Maybe Food: Why What We're Feeding Babies Is Iffy at Best

By James J. Gormley

About 60 percent of the brain/neurologic-boosting effects of breast milk are due to the concentration of omega-3 DHA (docosahexaenoic acid) and arachidonic acid (AA).

Despite the demonstrated advantages of breastfeeding vs. standard-formula-feeding, James W. Anderson, M.D., told me way back in 1999 that, in the U.S., "The DHA content in breast milk has gone down 67 percent in the last 60 years. The DHA levels in the breast milk of American women is 50 percent less than those of European women, and about 66 percent less than those of Japanese women."

Studies have also shown that infants fed formula supplemented with DHA and AA exhibited: improved mental development; better visual acuity; and significantly lower blood pressure at age six (which may reduce the risk of cardiovascular disease later in life).”

Although the United Nations' World Health Organization (WHO) issued a report in 1994 calling for the inclusion of DHA in all infant formulas, it took seven years for the U.S. FDA to allow DHA and arcahidonic acid. And the situation was not much better internationally.

On September 2004, I testified before Codex’ Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) at the FDA headquarters, during which I argued that while DHA was listed as an “optional component” for infant formula it should be a required ingredient. I, and others, also pointed to other problems with what was allowed in infant formula around the world, such as high-fructose corn syrup (HFCS) and very low-quality fats.

As to why HFCS would have ever been allowed in baby formula, as usual follow the money. In 2008, the Corn Growers Association was said to have spent $20 to 30 million on an 18-month public (dis)service ad campaign targeting mothers with the message that high-fructose corn syrup is just fine for toddlers and children.

While it appears that some headway has been made on infant formula, both here in the U.S. and internationally (e.g., high-fructose corn syrup and partially hydrogenated fats are no longer commonly found, or at least not labeled as such), serious problems still exist.

My recent trip to the infant-formula aisle was somewhat of an eye-opener for me. Apparently, “corn syrup solids” is the first or second ingredient in most infant formula and saturated-fat-packed palm oil (50% saturated fat) and coconut oil (90% saturated fat) are still major ingredients.

Unfortunately, challenges to babies’ health are not limited to infant formula, since sweetened juices are widely used in place of, or in alternation with, formula. Not a good thing.

According to the American Academy of Pediatrics’ Nutrition Committee on Nutrition (1999-2000), “Historically, fruit juice was recommended by pediatricians as a source of vitamin C and an extra source of water for healthy infants.” According to the Academy, the facts however are these:

1. Fruit juice offers no nutritional benefit for infants younger than 6 months.
2. Fruit juice offers no nutritional benefits over whole fruit for infants older than 6 months and children.
3. Fruit drinks are not nutritionally equivalent to fruit juice.
4. Excessive juice consumption may be associated with diarrhea, flatulence, abdominal distention, and tooth decay.

As daunting as are the problems associated with the ubiquity of unhealthful choices for infants, toddlers and very young children, we have a backdrop of global obesity that has more than doubled since 1980, according to the WHO, which also notes that over 40 million children under age 5 were overweight in 2010, a number which I think is extremely conservative.

As a global natural products industry, we can feel just pride in having steered over 54 of the world’s governments to require folic acid fortification, which has contributed to thousands fewer babies being born with devastating neural tube defects. We can also point to the inclusion of DHA and AA in many infant formulas around the world, which has helped the cognitive and visual development of so many children.

But there is much work to do on behalf of the babies of future generations. Natural ingredient makers can make higher quality ingredients a more attractive option for makers of formula and all of the various fortified foods and beverages for the little ones.

One approach to making natural-source ingredients more desirable is to work with existing finished product partners in developing and engaging a committed customer base of consumer activists, potentially via organizations that focus on infant and toddler development, such as (but not limited to) ZERO TO THREE, which can spearhead petition drives and letter-writing campaigns directed to the big formula and baby-food manufacturers (perhaps through such platforms as Change.org).

Because once the “bad stuff” becomes a public relations’ liability and a market negative, formula makers may well be poised to rapidly reformulate the offending products and to avidly consider the advantages of your premium, optimal nutritional ingredient or pre-mix.

Look what happened to non-recycled paper and BPA---they’re heading the way of the Dodo bird.

Looks like it’s time for the infant food giants to evolve.
[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

"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 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.

Children Are Not Little Adults

By James J. Gormley

One of my back-to-school memories in the late-1960s and early 1970s was going to the five-and-dime with my mother and choosing brand-new marble “composition pads” and #2 pencils. 

