Health at Gunpoint: Expo West Book Signing Coming Up!

By James J. Gormley

What forces and interests direct the Food and Drug Administration (FDA) and why is this out-of-control law enforcement agency working so hard to take dietary supplements out of our hands?

These are the central questions explored in Health at Gunpoint: The FDA's Silent War Against Health Freedom, what I hope you will consider to be a groundbreaking book that brings into clear focus the silent war now being waged by the FDA against all of us: American consumers.

The FDA was established in 1906 to protect the U.S. public from misbranded and adulterated foods, drinks and drugs. While the original intent may have been honorable, over the years the execution of this mission has become tainted by lobbyists and money.

In Health at Gunpoint, I present a history of both the natural foods movement and of this over-reaching Federal agency and examine how the agency has changed over the years. I then look at the FDA's most controversial decisions and the troubling reasons behind them.

Why did the FDA try to shut down the supplements industry by getting most supplements classified as drugs? Why did the FDA drag its feet on folic acid fortification while thousands of babies were born with devastating birth defects? Why did the FDA try to get life stages (such as pregnancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered food not labeled as such? Why does the FDA favor synthetic additives and dangerous drugs over natural ingredients and dietary supplements? Why did the FDA propose a guidance that would cripple the health food industry as we know it today?

Today, as in the past, the FDA is poised to make decisions that would have a major impact on the health of all Americans. Health at Gunpoint  not only sheds light on what is happening, but also explains what you can do about it.

Far from being a “conspiracy theory” book, Health at Gunpoint looks at how Americans made up their minds to develop a more food-secure, cleaner, and healthier world and how they had to fight vested interests and the FDA to create that world for themselves---and for us.

It informs, blows holes in myths, and hopefully will also inspire a brand new generation of health-freedom advocates to fight for their rights!

Note: If you are attending the 2013 Natural Products Expo West trade show in Anaheim, California, please stop by the Health at Gunpoint book signing at the Square One Publishers' Booth No. 804 on Saturday, March 9th, at 12:00 pm!

"Rules for a Young Lady" from The Journal of Health, 1829

Compiled by James J. Gormley

 

In the research for my health freedom book, I came upon these pearls of what would have passed for wisdom in the politically incorrect, feminism-deficient year of 1829. It totally cracked me up, political incorrectness by today's standards aside!

What's with the obsession with custard? And wine or a cordial for breakfast? Huh?

“Rules for a Young Lady.

Let her to go to bed at ten o’clock---nine, if she pleases. She must not grumble, or be disheartened […]

Her breakfast should be something more substantial than a cup of slops, whether denominated tea or coffee, and a thin slice of bread and butter. She should take a soft boiled egg or two, a little cold meat, a draught of milk or a cup or two of pure chocolate.

She should not lounge all day by the fire, reading novels, nor indulge herself in thinking of the perfidy of false swains or the despair of a pining damsel; but bustle about---walk or ride in the open air, rub the furniture, or make puddings---and when she feels hungry eat a custard in place of the fashionable morning treat of a slice of pound cake and a glass of wine or cordial.

In place of three of four cups of strong tea for supper she may eat a custard---a bowl or bread of milk---or similar articles, and in a few hours afterwards let her retire to bed.

At other periods of the day which are not occupied by business or exercise, let her read---no sickly love tales---but good humoured and instructive works---calculated, while they keep the mind unincumbered with heavy thoughts, to augment its store of ideas, and to guard it against the injury which will ever result from false perceptions of mankind and of the concerns of life.”

The Journal of Health, 1829

The FDA Needs A Warning Letter of Its Own

By James J. Gormley

In June 2007, the U.S. Food and Drug Administration (FDA) issued the final rule on Current Good Manufacturing Practices (cGMPs), which, according to Nutraingredients-usa.com, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.”

Vasilos Frankos, Ph.D, former director of the FDA’s Division of Dietary Supplement Programs, told health-food industry magazine, Nutritional Outlook, that the FDA is looking to greatly increase the number of inspections it performs.

If companies are inspected by FDA and receive a Form 483 letter (List of Inspectional Observations) noting noncompliance, Frankos said that they should respond to FDA quickly, preferably within 15 days. Form 483 letters are used by the FDA to document and communicate concerns discovered during these inspections. According to the FDA, these letters:

“...list observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance”

As of April 29th, reported Nutritional Outlook, FDA had performed 66 dietary supplement GMP inspections. “Ultimately, the agency may aim to perform as many as 191 inspections or more by the end of this year [2011],” the trade publication noted. “By contrast, FDA performed 84 total inspections in 2010.”

With reports noting that 25 percent of supplement companies did not pass their FDA GMP inspections, the “FDA is due to assist industry overcome these and other issues by producing a compliance program for dietary supplements that is in the clearance phase and is due to be published imminently,” FDA senior advisor, Carl Reynolds, told attendees at a recent industry conference.

