passed. If a supplement fits one of these two descriptions, the Food and Drug Administration (FDA) cannot arbitrarily ban it or reclassify it as a drug.

These protections are far from perfect. They discourage companies from developing new forms of supplements. New supplements may be arbitrarily banned by the FDA or adopted by drug companies in a way that precludes their further sale as supplements.

McCain’s bill would wipe out even the minimal protections contained in DSHEA. It would give the FDA full discretion and power to compile a discreet list of supplements allowed to remain on the market while banning all others.

Everyone knows that the FDA is friendly to drug companies (which pay its bills and provide good revolving door jobs) and hostile to supplement companies. Under this bill, this same Agency could quite arbitrarily ban any supplement it wished or turn it over to drug companies to be developed as a drug and sold for multiples of its price as a supplement.

We must prevent this bill from gaining traction! Protect your access to supplements by contacting your senators today and asking them NOT to co-sponsor the Dietary Supplement Safety Act but rather to oppose it.

McCain’s Dietary Supplement Safety Act (DSSA) appears to be supported by the US Anti-Doping Agency (USADA) which is funded by major league sports teams including baseball, football and others. The recent suspensions of NFL and other professional sports figures is much in the news, and the goal of the sports industry appears to be to shift the spotlight from their players to the supplements industry. In his comments, Senator McCain cited six NFL players recently suspended for testing positive for banned substances and purportedly exposed to these substances through dietary supplements.

The problem here of course is one of illegal sale and use of steroids. So why dismantle the supplement industry in order to control already illegal substances?

The FDA currently has complete and total authority to stop illegal steroids and, more broadly, to regulate dietary supplements. If the agency were doing its job, it could and would have prevented the sale of illegal steroids. The answer to this problem is not to give FDA more power. The Agency simply needs to do it’s job.

Why would a bill be offered to solve an illegal steroid problem that does not really address the steroid problem but instead gives the FDA complete and arbitrary control over all supplements? The answer is simple.

There are a lot of vested interests which are threatened by supplements. Drug companies do not like them because they represent a low cost, safer, and often more effective alternative to drugs. The FDA does not like them because supplements do not come through the FDA approval process and therefore do not support the FDA budget.

A Medical Doctor’s Open Letter Opposing the McCain Sponsored Dietary Supplement Safety Act (DSSA)

Dear Senator McCain:

Though I am a resident of New York, not Arizona, I suggest that someone in your staff reads my letter very carefully as I believe you are unwittingly sponsoring a bill with potentially onerous consequences, one that might if I read the information about it properly, lead to the death of hundreds of my patients fighting advanced, terminal cancer. I do not think, if I am correct in my interpretation, that you would want their death on your conscience.

As some background, I am a registered Republican, and in the past have donated many thousands to Republican causes including your re-election, even when it became clear to me the Party, including you, had strayed significantly from its mission of limited government, deficit reduction, and ultimately, protection of individual liberty. In terms of my professional activities, I am a former journalist (Time Inc), currently a physician and cancer researcher, who educated at three Ivy League schools (Brown undergraduate, Columbia post grad, Cornell for medical school). I finished a fellowship in cancer immunology under Robert A. Good, for ten years President of Sloan-Kettering, and the most published author in the history of medicine. Under Dr. Good’s direction, 29 years ago I began researching the use of diet, nutrients, and proteolytic enzymes against advanced cancer.

I am a serious scientist working seven days a week trying to help those for whom there is no other help. Though some consider my work “alternative” and though in the past my treatment has generated controversy since my therapy does not conform to the drug company model, I have been funded by very mainstream corporations and institutions including Procter & Gamble, Nestle, and the NIH. Congressman Dan Burton (R, Indiana) has long been a vocal supporter, and I have met with Senator Harkin at his invitation to discuss this treatment. My research has been featured in a lengthy profile appearing in the New Yorker Magazine (Feb 5, 2001) and more recently in the major best-selling book Knockout about innovative new approaches to cancer, written by the actress and writer Suzanne Somers. I appear regularly in the media, which increasingly has taken a very positive view of my work. In addition, my colleague Dr. Linda Isaacs and I recently published our first book in a projected series, The Trophoblast and the Origins of Cancer, that discusses in some detail the scientific support for our treatment approach. You can learn more about my background and therapy at our website: www.dr-gonzalez.com

In our New York practice, we are currently treating hundreds of patients diagnosed with terrible advanced cancer for whom no conventional options exist. Many are successfully battling their disease with our regimen of diet, nutritional supplements, and proteolytic enzymes—which are currently available legally as over-the-counter items. We use only high quality products, manufactured by my stringent specifications.

