Natural Products Industry Dot Edu

By James J. Gormley

These days there is much discussion — as there should be — about standards, certifications, and what’s in a given bottle of supplements (such as superior quality ingredients) and what’s not in it (e.g., GMO-free and gluten-free).

But what can empower a company to confidently map out the life trajectory of a dietary supplement from sprout to shelf? Education.

It is fortunate, then, for producers and consumers that the Natural Products Association (NPA) and UL (Underwriters Laboratories), a “global independent safety science company with more than a century of expertise innovating safety solutions” are now working together to offer “increased educational opportunities to NPA members,” according to a recent NPA announcement.

Having served on the NPA Education Committee some years ago, and having helped companies comply with regulatory requirements since then, I can confidently say that this educational boost will help participating member companies learn, brush up on, and master what is needed to navigate the oftentimes confusing seas of regulatory compliance.

From preparing for cGMP inspections, to cGMP quality control requirements, to production and process controls, to structure-function claims and labeling, to SOPs and more, the planned educational modules appear to address a whole range of critical areas important to the natural products industry.

The new partnership will combine NPA’s regulatory and compliance expertise with “top-notch training modules from EduNeering, the online regulatory training division of UL,” according to the NPA.

“Given the combined reputation and expertise of both NPA and UL, our collaborative efforts to bring elevated education to the natural products industry is the logical next step for both organizations,” said Daniel Fabricant, Ph.D., CEO of the NPA.

“NPA brings a level of regulatory expertise in Dr. Fabricant and Dr. Corey Hilmas that is unmatched in the dietary supplement industry, and UL is very pleased to be partnering with them in this new endeavor. Through this alliance, the industry and consumers will undoubtedly be better served,” said Mike O’Hara, general manager of global nutraceuticals for UL.

“Our combined vision is to see one program the industry can turn to for dietary supplement education, and we see this being that program,” Dr. Fabricant added. “We anticipate this to be the start of a lasting relationship between NPA and UL that will reflect this shared vision and impact our industry in a very profound and meaningful way.”

Given UL’s global recognition and universal adoption, I anticipate good things coming out of this collaboration, including a more savvy industry marketplace that is better equipped and stronger than ever before, which will benefit the industry and consumers.

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

Health Freedom and Politics: Taking Arms Against Seas of Trouble

Whether 'tis Nobler in the mind to suffer

The Slings and Arrows of outrageous Fortune,

Or to take Arms against a Sea of troubles,

And by opposing end them […]

----Hamlet’s soliloquy

By James J. Gormley

Politics. Health. Freedom. One would like to think that freedom is intertwined with both, but often freedom is at odds with the politics of control and held at arm’s length from anything approximating true health.

Why is this? Well, one definition of “politics” is: “the debate or conflict among individuals or parties having or hoping to achieve power.”

This power can be the ability to impose nanny-state, Big Government restrictions on access to natural health products and treatments and information about them.

The power can also stem from the lobbying largesse of Big Pharma and Big Agra, economic potentates that dictate what synthetic, genetically modified, or otherwise perverted foods, plants or chemicals (or systems governing them) get their way and why natural ingredients, botanicals, or dietary supplements do not.

But politics is not inherently bad; in fact, in ancient Greece being a politician was the greatest calling to which a person could aspire. Debate and conflict are not in essence bad, either; they are merely, at best, the means by which people or nations confront problems and protect interests.

Power, like a sword, can cut both both ways, depending on who is wielding it and to what end; it is, in essence, the currency or capital that can, at best, fuel change.

So as an executive and/or decision-maker in the natural product industry, how do you navigate the political minefield that surrounds us? How do you “take Arms against a Sea of troubles, And by opposing end them […]”?

As a natural products industry, we have taken arms against many seas of trouble in the past and, in most cases at least, we have risen victorious: the Hosmer-Proxmire Vitamin Bill in the 1960s and 1970s, USDA Organic and DSHEA in the 1990s, and the recent NDI Draft Guidance (so far at least).

To better navigate these seas, here are some common questions to which I will provide answers (or at least short, pithy, and potentially obnoxious suggestions):

• What are the best ways to stay on top of the industry’s political issues? First, turn to your contacts at the Natural Products Association (NPA), the American Herbal Products Association (AHPA), and the Council for Responsible Nutrition (CRN) to find out what are the latest issues and campaigns. Then, to get your consumer’s perspective, turn to Citizens for Health (CFH), the Alliance for Natural Health (ANH-USA) and the National Health Federation (NHF), because industry issues don’t always align with consumer interests, although they should.

• What is limiting your political clout: sketchy partners, bad business practices, etc.? You want to stand out from the crowd, but in a good way. Steer clear of companies trying gimmicks (such as religious exemptions, etc.) to avoid FDA scrutiny and also those companies that think USP standards and GMPs are football abbreviations.