But will it assist companies? And, more importantly, what’s really at stake here?

It’s hard to comply with every requirement when the FDA holds all of the cards and provides guidance that is either surfacey in many cases or nearly impossible to carry out in others. With the agency’s surfeit of discretionary authority, the FDA can decide what is adequate documentation and what constitutes satisfactory compliance—and what is or does not—with many well-meaning companies left bewitched and bewildered by the unexpected 483 letter or warning letter they receive.

According to Jonathan Emord, one of the lead architects of the Dietary Supplement Health and Education Act (DSHEA) of 1994, the FDA admits that cGMPs:

• may result in the elimination of over 100 dietary supplement companies;
• will likely increase the cost of dietary supplements;
• will likely decrease demand for dietary supplements;

“These regulations impose costly obligations on the industry and focus primarily on process rather than outcomes,” noted Emord.

Knowing this, Emord and his colleagues commissioned Dr. Steve Hanke, former senior economist on President Reagan's Council of Economic Advisers, to evaluate the economic impact of the cGMP regulations and he predicts the burden will be approximately 10 times higher than the FDA has predicted.

What if the FDA says a company’s paperwork is not in compliance? Failure to comply with the regulations is considered "adulteration," and the agency does not need any proof that products produced by the company “present an actual risk of illness or injury to the public.”

Emord and the consumer health group, ANH-USA, and others challenged this in federal court and sued the FDA over GMPs. “Our concern has been that FDA is given authority to treat all GMP violations the same—which means that a paperwork violation carries the same penalties as selling food that harms the public: for both infractions, one is deemed to be selling ‘adulterated’ products, with the same jail sentence,” noted ANH-USA.

“We said those regulations went beyond the statutory authority of the FDA to regulate dietary supplements—that they were unconstitutionally vague (in violation of the Fifth Amendment’s due process clause), arbitrary and capricious, and an abuse of the Administrative Procedure Act.” The judge in this case ultimately sided with the FDA.

Gormley Take-Away: The way the FDA is going about implementing the cGMPs is misguided, at best, and malign, at worst. No consumer, health food store or legitimate manufacturer has a problem with the concept and practice of Good Manufacturing Practices. However, we all should have a problem with supplement companies being set up for failure by a combination of flimsy guidance and cut-throat enforcement tactics. Companies deserve to have clear guidance and to not be buried in administrative recordkeeping and paperwork requirements. These same companies also deserve to be treated fairly and respectfully, for example to be given a heads up about something that needs correction instead of immediately being slapped with an FDA Warning Letter. While the FDA will be gunning for supplement companies in the second half of 2011, all of us need to be closely watching how our tax dollars-funded agency is conducting itself as well. Because it is high time that the agency receive a warning notice of its own from the American people that we will not tolerate continued tax dollars being spent on malicious witch hunts against companies that produce wholesome food products that help us live better and healthier.

Orrin Hatch Letter to John McCain About S. 3002

This letter was sent by Senator Orrin Hatch, senior member of the HELP committee, to Senator John McCain on March 4, 2010, in large part as a result of the massively successful letter-writing campaign initiated by Citizens for Health and several other groups.
Please click here.http://www.citizens.org/?p=1984

Take Action on S. 3002 Now!

To take action on Senate Bill 3002, please click on the poster below and act now!

The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley

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

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

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

One reason Ecstasy can be especially dangerous is the lack of content control. Ingredients are hard to get and manufacturers of the drug often use substitutes, mixing other harmful additives with the already dangerous mix. This practice is so common that “drug test kits” are often sold with the drug so users can test for purity.

Because of the uncertainties about the drug sources, pharmacological agents, chemicals used to manufacture them, and possible contaminants, it is difficult to measure the toxicity, consequences and symptoms that might be expected.

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

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

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

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

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

Legislation and Enforcement
On March 16th 2004, Joseph Rannazzisi, then deputy director of the DEA's Office of Diversion Control, said in testimony before the House Subcommittee on Crime, Terrorism and Homeland Security:

"The DEA has one mission: to protect the public from dangerous drugs. However, the current law regarding steroids causes regulatory delay, especially with respect to steroids that we know are hormonally, chemically or pharmacologically related to testosterone. Because DEA’s authority extends only to controlled substances, steroids that are not classified as controlled substances continue to fall outside our jurisdiction. H.R. 3866 [The Anabolic Steroid Control Act of 2004 ] will correct this problem."

Well, the Anabolic Steroid Control Act passed in October 2004. 

On the bill's passage, one of its sponsors, Sen. Orrin Hatch (R-UT), remarked:

"Under this bill, clever chemists will no longer be able to dodge the law by disguising their chemicals to skirt the legal definition of a steroid. Our bill gives the Drug Enforcement Agency the power to schedule nearly any steroid precursor now or in the future--giving the law flexibility we don't have to play catch-up with every new andro look-alike that comes along."

