Food Safety for 2010: the Good, the Bad … and the Ugly

By James J. Gormley  
courtesy of NOW Foods
In October, we alerted you to serious worries about Senate Bill (S.) 510. Now that we have just started the New Year, let’s take a look back at the whole food safety picture in 2009 and how things are shaping up for 2010.

Here’s a partial run-down on some of the biggest food safety news stories of 2009:

1. Starting in January 2009, a giant peanut manufacturing corporation began voluntary recalls of up to 3,918 products made with peanut butter and peanut paste that reportedly caused nine deaths and 714 confirmed cases of Salmonella in 46 states.
2. In June and July of 2009, a fast-food restaurant in Milan, Illinois had two workers infected with hepatitis A working at the eatery; in addition to workers and customers getting sick, 10,000 people were exposed by the time the situation was under control.
3. Beginning in July (going through December), two mammoth meat manufacturers (based in Denver, Colo. and Fresno, Calif.) recalled 1.314 million pounds of beef due to concerns that it was contaminated with three strains of antibiotic-resistant Salmonella.
4. On September 1st, the Washington Post alerted us to the case of a Nevadan woman severely injured by chocolate-chip cookie dough contaminated with E. coli 0157:H7.
5. On October 4th the New York Times’ Michael Moss reported that a children’s dance instructor from Minnesota was partially paralyzed from E. coli 0157:H7 in hamburgers she ate. The meat originated in massive slaughterhouses in Nebraska, Texas, Uruguay, and a South Dakota firm that treats fat trimmings with ammonia to kill bacteria.
6. In December 2009, a series of articles in USA Today uncovered that Jack in the Box, Burger King and Costco are “are far more rigorous”─up to 10 times more stringent─ in checking for dangerous bacteria than is the USDA in setting standards for beef served to our children via the National School Lunch Program.

And lest these cases create the impression that contamination only relates to beef or peanut butter, ConsumerReports.org posted “The 10 riskiest foods overseen by the FDA,”  which lists the top ten offending foods. In decreasing order of “riskiness,” the article listed (somewhat surprisingly) the following 10 foods and food products: leafy greens; eggs; tuna; oysters; potatoes; cheese; ice cream; tomatoes; sprouts; and berries.

What do 2009’s food-safety outbreaks mean to us?
What the outbreaks in 2009 (and, for that matter over the last 19 years) mean is this: Food production by gargantuan factories and slaughterhouses is questionable; one marked by potentially unsanitary practices and stopgap remedial treatments that don’t work well .

As to food safety bills on Capitol Hill, here’s where things stand as of this writing:

• H.R. 759, or the Food and Drug Administration Globalization Act of 2009, sponsored by Congressman John Dingell (Mich.); 10 co-sponsors; introduced January 28th, 2009; referred to House Committee on Energy and Commerce on January 29, 2009.
• H.R. 875, or the Food Safety Modernization Act of 2009, sponsored by Congresswoman Rosa DeLauro (Conn.); 40 co-sponsors; introduced February 4th, 2009; referred to House Subcommittee on Livestock, Dairy and Poultry on April 23rd, 2009.
• H.R. 1332, or the Safe Food Enforcement, Assessment, Standards, and Targeting (FEAST) Act of 2009, sponsored by Congressman Jim Costa (Calif.); 30 co-sponsors; introduced March 5, 2009; executive comment requested from the FDA and the USDA on April 23rd, 2009.
• H.R. 2749, or the Food Safety Enhancement Act of 2009, sponsored by Congressman John Dingell; 5 co-sponsors; passed under suspended rules on July 30, 2009.
• Senate Bill (S.) 510, or the FDA Food Safety Modernization Act, sponsored by Senator Richard Durbin (Ill.); 15 co-sponsors; placed on Senate Legislative Calendar under General Orders (No. 247).

There are a couple of issues in these bills that stand out like sore thumbs. As to H.R. 875, this bill calls for the creation of yet another agency with another “czar”, the Food Safety Administration; not a welcome addition to fans of limited or more efficient government.

As to H.R. 2749, which passed the House already, this column has previously noted problems associated with this bill, including registration fees for food facilities and powers to “restrict the movement of food” by effectively quarantining (i.e., shutting down) a town, city or region. These aggressive new police powers should be reserved for demonstrable risks to public safety, not given freely as a blanket trust and authority granted to unelected agency bureaucrats.

On the positive side, thanks to grassroots advocacy organization new language in S. 510 exempts safe dietary supplements and organics while softening language relating to the threat of harmonization with Codex Alimentarius; however, there are still some areas of concern.

What will be the legislative fate of these bills?
Since H.R. 759 is considered the flagship House food-safety bill by Congresswoman DeLauro (who is the sponsor of H.R. 875, above) and since Congressman Dingell is the sponsor of H.R. 759 and of the House Bill which was last introduced but which passed first, I foresee two scenarios.

One strong probability is that all of the other House food-safety bills will fall by the wayside, since H.R. 2749 already passed and since S. 510 is likely to pass in the full Senate this year or early next.

A second possibility is that portions of H.R. 875 and 1332 will either make it into negotiations on the Senate side for S. 510─not very likely since H.R. 2749 has already passed─ or will be incorporated into this year’s agriculture appropriations bill, more likely since Congresswoman DeLauro was the sponsor of the 2009 “agriculture bill” that passed in October 2009.

Gormley Take-Away: Senate Bill 510 will likely be the “last man standing” in terms of food-safety bills in the remainder of this current 111th legislative session of Congress─ and perhaps in the first half of next year’s 112th session─and we do need to be vigilant on this bill before it becomes law.   Nevertheless, regardless of whatever food-safety bills are introduced or debated in 2010, we must push for increasing support of local food production (including food co-ops and community supported agriculture [CSA]). We also need food manufacturers to take more responsibility for ensuring the safety of the foods they produce by the use and enforcement of existing audited GMP and HACCP systems, backed up by testing. This will continue to keep the public safe and prevent Congress from setting up overly broad enforcement mechanisms without fixing the underlying problems.

Haiti: United Nations Appeal Launched for Emergency Assistance

Thousands of Pregnant Women at High Risk in Haiti

UNITED NATIONS, New York, 15 January 2010 — Estimates that there could be as many as 37,000 pregnant women among the 3 million people affected by Haiti’s earthquake have led to an urgent appeal to meet their emergency maternal health needs.

The earthquake has devastated Haiti’s health system and many of the hospitals and clinics in Port–Au-Prince have been damaged. The remaining can barely handle the thousands in need of medical care. The current situation is putting the lives of thousands of women and their infants at risk from complications related to pregnancy and child birth.

To meet the urgent maternal health and other needs of women, UNFPA, the United Nations Population Fund, is seeking about $4.6 million as part of the coordinated United Nations Flash Appeal that will be launched today. The funding would supplement the supplies UNFPA is already providing in Haiti and address the specific needs of women, girls and other vulnerable populations for the next six months. The additional funds would enable UNFPA to help:

• Refurbish maternity wards to handle emergency obstetric care and other life-saving health services;
• Deploy skilled health professionals, such as midwives, obstetricians and nurses, to affected areas to provide maternal health and emergency obstetric care;
• Provide emergency safe delivery and reproductive health medicines and supplies to temporary clinics and health facilities being set up;
• Help safeguard the personal hygiene and dignity of women and girls by providing related sanitary supplies;
• Facilitate access of affected populations, especially young people, to psychosocial counselling and other services; and
• Carry out interventions to prevent gender based violence.

For further information, please contact:
In Santo Domingo: Trygve Olfarnes, Tel: +507 301 7362, Satellite:
+ 898 8169 3160 0057 1740, olfarnes@unfpa.org.
In New York: Jessica Malter, Tel: + 1 212 297 5190, malter@unpfa.org
Omar Gharzeddine, Tel: + 1 212 297 5028 gharzeddine@unfpa.org
 

Save the Internet

By James J. Gormley

On behalf of Citizens for Health, an IRS-recognized not-for-profit organization with approximately 100,000 individual consumer members across the United States, I ask you to join with me and with FreePress in stating your strongest possible support for Net Neutrality (FCC Docket No. 09-191).