Though I suspect you and your staff created this new bill with the good intention of protecting the public, as I read information about the bill, it appears to give the FDA near-dictatorial control over the manufacture and availability of supplements, allow them at their own arbitrary discretion to remove legitimate nutritional supplements from the marketplace, file complaints against particular legitimate supplements at their whim, and impose drug testing standards on each supplement. Testing of a single product to meet FDA standards for marketing of a new drug alone can cost hundreds of millions of dollars. No supplement company to my knowledge has the resources to fight or meet such regulatory impositions. As an end result, ethical supplement companies as they currently exist would, again if I read the bill correctly, be forced to shut down.

I have read that you are motivated by recent scandals involving the doping of athletes with illegal steroids, certainly a terrible tragedy, and have been approached by various professional athletic organizations such as Major League Baseball. I believe these organizations are trying to shift blame from their athletes to the supplement industry. Regardless, the FDA already possesses power to investigate and punish companies marketing and selling steroids improperly—the issue at stake here—and requires no additional authority to do so. It certainly does not now need added control over properly manufactured and properly marketed supplements or food substances and the companies that provide these products, in order to regulate illicit steroid spiking.

I suppose, on the surface, the bill sounds innocent enough, requiring manufacturers to provide the FDA with ingredients, etc. But current Good Manufacturing regulations to my understanding already require that supplement companies must provide proof of ingredients and quality. This proposed bill, whatever your stated goal, appears to play into the FDA’s long standing animus against the supplement industry at large, which to date has some protection from capricious regulatory harassment under the Dietary Supplement Health and Education Act (DSHEA). I believe, based on years of study, that such FDA antagonism even against ethically manufactured supplements stems from its close working relationship with the drug company giants. Like the FDA, the drug industry has sought for years to have supplements removed from the over-the-counter marketplace and transformed into prescription drugs which they alone could control and market and for which they could charge enormous prices, as is the case with any other drug. You seem to have played right into this effort. In your press conference, you alluded to expected opposition to your bill from the supplement industry. I suspect such opposition will be small compared to the opposition of the American public at large. In past decades, as the FDA, working with the drug industry, tried to gain complete control over the supplement industry, repeatedly the American people have fought back in vigorous campaigns, in true American fashion expressing their opinions to their elected officials in Washington. But the regulatory agencies in Washington never give up their dream of removing most if not all supplements from the free marketplace and turning them into restricted and expensive drugs, all to the benefit of the pharmaceutical industry and to the ultimate detriment of the public.

Ethically manufactured nutritional supplements when used appropriately are extraordinarily safe with considerable health benefits. We see this in our own practice daily, even with the most advanced, deadly of diseases. Furthermore, nutrients—again when manufactured and used appropriately—have in my long experience none of the terrible side effects of prescription items or even over-the-counter drugs. For example, it is estimated that 10,000 Americans die each year from bleeding resulting from intake of aspirin or over-the-counter anti-inflammatory drugs, yet the FDA does nothing to ban these products, which bring in untold profits to the drug industry. Nor to my knowledge have you ever held a press conference expressing your outrage over thousands of Americans tragically dying from aspirin use each year.

Certainly everyone would agree that an unethical company marketing potent drugs as supplements should be prosecuted to the full extent of the law, but again, the FDA already has such authority. It hardly seems reasonable, as could now be possible should your bill pass, to punish and perhaps even eliminate an entire industry because of a few renegade manufacturers.

Your bill, furthermore, seems to unravel the Dietary Supplement Health and Education Act (DSHEA) that provides protection from regulatory harassment for the many legitimate small supplement companies. In a flurry of misguided efforts to protect consumers, the FDA should not be given what it has long sought, the ability to regulate and control —and eventually, possibly even bankrupt—the supplement industry, all to the benefit of the drug companies. I believe your bill would allow the FDA to do just that.