On September 29, 2009, the DEA's Rannazzsi, now deputy assistant administrator, said this in testimony before the Subcommittee on Crime and Drugs:

"Although DEA does not have the authority to enforce DSHEA [the Dietary Supplement Health and Education Act of 1994], DEA does have statutory authority to investigate incidents involving the illegal manufacture and distribution of anabolic adrenergic steroids in the dietary supplement market. [...] DEA has the authority and responsibility to investigate companies that are marketing products as dietary supplements that are adulterated with controlled substances."

As well the DEA should; if yogurt were suddenly used as a delivery vehicle for sports steroids, would our guardians of public health call for a new law restricting access to yogurt or would increased enforcement and enforcement funding be directed to the DEA to get the job done? The latter, I would think.

If supplements are being adulterated by illegal labs, why then should supplements get a bad rap? Steroids and sports doping is all about unethical pharmacies and illegal labs.

Case in point, in January 2009, a 198-count DEA indictment was unsealed charging 12 pharmacists and pharmacy owners with participating in a conspiracy that dispensed and sold thousands of dosages of anabolic steroids, including powerful veterinary steroids approved for animal use only.

Another case in point: in October 2009 the DEA announced the completion of a 10-month undercover investigation into an illegal anabolic steroid manufacturing ring that led to three arrests. In the raid, agents seized over 500 vials and 1,850 capsules of anabolic steroid pills.

While the U.S. Food and Drug Administration (FDA) has been involved in sweeps relating to the illegal sale of unapproved or misbranded drugs, such as the recent Internet sweep in November 2009 called the "International Internet Week of Action," many observers, including this commentator, strongly believe that all investigation and enforcement of sports doping and illegal steroid distribution and use should immediately be more clearly placed under the aegis of the DEA, as sports doping is not a problem of food products (such as supplements) but a problem of drugs---a problem of dope, pure and simple.

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.

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. 

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.

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.

The Return of L-Tryptophan

By James J. Gormley
In the summer and fall of 1989, there was an epidemic outbreak of eosinophilia-myalgia syndrome (EMS) in the U.S. Symptoms of this heretofore rare disorder included: eosinophilia (high levels of this white blood cell); severe muscle pain; fever as high as 105 degrees F.; weakness; muscle and joint pain; swelling of the arms and legs; rash; shortness of breath; pneumonia; and potentially difficulty talking, memory impairment and trouble concentrating.

This outbreak was associated with L-tryptophan produced by a Japanese pharmaceutical company (Showa Denko K.K.); in fact, according to a 2001 position paper from the U.S. Food and Drug Administration (FDA), “more than 95 percent of the cases of EMS were traced to […] Showa Denko.”

In all, over 1,500 cases of EMS and 37 deaths were associated with this supply of L-tryptophan. Consequently, on November 17, 1989, the FDA and U.S. Centers for Disease Control and Prevention (CDC) issued a nationwide recall of all products containing 100 mg or more of L-tryptophan in a daily dose. That recall was expanded, on March 23, 1990, to all marketed product with certain exceptions, and, on February 19, 1991, was further enlarged to all legal products containing Showa Denko L-tryptophan.

And the Effects on the Category?
I spoke with Steven Bass, CEO of Tarzana-CA-based FTH Nutraceuticals, a maker of vitamins, antioxidants and amino acids, including pharmaceutical-grade Pure L-Tryptophan and Tryptophan Plus B6 and B2, and he had this to say: “The effects that the tryptophan debacle had on the nutritional industry—especially related to amino acids—were devastating. Millions of people who depended on L-tryptophan to boost their serotonin levels, and for other health reasons, were deprived of one of the most important natural supplements. Many had to resort to using side-effect-laden and dependency-creating doctor-prescribed sedatives, antidepressants and other drugs in order to replace the health effects of this nutrient.”

Enter Eli Lilly, the makers of Prozac, who were treated to a cover story in the March 26, 1990, edition of Newsweek magazine, “Prozac: A Breakthrough Drug for Depression,” which came out, coincidentally, only three days after the first expanded FDA recall of all marketed L-tryptophan supplements. Prozac quickly became the drug maker’s fastest rising star in 1989, contributing to windfall company profits of 22.5 percent on overall drug sales of $4.18 billion that year.

A Dalí-esque Regulatory Limbo
Despite the fact that U.S.-manufactured L-tryptophan has actually been continually available for sale, statements and testimony by FDA injected confusion early on into the then already unclear regulatory status of this supplement.

In fact, on July 18, 1991, Douglas Archer, Ph.D., then deputy director of the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), said, in testimony before the House of Representatives: “These approved uses [medical and infant formula applications], however, do not allow marketing of LT as a component of a dietary supplement.”