Visit this link: http://fjallfoss.fcc.gov/ecfs/hotdocket/list to file comments directly with the FCC. Once you are there scroll down (it should be near the top) to docket number 09-191 In the Matter of Preserving the Open Internet Broadband industry Practices. Once you click on the 09-191 it will shoot you to a page that already has all the docket details etc. this is the short form that you can use to easily file your comments.

The current Google censorship situation in China is a perfect example of why a 100 percent free and open Internet serves Americans and advances democracy.

Whether it is governments, corporations, advertisers or lobbyists (contributors), none of these groups should have any influence over a 100 percent free and open Internet that encourages the free-est possibly communication of ideas, opinions, facts, information, opportunities, and health information as well, whether it is health information about (or critical of) pharmaceuticals, diet, food, exercise, alternative medicine, herbalism, traditional healing traditions --- it should all be equally available and equally accessible to Americans.

Allowing Internet Service Providers (ISPs) the improper ability to slow down, hinder or block certain information (for example information that does not help their advertising partners) would be an outrageous and unacceptable violation of our Constitutional rights and would be wrong, unethical, anti-American and anti-democracy.

Filings by ISPs dare to suggest that this is about dictating to industry or assigning borders to an evolving medium --- that could not be further from the truth.

In point of fact, industry is attempting to gain greater control over what is, for now, a free highway of information and ideas; consumers are merely trying to protect this medium from telephone, wireless and cable companies’ efforts to turn this into an issue of virtual “eminent domain.” If these corporations and their lobbies are successful, it would make a mockery of this freedom and would not only violate article 17 of the Universal Declaration of Human Rights but would, as noted, violate the U.S. Constitution.

For all of these reasons, and many more, I, on behalf of the 100,000 members of Citizens for Health, ask you to call on the FCC to do the right thing: to pass strong and broad Net Neutrality rules.

Doing this will represent one of the most important regulatory protections any Federal agency can pass this decade, and perhaps even this century --- it will represent a legacy advancing democracy and protecting consumers for us, our children and future generations. 

Senate Bill 510: The $825 Million Dollar Folly

By James J. Gormley

courtesy of NOW Foods

Are you a backyard grower of heirloom tomatoes you sell on your own property or at a local farmer’s market? If so, you will be in for a whopper of a surprise if Senator Durbin’s Senate Bill 510 (S.B. 510) passes: you may be receiving a visit from inspectors.

Products not grown according to designated standards will be considered adulterated and your business records will be subject to warrantless searches by inspectors from the U.S. Food and Drug Administration (FDA), all this without any evidence that you have violated any law.

Wonder why the National Guard or Federal agents have effectively imposed martial law by quarantining your town? Under S.B. 510’s House counterpart bill, H.R. 2749 (Section 133b, “Authority to Prohibit or Restrict the Movement of Food”), sponsored by Congressman Dingell, the Secretary of Health and Human Services will have the power to prohibit all movement of all food within a geographic area, whether the food is in your grandmother’s grocery bag in her Toyota Hybrid or on a flatbed. No court order will be needed, just a phone call to the appropriate state official and a public announcement will be sufficient.

Upset that raw milk or raw milk cheeses (like feta) are no longer available in the U.S.? This could well happen thanks to the “performance standards” powers that would be granted to the FDA by S.B. 510, especially since the agency has made it clear that it is vehemently opposed to the consumption of raw milk products.

Amazed that U.S. food safety regulations strangely match those of other countries? Well, Section 306 of S.B. 510 would require “Recommendations to harmonize requirements under the Codex Alimentarius.”

And what about food supplement manufacturers, suppliers, distributors and health food stores? Will they be ensnared in this bill’s draconian, 1984-esque net? Very possibly so.

This all may seem far-fetched, but theoretically, this new law would give the government all this authority.

S.B. 510 (which would cost Americans $825 million in 2010 alone) and the House of Representatives version of this bill, H.R. 2749, which did pass under suspended rules, do not address the root causes of the U.S.'s food safety problems, which were highlighted in both a recent campaign by the Farm-to-Consumer Legal Defense Fund (FTCLDF) and by a letter to 99 U.S. senators by the Ranchers-Cattlemen Action Legal Fund (R-CALF USA).

According to Citizens for Health (http://www.citizens.org/), if this proposed law is enacted it would:

• Undermine DSHEA and move the U.S. one step closer to harmonizing our standards under Codex with those of supplement-restrictive regimes like the European Union. (DSHEA, or the Dietary Supplement Health and Education Act, asserts that supplements are food and are safe for consumption unless proven otherwise – ensuring that millions of Americans are able to enjoy access to safe, effective and affordable dietary supplements).

• Give the FDA unprecedented control over farms and direct-to-consumer distributors. If passed, the bills would charge facilities an annual $500 registration fee, require additional record keeping, and expand FDA authority to quarantine geographic areas for alleged food safety problems – all without significantly improving food safety.

• Cost U.S. taxpayers billions of dollars ($825 million in 2010 alone) while providing fewer physical inspections and less food safety overall.

• Harm U.S. organic farmers by imposing overlapping regulations.

• Hurt food supplements and health-food stores by imposing standards that are already covered by the AER (Adverse Event Reporting) Law, cGMPs (current Good Manufacturing Practices) and food facility registration.

• Cripple local food co-ops, farm stands, independent ranchers and artisanal food producers by imposing unnecessary standards and unfair bureaucratic burdens.

Clearly, S. 510, while purporting to increase food safety would actually leave consumers more vulnerable to foodborne disease since the FDA would be required to use a risky, risk-based food safety system rather than doing old-fashioned, effective physical, on-site inspections in plants, factory farms and slaughterhouses, where the actual food safety concerns are.

Furthermore, the U.S. has abrogated its duty to inspect and enforce food safety standards, both here and abroad, by allowing processing plants to regulate themselves under a failed system; and it has embraced policies that have driven independent U.S. farmers and ranchers out of business and replaced them with corporate-owned, industrialized food production units that are known to cut food safety corners to maximize corporate profits.

So what do we need to do?

Click here for an opportunity to send a letter opposing S.B. 510 as it is currently written.

Gormley Take Away: As of this writing, our nation is over $11.8 trillion in debt. Let’s not add $825 million more (actually several trillion dollar over the next few years) for a bureaucratic monster to be foisted upon an already deeply flawed U.S. food-safety system. S.B. 510 is sadly, and ironically, not about food safety, although I wish it were. It’s about food madness, pure and simple, and it must be fixed … or stopped.

Swine Flu: What To Do?

By Dr. Frank Lipman, Integrative Physician

Summer is over and the question I am being asked most frequently in my practice is, “what do I do about Swine flu?” My patients are wondering whether or not they should get vaccinated and the simple answer I give most of the time is ..NO!

From what you may have read, you might think that the swine flu vaccine is the answer to swine flu. Unfortunately this is not true and until we know that the vaccine is safe, I cannot in good conscience recommend it to most of my patients.

From the outset, let me say, I am not anti all vaccinations, rather I am pro vaccine safety and freedom of choice.

This is why am I not recommending the swine flu vaccine:

1) At this stage, for the most part the swine flu seems benign.

Over a million people in the US have already come down with swine flu, many of them without even knowing that they had it. The vast majority of people who get the swine flu recover after a week or so of high fever, aches, and respiratory distress. It’s not pleasant, but except in rare circumstances, it is not fatal. Most people who’ve been infected by swine flu think so little of it, they believe they just had a really bad cold or a regular flu. So unless the swine flu evolves to a much more virulent form, there’s no need for mass vaccination

2) We don’t know if the vaccine will be effective.

Vaccines are only useful against the specific viral strain that was available at the time of their manufacture. But influenza viruses mutate quickly, and as the WHO has already said, the real concern with H1N1 swine flu is that it will combine with seasonal flu in the Fall, creating a new strain that will of course be immune to all available vaccines.

3) We don’t know if the vaccine is safe.

The FDA has authorized an expedited approval process for the swine flu vaccine but we don’t know yet if it is safe. Even GlaxoSmithKline, one of the vaccine manufacturers has said, “The total population studied in clinical trials will be limited, due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.”

In other words, the only thing that is safe, is to say that no one knows. Since it’s never been used before and they have not had time to conduct any sufficient human testing, by getting vaccinated you are being a human guinea pig.

