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?

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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.”

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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. Sphere: Related Content

What if we had no law protecting our supplements? Our world without DSHEA

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.

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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. Sphere: Related Content

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. Sphere: Related Content

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. Sphere: Related Content