A 1970s-era ad ... the thinking has changed since then.

Although I preferred Jules Verne to geometry --- and really “digged” my summer vacations --- I was still psyched at the beginning of each new school year. I think it had something to do with the seemingly infinite possibilities for learning and success, fun and friendship. A clean slate (or blackboard).

Today, not every child has it as seemingly worry-free as that, unfortunately. In 2007, 5.4 million American children aged four to 17 were reported to have attention deficit hyperactivity disorder (ADHD) and, of these, over half of that number were being medicated for this disorder. In addition to that, autism afflicts more than 2 million people, the incidence of which increased 172 percent in the 1990s.

Artificial additives are linked to ADHD and, in addition, one of many contributing factors to this developmental disability is believed to be mercury exposure, including the historical use of thimerosal in vaccines.

According to Robert F. Kennedy, Jr., in a 2005 Rolling Stone article, “The FDA continues to allow manufacturers to include thimerosal in scores of over-the-counter medications as well as steroids and injected collagen.” In 2012, thimerosal is still being used in vaccines.

Kennedy added: “If, as the evidence suggests, our public-health authorities knowingly allowed the pharmaceutical industry to poison an entire generation of American children [with thimerosal], their actions arguably constitute one of the biggest scandals in the annals of American medicine.”

And as if things were not challenging enough for children without even considering exposure to toxins, the Federal Interagency Forum on Child and Family Statistics noted that the percentage of overweight children aged six to 17 years between 1976-1980 and 2003-2004 has gone from 5.7 to nearly 17 percent; in addition, 2 million adolescents (or 1 in 6 overweight adolescents) aged 12 to 19 have pre-diabetes, according to the American Diabetes Association.

There are, however, some indications of improvement in the lives of American kids. The percentage of children living in households classified as “food insecure” has gone down and educational attainment in high school is improving, noted the Forum.

One thing much better today for kids is the variety of dietary supplement options, from multivitamins to immune-boosters to omega-3s and more. Not only is the selection better in health-food stores but so is the manufacturers’ focus on including natural-source ingredients and excluding what I would have called “yucky” but my kids would probably call “nasty” artificial colors, flavors, binders, excipients and preservatives.

As customers visit retailers looking for healthy snacks, yogurt smoothies and kids’ vitamins, retailers can serve as an island refuge in a sometimes scary ocean of supermarkets and mass market behemoths.

Armed with good information, high-quality products and trustworthy guidance, you can help your end-user customers genuinely help their children.

In the meantime, the kids can get back to perhaps avoiding geometry and reading Jules Verne’s Journey to the Centre of the Earth, er … or would that be The Hunger Games?

Note: The title for this piece came from an ad I found (manufacturer name and ad copy cropped out) from July 23rd, 1978, subtitled: “Because Children Are Little Adults.” Of course, kids have different metabolisms and nutritional needs over and above the fact that they may be 25 to 50% less heavy than an adult, but this was the thinking in the late-1970s!

Courtesy of the SupplySide Community

Global Regulations: India | Nutritional Outlook

Global Regulations: India | Nutritional Outlook

By James J. Gormley

On April 12, the International Alliance for Dietary/Food Supplement Associations (IADSA; Brussels) commented in a press release that India’s recently-rolled-out regulations for its 2006 Food Standards and Safety Act (FSSA) “will boost foreign investment in the sector now that health supplements are clearly featured in the country’s food laws.”
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In Memoriam: Joe Bassett, Health-Freedom Legend

In Memoriam: Joe Bassett, Health-Freedom Legend

Joseph M. Bassett

Joseph M. Bassett, the co-owner of two Bassett’s Health Food stores and a long time leader in the natural products industry, died on June 6th; he was 79 years old. According to his obituary, Bassett died of complications of a bladder and kidney infection.

He was a U.S. Army veteran who served honorably during the Korean War. Bassett and his wife Patricia started Bassett’s Health Foods in 1969, bringing vitamins and supplements to the Toledo, Ohio area. The retail outlet also offered a range of private label products, with formulas developed by Bassett using his knowledge of nutrition. He was trained and licensed in nutritional and massage therapies.

He was also vigorously involved in supporting consumer access to dietary supplements, actively participating as a member of the National Nutritional Foods Association (NNFA, now the Natural Products Association, or NPA).
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Do Democrats Hate Supplements?