4) Vaccine manufacturers have been insulated from liability by the government.

The Department of Health and Human Services Secretary Kathleen Sibelius has granted legal immunity not only to the makers of the 2 drugs being used to treat swine flu, Tamiflu and Relenza, but also to the swine flu vaccine makers, for damages due to their use against swine flu. By effectively manipulating the legal system, the Pharmaceutical Industry through their powerful lobbyists have acquired almost complete and total insulation from any liability for their vaccines and adjuvants, which are additives added to generate a stronger immune response. It is believed that it is these adjuvants which often cause the problems. The last time the government embarked on a major vaccine campaign against a new swine flu was in 1976. Thousands filed claims for side effects such as paralysis caused by the vaccine and a number of people died. I am sure that the researchers know more now than they did last time and no one can say for certain that bad things will happen again or that you will suffer dire consequences if you get vaccinated. But this time you have no legal recourse even though this vaccine involves new factors, which makes it therefore experimental and unpredictable.

By shielding the manufacturers from any responsibility for any harm caused, the pharmaceutical firms have no financial incentive to make the safest product. In fact, they have a negative incentive to test it for safety, because if they are aware of problems, then they could potentially be held liable for willful misconduct.

Instead I advise my patients to build up and strengthen their immune systems to prevent viral infections.

Here are my top 10 recommendations:

1) Optimize your vitamin D levels.

Adequate levels of Vitamin D are essential for our immune systems to function optimally. Unfortunately there are no significant dietary sources of Vitamin D, most of our intake comes from exposure to sunlight. If you live far from the equator, you simply don’t get enough sun through Fall and Winter to make all the vitamin D you need. So unless you supplement during this period, your innate immunity will be compromised. Vitamin D plays such a crucial role in so many aspects of your body’s functioning, that supplementing with it makes sense whether you decide to get the flu shot or not.

We know that influenza always gets worse during the winter months. Now there is good evidence to suggest that this is because as sunlight hours lessen during the winter, the people living in the northern hemisphere become vitamin D deficient and are susceptible to influenza infections of all kinds. Here’s a great article available at NIH pertaining to this topic.

There is also some evidence that supplementation with a sufficient amount of vitamin D can help to prevent the onset of a flu or cold.

The current recommendations from the Food and Nutrition Board of the U.S. Institute of Medicine: from 200 to 600 IU/day depending on one’s age, are way too low. These values were originally chosen because they were found to prevent osteomalacia (bone softening) and rickets. It is now recognized that vitamin D has many additional physiological functions, for which these levels are totally inadequate. A number of scientists are therefore calling for the Food and Nutrition Board in the U.S. and its counterparts abroad to reassess their current recommendations.

To optimize your vit D levels, you will need to:
* Take at least 2,000 IU of a Vitamin D3 supplement daily.
* Get your 25 hydroxy Vitamin D level checked by your doctor (if that is not an option, you can self test your level with ZRT labs)

Although the current normal range is between 20 and 50ng/ml, this is much too low for optimal health. You want your level to be between 50 and 70ng/ml. This is the most important step you can take to prevent the flu!! It may require a number of months taking 5,000 to 10,000 IU of Vit D3 daily (especially during winter) under a doctor’s supervision, to optimize your blood level. Monitor your 25 hydroxy vitamin D status every 3 months until you are in the optimal range, then cut back to a maintenance dose of at least 2,000 IU a day.

2) Get adequate sleep, this is an indispensable requirement for a strong immune system.

3) Get adequate exercise, this keeps you robust.

4) Take actions to lower your stress levels.

Do breathing exercises, meditate, practice yoga, spend time doing something that makes you happy. Feeling spent, overwhelmed, and/or mentally run down has a causal relationship to your physical health.

5) Wash your hands frequently but not excessively.

It decreases your likelihood of spreading a virus to your nose, mouth or other people. Be sure you don’t use antibacterial soap because of the risk of creating resistant bacteria. Rather use a simple chemical-free soap.

6) Avoid sugar and processed foods as they decrease your immune function dramatically.

7) Eat phytonutrient rich meals (lots of colorful salads and dark greens)

8 ) Eat lots of garlic, it works as a broad spectrum antibiotic.

9) Take a probiotic daily (look for one with 10-20 billion organisms). A strong immune system relies heavily on having a strong foundation in the gut.

10) Keep a supply of antiviral herbal supplements on hand.

As opposed to antiviral drugs, antiviral herbs do not cause resistant strains because they are multifaceted and contain literally thousands of different medicinal compounds. Thus they are able to attack viruses with a full spectrum of synergistic substances. Andrographis, olive leaf extract, grapefruit seed extract and elderberry extract, all have antiviral properties. Use one or a combination of some of them as a prophylactic measure, for ex.whenever you travel (airports) or enter a potentially compromised environment such as a large office, auditorium, stadium, theater etc.

And if you really want to go all out, here are 4 more tips:

11) Take 1-2 grams (1,000-2,000 mg) of fish oils daily, its beneficial for immune function.

12) Take 2 grams (2,000 mg) of Vitamin C daily, yes it does help.

13) Stock your home pharmacy with an immune building formula. Look for one that contains Cordyceps and Astragulus. Take it throughout the flu season.

14) Keep homeopathic Oscillococcinum on hand

Take it at the earliest sign of a cold or flu. Early intervention is essential. If you are exposed to someone with the flu directly, you can take one dose twice a day for two days. You can also take one vial once a week throughout the winter, and two or three times a week during flu season, as a preventative measure.

Frank Lipman MD, is the founder and director of the Eleven Eleven Wellness Center in NYC a center whose emphasis is on preventive health care and patient education. His personal blend of Western and Eastern Medicine combined with the many other complimentary modalities he has studied, has helped thousands of people recover their energy and zest for life. He is the author of the recent SPENT: End Exhaustion and Feel Great Again (2009) and Total Renewal: 7 Key Steps to Resilience, Vitality and Long-Term Health (2003).

Lawmaking and the GAO Report: A Dose of Reality

By James J. Gormley

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?

Making the “Cut”: What the Latest Recall Tells us … and Doesn’t

By James J. Gormley

So we’ve all read the headlines about the recent recall of a line of 14 dietary supplements due to 23 reports of serious adverse events linked to (but not proved to caused by) the weight-loss and bodybuilding products in question.

The product recall that was requested by the U.S. Food and Drug Administration has been applauded by the natural products industry, as it shows how effective are the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the AER Law.

If truth be told, the manufacturer should have known better, regardless of where the final toxicology reports or class action lawsuits wind up, since a number of the recalled products were made with a modern version of the dangerous old “ECA stack” formula (ephedra-caffeine-aspirin, or ECA), with each serving containing stimulant herbs, over 400 mg of caffeine plus willow bark extract (natural aspirin).

That being said, the FDA, long believed to be a foe of the dietary supplements industry, is taking advantage of the recall to repeat its oft-voiced complaint that its hands are largely tied because it must rely on voluntary reports and post-market monitoring. “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective and an isolated incident is often difficult to follow,” said the FDA’s Linda Katz, M.D., M.P.H.

Katz and the mainstream media are missing the point.

Dietary supplements, because they are a class of food products, are considered largely safe. Food products, and products derived from foods and plants, are presumed to be benign and have very little, often no known, side effects.

The ingredients in supplements are mainly natural ingredients that have co-evolved with humans from time immemorial and especially since the creation of agriculture 10,000 years ago.
They form what ethnobotanist Dr. Jim Duke refers to as the “Green Pharmacy” of healing and healthful compounds. When not used properly or used by profoundly unhealthy, often heavily medicated consumers looking for a quick fix, they are linked to a few hundred adverse event reports each year.

Drugs are largely synthetic, powerful chemical compounds that are not found in the food supply and which are presumed to be dangerous and often have very serious, known side effects.
Drug chemicals are primarily artificial compounds synthesized to dramatically change, stop, block or boost a system or process in the body in order to improve symptoms. They cause over 100,000 deaths a year and close to 1 million serious adverse events.

“Dietary supplements are not regulated as drugs because they are not drugs,” adds Jeffrey Blumberg, PhD, FACN, director of the Antioxidants Research Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging, at Tufts University.