I am astonished that without much apparent thought of the consequences, you would consider introducing such legislation. The American people, by and large, want their nutritional supplements, and they want these products freely available without FDA interference. Yes, of course they also want scientifically sound and ethically manufactured products, but the FDA and FTC can already act against improperly marketed supplements and supplements deliberately contaminated with drugs. And a company determined to spike their products will do so whatever the additional regulations imposed.

We do not need yet another power grab in Washington, all intended for our alleged “good,” and to help protect us from ourselves. As a more personal note, I will tell you that hundreds of my very sick patients are very distraught about this bill since your press conference announced its introduction, angry that you, of all people, would sponsor legislation that might possibly eliminate their life-sustaining supplements from the marketplace, and essentially condemn them to death—all in the name of consumer protection. The mere possibility of such a turn of events has upset them enormously. I will also tell you that as we learn more about this proposed legislation, however you may position it, my patients are already considering mobilizing to support your opponent in every way possible, financially, as volunteers – even perhaps holding a “sit-in” at your offices for the benefit of the press. That is how seriously they are taking this situation. And let me assure you these people are not part of some supplement company conspiracy against safe manufacturing practices, they are Americans—many of them incidentally veterans —with terrible disease who do not want interference with their treatment choice. I can understand their dismay. Perhaps I am wrong in my interpretation, but if this bill were ever to pass, the repercussions do seem potentially disastrous, in ways far beyond your assurance that this issue is a “no-brainer.”

I would be happy to talk to anyone in your staff about the unintended consequences apparent in this bill. As I read the information, in my opinion it appears that ultimately it protects nobody except the drug industry and provides professional athletes with a convenient scapegoat. It certainly would not protect the American public that has over the decades repeatedly shown it wants free access to nutritional supplements without FDA interference. Certainly, it will not protect my patients, who, frankly, did not need to hear of this bill, the thought of which has added enormous stress to their lives as they daily fight their life and death battles.

Sincerely,
Nicholas J. Gonzalez, M.D.
www.dr-gonzalez.com

The Dietary Supplement Excuse

By James Gormley, Senior Policy Advisor for Citizens For Health
via www.thegormleyfiles.blogspot.com

[With the DSSA bill, S. 3002, now up for vigorous debate, it’s worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

Home-Birth Boost for Expectant Mothers

By JULIA MEDEW via www.theage.com.au
December 23, 2009

home birth

VICTORIAN women will be able to give birth at home – with hospital back-up for the first time – under a pilot project starting at three hospitals next year.

Health Minister Daniel Andrews said yesterday that the State Government had allocated $400,000 for midwife-led home births through Casey Hospital in Berwick and Sunshine Hospital in Melbourne’s west. A regional health service will also participate, but the Government has yet to decide which one.

Mr. Andrews said midwives employed in the one-year projects would be covered by their hospital’s insurance, and that women participating would have a midwife care for them throughout their pregnancy, with several back-up midwives available if their primary carer was sick or unavailable when they went into labour.

Antenatal care would also be provided by the hospitals so they could keep track of the mothers’ medical history.

The announcement is a boon for women in favour of home births, who up until now have had to pay between $1800 and $6000 for their own private midwives without organised access to hospitals if something went wrong.

”The new pilot programs will give Victorian families greater choice in maternity care and provide women with greater control of their birthing experience,” Mr. Andrews said.

”Once the public home-birth program is evaluated, it may be more widely offered through the public health system.”

Professor Euan Wallace, director of obstetrics at Southern Health, which oversees Casey Hospital, said it was an excellent initiative that would probably appeal to women who had previously had uncomplicated births. He said women and private midwives planning home births had complained about a lack of support from hospitals if something went wrong and hospitals had also been unhappy about last-minute referrals for care.

”If there’s any problems during labour for women participating in the pilot, they can be brought into the hospital where they will be looked after by their midwives and hospital staff. Everything will be seamless. It’s fantastic,” he said.

Professor Wallace said about 200 Victorian women had their babies at home each year – 0.3 per cent of all births in the state.

”Our expectation is that that number will go up as we make a high-quality home-birth service available that reports on all its outcomes in a transparent manner,” he said. Mr Andrews said he hoped the pilots would attract privately practising midwives into the public system where there is a shortage, and that about 50 women would participate in each hospital’s program next year.

