The Right to No --- GMOs Must Go

By James J. Gormley

Her chariot is an empty hazelnut [ . . .] 
And in this state she gallops night by night [ . . .] 
o'er lawyers' fingers, who straight dream on fees  
--- Mercutio, Shakespeare's Romeo and Juliet, Act 1, Scene 4

Not that lawyers only think of (or dream about) fees, however it is worth noting that when Californians vote this November 6^th on the Right to Know Genetically Engineered Foods Act (aka the GE Foods Mandatory Labeling Initiative), they will not only, fortunately, be taking an historic stand for consumer rights but also, unfortunately, throwing down a wild card on the table, one that could potentially open up the floodgates to private actions (lawsuits) against makers of all manner of raw and processed foods, food supplements and packaged goods, in short: 60 to 80 percent of products on store shelves in The Golden State.

In the case of non-processed foods, the words ‘Genetically Engineered” will appear on the front of the package; in the case of processed foods with a variety of ingredients, the words “Partially Produced with Genetic Engineering” or “May be Partially Produced with Genetic Engineering” will appear on the front or back of the package. I wish the term “Produced with Genetically Modified Organism [GMO] Ingredient Technology,” or something similar, had been chosen instead.

Natural Genetic “Engineering” … and Frankenfoods

Why? Because as early as 8,000 B.C. farmers had already domesticated many wild food-plant species, with growers having selectively bred thousands of different strains, each with its own hereditary genetic material, or “germ plasm.”

While our ancestral farmers did not understand hybridization, and could not engage in mutation breeding (exposing plants to chemicals or radiation to create beneficial mutations) or utilize genetically modified organism (GMO) technology, clearly plant husbandry was an early version of genetic engineering: farmers using what they knew about a plant to select for specific desirable traits to develop improved varieties.

Examples of crops that are the product of traditional hybridization techniques include grapefruit (which was a cross of two different citrus fruits) and maize (a plant that was domesticated in Mexico 10,000 years ago that produced very tiny cobs).  

Animals have not been immune to human-made genetic crossing as well, and centuries of domestication and breeding for specific traits. In this example, we of course have mules (a horse and donkey cross) and anywhere from 150 to 600 breeds of domesticated dogs all bred to bring out certain characteristics.

This is of course far different from producing a hybrid plant that could never have existed in nature, especially using genes from one species (even an alien species, like fish) to create changes in another species. 

Courtesy azrainman.com

For example, in 1991 a company genetically engineered a tomato with a gene from the arctic flounder in order to convey a trait of cold-storage resistance to the tomato. 

While the fish tomato thankfully never made it to the produce aisle, other cross-species combos have. A gene from the Bacillus thuringiensis bacteria was inserted into corn to combat a corn-eating worm; today, 63 percent of the U.S. corn crop uses this Franken-seed.

The use of genetically engineered bacteria to create nutraceutical compounds has had a disastrous track record. Case in point: in 1989 over 1,500 people became very sick and nearly 40 died as a result of ingesting contaminated L-tryptophan that had been made by a foreign pharmaceutical company using genetically engineered bacteria. 

This is a perfect example of the grave concerns over 90 percent of Americans have regarding GMOs and why they want products with GMOs to be labeled as such.

Europe Has Taken A Hard Line Against GMOs; the U.S. Government Is a Huge GMO Advocate

The European Union (EU) took a more aggressive approach, at least initially, with a six-year moratorium on gene-altered products than ran from 1998 to 2004. Sadly, the U.S., Canada and Argentina challenged it in court and, in 2006, the World Trade Organization (WTO) ruled that the EU ban was illegal.

At the time, Eric Gall of Greenpeace told EurActiv.com that "All this verdict proves is that the WTO is unqualified to deal with complex scientific and environmental issues, as it puts trade interests above all others. Its only effect has been to reinforce the determination of EU countries to resist bullying by pro-GE governments and to say no to GE crops and food."

Case in point: After the May 2006 WTO ruling, American exports of rice to Europe were stopped when a majority of the U.S. crop was confirmed to be contaminated with unapproved engineered genes.

In the interim, in April 2004 Hugo Chavez had announced a total ban on genetically modified (GM) seeds in Venezuela and, in January 2005, the Hungarian government had issued a ban on the importation and planting of GM maize seeds, which was subsequently upheld by the EU .

Which brings us back to December 18 of 2006, when the EU’s environment ministers officially rejected the WTO’s ruling, specifically the proposal to force Austria to lift its bans on GM foods and crops. National bans have also been issued in Bulgaria, France, Germany and Ireland.

All in all, according to journalist Jeremy Stahl in the June 14, 2012 edition of Slate.com, public opinion in the EU has for years been adamantly against GMOs. “European policymakers have responded to their constituents rather than their scientists, and only two GM crops have been approved for farming in EU states, while 90 have been permitted by the FDA for use in the United States.”

That being said, the tide may be turning in the other direction in Europe just as the U.S. (California most prominently) is shifting back to where the EU was. The European Food Safety Authority (EFSA) rejected the French ban on GM corn. While the EU Commission is deciding how to enforce the ruling, EU’s health commission has said that it “could now ask France to lift the ban,” wrote Stahl.

Will GMO Labeling Help or Confuse Consumers?

Peggy Lemaux, Ph.D., a cooperative extension specialist at the University of California, Berkeley who manages a website on biotechnology told Eliza Barclay of National Public Radio (NPR) in a May 14, 2012, interview, that the GE label may “scare less savvy consumers away from affordable, healthful foods.”