• When should you decide to support a politician? And, if you do, how do you go about doing that? While an individual may give a maximum of $2,600 to an individual politician, PACs (Political Action Committees) can received donations of $5,000 for candidate committees and Super-PACs have no limits. Before donating any money, check out the lawmaker’s entire voting record.

• When should you back down from an issue? Better than backing down, gauge consumer sentiment before backing an issue, so you never have to back down.

• When should you get involved in foreign politics? I don’t think we should ever get involved in foreign politics, however we should not hesitate to get involved in international food trade and safety negotiations. Industry representatives include IADSA and CRN and consumer representatives include the National Health Federation.

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

Menopause: On Female Power and Healthy Options (Part 2 of 2)

By James J. Gormley

Click here to read Part 1.

In 2006, I asked Jacob Teitelbaum, MD, whether menopause has been politicized.  “Not so much politicized as commercialized,” said Teitelbaum.

“There is big money to be made in supplying hormones to women in menopause. Unfortunately, natural hormones were not able to be patented, so the drug companies used Premarin, which is simply pregnant horse urine. The process for making this was patentable. Because of this, almost all marketing and research was done on Premarin. This was despite holistic doctors saying for over a decade that it was insane to use pregnant horse urine in human females.”

“Now that the research has shown HRT to potentially be dangerous, even though the research suggests that the bioidentical hormones are much safer and likely less noxious in terms of side effects; the drug companies are paying for a very expensive misinformation campaign to mislead the American public,” Teitelbaum added.

“Because bioidentical hormones present a major competition to them (they are cheaper, safer, and simply what your body is used to making), they are paying to make sure that people get confused so that they keep buying the expensive prescription forms of estrogen and progesterone. It reminds me of the old days when doctors were being paid to promote smoking and also to convince mothers that anyone who breast-fed was a primitive who was damaging her child.”

Fortunately, natural support abounds.

Many studies, for example, support the use of black cohosh for relieving menopausal symptoms. In fact, previous trials have shown black cohosh to be as effective as HRT for reducing hot flashes. St. John’s wort has been found to help relieve mild-to-moderate depression. In addition to black cohosh (Cimicifuga racemosa), other ingredients and products are also on the market, including: red clover; soy; chaste tree (Vitex); hops; dong quai; sage; essential fatty acids; and good, old-fashioned diet and exercise.

In line with this, on October 20th, 2012, the Natural Health Research Institute (NHRI) held its 8th Annual NHRI Scientific Symposium, entitled, “The Effectiveness of Natural Products for Women’s Health.”

The conference covered such topics as: the safety and efficacy record of black cohosh; the benefits of ginseng, kava, kudzu, maca, Pycnogenol, Sibiric rhubarb, St. John’s wort, valerian, omega-3 fats, and multi-ingredient combinations; detailed research into botanical alternatives to HRT, including promising studies on hops, red clover and (once again) black cohosh; and the importance of reducing body fat, in addition to supplementation with chromium, carb blockers, green tea extract, and conjugated linoleic acid.

So, all in all, there’s a lot of good research out there on safe options for female consumers (and those who love them) to empower themselves with safe, effective, science-backed supplements that will support, nurture, and cherish women on their health journeys.

Courtesy of Natural Products INSIDER Supplement Perspectives

Menopause: On Female Power and Healthy Options (Part 1 of 2)

By James J. Gormley

[Courtesy of 'marsmettn tallahassee'
via Creative Commons]

Menopause is a life stage, just like puberty. In fact, in an interview I conducted in 1996 an editor for the American Botanical Council (ABC) put it this way:

“In puberty, a girl comes into her power as a woman. In menopause, a woman’s power deepens and strengthens. Menopause is a time for self-reflection—a time to evaluate where one has been, where one is presently, and where one wants to go. It is a time when women experience what Joseph Campbell calls their ‘function to be.’ ”

This initial time of change, referred to as peri-menopause, often kicks in several years before a woman’s last menstrual period. It lasts for one year after her last period, the point in time known as menopause. In fact, a full year without a period is needed before a woman can say she’s been “through menopause.”

The average age of menopause is 51.4, but before this, as mentioned above, usually in a woman’s 40s, changing levels of estrogen and progesterone often signal what are eventually considered symptoms of menopause. Women may have different signs or symptoms during menopause, mainly because estrogen is used by many parts of her body. That does not mean that she will have all, or even most, of them.

Moreover, signs that occur around the time of menopause may actually be a result of growing older, not changes in estrogen, such as: mood changes; hot flashes; osteoporosis; sleep problems; and heart disease.