Patrice Hickey, midwifery group practice mentor at Sunshine Hospital and Victorian president of the Australian College of Midwives, said midwives were thrilled about the pilot, which would make home birth a mainstream choice for women who wanted it and met the criteria for it.

”This has been a dream for a lot of midwives over many years,” she said.

”A lot of women don’t want to have home births in an isolated fashion, but are more than happy to do it in a collaborative, seamless service for women like this.”

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Preventing The Swine Flu: A Comprehensive Approach

contain

Sneezing, coughing, fever, aches and pains…

Worried about flu symptoms like these? As winter approaches, most of us are.

But this year, the flu seems even more alarming, thanks to increased health concerns about the H1N1 influenza strain, also known as the swine flu. Even though this strain doesn’t appear to be particularly threatening, it has the potential to mutate into a more dangerous form.

The main question my patients have been asking is whether they should get vaccinated against H1N1 or against the regular flu.

This is not a simple yes or no answer. The guiding principle of functional medicine is personalized care, not the one-size-fits-all belief that everyone should have the same treatment. This applies equally to vaccines. There is risk and benefit to every medical treatment or procedure.

That is why in today’s blog I want to review what you need to consider if you are thinking about vaccination, discuss some of the risks involved, and provide you with a comprehensive 7-step plan for preventing swine flu and staying healthy all winter long.

Should You Get Vaccinated?

The choice to get vaccinated is an individual one. Selective vaccination may be helpful for some groups of people–but not everyone. Here are the facts as I see them:

The current strain of H1N1 is a generally mild strain of the flu. It sounds scarier, but, so far, fewer people have actually died from it than from the traditional flu. It may mutate but it hasn’t yet. Pushing widespread vaccination on low-risk populations exposes them to unnecessary risks.

If the H1N1 mutates, the current vaccine may not be effective against it.

The studies on the H1N1 vaccine have been limited in the rush to market.

The 1976 swine flu vaccine was linked to a serious neurological disease called Guillain-Barré syndrome, which causes severe (but usually temporary) paralysis.

The government has agreed to protect vaccine manufacturers from any lawsuits due to side effects of the vaccine, otherwise pharmaceutical companies would not make it.

Steroids Disguised as Dietary Supplements

Baseball
original link: www.usatoday.com
By A.J. Perez, USA TODAY, 9/28/2009

When federal authorities raided BALCO six years ago, investigators found the San Francisco Bay Area firm had supplied performance-enhancing drugs to a select roster of elite athletes.

The Senate Judiciary Subcommittee on Crime and Drugs will explore the availability of banned substances — including those developed for BALCO — at health food stores in a hearing this afternoon.

“There are certain steroids and other drugs being masqueraded as dietary supplements,” said U.S. Anti-Doping Agency CEO Travis Tygart, one of four experts called to testify. “We’re seeing the migration from clandestine labs where designer steroids were being produced for the elite-level athlete to these being distributed to the mainstream where high school and junior high school athletes have access to them.”

The subcommittee is focusing on products that contain steroids or steroid precursors that are marketed as supplements, which make up a fraction of the $24 billion food supplement industry in the USA. The hearing was called by subcommittee chairman Sen. Arlen Specter, D-Pa., a fan of the Philadelphia Phillies, a team that went without reliever J.C. Romero for 50 games this season after he tested positive for a banned substance linked to a testosterone-boosting supplement.

Tygart said legislation may be needed to close loopholes that allow products to go on the market without approval by the Food and Drug Administration.

Richard Kingham, a Washington-based lawyer who is also scheduled to testify, said consumers can be protected if the FDA and the Drug Enforcement Administration are given the resources to enforce the laws on the books now.

“This is a law enforcement issue,” said Kingham, whose area of concentration is food and drug law.

Kingham said last week’s raid of supplement dealer Bodybuilding.com is a prime example.

Over the last two years, 23 of 31 supplements purchased by FDA investigators from Bodybuilding.com contained anabolic steroids, according to a search warrant unsealed when the company’s headquarters in Boise, was searched on Thursday.

Amanda Cheslock, spokeswoman for Bodybuilding.com, said the website does not manufacture the products and is cooperating with the investigation.