By James J. Gormley

I thought that would get your attention.

Of course the answer is not (categorically) yes.

There are staunch and stalwart dietary supplement champions on the “D” side of the aisle, such as Sen. Tom Harkin (D-Iowa), and one of the greatest supplement industry gladiators of all time, Democratic Sen. William Proxmire (Wisconsin), whose name is attached to one of the most important pro-supplement bills ever passed in the last 100 years, what is often referred to as the Proxmire Vitamin Bill of 1975, or Senate Bill 548, which was signed into law in 1976.

As we approach the November 2012 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  Washington, D.C. lobbying firm, Van Scoyoc Associates Inc., told "The Gormley Files" in 2008 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.”

Red States, Blue States and Purple States?

Unfortunately, however, goo-goos from the Democratic Party have been consistently proposing, co-sponsoring and advocating for the worst anti-supplement pieces of legislation since the bi-partisan passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994.

In May 2012, the latest challenge to dietary supplements was Sen. Durbin’s Senate Amendment 2127 that was defeated by a vote of 77 to 20.

Assuming blue states lean Democratic, red states lean Republican, and purple states are up-for-grabs, 13 out of the 20 Senators (or 65%) who voted in favor of Durbin’s amendment (or more technically, voted for it to stay attached to Senate Bill 3187) were from blue states, four were from purple states (20%) and three were Democrats from red states (15%). Here was how the voting went.

Looking back to last year, Sen. Leahy’s Food Safety and Accountability Act, S. 216 (originally introduced as S. 3767), which could potentially criminalize nearly anything related to food and food supplements that the FDA wants, was a fully Democrat-sponsored bill that passed the Senate last April. Looking at this year, it has now moved on to the House.

Also, Democrats have received (and continue to receive) a great deal of criticism from constituents and stakeholders for their weak (or non-) response to the FDA's outrageous NDI Draft Guidance that was proposed last year.

Of course not all anti-supplement legislation originates on the “donkey” side of the aisle. In 2010, Sen. John McCain (R-AZ) introduced the widely vilified Dietary Supplement Safety Act of 2010, or S. 3002, which the Senator was forced to withdraw after massive grassroots opposition.

Of the two much-despised House bills from 2009 (Rosa DeLauro’s HR 875 and Jim Costa’s HR 1332), the former was a 100% Democrat-sponsored bill (with 41 co-sponsors) and the latter was largely (approximately 66%) backed by Democrats.

And for clarity’s sake, it is important to remember that although almost all (if not all) anti-supplement bills are couched in names that carry the word “safety” in their titles, they do not advance safety at all but, instead, reduce consumer access to high-quality, innovative supplements; they are, therefore, anti-safety bills or, at a minimum, anti-health!

Gormley Take-Away: The point of this commentary is not to point any fingers at any one party, as all American patriots are presumably both democratic and republican (lower-case intentional). It is merely to recommend that you do your homework before the November presidential and Congressional elections so that you know which candidates seem most likely to be supportive of health freedom and supplements . . . and which do not. You may also be able to educate your U.S. legislator on the issues if he or she is not familiar with the science, benefits and safety of nutritional supplements. Ask your legislator to join the Congressional Dietary Supplement Caucus, which is currently co-chaired by 2 Democratic Congressmen (Frank Pallone and Jared Polis) and 2 Republican Congressmen (Dan Burton and Jason Chaffetz); Sens. Orrin Hatch (R) and Tom Harkin (D) have previously served as co-chairs. Your U.S. legislators can reach the Caucus at 202-225-2161 (Cannon House Office Bldg., Room 501).

The FDA's DMAA Gamble

By James J. Gormley
Senior Policy Advisor, Citizens for Health

Courtesy of the SupplySide Community

On April 24^th, the U.S. Food and Drug Administration (FDA) sent warning letters to 10 companies cautioning them, in the strictest possible terms, that their DMAA (1,3 Dimethylamylamine)-containing products may be considered new dietary ingredients for which notifications have not been submitted and, so, would be adulterated products in violation of law and subject to seizure.

And, oh, by the way, since DMAA is a synthetic version of what may or may not be a constituent in geranium, it could not even be an NDI if it wanted to be, according to the FDA.

The FDA is resting its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA’s NDI Draft Guidance.

For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated.

Most dietary supplements on the market today contain synthetic analogues of naturally occurring natural ingredients, including vitamin C, alpha lipoic acid, and various amino acids.