In modern times, moderate-to-severe menopausal complaints were managed via conventional medicine with hormone replacement therapy (HRT). However, since a body of published research links the use of HRT with increased risks of breast cancer and heart disease, the search for safer alternatives has intensified.

In a 2004 review article by Taya McMillan, MPH, and Saralyn Mark, MD, in the Journal of the American Medical Women’s Association, “Forty percent of all menopausal women seek medical attention to alleviate symptoms of menopause.” They added that, “increasing evidence suggests that women are looking to complementary and alternative therapies for management and treatment of menopausal symptoms.”

“While many hormonal, physiological and digestive changes take place during menopause, perhaps the aspect most focused on by women and in medical literature is the symptom of hot flashes—for many women this symptom is one from which they simply want relief,” the ABC added.

Unfortunately not content to allow women to take charge of their own health without medicalizing their bodies, the FDA, at the behest of Big Pharma, on April 29, 1998 proposed re-classifying common conditions associated with natural states, such as hot flashes associated with menopause or premenstrual syndrome associated with the menstrual cycle, as “diseases”—a proposal which generated over 100,000 comments, most of which were in strong objection.

Next time, I’ll look at the aftermath and how the natural products industry can provide a safe and healthful solution.

Click here to read Part 2.Courtesy of Natural Products INSIDER Supplement Perspectives

Beware the Devil’s Seed(s)

Guest post by Kathleen Barnes

As I prepare to put in my garden this year, I feel a little like some whacko-zombie apocalypse fanatic. I am on a fervent mission to find non-GMO seeds and plants.

It’s not as easy as you might think since Monsanto, the father of Frankenfoods and RoundUp (what a pair!) has not only managed to protect itself against lawsuits from consumers whose health is damaged by its GMO products, it has also managed to buy up most of the seed companies and insert genetically modified organisms (GMOs) into their products.

The day is not far off when it will be impossible to buy seeds that have not been modified.

Until very recently, Monsanto had targeted corn, canola, soy and cotton, but now its gobbled up the market for the seeds you and I plant in our backyard gardens. Monsanto now owns 90 to 95 of all seed companies in the U.S. While Monsanto says it has no intention of making all seeds GMO, I can only say: If you believe that, I’ve got a bridge I’d like to sell you.

Let’s back up a few weeks to March 29 when President Obama signed into law, which has been dubbed the Monsanto Protection Act. The bill allows Monsanto to promote and plant genetically modified organisms (GMOs) and genetically engineered (GE) seeds and precludes the courts for litigating any cases contending the products are unsafe.

This unprecedented legal protection also gives Monsanto a green light to continue producing and expanding its market for GMO crops and seeds.

The danger now is that according to US laws, Monsanto always wins, even if its experimental crops are proven to be hazardous to human health and even if they cause a runaway crop plague. Now, the American government has given away the judicial power to prohibit the planting and harvesting GMO crops in almost any case.

Zombie apocalypse, indeed!

GMO foods have been scientifically linked to obesity, diabetes, immune system alterations and impaired ability to digest protein. malfunction. The Bt-toxin introduced by Monsanto in the 1990s to kill insects has now been found in the blood of 67 percent of all women, 93 percent of all pregnant women and 80 percent of umbilical cord blood in their babies.

That’s just the tip of the iceberg. At least we, as consumers, have the right to know what we’re eating. Well-financed corporate interests helped defeat the GMO labeling amendment in California. Washington state has a labeling initiative pending. More than 60 countries now requires GMO labeling, but not the U.S. This is everyone’s fight, so I encourage you to get involved.

Back home, I’m seeking out heirloom seeds and plants for my garden. I found a good list at Garden of Eatin’that not only give us a very short list of seed companies that have signed a non-GMO statement for their products and a much longer list of those that are either owned by Monsanto or have at least some GMO seeds.

Today’s revolution is with our pocketbooks. Don’t buy products from companies that have bought into the Monsanto lie.

This is a complex issue that I’ll be visiting and re-visiting frequently in the future. Stay tuned. Your health and mine and the health of the planet for the next seven generations depends on it.

All content is written by Kathleen Barnes and may be used freely if unedited and attributed.

Sustainability = The New Green

By James J. Gormley

Green, or ecologically conscious, politics have been around, in one shape or form, since 1892, when the Sierra Club was founded. Other verdant-hued milestones include, but are not limited to:  the 1912 founding of the National Audubon Society, the establishment of the World Wildlife Fund in 1961, the publication of a book that launched a movement, Rachel Carson’s Silent Spring in 1962, and the release of Davis Guggenheim’s documentary starring Al Gore, An Inconvenient Truth, in 2006.

While the green movement has been, and still represents, a path humanity must consider in order to preserve our planet and its people from total ecological collapse, global economic meltdown and social catastrophe, the recent eco-based climate push was considered by some to be “a total flop,” wrote New Republic’s Bradford Plumer in 2011.