The July 5^th issue of trade magazine, Retail Leader, noted the concerns of opponents to the California initiative who ask readers to “consider how costs could increase and small businesses could be hurt if the mandate encouraged frivolous lawsuits against companies that didn’t carry a GMO label but were sued nonetheless.”

As I noted in my April 3^rd, 2012 commentary, the last time there was a mandatory labeling initiative in California was 1986, when “The Safe Drinking Water and Toxic Enforcement Act” (aka Proposition 65, or Prop 65) was passed into law via a direct voter initiative.

Another Gravy Train for Lawyers and Their Straw Man Plaintiffs?

Prop 65, a well-intended yet disastrously misguided law that should instead be called the “Private Attorney Enrichment Via Straw Man Plaintiffs Act,” has done little to protect consumers but has done much to hurt businesses operating in or selling into California, including dietary supplement companies.

Courtesy Robert Huffstutter

In addition to providing a disgraceful “gravy train” for unscrupulous consumers and avaricious attorneys, it does nothing to truly help consumers as its labeling requirements make it seem that virtually every product a consumer sees, walks on, sits on, wears, consumes or somehow comes in contact with is carcinogenic. It becomes the state government version of a student with bad study habits who yellow-highlights 99 percent of the text in a chapter as a test preparation, which of course is the same as not highlighting anything.

And lawsuits for GMO labeling are a very real prospect, indeed. 

While the organizers of the California initiative point to the fact that the lawsuit will not authorize the awarding of Prop 65-like “bounty hunter fees” to lawyers who bring suits, which is true, what is not brought out is that (1) anyone can sue to enforce the new statute, (2) they can be awarded their attorney fees and costs of bringing suit, and (3) they don’t have to prove anything---such as facts, damage or loss---or to even win the case as such for the Court to award them fees.

In a legal analysis of the initiative by James C. Cooper, JD, Ph.D., entitled “Proposition 65 and the Proposed California Right to Know Genetically Engineered Foods Act: A Comparison of Litigation Incentives,” Cooper wrote: “The adoption of Label GMO likely would result in private lawsuits to enforce its provisions.” 

In an interview with The Gormley Files, when asked as to how widespread the “private lawsuit business will be,” Cooper said: “As I note in my paper, because there is a private right of action, we can expect private suits, however there are reasons to believe that the GMO ballot initiative will not yield the levels of abusive litigation associated with Prop 65.”  We shall see.

Will Labeling Stop the Virulent Spread of GMOs?

And while it is hoped that GMO labeling will allow consumers to vote with their pocketbooks and that they will choose the few remaining products over the 70 to 95 percent of products contaminated with GMOs, we don’t know this for certain, regardless of whatever poll numbers suggest.

As California consumers make those choices over the coming years, growers and countries will continue to abandon old, land-race crops in favor of GE, single-variety monocultures, thus setting the stage for the entire world’s complete, and utter, destruction, as a single disease, or only a few of them, could then wipe out the planet’s food supply before we could stop it.

Deforestation in the Pacific Northwest

Clear-cutting across virgin lands annihilates natural vegetation, bringing on what is called natural erosion. 

It is predicted that by the year 2050, 25 percent of the world’s 250,000 plant species will disappear due to deforestation, the shift to genetically uniform crops, over-grazing, water control projects and urbanization.

In April 1991, plant geneticist Jack Harlan (1917-1998) warned: “The diversity of our genetic resources stands between us and starvation on a scale we cannot imagine.” 

To prevent worldwide disaster scenarios such as this, groups are tracking down the wild relatives of modern crops in habitats believed to favor their survival, then preserving their germ plasm in a global network of seed banks (or gene banks)---such as the Svalbard Global Seed Vault---and protected natural sites. 

However, better oversight and controls need to be devoted to these efforts, as not only have many seed banks fallen into decay but the funding for these efforts appears to have been, thus far, subverted by the same company that rules the GMO roost.

The Way Forward?

Assuming the ballot initiative passes, only time will tell as to who will truly benefit and who will truly lose, especially as similar initiatives are on the hopper in several other states and the Federal government.

But the bigger question is this: Why don’t we push for a full ban of GMOs?

It’s no accident that only 5 percent of food in Europe contains GM traces, which is thanks to a “zero tolerance” policy that the EU has had.

For Europe, moving to zero would be a lot easier than for us, however a staged approach to eliminating GMOs for U.S. agriculture and the food industry might just work, similar to the milestones associated with vehicle emission requirements (e.g., hydrocarbons, carbon monoxide and nitrogen oxide) staged for five milestone years, including those coming up in 2017 and 2025.

Perhaps modest incentives and tax breaks can be offered to GM seed makers if they agree to phase out the development and sale of GM seeds and GM-seed-specific pesticides and help farmers in remediation efforts to restore their crops to non-patented, non-GM varieties, and agree to cease the persecution of farmers for using traditional, seed-saving practices that have been part of agriculture for 10,000 years. Certainly, the U.S. Department of Agriculture (USDA) would need to phase out its GE/GM development mission, as well.

All of this will take a great deal of political will driven by consumer grassroots’ demand, but it can be done, as we have seen in Europe. 

A world free of GM plants and crops may well be the ultimate answer. Not just the “The Right to Know,” but the “Right to No.” 

As in no GMOs.

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 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]