“We’re glad the Congress is looking into this, because anything we can do to separate the legal, safe and healthy dietary supplement industry from the seedy, fly-by-night and unsafe world of illegal steroids is worthwhile,” said Daniel Fabricant, interim executive director and CEO of the National Nutritional Foods Association. Fabricant will testify in front of the subcommittee.

link to related article by James Gormley: click here

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Arnica Montana – Natural Treatment for Inflammation and Trauma

Arnica

original link: www.healthnews.com
By Melanie Grimes

Arnica montana is one of the most valuable homeopathic remedies. Also known as Leopard’s bane, this member of the Compositae—or Sunflower —family is used as a specific to reduce bruising and swelling, particularly after physical traumas such as falls or blows. It can be applied in a cream, gel, salve, or tincture, or taken internally.

Used by Native American and Europeans for centuries, Arnica was first described in the sixteenth century by the naturalist Tabernae Montanus, for whom it is named. The plant grows in the mountains in Europe and Siberia, where the grazing goats and oxen eat it. The yellow flowers, which are the medicinal part of the plant, are two to three inches in diameter and look similar to a daisy, hence its name Mountain Daisy. Because Arnica requires specific soil conditions, it has proved difficult to cultivate and the natural supply has become endangered.

Arnica is a wonder drug for treating trauma. It can be used to aid injuries from accidents and hemorrhages, both internal and external. Arnica can be given to treat the acute and chronic effects of injuries, but its main area of effect is for shock and trauma. It offers quick relief of concussions and contusions, aiding in the reabsorption of blood from injured tissues.

Inflammation is a reaction caused by damaged cells. It produces chemicals that cause tissue to swell and dilate. This reaction allows more blood to reach the effected area, to bring nutrients and oxygen to speed healing. This is a healthy reaction, but in times of great trauma, the increase in pressure caused by the swelling can be damaging in itself, for example in head injuries. And when the inflammatory process is continual, as in chronic disease, the swelling begins to deteriorate the tissue because of the continued overheating caused by the inflammation.

Selling the “Vitamins Don’t Work” Myth: What’s the Real Story?

By John Pittman, MD via www.acam.typepad.com

Vitamin

In recent years, newspapers have been trumpeting the news that vitamins C, D and E—as well as multi-vitamins preparations—do not prevent heart attack, stroke or cancer. These reports have led to a great deal of confusion and disillusionment among health-conscious consumers, many of whom already take supplements and are genuinely interested in practical ways to bolster their health and well-being. But is it really true that vitamin supplements are a waste of money and possibly even harmful for you? What are we to make of recent media pronouncements that most people are popping these pills without deriving any benefit whatsoever?

First of all, it’s important to understand that the vast majority of these negative reports are, in reality, old news wrapped in tabloid-style headlines. Many news reports fall woefully short of telling the whole story about a scientific study or about the conclusions of the scientific community regarding a specific issue. Media reports often present a study’s findings in a scattershot, fragmented manner, and without the proper scientific context—for example, by failing to acknowledge the many studies that have, in fact, found vitamins to be beneficial to the people who take them.

Jane Brody’s Personal Health column in the 24 March 2009 edition of the New York Times is a case in point. The report was titled “Extra Vitamin E: No Benefit, Maybe Harm.” Because Brody is widely respected as a health journalist, her messages are often taken as gospel. But those who understand the fundamentals of nutrition and the science of supplements can read between the lines. For example, before discussing the vitamin E research, Brody makes this comment: “Some vitamin E enthusiasts object that the clinical studies used what they consider the wrong form of the vitamin, saying that each of the vitamin’s eight forms has its own biological activity. But the kind of vitamin E used in most studies, alpha-tocopherol, is the most active form in humans, according to the National Institutes of Health’s (NIH’s) Office of Dietary Supplements.”

Placebos Are Getting More Effective. Drugmakers Are Desperate to Know Why.

By Steve Silberman via www.wired.com

placebo

Merck was in trouble. In 2002, the pharmaceutical giant was falling behind its rivals in sales. Even worse, patents on five blockbuster drugs were about to expire, which would allow cheaper generics to flood the market. The company hadn’t introduced a truly new product in three years, and its stock price was plummeting.

In interviews with the press, Edward Scolnick, Merck’s research director, laid out his battle plan to restore the firm to preeminence. Key to his strategy was expanding the company’s reach into the antidepressant market, where Merck had lagged while competitors like Pfizer and GlaxoSmithKline created some of the best-selling drugs in the world. “To remain dominant in the future,” he told Forbes, “we need to dominate the central nervous system.”