“By late 2010, the main cap-and-trade bill had fizzled in the Senate [. . .] Greens ended up winning zilch from Congress, not even minor legislation to boost renewable electricity or energy efficiency,” added Plumer. “All those flashy eco-ads and all that tireless eco-lobbying only got us even further from solving climate change than we were in 2008.”

Plumer cites the 2011 publication of an 84-page report, Climate Shift, by American University’s Matthew Nisbet, which aimed to dope out why climate activism has flopped so badly in the past several years. Nisbet argued that greens were not badly outspent by industry and that media coverage was not the problem. He believes that greens used a much too simplistic approach, treating the complex macro issue of global warming as a simple, easily defined problem such as “acid rain,” and that they did not focus enough on boosting innovation and helping to make clean energy cheaper.

Aside from not engaging with voters and legislators in a powerful enough way regarding climate change, according to a Roper Green Gauge study released by GfK Research on September 24, 2012, “While 93% of consumers say they have personally changed their behavior to conserve energy in their household, they’re becoming less willing to pay more for green products,” wrote Advertising Age about the report.

Diane Crispell, GfK’s director, told the Examiner that the green-pushback from consumers appears to stem from several factors, including: cost; efficacy (that they don’t work well); and message fatigue due to years of “overpromise and hype.”

So if eco messaging doesn’t get us to where we want to go, what does? What if we took over from within? Enter: corporate social responsibility, which is sustainability put into practice in how businesses operate and engage in the world.

What is “sustainability”? According to the U.S. EPA, “Sustainability is based on a simple principle: Everything that we need for our survival and well-being depends, either directly or indirectly, on our natural environment.  Sustainability creates and maintains the conditions under which humans and nature can exist in productive harmony, that permit fulfilling the social, economic and other requirements of present and future generations.”

Tim Mohin, author of Changing Business from the Inside Out: A Treehugger’s Guide to Working in Corporations (2012), wrote in Forbes that the unstoppable corporate (and political) march toward globalization will “continue to stretch the scope of corporate responsibility,” referring to the recent conflict minerals tracking rules created by the Dodd-Frank Financial Reform Act, as one example.

Mohin predicts ever-increasing “levels of transparency and disclosure” will become the norm, noting that, in 2011, over 5,500 companies across the globe issued sustainability reports, reports which don’t just note how many rolls of recycled toilet paper were purchased but describe the many ways companies are being good global citizens and investing in:  education, human rights, health care, communities, social justice and a whole range of sustainable activities.

In addition, noted Mohin, not only are people who work for socially responsible companies 43% more efficient than their counterparts who work for non-CSR-focused companies, they are also 38% more loyal and enjoy a 55% higher level of morale.

And as far as the concern goes over green-bored customers, Mohin wrote that “Consumers are increasingly tuned in to sustainability when making their buying decisions.” He cites the Cone Communications 2010 Cause Evolution Study which notes that “even as cause marketing continues to grow, consumers are eager for more. In fact, 83 percent of Americans want more of the products, services, and retailers they use to support causes.”

With a world population that exceeded 7 billion in 2011, Mohin observes that, “The imperative to stretch resources even further will make sustainability a central design principle for the winning corporations of the future.”

While green labeling and marketing will continue to have a place, just as the meaning of “sustainable” means “to endure,” sustainability as an over-arching principle and governing force is not a fad or short-lived trend, but our last best chance to save lives, provide hope, ensure opportunity, grow responsibly, and, oh yeah by the way, also save the planet and all its inhabitants.

Sustainability truly is the new green.

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

What's the real take-home message of a new, negative Department of Health and Human Services report regarding dietary supplements?

By James J. Gormley

On October 2nd, 2012, Daniel R. Levinson, Inspector General of the Department of Health and Human Services (HHS), issued two reports regarding dietary supplements.

The first report, regarded as the more serious of the two, entitled “Dietary Supplements: Structure/Function Claims Fail to Meet Federal Requirements,” captured immediate public attention and could have, say some, lasting negative impact on the dietary supplement industry. But are the report’s allegations true ... or fair?

The Report: What Does It Say Its Says?
With its first report on structure-function claims, HHS purported to assess industry compliance with structure-function claim requirements. As such, HHS’s Office of the Inspector General (OIG) purchased 127 dietary supplement products—specifically, immune support and weight-loss supplements—on the open market to examine their structure-function claims.

In total, OIG purchased 67 immune support supplements and 60 weight-loss supplements, 67 of which were from Internet sites and 60 of which were from retail stores. Aside from other alleged problems, the HHS report said that 20 percent of the products displayed prohibited disease claims.