In truth, DMAA is a constituent of the geranium (Pelargonium graveolens) plant, having been identified in the oil obtained from the steam distillation of the stems and leaves. This DMAA-containing plant has been used for centuries as a food item (e.g., leaves are infused for teas and added to desserts and confections, flowers are used in salads, while the oil has been used as a flavoring agent). In fact, the geranium plant and its oil are generally recognized as safe (GRAS). In terms of safety, GNC, for example, has sold 440 million servings of DMAA since 2007, with only one reported adverse event.

The FDA is following on the heels of the Defense Logistics Agency, which took products containing DMAA off military base shelves earlier this year based on two cases of death anecdotally linked to DMAA—despite the fact that the Pentagon has acknowledged no link between DMAA and the soldiers’ deaths.

On September 6^th, 2011, Barry Lynch from Cantox Health Sciences International issued an open memo in which he stated that not only do published data already exist (Ping et al., 1996) confirming that DMAA does occur in geranium oil, but also that USPlabs (the maker of Jack3d) has obtained new data “from two independent and highly respected analytical chemistry laboratories, utilizing advanced validated […] instrumentation and methods, [that] corroborate the original data published by Ping et al., and further demonstrate the occurrence of DMAA in the geranium plant […] and its edible oil.”

To be clear, the FDA is outrageously overstepping its bounds by using (although not overtly citing) non-binding opinion from a draft guidance document in Warning Letters in order to not only scare the named companies from using DMAA any longer but to also cause a widespread chilling effect in the marketplace where gun-shy companies preemptively pull an ingredient that is attracting the FDA’s attention rather than go to bat for it or join with other companies that are.

We see this happening already. Even companies that did not receive a Warning Letter are reformulating or have already reformulated their products into non-DMAA alternatives.

This is exactly what the FDA wants. Use inexpensive Warning Letters (as opposed to attempting to drag companies into Federal Court or to actually prove anything, which it cannot) to frighten the marketplace into “complying” with a version of the law that the Agency wished were in place but is not.

But no matter, if the industry decides that is much easier, and safer, to just sacrifice DMAA to avoid nasty letters from the FDA and to shield itself from frivolous class-action lawsuits citing non-binding Warning Letters, then it will have conceded defeat without a live bullet having even been fired.

And this is not to be critical of industry firms either, which honestly need to balance legal and regulatory exposure with the perceived or actual value of keeping a now-controversial ingredient in products, not to even mention public companies’ shareholder concerns and jittery insurance company worries.

That being said, the whole ugly mess reminds me of the early years in our current millennium when ephedra’s neck was on the proverbial chopping block. Many of us testified on behalf of this wonderful master botanical and tried to enlist the aid of an ephedra council from which the members had fled as if from a burning house---the San Diego ephedrine scandal did not help things, to put it mildly.

Now we have an ingredient on the chopping block.

It may not be a master herb with thousands of years of traditional use. It is not a full-spectrum botanical. And it has been included in some products whose marketing is not what we would hold up as a shining example of advertising probity and conservatism. But it does represent a line in the sand drawn by the FDA.

If we were to fully cave on DMAA, the FDA will use this as precedent for establishing a beach head on the shore of “nothing synthetic can be an NDI,” and then where will we be and what will we have gained---or lost?

Going GE-Free and GMO-Free Labeling: The Right Way to Do It

By James J. Gormley

On March 12^th, 55 members of Congress submitted a joint letter to the U.S. Food and Drug Administration (FDA) in support of a legal petition backed by over 400 organizations and businesses calling on the agency “to protect  consumer  rights  and prevent consumer  deception by requiring the labeling of genetically engineered  [GE] foods.”

With over 500 organizations and companies now behind it and over 1 million petition signatures submitted to the FDA before the FDA’s comment deadline, it is clear that there is a renewed groundswell of consumer support for the labeling of GE (or genetically modified, GM) foods and ingredients.

On Tuesday, March 27^th, the FDA responded to the petition by saying it had not yet made a decision and needs more time; it also only recognized 394 signatures rather than 1 million, an anomaly due to the FDA’s peculiar way of handling and recording petition drives and form letters.

Nevertheless, 17 states have reportedly introduced GE-labeling legislation, with bills in Connecticut and Vermont currently standing the best chance of passing. Meanwhile, Californians are being mobilized to secure a place for a mandatory GE-labeling ballot initiative in time for the November general election.