His plan hinged on the success of an experimental antidepressant codenamed MK-869. Still in clinical trials, it looked like every pharma executive’s dream: a new kind of medication that exploited brain chemistry in innovative ways to promote feelings of well-being. The drug tested brilliantly early on, with minimal side effects, and Merck touted its game-changing potential at a meeting of 300 securities analysts.

Behind the scenes, however, MK-869 was starting to unravel. True, many test subjects treated with the medication felt their hopelessness and anxiety lift. But so did nearly the same number who took a placebo, a look-alike pill made of milk sugar or another inert substance given to groups of volunteers in clinical trials to gauge how much more effective the real drug is by comparison. The fact that taking a faux drug can powerfully improve some people’s health—the so-called placebo effect—has long been considered an embarrassment to the serious practice of pharmacology.

Ultimately, Merck’s foray into the antidepressant market failed. In subsequent tests, MK-869 turned out to be no more effective than a placebo. In the jargon of the industry, the trials crossed the futility boundary.

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Lawmaking and the GAO Report: A Dose of Reality

By James Gormley via www.thegormleyfiles.blogspot.com

At the end of 2007, the U.S. dietary supplement industry recorded sales of $23.7 billion, according to Nutrition Business Journal. With roughly 33,000 dietary supplements on the U.S. market, it’s no surprise that with today’s nutritionally challenged diet there were 192 million Americans using supplements in 2007, a number that is expected to keep growing.

In addition to wanting to provide a basic nutritional “insurance policy” offered by a multivitamin, people take nutritional supplements for a variety of health-promoting reasons. In a 2000 survey conducted by Yankelovich Partners and commissioned by the Natural Products Association (NPA), seven out of 10 Americans take supplements because they make them feel better.

With the December 22nd, 2006, enactment of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (often called the Serious Adverse Event Reporting [SAER] Law) and the August 24, 2007 implementation of the final rule on Current Good Manufacturing Practices (often called the cGMPs of federal GMPs, 21 CFR Part 111) — along with complementary and innovative industry self-regulatory programs—consumers have arguably never been better protected.

Not so, says a new report from the U.S. Government Accountability Office (GAO), entitled Dietary Supplements: FDA Should Take Further Actions to Improve Oversight and Consumer Understanding.

Broadly, the GAO report recommends: “…that the Secretary of Health and Human Services direct the Commissioner of the FDA to request additional authority to oversee dietary supplements, issue guidance on new dietary ingredients and to clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.”

“I am troubled that the FDA lacks the basic information necessary to protect consumers from unsafe dietary supplements […] The FDA clearly needs more resources to give consumers real protection,” announced Rep. Henry A. Waxman (D-CA) upon release of the report.

His colleague, Rep. John D. Dingell (D-MI), added: “FDA needs the resources and adequate authorities [sic] so the agency can start addressing this problem.”

Among the report’s many conclusions, the GAO notably recommends that the Secretary of the Department of Health and Human Services (HHS) “direct[s] the [FDA] Commissioner” to require dietary supplement companies to “report all adverse events related to dietary supplements.”

The SAER Law already well protects consumers and has already demonstrated its ability to provide a signal to the FDA for action. The number of serious adverse event reports is in the hundreds, as compared to the hundreds of thousands of deaths and millions of serious adverse events for drugs and foods.

Why then would the GAO report require the reporting of all dietary supplement adverse events when this is not required for foods or drugs? This simply does not make any sense.

On top of this, the FDA itself doesn’t even think this makes sense. In its response to the report, the FDA wrote: “[…] it is not clear that all the information would actually enhance product safety.”

Finally, to top it off, did you know that the GAO, in fact, works for Congress? The head of GAO, the Comptroller General of the United States, is appointed to a 15-year term by the President from a slate of candidates Congress proposes, so clearly its reports are developed to provide support for agenda-driven “requests” from Senators and members of Congress, including the ones who requested this report. Ergo, it’s not always, or necessarily, the independent watchdog it’s often thought to be.

Gormley Take-Away: Lawmakers grandstanding and the GAO report notwithstanding, dietary supplements are by far much safer than foods and drugs. What happened to the facts?