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Food Safety Bill’s Ban on BPA Resisted

By Lyndsey Layton, Washington Post Staff Writer

The food industry and major business groups, including the U.S. Chamber of Commerce, are threatening to withdraw support for a long-pending bill to improve food safety, saying they are upset by a proposed amendment that would ban bisphenol-A, a controversial chemical, from food and beverage containers.

The bill is the Senate version of legislation passed overwhelmingly by the House last year. It is designed to give the Food and Drug Administration vast new regulatory authority over food production and place greater responsibility on manufacturers and farmers to produce food free from contamination. It had broad bipartisan support and backing from the White House, and it was expected to come to the Senate floor before the Memorial Day recess.

But in a letter to Sens. Tom Harkin (D-Iowa) and Mike Enzi (R-Wyo.), the chairman and ranking minority member on the Senate Health, Education, Labor and Pension Committee, the business groups said last week that they oppose an amendment by Sen. Dianne Feinstein (D-Calif.) that would ban bisphenol-A, or BPA, from food and beverage containers.

“We will not support food safety legislation that bans or phases out BPA from any food and beverage container,” said Scott Faber, vice president for federal affairs for the Grocery Manufacturers Association, which represents food companies and retailers.

BPA is used in thousands of consumer goods, including compact discs, dental sealants, and credit card and ATM receipts, but health advocates say they are most concerned about BPA’s presence in plastic food containers, bottles and the epoxy linings of metal cans because it can leach into food and beverages. It is found in the urine of more than 90 percent of the U.S. population, according to federal estimates.

More than 200 studies have connected BPA to a range of health concerns, including cancer and developmental and reproductive problems. Some U.S. states and cities have banned its use in certain products, primarily in items for young children that come into contact with food. Many companies have voluntarily removed BPA from their products or required suppliers to provide BPA-free options.

The FDA said in January that it had “some concern” about possible health effects linked to BPA but did not have enough reason to restrict its use and would study the question over 18 to 24 months. The Environmental Protection Agency says that it, too, wants to study the matter. And the National Institutes of Health are spending $30 million over the next two years, also examining whether BPA poses a health risk.

“We trust the FDA to complete a safety assessment for BPA, and we don’t think the Senate should short-circuit and undermine the FDA,” Faber said.

But Janet Nudelman, director of program and policy at the Breast Cancer Fund, said: “There’s really no question that BPA is a food safety issue. The food safety bill is absolutely the right place to move this forward.”

Feinstein and Rep. Edward J. Markey (D-Mass.) introduced a bill last year to ban the chemical from baby bottles, sports water bottles, reusable food containers, infant formula liners and food can liners. Feinstein is using that as a model for an amendment to the food safety bill, her staff said.

“I feel very strongly that the government should protect people from harmful chemicals,” Feinstein said in a statement released by her office. “BPA should be addressed as a part of the food safety overhaul.”

BPA was developed in the 1930s, and commercial uses exploded in the 1950s after scientists discovered its ability to make plastics more durable and shatterproof. A ban would create significant problems for many food manufacturers who do not have BPA-free alternative packaging, Faber said.

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Proposed FDA Food Safety Bill Modified to Protect Natural Supplements

original link:

According to information reported by the Alliance for Natural Health, a Congressional bill designed to overhaul food safety regulations has been modified to exempt food supplements from regulations included in the bill. The FDA Food Modernization Act (S. 510), which has been a source of concern for supplement sellers and consumers, had included language which implied that U.S. trading partners would have to “harmonize” with Codex Alimentarius. The Codex is an international set of regulations that would affect access to many supplements, as it establishes uniform regulations that would supersede national laws governing foods and supplements. Already, a number of European countries and Canada have enacted regulations that greatly restrict the sale and purchase of herbal and nutritional supplements. Supplements under these provisions are addressed more like pharmaceutical drugs, which require extensive time and enormous expense to get government approval.