As to what stimulated the HHS OIG to conduct the review, the structure-function report’s preamble only states that the investigation was a response to inquiries from both the Government Accountability Office (GAO) and “public interest groups.”

A Cherry-Picked Sample?
A number of industry organizations and consumer advocates challenged whether such a small sampling of products could be regarded as representative of the dietary supplement industry at large, including the industry’s many responsible companies.

As Washington, D.C.-based Natural Products Association (NPA) executive director and CEO John Shaw, said in an an interview with me for Nutritional Outlook magazine, “The OIG only checked 127 supplements out of more than 29,000 on the market. The report itself says that the results cannot be generalized across the entire industry. Therefore, a small sampling of supplements should not be used as a smear against a legitimate industry that cares about the safety and health of consumers.”

Others expressed concern regarding the OIG’s sampling methods, expressing doubt that 20 percent of randomly chosen products would have had disease claims.

Justin J. Prochnow, a Denver-based attorney with Greenberg Traurig, discussed the sampling question. “My inclination would be to believe that the majority of the products cited in the report said to be marketed with alleged disease claims were being marketed online from websites without an established reputation. It has been my experience that ‘brick and mortar’ stores, as well as reputable online stores, are putting products through a pretty comprehensive label and claims review process before allowing them to be sold.”

“I would be very surprised if many of the products used as the basis for the report were purchased at well-known stores or from reputable online retailers,” he noted. In addition, industry members criticized the HHS report for intentionally not identifying the questionable products.

"They don’t identify the companies, so you don’t know which ones were in the 20 percent [of questionable products],” said Steve Mister, president and CEO of the Washington, DC-based Council for Responsible Nutrition in an interview with me for Nutritional Outlook. “You don’t know if they were all fringe companies on the edges of the internet that maybe collectively had sales of a million dollars, and whether everybody else, the ones that got it right, were the NBTYs and the Pharmavites.”

In an attempt to tackle this question, on behalf of Nutritional Outlook magazine I submitted a Freedom of Information Act (FOIA) request to the IG’s office asking them to reveal the names and manufacturers of the products with questionable claims, in addition to information on what websites the products were purchased from.

In addition, some take issue with the fact that the OIG’s office asked companies to voluntarily send substantiation data, but then in the reports criticized the submissions for not also containing negative data—a criticism that Mister dismisses.

“If the OIG wrote to me in a voluntary survey and asked for my substantiation, why would I ever send them anything that was negative?” Mister said. “Even if I had [negative substantiation] and I gave it to FDA, why would I send it to the OIG? I wouldn’t. However, the OIG says, ‘Well, you didn’t meet all of [our] criteria because you didn’t disclose studies that went the other way.’ But did OIG ask those companies to do so? No. Instead, OIG said, ‘Send us your substantiation for your product,’ so naturally a company is only going to send OIG the substantiation that’s supportive.”

What Does It Really Say
Since Inspectors General (regardless of department of agency) are almost always charged with primarily investigating internal fraud, waste, abuse and mis-management, what did the IG find regarding how the FDA manages dietary supplements?

When the FDA was asked by the IG to produce substantiation documents that had been previously submitted by companies, the FDA had no idea where to find them and, indeed, had no system in place to record, archive, track and retrieve submission documents that its own regulations require!

Here’s what the IG wrote:

“FDA could retrieve notification letters for only 21 of 127 supplements in our sample. FDA’s failure to locate notification letters raises questions about its ability to adequately monitor and enforce manufacturers’ compliance with structure/function claim requirements” [emphasis mine].

In addition, as mentioned above, the IG wrote that the FDA “lacks a reliable tracking system for notification letters.” The report said:

“FDA saves letters in a PDF format that cannot be searched by keyword. As a result, FDA could not locate letters for our sampled supplements using the product name or the manufacturer’s name. As of December 2011, FDA staff told us the agency had letters waiting to be scanned that dated back almost a year. FDA files the paper copies of notification letters chronologically. Therefore, FDA would have had to search thousands of files by hand to locate letters for our sample of supplements” [emphasis mine].

So, as the saying goes, the elephant in the room was the obviously horrible mismanagement and disorganization (perhaps incompetence) of an agency, in this case the FDA, an agency that the IG is suggesting be given even more power and responsibility over supplements despite the fact that the agency has proven that it cannot even handle the most basic of its existing responsibilities. This serious indictment of the FDA was half-buried in the report itself and completely ignored by the mainstream media.

Future Effects?
Despite the serious flaws in the report, to the average consumer the HHS reports have the potential to paint the broad supplements industry in a bad light, indeed. The media was quick to gravitate to this. Among the alarmist headlines following the reports’ release: Huffington Post’s “Dietary supplements illegally labeled: Dozens make false claims, report says;” CBS News’ “Study: Some dietary supplement labels illegal;” and from that most balanced of news sources, the American Medical Association (AMedNews.com), “Dietary supplements often lack reliable evidence to support health claims.”