Let's Be Careful What We Ask For

Do we remember the last time there was a mandatory labeling initiative in the Golden State? The year was 1986. That was when “The Safe Drinking Water and Toxic Enforcement Act” was passed into law via a direct voter initiative.

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.

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.

Let's Think It Through First

So the cautionary here is: We must be careful what we ask for, because if we don’t think through the proposed pieces of legislation downstream to the level of roll-out, regulation and enforcement, and how they will affect the labeling of food supplements and other functional or fortified consumables, then we might well be in for a surprise.

For example, it is known that between 65 to 72 percent of corn in the U.S. in GE (some estimates have this as 88 percent), in addition to 94 percent of soy, 95 percent of sugar beets and over 90 percent of canola (rapeseed). Not only that, but 75 percent of wheat farmers are interested in “going GE” and over 30 percent of riceland has already been contaminated by herbicide-resistant GE rice.

In fact, on a global scale, over the past 15 years more than 2.47 million acres (an area larger than China and the U.S. combined) have been planted with GE crops.

“By anyone’s reckoning, it’s a fast-moving train,” wrote Cookson Beecher of Food Safety News on January 27^th. “Biotech crop cultivation jumped 87-fold between 1996 and 2010, making genetically engineered crops the fastest-adopted crop technology in the history of modern agriculture.”

Let's Support Non-GE From The Ground Up

So, in a practical sense, if we don’t support market changes from the ground up, we may hurt some of the same health-food companies we are trying to help. For example, if only 6 percent of soy acreage is non-GE, there may not be a sufficient supply to meet the demand of consumers who are looking for GMO-free soy protein isolate powder at their local store.

In addition to issues of a nearly non-existent supply, there are also important price considerations for consumers and stakeholders to consider. According to chef Eric Ripert as quoted by FoodNavigator-USA.com, if people want to solely eat non-GMO, “they need to increase their food budgets---and prioritize their spending on food over luxuries, such as the latest iPhone.” He also suggested that people could consume smaller portions.

So if we are going to encourage that producers shun 65 to 95 percent of ingredients on the market, what mechanisms are we going to campaign for to increase investment in sustainable, GMO-free cropland? It takes over 3 years to convert from non-organic to organic, and organic farms do not currently receive USDA subsidies. That needs to change.

We need to generate the political will in Washington and Maryland to make sure that attractive subsidies, interest-free loans, equipment discounts and tax breaks are offered to farmers for converting their farms to organic and for new, family farmers to get started. This must be supported by consumers and by the food and food supplement producers who can, and should, commit to sourcing their ingredients with suppliers who work with these family farms.

And consumers must be made aware of the importance of purchasing products made with these ingredients while keeping in mind that it will take some years for the market and the products to catch up to the demand, and to be patient with companies who are committed to increasing their percentage of non-GE ingredients each year in line with the ever-increasing supply of those ingredients.

Gormley Files Take-Away: If we support the market of and for non-GMO this way, organically if you will, we will reduce or eliminate the economic incentives for agri-business to take over the last-remaining cropland and will encourage a staged, gradual conversion of farmland to sustainable, non-GMO crops in a way that helps family farmers, helps suppliers, helps food supplement manufacturers, helps health-food retailers and helps consumers---all without devastating supply or retail prices, collapsing markets and disappointing consumers.

The FDA’s Double-Barreled Shotgun Aimed at Dietary Supplements

By James J. Gormley

The Food and Drug Administration (FDA) plans to publish a proposed rule to revise the Nutrition Facts panel and related rules by the end of 2012.

According to Elaine Watson in Nutraingredients-usa.com, the FDA said it is “expected to look at serving sizes, daily values, adjustments to label formats and additional nutrient declarations, all of which have the potential to cause controversy.”

For example, if the FDA proposes that daily values be based on Estimated Average Requirements (EARs) instead of Recommended Dietary Allowances (RDAs) or Daily Reference Values (DVRs), the published dosage needed to achieve 100 percent of your daily value would drop dramatically, since EARs are significantly lower than are RDAs.

 
In essence, consumers might believe they are getting enough or a high-potency level of certain nutrients and forego purchasing or buying dietary supplements.

Suppliers of the country’s National School Lunch Program would probably be overjoyed since they could provide less nutritious foods to our kids and still “honor” their USDA contracts.