Fears that S. 510 would limit access in America to natural supplements led health freedom advocates to lobby Senators such as Orrin Hatch (R) and Tom Harkin (D) to modify the legislation. The new language inserted in the bill states that “Nothing in this section shall be construed to affect the regulation of dietary supplements.” This language is not present in the already passed House of Representatives version of the FDA Food Modernization bill. The final draft of the bill may soon be voted on by the Senate, and although the current version appears to protect dietary supplements there is no guarantee that a final version which integrates the House and Senate versions of the bill would retain this protection.

The Senate bill S. 510 was initially sponsored by Senator Richard Durbin (D). Natural health advocates have been vocally concerned with this bill as well as a legislation introduced by Senator John McCain (R), which more directly challenged existing limits on the FDA’s regulations covering the natural supplement industry. Although the McCain bill appears to have been dropped from the current legislative agenda, there are concerns that the agenda of imposing tyrannical restrictions on supplements will be renewed or brought forward in more covert ways. Advocates of the new legislations claim that laws are needed to protect the public from product hazards. However, critics counter that sufficient safety regulations already exist and just need to be properly enforced.

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Health Freedom Nation: Consumers Take Control

By James J. Gormley, The Gormley Files

Courtesy of NOW Foods

Consumers and the health-food industry may have stopped S. 3002 in its tracks, but S. 510 and other threats to health freedom remain. Nevertheless, a new slate of bills, along with a re-invigorated health-freedom movement, offer new hope for the future.

Since the health-food movement’s earliest origins in New Hampshire in the 1790s, there have been many champions of health freedom. The one who immediately springs to mind, at least for me, is Frank Murray, who happened to be my first boss before I became editor of Better Nutrition magazine in 1995.

In 2006, Frank was the recipient of the Natural Product Association (NPA) President’s Award for “long-time contributions to the natural products industry.”

He was for many years editor of Health Foods Retailing, the health-food industry’s very first trade publication and the official magazine of the NPA for 50 years, from the late-1930s until the mid-1980s.

More Than One Slingshot
A bestselling health-book author, Frank has been one of the industry’s most articulate, enthusiastic and tireless crusaders, having stood arm-in-arm with Milton Bass, Max Huberman and NPA in successful opposition to the Vitamin Volstead Act from 1966 through 1976, when the Proxmire Vitamin Bill was signed into law.

His book, More Than One Slingshot, which was written for the association, tells the history of the health food industry from its origins in the late 1890s up through the early 1980s.

The book has this great, dated cover that I love, one which depicts David and Goliath, a popular representation of the battle between the health-food industry and the U.S. Food and Drug Administration (FDA).

Today, in early 2010, we face many of the same threats to health freedom even if the names of the bills and the players have changed.

Today’s Threats to Health Freedom
In March of 2009, Sen. Richard Durbin (D-IL) introduced S. 510, the Food Safety Modernization Act, a bill that would hand over extensive, unwarranted powers to an agency, the FDA, that has shown that it cannot objectively and properly fulfill its mission regarding dietary supplements since it constantly works to undermine the Dietary Supplement Health and Education Act of 1994 (DSHEA) through coordinated suppression of supplement companies and health information regarding products sold by legitimate manufacturers.

As this bill was reviled by consumers and farmers across the country, it appeared to fall by the wayside, that is until Sen. John McCain introduced S. 3002, the Dietary Supplement Safety Act of 2010.

Senate Bill 3002 was said to be about athletics ? trying to protect athletes from spiked or doped supplements (although one would think the athletes would know what they were taking, especially if they themselves ordered these products from shifty chemists and fly-by-night pharmacists), but it included a whole host of anti-supplement provisions that almost made S. 510 pale by comparison.

A firestorm of consumer outrage ensued: many tens of thousands of letters were sent to the Senate thanks to powerful grassroots advocacy campaigns organized by Citizens for Health, the Alliance for Natural Health and the NPA. In early March, Sen. McCain decided to withdraw his support of the bill, with the caveat that certain provisions should be carried over to S. 510, most of which are already in S. 510 as it now stands.