That’s interesting since, in a letter to me dated October 24, FDA spokesperson Arthur Whitmore, who’s with FDA’s office of food safety, defense and outreach wrote, quite clearly: “The agency has not concluded that any particular product is adulterated under the Act; therefore the FDA has taken no steps to limit the availability of dietary supplements containing L-tryptophan produced in the U.S.”

He added: “While we are unaware of conclusive scientific data that would establish that dietary supplement L-tryptophan would be safe, if a firm has information that it believes establishes that a product containing L-tryptophan is safe within the meaning of the Act, it could market such a product as a dietary supplement.”

“In light of the above,” concluded Whitmore, “Import Alert #54-04 was cancelled on April 29, 2005, which means that L-tryptophan intended for use in dietary supplements may be imported into the United States.”

Not only have retailers, manufacturers and suppliers been confused about L-tryptophan’s status, but so has Showa Denko K.K., which discontinued manufacturing and sale of L-tryptophan immediately after the 1989 outbreak. An October 20 note from Sara D. Schotland, of Washington, DC law firm, Cleary Gottlieb Steen & Hamilton LLP—which represents Showa Denko K.K.—noted: “we assume the ban on LT remains in effect.”

“You know, FDA never banned it as such, though several states did,” said Robert Ullman, partner at New York City-based Ullman, Shapiro and Ullman. “Even now, FDA won’t concede that the problem was solely that of a particular manufacturer’s product. At the time, the scope of the liability claims and what would have then been inescapable bad press associated with any attempt to market fully tested product were more than any company was willing to take on.”

A Favored Son of Holistic Practitioners
After the health crisis caused by the bad batch (or batches) from Japan, L-tryptophan stayed on as a continued favorite modality of practitioners and other health providers. It was a supplement that began to occupy a nebulous channel available to health practitioners via a network of progressive (and in many cases courageous) compounding pharmacists.

Julia Ross, M.A., founder of The Recovery Systems Clinic in Mill Valley, CA, and author of The Mood Cure (2002/2003), remembers it this way: “We began using L-tryptophan in 1994, when the compounding pharmacists defied the ban and began supplying it by prescription. We’ve seen over 3,000 clients since then, and a third of whom have used L-tryptophan with benefit.”

Daniel S. Smith, D.C., is the founder of the Alamo Chiropractic Healing Center in Alamo, CA, and president of Genesa Inc., a specialty manufacturer of the Total Amino Solution™ product which includes L-tryptophan and was, according to Smith, just picked up by Whole Foods Market in September.

A big believer in L-tryptophan, Smith said: “At the time L-tryptophan was taken off the market in 1989 I was not using nutritional support in my chiropractic office. The exciting thing, for me, was in 1999, when I discovered the effects of L-tryptophan in myself and my patients, this opened the door for me to really understand the importance of nutritional support as a primary recommendation in my chiropractic service.”

What About L-Tryptophan Today?
“The story of L-tryptophan,” said Marc Ullman, partner at New York City-based Ullman, Shapiro and Ullman, “is a story of the disappearance (and re-appearance) of a beneficial, well-liked ingredient from the marketplace due to a combination of regulatory concerns and marketplace overreaction.”

Marc Ullman added: “It’s a marketplace decision to undertake, or not undertake, the necessary effort to rehabilitate an ingredient, or product, in consumers’ minds.”

That being said, L-tryptophan products are once again being sold as dietary supplements in the U.S.; it seems that they have been rediscovered.

Source Naturals (Scotts Valley, CA) uses FTH Nutraceuticals’ raw ingredient L-tryptophan for its L-tryptophan dietary supplement. In addition, San Clemente, CA-based Doctor’s Best has recently come out with its Best Tryptophan with vitamin B6 & niacinamide. There are also a variety of online sources with product of, in some cases, unclear sourcing provenance, that are best for retailers to avoid.

What is L-tryptophan used for today? “L-tryptophan is commonly used for mood elevation; nervousness, premenstrual syndrome (PMS), jet lag, depression, chemical withdrawal and dieting (since it helps to reduce carbohydrate cravings),” added FTH’s Bass. “What most people don’t realize is that even during the time that it was not available (due to the one bad batch from Japan) it was still added to all baby formula manufactured in the U.S.”

“As consumers become educated about the importance of L-tryptophan and its vital role as it relates to the neurotransmitter, serotonin, I believe that they will want to use it daily as part of their wellness supplementation,” added Dr. Smith.

“The demand for L-tryptophan is increasing dramatically,” observed Bass, “which is one reason why we’re happy to be the largest distributor of L-tryptophan in the U.S.”

[Adapted from an article by James Gormley that was originally published in Vitamin Retailer magazine in December 2006]