This new food-labeling scheme is reminiscent of the nutrient potency-labeling shenanigans that  preceded the Proxmire Vitamin Bill battle, albeit, in this case, attempting to dumb down foods while making them appear to  be more nutritious.

As Steve Mister and John Hathcock PhD (from the Council for Responsible Nutrition) wrote:

"In the early 1970s, FDA proposed to restrict the potency of vitamins and minerals in supplements to 150 percent of the Recommended Dietary Allowance (RDA); levels above that would automatically redefine a supplement as a drug and require the agency’s premarket approval. FDA ignored the fact that even some unfortified conventional foods can contain many multiples of the RDA for certain nutrients (e.g., vitamin B12 in liver) and thus be far more ‘potent’ than the vitamin supplements it sought to regulate. Consumers and the industry resisted, and Congress passed Section 411 (Rogers-Proxmire Amendment) to the Food, Drug and Cosmetic Act (FDCA), which specifies that FDA may not classify a supplement as a drug solely on the basis of potency."

The NDI Draft Guidance is engineered to gut, through misinterpretation, many of the most important features of the Dietary Supplement Health and Education Act of 1994 (1994), a law that was partly stimulated by FDA attempts to regulate dietary supplements as food additives, as Mister and Hathcock recently wrote in Nutritional Outlook magazine:

"Thwarted in that effort to call supplements unapproved new drugs [prior to Proxmire], FDA next attempted to classify dietary supplements as unapproved new food additives, thereby imposing on particular dietary ingredients the same requirements for premarket approval as applied to chemicals that were added to food for non-nutritive reasons.  [ ...] Congress then passed DSHEA, which states that dietary supplements shall not be regulated as food additives."

If the NDI Draft Guidance were to be finalized as written, and enforced along the same lines, many of the innovative dietary supplement products consumers use and rely on today would go the way of the dodo bird.
 
The Gormley Files Takeaway: Via two very different tacks, the FDA is attempting to overtly (in the case of the NDI Draft Guidance) and covertly (in the case of the food labeling scheme) roll back or undermine, respectively, the two biggest health-food-industry and consumer victories ever won against the FDA.

NDI Groundhog Day: Let’s Start a New Day!

NDI Groundhog Day: Let’s Start a New Day!

Whistleblower Lawsuit Puts Spotlight On FDA Technical Reviews - ScienceInsider

Whistleblower Lawsuit Puts Spotlight On FDA Technical Reviews - ScienceInsider

Hershey Will Offer Certified Chocolate Following Consumer-Driven Campaign

Company announces new commitment to buying Rainforest Alliance certified cocoa after hearing from over 100,000 consumers; takes first step to addressing child labor

WASHINGTON, D.C.///February 1, 2012/// The Hershey Company announced yesterday that it will make its first commitment to sourcing independently certified cocoa for its Bliss line by the end of 2012. The announcement was made days before International Labor Right Forum was scheduled to run a Super Bowl ad highlighting Hershey’s use of child labor and follows a multi-year campaign that generated over 100,000 letters to Hershey, including from 50,000 supporters on Change.org asking Hershey to improve its cocoa sourcing practices.

The “Raise the Bar, Hershey! Coalition”, a group of responsible cocoa advocates led by Global Exchange, Green America, and International Labor Rights Forum, started the campaign after identifying Hershey as behind its competitors on addressing child labor, forced labor, and other abuses in the cocoa industry.

"We are heartened to see Hershey's taking this first step towards accountability in their supply chain and we will continue to dialogue with them about how to ensure they no longer depend on forced child labor," said Judy Gearhart, executive director of the International Labor Rights Forum. "The threat of a Super Bowl ad forced the announcement, but Hershey’s new moves are really the result of thousands of consumers, students, church congregations and community groups writing to them over the past two years.”

The Raise the Bar, Hershey Coalition has been increasing pressure on Hershey, including launching a petition on Change.org, creating “brand-jamming” photos and videos of Hershey products, blanketing the company’s Facebook wall in messages, organizing rallies at Hershey flagship stores, and delivering more than 100,000 letters from concerned consumers to Hershey’s corporate headquarters on Halloween.

“The Raise the Bar, Hershey! Coalition is excited to see Hershey listening to consumer demand for ethically sourced cocoa,” said Elizabeth O’Connell, fair trade campaigns director for Green America, “but we also recognize there is much more work to be done to fight child labor and other abuses in the cocoa industry, and we will continue to encourage Hershey to develop ethical sourcing practices.”