As largely unimportant as the report might seem since it is a small study with limited applicability and potentially flawed, both industry and consumer groups view it as likely ammo the dietary supplement industry’s foes in Congress could try to use in support of efforts to expand FDA’s authority over dietary supplements, which we’ve shown would be disastrous for several reasons.

“I’m particularly concerned about [one] recommendation [in particular], because I think this is the most damning line in the report, which says, ‘FDA could seek legislation requiring approval for all structure-function claims in the labeling of dietary supplements,’” added Mister. He noted, “I don’t think FDA has a right to do that under the law, and certainly even if it had a right to do that under the Constitution, obviously [the dietary supplements industry] would fight that tooth and nail in Congress.”

Mister speculated how the FDA might use the first report for a longer-term plan that might include the revocation of some, or many, structure-function claims, with the agency reasoning, “Well, you know what? These have really become de facto disease claims,” he said.

“This dubious document, which we believe will serve as an advocacy [tool] for greater FDA regulation of free speech, is a far cry from the OIG’s stated mission, which is to audit and investigate HHS programs to prevent and detect fraud and abuse,” added Gretchen DuBeau from the Washington, DC-based Alliance for Natural Health.

DuBeau summed it up in this way: “FDA chooses not to provide or improve guidance for the industry. [When] a few bad apples exploit the regulatory uncertainty, those bad apples are then used by advocacy groups and members of Congress to reduce our access to all supplements.”

Editor's note: The Gormley Files is very grateful to Nutritional Outlook magazine for permitting some text from the upcoming November 2012 "Global Regulations" story to be adapted for use here.

The FDA's Record on Slimming Products: Weighing In

By James J. Gormley

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

Considering the U.S. Food and Drug Administration’s (FDA) record as a flibbertigibbet on weight-loss product enforcement (dragging its feet on ephedrine for years while green-lighting dangerous weight-loss drugs on a dime) — and in light of the FTC’s record of multimillion dollar fines and orders against makers of supplement weight-loss products — for any company to enter this arena, either with a proprietary slimming ingredient or with a finished product, it is a minefield out there. Witness warning letters sent by the FDA to makers of HCG diet products.

Despite (or due to) the aforementioned spotty record, it is hard to fathom an FDA agency advisory committee’s recent green light for a combo of phentermine and topiramate (Qnexa), a diet pill that has, according to the Alliance for Natural Health, “documented risks of causing birth defects and heart problems.”

Abdominal Cramps Anyone?

On January 24, 1996, the FDA approved the synthetic fat-substitute, olestra, for use in snacks. But would you want a product with this warning? “This Product Contains Olestra. Olestra may cause abdominal cramping and loose stools. Olestra inhibits the absorption of some vitamins and other nutrients.”

Anal leakage is most certainly not on my “hit parade” of things I am looking for in a snack beverage, or any product for that matter!

According to an update by Center for Science in the Public Interest (CSPI), “Olestra is a moribund, if not totally dead, product.” No surprise there.

A few years later, in March 1999, consumer and industry advocates successfully testified on Capitol Hill to oppose the FDA’s proposal to redefine disease to include life stages and normal discomforts, such as pregnancy, aging, menopause and headache.

The FTC Steps Into the Breach

On November 9, 2004, the Federal Trade Commission (FTC) launched “Operation Big Fat Lie,” what it billed as “a nation-wide law enforcement sweep against […] companies making false weight-loss claims in national advertisements.”

According to the FTC at the time: “Operation Big Fat Lie is the latest in the Commission’s efforts to: stop deceptive advertising and provide refunds to consumers harmed by unscrupulous weight-loss advertisers; encourage media outlets not to carry advertisements containing bogus weight-loss claims; and educate consumers to be on their guard against companies promising miraculous weight loss without diet or exercise.”

Agreed, although the FDA’s track record on weight-loss products in all categories has not helped American consumers very much, either.

Alley-oop!

In 2006, GSK applied to get its drug (orlistat) — which was said, at the time, by the group Public Citizen, to have a history of side effects and gastrointestinal problems — re-classified as an OTC weight loss drug called alli™.

Shades of olestra, Public Citizen’s objections cited such embarrassing product usage problems as anal leakage and such serious problems as pre-cancerous lesions. On February 7, 2007, the FDA dismissed the group’s well -argued petition, saying that the product label already warns people about the messy bowel problems.

As to those pesky pre-cancerous cellular changes allegedly caused by the drug (called “aberrant crypt foci”), the FDA said they aren’t of “clinical significance.”