According to David Seckman of the Natural Products Association (NPA), “This prompt action shows that the current DSHEA [law] works and that the adverse event reporting (AER) law that we helped to pass is working to enable the agencies to detect signals of any threat to public health. Thus, the industry is more than appropriately regulated and necessary consumer protections are in place.”

“They are regulated in exactly the same manner as all food and beverage products, including review of labeling claims, [post-market] surveillance, adverse event reporting, and so forth” agreed Blumberg. “The research base regarding most essential nutrients is more extensive than that of most drugs.”

Gormley Take-Away: DSHEA and the AER Law work very well. The FDA should cooperate with the responsible core of the natural products industry rather than criticizing the very laws that the American people saw fit to pass and which the FDA is sworn to uphold and enforce. While consumers should not be scared about this rare product recall, some manufacturers (and these few companies know who they are) should take a hard look at their products and their safety and testing data to make sure they are not repeating mistakes of the past relating to formulas and claims, because nobody benefits from inadequate vigilance, the companies included.

One flu over the cuckoo’s nest? Phony Swine Flu products are dangerous

By James J. Gormley

“These are the times that try men’s souls.”
---“The Crisis” by Thomas Paine, December 23, 1776

As of May 17, 2009, 39 countries had officially reported 8,480 cases of “swine flu” (influenza A (H1N1) infection. Most confirmed cases were identified in Mexico (2,895 cases, 66 deaths) and the U.S. (4,714 cases, 4 deaths). The following states were hardest hit: Illinois (638 cases), Wisconsin (613), Texas (506), California (504), Arizona (435), Washington (246) and New York (242).

Although times of crisis, such as national health emergencies and global pandemics, bring out the best in most Americans, there have unfortunately always been some marketeers and hucksters who take advantage of the panic resulting from these tragic, and trying, times.

The current swine flu epidemic is no exception. On April 27th, 2009, within days of the first confirmed flu cases in the U.S., I received a press release announcing a nano-silver swine flu kit that was already being packed for shipment in “pre-paid overnight FEDEX boxes.”

I also received a “Swine Flu Alert” about a liquid silver supplement that allegedly “destroys MRSA, SARS, malaria, anthrax […] hepatitis C, HIV […] and bird flu.”

A day later, I stumbled upon an article posted on a Bulgarian news agency site with the following lead: “Bulgaria expects a huge increase in orders for two anti-flu dietary supplements in light of the current swine flu epidemic.” One of these products had already been the subject of a new dietary ingredient (NDI) rejection by the U.S. Food and Drug Administration (FDA) in early 2000.

On April 28th, I alerted Gary Coody to these scams; Gary is the national health fraud coordinator in the FDA’s Office of Enforcement. I also reached out to officials from the U.S. Federal Trade Commission (FTC).

Meanwhile, others in the natural products industry, including leading organizations, were quick to respond to these opportunistic peddlers. Industry responders included the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) --- which issued a joint press release, on May 1st, that included the following call-to-action:

“Marketers and retailers of dietary supplements are urged to refuse to stock or sell any supplements that are presented as treating or curing swine flu.”

According to Michael Chappell, FDA’s acting associate commissioner for regulatory affairs, “In conjunction with the [FTC], the FDA has developed an aggressive strategy to identify, investigate and take regulatory or criminal action against individuals or businesses that wrongfully promote purported 2009 H1N1 influenza products in an attempt to take advantage of the current flu public health emergency.”

“Scam artists follow the headlines, trying to make a fast buck with products that play off the news --- and prey on concerned people,” said Eileen Harrington, acting director of the FTC’s Bureau of Consumer Protection. “We’re online and telling e-marketers their sites must comply with the law.”

The FTC has developed a new consumer alert, “Rx for Products That Claim to Prevent H1N1? A Healthy Dose of Skepticism” (http://ftc.gov/bcp/edu/pubs/consumer/alerts/alt083.shtm). It warns the public to be skeptical of claims that products like pills, air filtration devices and cleaning agents can supposedly kill or eliminate the virus.

This is, of course, not the first time that Internet peddlers have tried to take advantage of consumers during scares and epidemics.

By March 2002, the FTC had sent warning letters to 121 web sites selling products to “protect against, detect or treat illnesses caused by biological or chemical agents, including anthrax.” The products, most of them bogus or ineffective, included herbal remedies, air filters, gas masks and “do-it-yourself kits to test mail for anthrax.”

In 2005, the FDA issued warning letters to nine companies marketing phony avian flu products. The use of these fake products “increases the risk of catching and spreading the flu rather than lessening it because people assume they are protected and safe and they aren’t,” said the acting FDA commissioner on December 13th, 2005.

Gormley Take-Away: We should steer clear of any dietary supplements which claim to prevent, treat or cure swine flu --- and, for that matter, any virus or outbreak of any kind. Legitimate supplements, including herbals, are great for promoting health and helping us cope with the common, everyday nasties that come our way. But let’s leave the gas masks in the fallout shelters, okay?

How DSHEA Was Really Won

By James J. Gormley

DSHEA, the Dietary Supplement Health and Education Act of 1994, is the law which protects our access to dietary supplements and to truthful information about them; it also provides for the quality and safety of supplements.

What led to the passage of this law was a historic grassroots and political battle, a struggle that actually had its roots in the early days of the modern health-food industry.

In 1990, President George H.W. Bush signed into law the Nutrition Labeling and Education Act (NLEA). This legislation was intended to improve nutritional information regarding health claims made for products. The FDA was given the job of implementing the law, but because of its broad wording, the agency began to capitalize on the opportunity to over-regulate safe and beneficial nutritional products.

In 1992, the Health Freedom Act was introduced in the Senate by Sen. Orrin Hatch, along with a similar bill in the House of Representatives, to protect the rights of U.S. citizens to choose safe and effective dietary supplements.

“The basic principle of the Health Freedom Act […] was that supplements aren’t food additives, they aren’t drugs and they need to be defined,” said Loren Israelsen, head of the LDI Group and the United Natural Products Alliance in Salt Lake City in a 2004 interview with Mitchell Clute in Natural Foods Merchandiser (NFM) that ran as a “10 years after DSHEA” anniversary article.

In an April 27th 2009 interview, Israelsen told The Gormley Files that “FDA began using the food additive provisions of the law as a tool to go after dietary supplements FDA did not like. This misuse of the law really ticked off a lot of people (me included).”

“The FDA Commissioner at that time, David Kessler, had commissioned a panel to study the question, ‘What should we do with supplements if we were to start afresh?”, noted Israelsen.

“Initially, FDA refused to make the report public. Ultimately, under pressure they did, and it confirmed our worst fears. Those are a few examples of the long fuse that burned up to 1992 when the first version of DSHEA called ‘The Health Freedom Act’ was introduced.”

The agency took the position that all supplements that did not have what it considered defined nutritional value were unapproved food additives. In this way, said industry attorney Marc Ullman, the FDA was able to keep many herbal supplements from American consumers. The FDA essentially went on an enforcement rampage.

The case that mobilized consumer opinion most against FDA was the Jonathan Wright case. Wright, a physician in Washington state, continued to prescribe L-tryptophan to his patients, knowing that while the U.S. had temporarily issued a ban on its sale as a dietary supplement, it had not explicitly banned its use for medical purposes.

On May 6th 1992, in what is today remembered as the Tahoma Clinic Raid, the FDA stormed Wright’s clinic with armed sheriffs who terrorized patients and seized vitamins, equipment and medical records. “The raid made no sense,” noted Israelsen. “There was no rational explanation. People began to think, ‘Wow, what are they prepared to do to stop us from taking vitamins.’ “

And this legitimate fear began to spread like wildfire across the country.

On the grassroots side, Joe Bassett and the northwest region of the Natural Products Association (or NPA, then NNFA) expanded an early incarnation of Citizens for Health (CFH) in order to mobilize consumers and health-food stores against these threats. Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Alex Schauss, Craig Winters and others.

The American Botanical Council and the American Herbal Products Association (AHPA) were also important forces from the industry side.