“The growth and ultimate success of Raise the Bar, Hershey’s petition on Change.org is incredible,” said Change.org Director of Organizing Amanda Kloer. “Hershey responded to consumer pressure with a significant improvement in cocoa sourcing transparency. It has been empowering to watch this group of concerned organizations and individuals use Change.org’s tools to fight for changes at the Hershey Company.”  

In response to Hershey’s announcement, eighth grader Jasper Perry-Anderson has created a follow-up campaign on Change.org asking the Hershey Trust to ensure the Hershey Company expands its commitment to certified cocoa to all its products in the future.

Journalists interested in contacting Hershey’s public relations staff should try:

Andy McCormick, Vice President, Public Affairs
717-534-5739
anccormick@hersheys.com

Kirk Saville, Spokesperson
800-468-1714
ksaville@hersheys.com

The Raise the Bar, Hershey! Coalition is led by the following organizations:

GREEN AMERICA is the nation’s leading green economy organization. Founded in 1982, Green America (formerly Co-op America) provides the economic strategies, organizing power and practical tools for businesses and individuals to solve today's social and environmental problems. http://www.GreenAmerica.org

GLOBAL EXCHANGE is a membership-based international human rights organization dedicated to promoting social, economic and environmental justice around the world.http://www.GlobalExchange.org

INTERNATIONAL LABOR RIGHTS FORUM is an advocacy organization dedicated to achieving just and humane treatment for workers worldwide.http://www.LaborRights.org

ABOUT CHANGE.ORG

Change.org is the world’s fastest-growing platform for social change — growing by more than 500,000 new members a month, and empowering millions of people to start, join, and win campaigns for social change in their community, city and country. For more information on Change.org, please visit: http://www.change.org/about

Good fats and vitamins keep the brain young!

By James J. Gormley

“Get rid of all trans fats in your diet!” is the main takeaway message from a December 28 study on vitamins and the brain in the journal Neurology.

According to lead author Gene Bowman ND MPH, an assistant professor of neurology at the NIA-Layton Center for Aging & Alzheimer Research at Oregon Health and Science University in Portland, the study, entitled “Nutrient biomarker patterns, cognitive function, and MRI measures of brain aging,” looked at the relationship between nutrient status, cognitive function and brain health in 104 elderly participants, 62 percent of whom were women.

Utilizing eight distinct nutrient biomarker patterns (NBPs) out of 30 that were originally developed, the authors were able to see, by using psychological and cognitive tests, blood tests and nuclear magnetic resonance imaging (MRI) which participants had less brain shrinkage, or atrophy, and what these nutrient profiles suggest as to what dietary practices may be associated with better cognitive health as we age.

The nutrient biomarker pattern (NBP) was first tested and validated against food frequency questionnaire studies by Bowman and his colleagues in an earlier 2011 study which appeared in the journal, Alzheimer’s Disease & Related Disorders.

“What we’re doing is picking up on the plasma signatures of different nutrient combinations, which will help us come up with better nutritional and public health recommendations,” said Bowman, in a December 29 phone interview.

The results indicated that those who had the highest blood (plasma) levels of vitamins B, C, D and E and omega-3 fats (good fats) did the best on cognitive tests and had the healthiest brains; those who had the most bad fat, specifically trans fat, in their blood did the worst on cognitive tests and had the least healthy brains – meaning their brains showed some initial signs of volume loss, or shrinkage, an early warning for potential dementia or Alzheimer’s disease down the road.

According to Jeffrey Blumberg PhD, director of the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University in Boston, the results of “the Bowman study are consistent with several of the studies completed by Martha Clare Morris (and her colleague, Christy Tangney).

“They are also consistent with those showing a beneficial relationship of B vitamins (especially B12) and brain volume published a couple years ago (from a British group). Similarly, observational studies have shown an inverse correlation between folate [folic acid] intake/status and risk for age-related dementias. The Physicians Health Study found beta-carotene is associated with less cognitive decline in aging. And some (but not all) studies have found a benefit of vitamin E supplementation on cognitive performance and/or rate of decline in Alzheimer’s disease.”

It is known that trans fats, which are found in deep-fried foods and as partially hydrogenated oils found in packaged snack and other processed foods, are bad. This study, however, is “the first study to look at trans fats in the context of brain health and functioning,’ added Bowman.