Interesting, because according to the NIH National Cancer Institute, aberrant crypt foci represent “one of the earliest changes that can be seen in the colon that may lead to cancer.”

But, then again, FDA’s approvals were being called into question — institutional arrogance can’t allow that — and a powerful drug maker’s products were also being questioned.

Still dead set on the weight-loss market, on April 17, 2008, GSK and groups it funds submitted a Citizen Petition (FDA-2008-P-0248-0001) calling for the FDA to reclassify all weight loss support claims for dietary supplements as disease claims.

GSK was joined in this petition by the American Dietetic Association, the Obesity Society, and Shaping America’s Health. The organizations’ signatories included a lobbyist, a person who helped get obesity classified as a disease and a fundraising guru.

In the petition’s summary, GSK and its co-petitioners stated: “Moreover, the actions requested in this petition would help address concerns about the safety of weight loss supplements” and “By requiring weight-loss supplements to undergo pre-market review, FDA would shift the burden to manufacturers to show that their products are safe.”

What about the potential safety problems related to GSK’s alli? This product went through both a prescription drug and (an albeit cursory) OTC safety review process and it still has a number of reported concerns associated with it.

Takeaway: Allowing questionable weight-loss drugs and prohibiting legitimate claims for dietary supplements that assist people in achieving body composition and weight-loss goals provides Big Pharma an El Dorado, like the legendary lost city of gold, and cheats consumers out of safe, effective products while exposing them to unwarranted risk.

Where Supplement Ingredients Go to Play When We're Not Looking

By James J. Gormley

OK, so we all know about the gut-friendly benefits of beneficial bacteria, those good “bugs” which wage a neverending battle for Truth, Justice and the American Way! Sorry, that was George Reeves as TV’s Superman in the 1950s, but you get the picture.

Consumers get them in yogurt and in high-potency probiotic supplements with billions and billions of colony forming units (CFUs).

Interestingly enough, there are other applications for friendly bacteria, including products that help plants grow better with less reliance on fertilizers and pesticides. One product with soil probiotics (Trident Products’ Growtastic) is said to stimulate root and plant growth, increase the bad-bug-killing benefits of pesticides and help defend plants from disease. Other products (e.g., Green Earth Agriculture’s Quantum Growth, John & Bob’s Grow Green, and Custom Biologicals’ Biota Max) are combined with other inputs, such as nutrient-rich organic matter and beneficial fungi.

Ever wonder if there are eco-friendly approaches to tackling wastewater, sewage and environmental bio-remediation? Probiotics to the rescue again, as Kansas City, MO-based SCD Probiotics has a range of industrial solutions using good bacteria. This company also offers probiotics for aquaculture.

If we are surprised at these industrial uses for supplement ingredients, we shouldn’t be, especially if we consider the wide range of uses for plants and botanicals in food products and non-food products.

Example: corn starch. Although we may know it as a processing aid in tableting or as a thickening agent in gravies, corn starch was originally only used industrially for starching laundry and for adhesives and coatings.

Natural preservatives for foods and supplements are another example of non-nutritional uses of nutrients: antioxidant vitamins and BI Nutraceuticals’ RoseOx® are very well known to food technologists.

Algal-based products and technologies have also stimulated a great deal of industrial interest, witness the 2009 overture of BP to Martek/DSM for the development of algae-based fuels.

So it's not surprising that plant-based ingredients are also used in cleaning products. Wonder why that all-purpose cleaner is so versatile? Look no further than the plant-derived alkyl polyglucoside in the ingredients list. Why does the cleaner lather so well even though I use hard water? Citric acid and lactic acid from corn reduce minerals to soften hard water and increase cleaning power. We already know about enzymes fighting blood and other stubborn stains, but did we know plant-based lauramine oxide and sodium lauryl sulfate help remove dirt to give us sparkling dishes?

Don’t even get me started on plant-based nano-materials: can you say nanocrystalline cellulose (NCC) from Alberta, Canada 10 times fast?

All in all, I think it’s fascinating (and cool) that there are so many known, not well known, and emerging applications for plant- and organism-based ingredients. Provided the beneficial exploitation of these opportunities doesn’t imbalance agriculture by siphoning off production that could be used for better purposes, such as feeding the world, we have a fascinating road ahead.
Courtesy of the SupplySide Community

An Open Letter to Consumer Reports: 10 Misinformation Hazards in Your “10 Surprising Dangers of Vitamins and Supplements” Article

By James J. Gormley

It is personally disappointing for me that Consumer Reports, the flagship of the respected marketplace-empowerment organization, Consumers Union, has once again seen fit to arm the American consumer with detrimental misinformation regarding safe, beneficial food supplements.