Consumers, and the natural products industry, must be especially vigilant now and throughout 2010 ? regarding S. 510 so that the bad provisions in this bill are dropped or drastically revised, and that nothing even worse from the dry-docked S. 3002 winds up being added to S. 510.

Tomorrow’s Health Freedom Opportunities
As to bills that offer a ray of hope, there are currently three main ones: H.R. 4913, H.R. 3394 and H.R. 3395.

On March 23rd, Rep. Jason Chaffetz (R-Utah) and Rep. Jared Polis (D-CO) introduced the Free Speech about Science Act (H.R. 4913); since then, Rep. Dan Burton (R-Indiana) has signed on as a co-sponsor. The bill allows producers of healthy foods and dietary supplements to cite legitimate scientific studies on the health benefits of their products.

Rest of article can be read here

Swine Flu Response: Alarmist or Legit?

By Frank Jordans via

GENEVA – A group of outside experts will scrutinize the World Health Organization’s response to the swine flu outbreak and likely examine whether the term pandemic was appropriate for what has turned out to be a relatively mild disease, the World Health Organization said Monday.

The review starting later this month will be conducted by around 30 scientists and public health officials, and their initial findings will be presented to member states by WHO Director-General Margaret Chan in May, a senior official told reporters in Geneva.

“The assessment itself is going to address many of the questions which are being raised now,” said Dr. Keiji Fukuda, WHO’s top flu official.

WHO’s pandemic alert scale, or “phases,” and the role that disease severity plays in the global body’s assessment of an outbreak are likely to be among the “critical issues” the group will examine, he said.

Several governments urged WHO last year not to declare swine flu a pandemic, saying it could cause unnecessary alarm if the virus turned out to be harmless. The U.N. health agency went ahead anyway, arguing that the term pandemic signifies only that a new strain is circulating worldwide, but says nothing about how dangerous it is.

Fukuda acknowledged Monday that the choice of words may have to be reconsidered in the future, to avoid confusion and anger from people who believe WHO and others overplayed the threat the virus posed.

“If we look back to the beginning of the pandemic there was a lot of discussion about what do you call these things,” he said. “These things affect how people perceive outbreaks and pandemics so I think it’s one of those issues that we have to think about.”

The expert group, which will include “very well-known scientists,” will hold its first meeting April 12-14 and consultations will probably continue over the course of the year, Fukuda said.

A final report will be presented at the WHO’s annual meeting of member states in May 2011, he said. WHO is holding a separate, internal review of its handling of the outbreak.

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9 Reasons S. 3002 Has to Go

By James Gormley, Senior Policy Advisor, Citizens for Health
More Info @ The Gormley Files

1. No phase-in period or “effective date”. Since legitimate dietary supplement companies and health-food stores would not have even one day to come into compliance with the new law, they would effectively be breaking the law the day after S. 3002 is passed.

2. Registration of supplement licensors. S. 3002 would require outfits that license dietary supplements to register their “facilities” under the FDA Food Facility program established by the Bioterrorism Act of 2002. Including these requirements would go against the purposes of the Bioterrorism Act and would serve no useful purpose other than creating more bureaucracy and red tape.

3. Registration of health-food stores. S. 3002 is unclear as to whether the current retailer exception to the Bioterrorism Act registration requirement is intended to be honored for supplement retailers.

4. Product and ingredient registration. The product/ingredient registration process included in S. 3002 is unclear in its use of the terms “ingredients” and “labeling.” As worded, S. 3002 would apparently require duplicate, therefore unnecessary, registration of every product at every point in its distribution! This would be an incredible burden, one that would mandate annual updates, and one that would not protect any proprietary information that is not required on product labels but that that may be required to be submitted in the registration process.

5. Replacement of new dietary ingredient (NDI) requirements with an FDA positive list. FDA received information between 1996 and 1998 from dietary supplement trade associations to record ingredients believed to be marketed in the U.S. prior to the passage of DSHEA. If there is any lack of clarity as to what dietary ingredients are “old,” the agency should initiate rulemaking to formally adopt the ingredients directly submitted by the trade associations.