This study, said Bowman, was funded by the U.S. National Center for Complementary and Alternative Medicine (NCCAM). A future study, one that is in the works, will look at the impact of diet on cognition in people over many years or even decades, which is called a longitudinal study.

“Is all that frozen pizza really worth it?,” asked Bowman, who suggests, on the positive side, that people should consider eating more “fish, beans, citrus fruits [and] dark green leafy vegetables.”

Gormley Files Take-Away: Is pizza bad? No, it can be pretty healthy, and frozen pizza at your local health-food store is probably very healthy! But the takeaway here is the very real science that shows that diets drenched in nasty, oxidized trans fats and saturated fats, and low in nutrients makes the brain atrophy, or shrink. Diets rich in omega-3 fats, B vitamins and antioxidants (and low in the bad stuff) keep the old neuroprocessor between our ears healthy and peppy!

Avoiding Avoidance; The Skinny on Weight-Loss Supplements

By James J. Gormley

[Note: Adapted from an article which originally appeared in Natural Products INSIDER Supplement Perspectives]

In marketing geared to weight loss supplements, avoidance language and strategies have been ubiquitous. These “Don’t eat this!” or “Don’t do that!” messages are also dis-empowering for consumers, at best, and dangerous, at worst.

Some industry members will remember the mid-1990s thermogenic ads on double-page spreads in leading consumer magazines promoting products with ma huang and chromium. Other ads touted extracts of Garcinia cambogia and guarana (i.e., avoiding energy loss or fatigue) --- while there were also the “water pill herbal formula” diuretics (i.e., avoiding water retention), as well.

We all know how well inappropriate use of stimulants and diuretics went, now don’t we?

Today, falsely marketed as a “new” ingredient in body-building circles, Beta-PEA (Beta-Methoxy- Phenylethylamine) was originally featured in mid-1990s weight loss ads as a thermogenic “feel good” compound.

While some ads seemed to suggest that nothing else needed to be done lifestyle-wise to lose weight, other products (such as meal replacements) were geared to restore nutrients for people who were on severely calorie-restricted diets (i.e., avoiding food!).

Avoidance diets targeting specific food groups also became greatly popular, including the Atkins’ low-carb/high-protein revolution in the early 2000s. These carb-avoidance diets, often inexpertly followed, led to cases of hyperproteinemia and ketosis.

Today, there are still a number of avoidance diets and products on the market, most of which are almost exclusively sold online or via TV promotions, and feature such questionable approaches as:

• master cleanse diet (avoiding toxins and food!);
• cabbage soup diet (avoiding almost all nutrients; are they kidding?);
• salt-free diet (avoiding a critical electrolyte);
• the HCG [human chorionic gonadotropin] diet (avoiding most food and taking a fertility hormone); and    other water-based or juice-based diet scams.

I won’t even hazard a guess as to how long the FDA will allow a fertility hormone (HCG) to be sold as a weight-loss supplement, but probably until there is a tragedy (or 100).

Of course underlying (or offsetting) all of these weight-loss ads are the following truths:

• People prefer positive calls-to-action and affirmations to negative, avoidance messages, e.g. “Eat healthy!” versus“ Don’t eat that ice cream, you pig!”
• Avoidance messages are turn-offs, and make us feel like we are missing out on something (or a lot of somethings, given the above diets), so we feel (or we are) deprived.
• Avoidance diets are often misguided and dangerous.
• Think: improved body composition instead of “weight loss.”

Takeaway? All of us who manufacture or sell weight loss, or improved body composition, products or ingredients should keep the above in mind as we develop and market these products.

Because what consumers will gain by properly sourced, manufactured, and marketed “weight loss” products is of hefty value, indeed: an opportunity to complement a full, lifestyle approach to healthier body composition and improved self-esteem.

That’s not something to avoid, now is it.  

IPA founder: EU probiotic approach is “dirty pool”

IPA founder: EU probiotic approach is “dirty pool”

Inaccurate media coverage and misguided attempts at regulation? A year in consumer health advocac...

Inaccurate media coverage and misguided attempts at regulation? A year in consumer health advocac...

Citizens for Health NDI guidance withdrawal petition signatures approach 15,000

Citizens for Health NDI guidance withdrawal petition signatures approach 15,000

You Did It!!!!!

You Did It!!!!!

10,000 Americans Tell FDA: Withdraw the “NDI Draft Guidance”!!

10,000 Americans Tell FDA: Withdraw the “NDI Draft Guidance”!!