In the alarmist piece which appears in the September 2012 issue, the anti-supplement subtitle reads: “Don’t assume they’re safe because they’re all natural.”

Here are the “10 Surprising Dangers” along with some accurate information and perspective:

“1. Supplements are not risk free.”
With 3,000 deaths and 128,000 hospitalizations a year from food poisoning, it is clear that nothing in life is risk-free, but we already knew this. It would be of better service to do an expose on the dangers of properly prescribed pharmaceuticals, which injure over 1 million and kill over 100,00 Americans each year in hospitals alone. The subtitle on a prescription drugs-focused article could read: “Don’t assume they’re safe because they’re FDA-approved.”

The fact of the matter is that food supplements are inherently benign and pharmaceuticals are inherently dangerous; they are part of a completely different risk paradigm. With the millions of supplements sold and safely used every year, dietary supplements have an enviable consumer safety record.

Since the 1994 enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA), FDA has had the authority to remove any dietary supplement from the market if FDA shows that it presents "a significant or unreasonable risk of illness or injury" or that it contains "a poisonous or deleterious substance which may render it injurious to health." In fact, the FDA can act immediately against any product that poses an "imminent hazard to public health or safety." With the passage of the Food Safety Modernization Act (FSMA) in 2011, the FDA’s mandatory recall authority was affirmed and expanded.

Recently released data from risk-management expert Ron Law confirmed that food supplements are by far the safest substances that people are exposed to daily (http://tinyurl.com/ron-law-data).

“2. Some supplements are really prescription drugs.”
Supplements are a class of food, not drugs, so drugs masquerading as supplements is a drug adulteration problem best handled by the Drug Enforcement Administration (DEA), something which I and Citizens for Health have been calling for since early 2010 (http://tinyurl.com/dea-should-take-over), which is now being supported by industry as well (http://tinyurl.com/dea-and-steroids).

“3. You can overdose on vitamins and minerals.”
With only a few exceptions (e.g., iron, selenium, zinc, vitamin A), even with the dosages found in high-potency supplements there is a window of safety on supplements of several hundred percent; in fact, most supplements are so safe that no upper limit can even be determined. What we really have to worry about are the over 13,000 truly dangerous prescription drugs on the market with known side effects.

“4. You can’t depend on warning labels.”
True, but since dietary supplements are inherently benign with a margin of safety a mile wide, there is virtually nothing to warn consumers about. To be conservative, many products carry cautions relating to consumption by children and pregnant/breastfeeding women, but this is more to protect companies from actions stemming from gross misuse.

“5. None are proven to cure major diseases.”
The same can be said for prescription drugs. And even if they did, supplement manufacturers would not be allowed to tell consumers about it. Regardless, supplements are complements to the diet not substitutes for healthy food and physical activity.

“6. Buy with caution from botanicas.”
I would venture to say that apart from cities bordering Mexico, over 99.999% of herbal products are sold through mainstream channels of trade. We could also say “don’t buy prescription pain killers” on the black market or from peddlers in back alleys, but some level of common sense usually prevails.

“7. Heart and cancer protection: not proven.”
The American Heart Association recommends a diet rich in marine-based omega-3s, and the U.S. government has approved health claims for vitamin D and calcium supplementation. In 2005, Harvard researchers estimated that low intake of omega-3s in the U.S. diet accounted for 72,000 to 96,000 deaths from cardiovascular disease. There have been numerous animal studies showing direct cancer prevention with omega-3s and epidemiological studies associating high levels of dietary omega-3s with reduced rates of cancer.

“8. Choking.”
Now Consumer Reports is really reaching. Anybody who tries to dry-swallow any pill can experience a gag reflex, which is not a problem unique to any one class of products.

“9. Some natural products are anything but.”
Most dietary ingredients are analogues of natural extracts; technologists are not standing around with wooden mallets, mortars and pestles. There are only one or two cases where a true synthetic is not as efficacious as a natural source nutrient, and that is with vitamin E.

“10. You may not need supplements at all.”
But we need drugs? For decades the USDA has shown that most of us do not get anywhere near a basic level of vitamins and minerals from the standard American diet, so it would be a rare person indeed who would not stand to benefit from a multivitamin/multimineral supplement at the very least.

Although Consumers Union has a long, and illustrious, track record in advocating for consumers, Consumer Reports appears to have a bug in its bonnet regarding dietary supplements, either that or single-copy newsstand sales soar when “supplements are bad” stories are run.

This is unfortunate, since scare-mongering re safe, well-regulated and effective dietary supplements will, at best, only serve to unfairly cause consumers to wrongly distrust a beneficial class of products and, at worst, drive even more Americans away from responsible self-care into the welcoming arms of drug-happy conventional medicine.

That’s not what I call consumer advocacy.

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]

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.