Meanwhile, a dramatic public-service ad (PSA) was developed. In the ad, federal agents equipped in full Special Forces gear, including night vision and weapons, converge on Mel Gibson, in this now-famous cameo, who says, in defense as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

This call-to-action video (which was produced by noted Los Angeles-based producer/director, Back Home Pictures' Charles Abehsera and funded by an industry task force that included Patrick Mooney of California.-based Super Nutrition) warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?”

Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?” While the video was a dramatization to be sure, it visualized a nightmarish scenario that was truly only one step away from reality at that time.

Another dramatic, and effective tactic used to educate consumers about the threats posed by the FDA’s efforts was the blackout day that was held.

Bill Crawford, today director of retail publishing programs at New Hope Natural Media, was working at a health-food store before DHSEA was passed.

“I vividly recall our putting on a ‘black out’ day. We got black mesh fabric and covered every product that would not be available for sale if DSHEA did not pass. It was nearly our entire supplement section! Products were available for sale but our staff was telling people why we had this restrictive covering […] and signage […] as well. Tables and chairs were set up for any customers who wanted to write a letter to Congress telling them how important access to dietary supplements was to them.”

Meanwhile, industry champions such as Loren Israelsen, Scott Bass (son of the late Milton Bass), Hal Drexler (of Country Life), Jarrow Rogovin (of Jarrow Formulas) and many others, were devoting considerable resources to the battle for DSHEA up to (and past) the 11th hour.

Although the Democrats had a majority in the House and Senate, indicators were that the party was in danger of losing a number of seats in the 1994 election and the Democratic leadership was not eager to look like bad guys to the millions of Americans who supported the Hatch-Harkin-Richardson Bill (DSHEA).

“Then a miracle happened,” Israelsen told NFM. Over the course of several hours, Senators Hatch, Kennedy, Harkin, Waxman and Congressman Dingell were able to hammer out a compromise bill.

“The bill never went through committee and was never voted on, contrary to popular myth,” said Israelsen in NFM. “It went from a zero, a nothing in the House to being a bill flying through by unanimous consent in the middle of the night. I think the FDA thought this bill would never pass and when it did they couldn’t believe it.”

“DSHEA was crafted in a very specific way to keep supplements within the confines of current food law and statutory interpretation,” Israelsen told The Gormley Files.

“There were a number of reasons this was done. We could have opted to make dietary supplements a separate category from foods and drugs. However, this would have left us with essentially no ‘software or hardware’ to deal with lots of issues for which we needed some framework and existing law.”

Although the story of how DSHEA was truly won is sometimes not told accurately, however, “Those who made a difference know what contributions they made,” noted Alex Schauss.

“They will always find satisfaction in having made a difference that influenced the course of history. Everyone made a difference. That’s the real story that hasn’t been told.”

The FDA: A Dose of Reality

By James J. Gormley

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 bankrupt 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 (emphasis mine): “…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 many recommendations, 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.” Aside from the fact that the number of adverse events directly attributed to dietary supplements would be trivial, in general, especially when compared to prescription and non-prescription drugs, the SAER Law already well protects consumers.

On top of this, the FDA 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.”

What I would argue is that why should America give more power and more money to an agency that is ill-equipped to handle, and undeserving of, either?

Here is a brief snapshot of an agency that is in chaos, completely mismanaged and rife with corruption:

• On September 20th, 2006, Sen. Chuck Grassley (R-IA)’s “oversight of the drug-safety agency” “exposed a “too-cozy relationship with the pharmaceutical drug industry and an agency culture that has sought to suppress concerns of agency scientists about drug safety reforms.” Grassley’s demand to the FDA pointed to violations of the public trust, including: “FDA’s suppression of scientific dissent and pressure to alter or exclude [negative] information” relating to drug approvals.

• On October 17th, 2006, the U.S. federal court (Case Number 06-438M) charged a now former FDA commissioner with conflict of interest and related offenses relating to undisclosed pharma connections.

• In November 2007, the Subcommittee on Science and Technology issued a damning report on the FDA entitled FDA Science and Mission at Risk. The report concluded, in part:
a. FDA’s evaluation methods have remained largely unchanged for the last half century.
b. FDA’s scientific workforce does not have sufficient capacity or capability.
c. The FDA has demonstrated a consistent inability to implement needed changes.
d. The recommendations of reviews of the FDA are seldom followed.

• Congressman Dingell --- a leading voice now demanding more resources for FDA --- back on November 17th, 2008, charged the agency with “mismanagement of agency resources” and launched an investigation into the “integrity of the Food and Drug Administration.”

• According to the non-profit group, the Project on Government Oversight (POGO) on February 18th, 2009, “Since 2006, the FDA is not ensuring that medical devices such as defibrillators, pacemakers, replacement heart valves and coronary stents are being tested according to good laboratory practices (GLPs).”

Fortunately, a number of far-sighted consumer organizations want to improve the FDA from its foundations, such as the American Association for Health Freedom, which is leading a campaign to reform the troubled agency.

Gormley Take-Away: Despite the grandstanding consumer-safety posturing from certain lawmakers suggesting that consumers are not protected from supplements, what we all desperately need protecting from is the FDA, itself, which, in its current state, is powerful, unresponsive, political, inept and corrupt. Should we perhaps establish an agency to shield us from the FDA? Better yet, let’s completely reform the agency from the bottom up, but let’s not give more power to an agency that already has more than it deserves to wield or give more resources to FDA until it proves it has (1) eliminated corruption and (2) knows how to better manage the resources (and authority) it already has.

What if there were no law protecting our supplements?

A public-service ad that first aired in December 1993 showed camouflaged Federal agents equipped in full Special Forces gear, including night vision and weapons converging on Mel Gibson, who says, in defense, as he holds up a supplement bottle: “Hey. Guys. Guys. It’s only vitamins.”

Before DSHEA
This call-to-action video (which was produced by noted Los Angeles-based producer/director, Charles Abehsera) warned consumers that the Federal government is “actually considering classifying most vitamins and other supplements as drugs. The FDA has already conducted raids on doctors’ offices and health food stores. Could raids on individuals be next?”

Near the end of the ad, as Mel Gibson’s character is being arrested, he says in desperation: “Vitamin C, you know, like in oranges?”

While the video was a dramatization to be sure, it visualized a dystopian U.S. society that was truly only one step away from reality at that time.

This ad, together with many other coordinated grassroots efforts, created a groundswell of support for what would become the Dietary Supplement Health and Education Act of 1994, or DSHEA, the law that today protects our access to dietary supplements and to information about these products.

In the 1990s, however, the marketplace and the regulatory landscapes were quite different from today’s. In some ways, the enforcement climate had reverted to that of the days before the Proxmire Vitamin Bill (The Food Supplement Amendment of 1973).

The FDA: an agency on the warpath
Raids, perhaps not as dramatic as the one with Mel Gibson but scary nonetheless, were not uncommon occurrences before DSHEA.

“Although FDA [the U.S. Food and Drug Administration] had been carrying out raids against health-food stores and alternative medicine clinics around the country to harass the supplement industry, when the Health Freedom Act of 1992 was introduced---which became DSHEA---ethical supplement companies knew that there was an uneven playing field on which unethical companies were selling products that did not meet label claims for content or purity and who were making untruthful and misleading health claims for their products,” said Alex Schauss, Ph.D., managing director of AIBMR Life Sciences.

In the 1990s, Bill Crawford, today director of retail publishing programs at New Hope Natural Media, was working at a health-food store. He described the countrywide “black out” day this way: “I vividly recall our putting on a ‘black out’ day. We got black mesh fabric and covered every product that would not be available for sale if DSHEA did not pass. It was nearly our entire supplement section! Products were available for sale but our staff was telling people why we had this restrictive covering […] and signage […] as well. Tables and chairs were set up for any customers who wanted to write a letter to Congress telling them how important access to dietary supplements was to them.”

How, then, did we go from our victory in the mid-1970s with the Vitamin Bill to the anti-supplement climate of the 1990s?

Annette Dickinson, Ph.D., a noted supplement industry expert, told it to me this way: “In the early 1990s, FDA, under then-commissioner David Kessler, was on a path toward restricting the availability of dietary supplements.