6. Retailer evidence of compliance. The bill’s proposal to require health-food stores to obtain evidence of compliance with product registration and NDI notifications is would be ridiculously burdensome and something that is not required for other regulated goods.

7. Civil penalties. The bill would establish new, unnecessary civil penalties despite the fact that current law already imposes adequate fines and penalties for violations of the Food Drug and Cosmetic Act.

8. Non-serious adverse event reports. The FDA itself has made it clear that it would not be helpful for the agency to receive boatloads of minor or trivial (and probably not substantiated) adverse event reports associated with dietary supplements. Under current law, dietary supplement companies are already required to maintain records of all adverse event reports for 6 years and the FDA has the authority to inspect these records at any time.

9. FDA recall and “cease distribution” authority. S. 3002, as well as other food safety legislation already introduced in the 111th Congress (such as S. 510), would provide FDA with authority to mandate products recalls when health risks are presented by marketed products, which is fine. However, what is not fine is that S. 3002 would obligate the agency to issue a “cease distribution” order for any supplement identified as adulterated or misbranded, even in the absence of any perceived health risk.

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The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley
original link: The Gormley Files

In February 2010 in New Orleans, three men were charged by the U.S. Drug Enforcement Administration (DEA) with drug-trafficking Ecstasy, or MDMA (3-4-Methylenedioxymethamphetamine), a synthetic chemical that can be derived from an essential oil of the sassafras tree.

If convicted, the defendants face a possible maximum sentence of 20 years in prison, a $1 million fine and at least three years of supervised release for each count.

MDMA is also one of the easiest illegal drugs to obtain. Its effects are similar to those of amphetamines and hallucinogens. First developed as an appetite suppressant in 1912, MDMA was used as a psychotherapeutic tool and also started to become available on the street is the late 1970s and early 1980s. It wasn’t until 1985 that Ecstasy was made illegal. It is classified as a “Schedule 1” controlled substance along with other narcotics like heroin, cocaine and LSD.

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

Herbal Ecstasy is another form of MDMA that is composed of ephedrine (ma huang) or pseudoephedrine and caffeine from the kola nut. Also sold in tablet form, Herbal Ecstasy can cause permanent brain damage and death. Though not currently classified as a controlled substance, Herbal Ecstasy shares many of the same qualities and effects as MDMA. Also known as Cloud 9, Herbal Bliss, Ritual Spirit, Herbal X, GWM, Rave Energy, Ultimate Xphoria and X.

Anabolic Steroids

Anabolic steroids are synthetically produced versions of the naturally occurring male hormone, testosterone. Both males and females have testosterone produced in their bodies: males in the testes, and females in the ovaries and other tissues. The full name for this class of drugs is androgenic (promoting masculine characteristics) anabolic (tissue building) steroids (the class of drugs).

Some of the common street names for anabolic steroids include: arnolds, gym candy, pumpers, ‘roids, stackers, weight trainers and juice. Currently, there are more than 100 different types of anabolic steroids that have been developed, and each requires a prescription to be used legally in the U.S.

Anabolic steroids can be taken orally, injected intramuscularly, or rubbed on the skin when in the form of gels or creams. These drugs are often used in patterns called cycling, which involves taking multiple doses of steroids over a specific period of time, stopping for a period, and starting again. Users also frequently combine several different types of steroids in a process known as stacking. By doing this, users, more properly abusers, believe that the different steroids will interact to produce an effect on muscle size that is greater than the effects of using each drug individually.

Another mode of steroid use is called “pyramiding.” With this method abusers slowly escalate steroid use (increasing the number of drugs used at one time and/or the dose and frequency of one or more steroids), reach a peak amount at mid-cycle and gradually taper the dose toward the end of the cycle. The escalation of steroid abuse can vary with different types of training. Bodybuilders and weight lifters tend to escalate their dose to a much higher level than do long distance runners or swimmers.

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:

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.

Nicholas J. Gonzalez, M.D.

The Dietary Supplement Excuse

By James Gormley, Senior Policy Advisor for Citizens For Health

[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

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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