“In 1993, FDA published a [notice] outlining concepts put forward by the famous ‘Dykstra committee’ suggesting that limits should be placed on vitamins and minerals (perhaps at a few multiples of the RDA), that amino acids were unapproved food additives when used in supplements, and that botanicals […] were inherently […] drug-like and possibly unsafe.”

Mark Blumenthal, the head of the American Botanical Council

agreed: “The Dykstra Report was one of the primary motivators for industry groups that [propelled] industry […] to propose and support Sen. Orrin Hatch’s Health Freedom Act in 1992 which, the next year, was revised and introduced into the Senate as DSHEA.”

Health-freedom advocate and commentator, Elissa Meininger, said that, “Among the events that led up to the passage of DSHEA was the publication of the

FDA’s Task Force Report on Dietary Supplements. In it, there was a statement that I saw as a smoking gun. It stated that the presence of dietary supplements on the market represented a ‘disincentive’ (the FDA’s word) for patented drug research.”

A world without DSHEA
“Without DSHEA,” said Scott Tips, attorney and National Health Federation counsel, “there would be far more single-ingredient supplements at lower potencies, less innovation and the FDA would be able to squeeze far more than it can now any ‘non-compliant’ companies with fines and compliance actions. The thousands of new products that have hit the supplement market since […] DSHEA would have been a trickle instead.”

In many ways, our country would be similar to Europe minus the natural medicine tradition. I have heard from a number of health-freedom advocates across the Atlantic who have to shop in pharmacies for their supplements, supplements for which they often require prescriptions. High-potency (read: American) supplements are hidden behind the counter and are sold to people only upon request, and on the “QT” at that. Sounds like a black market, doesn’t it?

“Because the American people will not be swayed from their supplements, it is likely that a black market of supplements would have [arisen],” observed Beth Clay, senior vice president at Capitol Strategy Consultants. That’s what it would be like here, in the U.S., without DSHEA. But this black market would come at a price – without the controls such as Good Manufacturing Practices, FDA guidance on labeling and structure function claims, FTC guidance on truth in advertising, and Adverse Event reporting procedures. This would make for a return to the “snake oil” days of the early part of the century.

Now we have had a glimpse of what our country, and our dietary supplement choices, would look like without DSHEA. In what ways is DSHEA better?

“I think one of the biggest differences from the pre-DSHEA time period is that DSHEA really helped ‘legitimize’ the dietary supplement industry in the minds of many consumers, as it set down specific rules and regulations that manufacturers had to follow in order to be in compliance with DSHEA, such as labeling standards,” noted Daniel McSweeney, owner and president of Vitamin Retailer Magazine Inc.

Gormley Take-Away: So although we must feel fortunate that DSHEA exists, we must remember that the price of liberty is eternal vigilance. In recent years, the Federal Trade Commission (FTC) has picked up where the FDA left off and, by its numerous enforcement actions, “threatens to diminish the industry’s inventiveness for new products that could benefit and support consumer health,” warned Schauss.

Vitamins C and E: The Facts Behind the Headlines

By James J. Gormley

Howard Sesso and his Harvard colleagues have just come out with their PHS II paper, “Vitamins E and C in the Prevention of Cardiovascular Disease in Men: The Physicians’ Health Study II Randomized Controlled Trial” (JAMA 300[18]:2123-2133, 2008)

There is even a video in which a couple of the researchers are interviewed (http://pubs.ama-assn.org/media/2008jer/1109.dtl#vnrscript ). Suffice it to say that it is likely that mainstream media shall have a field day with this paper, regardless of what it says … and what it does not say.

In reference to what PHS II does say — and these are statements that will likely go unacknowledged by most media in the next few weeks — Sesso and colleagues themselves state:

“Moreover, results in PHS II did not corroborate the significant 24% reduction in cardiovascular death or the significant 26% reduction in major cardiovascular events among women aged 65 years or older in the Women’s Health Study.

In addition, the putative increase in hemorrhagic stroke attributed to vitamin E in PHS II, was, according to Sesso and colleagues, “not observed in other primary [de Gaetanoa, 2001; Lee, 2005] and secondary [GISSI, 1999; Yusuf, 2000; Lonn, 2005; Cook, 2007] prevention trials testing individual vitamin E supplement use.”

It is doubtful that these observations will make it into most coverage, however.

What does the established body of research on vitamins C and E really show?

A wide body of scientific evidence has established that taking antioxidant supplements — including vitamins C and E, beta carotene, selenium and zinc — can help reduce the risk of chronic disease.

That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.

A number of landmark epidemiological studies have, in fact, established that vitamin E supplementation reduces cardiovascular disease progression and reduces mortality.

In the Cambridge Heart Antioxidant Study (CHAOS) (Lancet, 1996), investigators wanted to see if supplementation with 400 or 800 I.U. of vitamin E for roughly 510 days would reduce risk for myocardial infarction (MI) and cardiovascular death in 1,035 patients with ischemic heart disease (967 more received a placebo). The findings were that high-dose vitamin E supplementation significantly reduced the risk of cardiovascular death and non-fatal MI.

In a study by Boaz et al. (Lancet, 2000), hemodialysis patients with cardiovascular disease (aged 40 to 75 years) received either 800 I.U./day of vitamin E or a placebo for approximately 519 days. The results? There was a significant decrease in cardiovascular disease (endpoints) and myocardial infarction.

In another study from 2000 (Salonen et al., J Int Med), a combined supplement of both vitamin E and slow-release vitamin C reduced the progression of atherosclerosis in men by 74 percent over a three-year period of supplementation.

In the Nurses’ Health Study (Stampfer, 1993) of 87,000 female nurses over eight years, among the 13 percent of women who regularly used vitamin E supplements (of at least 100 I.U. per day), there was a 31 percent reduction in relative risk for nonfatal myocardial infarction and death from cardiovascular disease compared with women who did not take vitamin E.

In a study by Rimm (1993), in which 39,000 male health professionals were studied for four years, 17 percent of the men took vitamin E supplements. Of those who took the highest doses (median of 419 I.U. per day) had a 40 percent reduction in the relative risk for nonfatal myocardial infarction or death from coronary hearth disease.

That’s what the science really shows.

While every study, even those with null results, can contribute to the body of knowledge regarding nutritional supplementation and prevention of chronic or acute disease, it is always unfortunate when studies produce anomalous findings that contradict the already well established evidence that antioxidant vitamins are critical for health promotion, disease prevention and treatment.

The 2008 elections and dietary supplements

By James J. Gormley

As we approach the November elections, we may well wonder if one party or another is a better champion of dietary supplements.

Some political observers have suggested that the Democratic party may boast a few more anti-supplement foes in Congress than does the Republican party. But do party labels matter when it comes to dietary supplements?

What the Experts in Washington Tell Us
Edward Long, Ph.D., vice president of congressional relations for Washington, D.C. lobbying firm, Capitol Associates, Inc., said that there is no one completely pro-supplement and pro-health freedom party, and that different ideologies run through both major parties.

“There are two strains of Democrats,” noted Long. “One is a populist strain, which goes back to the 1890s, the goo-goos, the good government people who believe that American citizens need to be protected by government in every possible way and to be told what to do. It’s from this camp that a few of dietary supplements’ greatest critics have emerged.”

“Then there’s the more liberal, anarchistic side of the Democratic Party that goes back to the 1960s and 1970s, which holds that mainstream medicine doesn’t really work. It’s out of this strain that we have found a few of dietary supplements’ greatest advocates.”

What about the Republicans? Long said that while there is a sizeable subset of the Republican Party that is opposed to regulation, and over-regulation, in general, “there’s another strain that believes that, in certain cases, we need more regulation, such as with DHEA [dehydroepiandrosterone],” a beneficial supplement especially important for seniors.

When asked about dietary supplements and the upcoming general elections, David Seckman, the CEO and executive director of the Washington, D.C.-based dietary supplement industry group, the Natural Products Association, offered some insights.

“When it comes to supplements and how members of Congress vote on legislation impacting the industry,” said Seckman, “one rule seems to always ring true: supplement issues are truly non-partisan.” Looking at the many past and current legislative champions for the industry, Seckman added that “we have almost the same number of ‘friends’ and ‘champions’ on either side of the aisle.”

As to the presidential election, Seckman concluded that while “conventional wisdom says that Republicans favor less regulation, we need to remember that DSHEA [the Dietary Supplement Health and Education Act of 1994] was passed with a Democratic administration” and that “the industry has enjoyed fairly broad bipartisan support.”

Stay Connected to Advocacy Groups
This November, don’t assume that either of the major parties will necessarily be zeroing in on protecting our access to dietary supplements and the industry’s ability to provide them. That’s our job.

As consumers we can stay on top of opportunities for (and threats to) dietary supplements by visiting Citizens for Health (http://www.citizens.org) and clicking “Join Us” and the American Association for Health Freedom (http://www.healthfreedom.net) and clicking “Free Alerts.”

Health-food retailers can stay linked in to the issues by visiting the Natural Products Association website (http://www.naturalproductsassoc.org) and signing up for Action Alerts.

Communicate with Your Legislators
All of us should try to regularly communicate (effectively and politely) with our own district’s Senators and U.S. Representatives to ensure that our access to dietary supplements is always protected and that DSHEA is never weakened.

Codex—U.S. and global implications

By James J. Gormley
Codex Alimentarius is Latin for “food code” or “food law”. The Codex Alimentarius Commission (CAC) is one of the international bodies recognized by both international treaties and the World Trade Organization (WTO) for establishing global food standards.

According to the advocacy organization Public Citizen, recent international trade agreements have caused a radical change in the impact of Codex. The General Agreement on Tariffs and Trade (GATT) of 1994 and other treaties have altered the nature of Codex standards by “designating Codex as the international body” establishing internationally recognized food safety standards for use in trade.

After global trade negotiations in 1994, several international agreements were established, agreements that were intended to blur the lines of distinction among different national regulatory requirements regarding public health and food safety and to eliminate barriers to international trade.

According to the New Zealand Food Safety Authority, “Codex standards are considered scientifically justified and are accepted as international yardsticks,” wrote the New Zealand authority in 2001. WTO member standards that differ from Codex standards may be challenged as trade barriers if they only allow lower levels that serve to restrict trade.

Critics Voice Concerns
According to the Center for International Development at Harvard University: “These measures are criticized by some who claim the agreements are too invasive and deny them sovereignty of domestic regulation. Others assert that the agreements do not go far enough and domestic regulation is often a form of protectionism. Developing countries protest that the standards promoted in the agreements lack their input and are dominated by the interests of developed countries.”

“In the highly contentious debate over genetically modified foods,” wrote the Center, “some non-governmental organizations argue that these agreements” make it hard for countries to make their own decisions as to, for example, simply banning or allowing GMOs for sale in their country.

Others have criticized Codex’ use of the same standards that apply to toxic chemicals and environmental hazards with food and dietary supplements.

Some observers have said that Codex’ application of the precautionary principle—banning something because it might be harmful—is hypocritical: it is applied to dietary supplements, where it is not needed, but it is not applied to toxic additives, where it is needed.

Other issues at stake
Codex is looking at what forms and potencies of vitamins and minerals should be allowed for international trade, allowing individual nations to restrict other forms and potencies. Codex does not currently address other ingredients used in dietary supplements.

Calls for inclusion of DHA (docosahexaenoic acid) and ARA (arachidonic acid), and exclusion of partially hydrogenated fats and high fructose corn syrup, in infant formula standards have seemingly fallen on deaf ears, as have many other issues, say some, including concerns about GMOs.

Sustainability is another issue on the Codex horizon that may impact how some U.S. companies operate in terms of ingredient sourcing and also in terms of rising global demand for eco-friendly harvesting and production.

So how does Codex affect me?
Codex can affect you in a few ways:
1. Its guidelines regarding risk assessment have the potential to support low potencies for nutritional ingredients; that impacts what is available on store shelves if the U.S. products have had to be dumbed down based on low potencies allowed in Europe and supported by Codex. Large companies that export rely on economies of scale that will encourage them to formulate for the broader world market with restricted forms and potencies.

2. There is the real risk that the US government may copy some of these foreign and international trade standards as maximum levels for its own citizens, thus restricting our right to buy the full range of currently available dietary supplements.

3. Codex’ foot-dragging on GMOs and unhealthful ingredients (such as trans fats and high fructose corn syrup) will encourage functional food and beverage manufacturers to continue to use these controversial cheap, fattening and sweetening substances.

Gormley Take-Away: While Codex apologists are telling you we have nothing to worry about and “the sky is falling” alarmists are saying that we have everything to worry about, very real concerns and opportunities, such as those outlined above, could get lost in the shuffle. Solution? Stay tuned to what our industry associations are saying about Codex but also stay tuned to what credible consumer health advocacy organizations are saying (such as Citizens for Health). That way, you will have different perspectives that are not always 180 degrees apart and which, together, offer you a balanced view, whether pro, con or wait-and-see.

The Fear Mongers

By James J. Gormley

On March 4th, 1933, in his first inaugural address, Franklin Delano Roosevelt delivered the following inspiring words: “So, first of all, let me assert my firm belief that the only thing we have to fear is fear itself […]”

Now while FDR was, at the time, addressing a nation in the depths of the Great Depression that had recently been rocked by bank runs and was experiencing crushing unemployment and epidemic business debt, if uttered now these same words could just as well apply to the irrational, yet no less viral, fear of dietary supplements on the part of certain scientists, legislators and public health officials today.

Today, we are experiencing a new Great Depression of unhealth and chronic disease, marked by conditions which modern medicine, with its drugs and invasive procedures, is often ill-equipped to safely and effectively handle.

Instead of bank runs, we are witness to countless “pharmacy runs” and visits to mainstream physicians.

In point of fact, Americans reportedly spent $287 billion dollars on prescription drugs in 2007¹ and $16.1 billion on over-the-counter drugs.²

In August 2008, the U.S. Centers for Disease Control and Prevention (CDC) noted that, in 2006, Americans paid 1.1 billion visits to doctors and clinics.³

With epidemic levels of obesity, insulin resistance and type 2 diabetes, our most critical national debt is the good health to which our country’s citizens are entitled.

With this backdrop of America’s tragic overuse of drugs coupled with nutritional bankruptcy, a group of researchers recently published a paper entitled, “Dietary supplement use among elderly, long-term cancer survivors” (Journal of Cancer Survivorship, Paige Miller, et al.).⁴

Since chemotherapy is known to be either ineffective or marginally effective but laden with toxic side-effects, I had hoped that this study (based on two phone surveys with cancer survivors) would add another rock to the foundation of research supportive of dietary supplements in supporting immunity, fending off cancer and reducing the side effects of cancer drugs.

Instead, the researchers (from Penn State University, UT-MD Anderson Cancer Center, Duke University and a VA Medical Center) chose to highlight supplement use among elderly cancer survivors while, at the same, time raising the specter of largely theoretical supplement dangers while soft-soaping their well-supported benefits.

For example, the authors’ main support for the argument that supplements could be “risky” are several articles by supplement critic Golan Bjelakovic who, in 2007, co-authored an article with the cynical title, “Surviving Antioxidant Supplements.” ⁵

The rest of the study by Miller and colleagues does not seem to really offer a coherent message. The paper, for example, indicates that the survey participants who used the most supplements were better educated, ate more fruits and vegetables, ate more grains and, in general, had better nutrient profiles than did their less healthy co-participants. Problems of equal access to nutritional supplements notwithstanding, how is this a problem?

Other parts of the paper suggest that older Americans do not get enough of certain nutrients (e.g., magnesium, calcium and vitamin D) but elsewhere the researchers warn that people should be careful to not get too much. The study also cautions older Americans against getting too much zinc while later bemoaning the fact that many cancer survivors need more of this mineral.

In addition to the lack of a clear, practical value to this Journal of Cancer Survivorship paper (aside from adding to usage data re supplement use in older Americans who are cancer survivors) and the mixed, in some cases contradictory, messages that are communicated relating to supplementation, there is a rich body of established research—largely ignored here by Miller and colleagues—which strongly supports the use of dietary supplements to: reduce cancer risk^6-11, treat cancer patients after diagnosis or surgery^12-16, and improve health markers or reduce side effects in patients undergoing chemotherapy^17-21.

Why then do fear-mongering papers continue to get published (time and again) and attract undue media attention while the majority of studies that are supportive of dietary supplements and cancer are rarely cited by researchers or noted by reporters?

I think there are, perhaps, several reasons. One is that skepticism and cynicism are often mistaken for intellectual probity—people seem smarter when knocking something.

Another potential reason is misplaced paternalistic protectiveness: researchers may feel that they are serving a public good by alerting doctors and the world to the putative, albeit ephemeral and largely baseless, “dangers” of dietary supplements.

The fact that universities and their medical centers regularly receive endowments from pharmaceutical corporations may also have an insidious effect that trickles down to researchers who are on the bench, working with patients or punching data into their biostatistical calculators.

Ultimately, however, what matters most is that, armed with science and evidence-based facts (the results behind what actually works, and what doesn’t), we continue to be open to the benefits of dietary supplements in virtually all areas of health and wellness and not immediately, or uncritically, buy into the anti-supplement brigade’s usual messages designed to sow unreasoning doubt and inspire baseless fear.

References

1. Colihan K. Shop around if you pay for pills. WebMD Health News. Website: http://www.medicinenet.com/. Accessed August 31, 2008.
2. Consumer Healthcare Products Association (CHPA). OTC Retail Sales—1964-2007 [chart]. Website: http://www.chpa-info.org/. Accessed August 31, 2008.
3. CDC. Americans made over 1 billion hospital and doctor visits in 2006. August 6, 2008. [press release] Website: http://www.cdc.gov/. Accessed September 1, 2008.
4. Miller P et al. Dietary supplement use among elderly, long-term cancer survivors. Journal of Cancer Survivorship. Published online July 11, 2008.
5. Gormley J. Antioxidant supplements won’t hurt us, but misinformation might. Blog: The Gormley Files http://www.thegormleyfiles.blogspot.com/. Posted online May 4, 2008.
6. Reid ME et al. The nutritional prevention of cancer: 400 mcg per day selenium treatment. Nutrition and Cancer. 60(2):155-163, 2008.
7. Weingarten MA et al. Dietary calcium supplementation for preventing colorectal cancer and adenomatous polyps. Cochrane Database of Systematic Reviews. 23(1):CD003548, 2008.
8. Lappe JM et al. Vitamin D and calcium supplementation reduces cancer risk: results of a randomized trial. American Journal of Clinical Nutrition. 85(6):1586-1591, 2007.
9. Kirsh VA et al. Supplemental and dietary vitamin E, beta-carotene and vitamin C intakes and prostate cancer risk. Journal of the National Cancer Institute. 98(4):245-254, 2006.
10. Galan P et al. Antioxidant status and risk of cancer in the SU.VI.MAX study: is the effect of supplementation dependent on baseline values? British Journal of Nutrition. 94(1):125-132, 2005.
11. Duffield-Lillico AJ et al. Selenium supplementation, baseline plasma selenium status and incidence of prostate cancer: an analysis of the complete treatment period of the Nutritional Prevention of Cancer Trial. BJU International. 91(7):608-612, 2003.
12. Li Z et al. Feasibility of a low-fat/high-fiber diet intervention with soy supplementation in prostate cancer patients after prostatectomy. European Journal of Clinical Nutrition. 62(4):526-536, 2008.
13. Gold EB et al. Dietary factors and vasomotor symptoms in breast cancer survivors: the WHEL Study. Menopause. 13(3):423-433.
14. Ishikawa H et al. Aged garlic extract prevents a decline of NK cell number and activity in patients with advanced cancer. The Journal of Nutrition. 136(3 Suppl):816S-820S, 2006.
15. Stratton MS et al. Selenium and inhibition of disease progression in men diagnosed with prostate carcinoma: study design and baseline characteristics of the ‘Watchful Waiting’ Study. Anticancer Drugs. 14(8):595-600, 2003.
16. Jatoi A et al. A cross-sectional study of vitamin intake in postoperative non-small lung cancer patients. Journal of Surgical Oncology. 68(4):231-236, 1998.
17. Block KI et al. Impact of antioxidant supplementation on chemotherapeutic toxicity: a systematic review of the evidence from randomized controlled trials. International Journal of Cancer. 123(6):1227-1239, 2008.
18. Read JA et al. Nutrition intervention using an eicosapentaenoic acid (EPA)-containing supplement in patients with advanced colorectal cancer. Effects on nutritional and inflammatory status: a phase II trial. Supportive Care in Cancer. 15(3):301-307, 2007.
19. Mantovani G et al. A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, anti-cyclooxygenase-2 showing efficacy and safety in patients with cancer-related anorexiz/cachexia and oxidative stress. Cancer Epidemiology, Biomarkers & Prevention. 15(5):1030-1034, 2006.
20. Gramignano G et al. Efficacy of L-carnitine administration on fatigue, nutritional status, oxidative stress, and related quality of life in 12 advanced cancer patients undergoing anticancer therapy. Nutrition. 22(2):136-145, 2006.
21. Altundag K et al. Selenium supplementation may increase the efficacy of cetuximab in metastatic colorectal cancer patients. Medical Hypotheses. 64(6):1162-1165, 2005.

Antioxidant Supplements Won’t Hurt Us, But Misinformation Might

By James J. Gormley

Lately we’ve heard quite a lot about how nutritional supplements, including antioxidant vitamins, are regarded by a few scientists as a great danger—or so we might gather from recent media coverage that has treated us to such fear-mongering headlines as “Potential for harm in dietary supplements”(1), “Vitamin pills may do more harm than good” (2) and “Why some popular pills might kill you” (3). The scientific review to which these sensationalistic stories refer was a meta-analysis in the Cochrane Database of Systematic Reviews (4).

A meta-analysis is supposed to be careful re-review of many studies whose results are pooled together. The Cochrane Database meta-analysis, authored by Goran Bjelakovic and others, is an updated version of a review that originally appeared in the Journal of the American Medical Association (5) that had been roundly criticized by scientists.

While 67 clinical trials were included in this new review, most people are not aware that 748 trials were excluded for a number of reasons, including 405 studies that failed to show anybody died (6).

One could persuasively argue that the authors of this review only included studies which could be molded to support the viewpoint that antioxidant vitamins are dangerous.

Dr. Bjelakovic has made no bones about his skeptical attitude towards dietary supplements. In 2007, he co-authored an article in the Journal of the National Cancer Institute entitled: “Surviving Antioxidant Supplements” (7) and has posted an article on a newspaper syndicate entitled “Do antioxidant supplements work?” (8).

While meta-analyses, when properly conducted, can be an insightful tool; when ill used they are subject to bias by those who hold pre-determined conclusions and are seeking a way to force studies into them.

A wide body of scientific evidence has established that taking antioxidant supplements — including vitamins C and E, beta carotene, selenium and zinc — can help reduce the risk of chronic disease. That being said, we know that antioxidant supplements (and supplements, in general) are not magic bullets, but they can be an important complement to a healthful diet.

If we twist science to create worldwide distrust in healthful dietary supplements, then we are truly harming consumers.

References
1. Brody J. Potential for harm in dietary supplements. New York Times April 8th, 2008.
2. Vitamin pills may do more harm than good. Scotsman UK. http://news.scotsman.com/health/vitamin-pills-may-do-more.3984844.jp
3. Why some popular pills might kill you. The Herald UK. http://www.theherald.co.uk/news/news/display.var.2199569.0.Why_some_popular_pills_might_kill_you.php
4. G. Bjelakovic, D. Nikolova, L.L. Gluud, R.G. Simonetti, C. Gluud. Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD007176.
5. G. Bjelakovic, D. Nikolova, L.L. Gluud, R.G. Simonetti, C. Gluud. Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis. JAMA 2007 Feb 28;297(8):842-57.
6. Daniells S. The dangers of selective science. Nutraingredients.com April 12, 2008 [online news portal] http://www.nutraingredients.com/news/ng.asp?id=84792-meta-analysis-antioxidants-randomised-clinical-trials
7. Bjelakovic G and Gluud C. Surviving antioxidant supplements [editorial]. JNCI Journal of the National Cancer Institute 99(10):742-743, 2007.
8. Bjelakovic G. Do antioxidant supplements work? Project Syndicate [online]. http://www.project-syndicate.org/print_commentary/bjelakovic1/English