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the Hosmer-Proxmire Vitamin Bill in the 1960s and 1970s, USDA Organic and DSHEA in the 1990s, and the recent NDI Draft Guidance (so far at least).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

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.

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.  

The Next Ephedra is Ephedra?

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

By James J. Gormley

It would seem so based on recent ads in the musclehead magazines.

In a recent issue of one mag, there are double-page ad spreads from a company that one would think has had enough enforcement actions against it to last several lifetimes. The ads feature images and cartoons of women who look either like Vegas strippers or hookers along with ad language screaming that these products have 25 mg of ephedra extract, but with caveats that say "we're not breaking the law, folks; these things are perfectly legal."

The only way these products could not be in direct and flagrant violation of the law is if: 1.) they are not dietary supplements but are instead special classes of OTC remedies (which they are not); or 2.) the so-called ephedra is not really ephedra but some other botanical.

Well, there are a few big problems here. If the main active is not ephedra, then the FTC could slam the company for false and deceptive advertising and for claiming their products have a banned ingredient. If the flagship ingredient is ephedra, well the enforcement pathway on that is pretty clear!

If, however, the so-called ephedra extract is actually derived from the Acacia rigidula plant (as one of the ads suggests), it may not contain ephedra alkaloids but it may well contain methamphetamine, mescaline and nicotine, not the safest profile, to say the very least.

Seeing these ads really got me mad, and I wound up calling Marc Ullman, who was equally incensed. I sent these ads to the FTC, FDA and the USDA import-export officials, in addition to copying the trade associations.

Precisely because the vast majority of supplement manufacturers are responsible and ethical, it behooves us as an industry to do everything we can to not only protect consumers from misinformation and harm but to also shine a light on gray-market profiteers who are taking advantage of the DSHEA regulatory pathway yet whose products are merely masquerading as nutritional supplements.

It’s hard for us to stand tall when these bottom-feeders are muddying the waters for all of us.

There have been astounding advances in athletic-performance-related nutritional research along with the introduction of powerful, science-based sports supplements, but until we call out, shame and shun these jokers, we will have our treadmill set to “uphill” for a long time.

Busting the Anti-Supplement Myth Machine

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

By James J. Gormley

Pick up any newspaper, scan your daily news feed, glance at the TV --- and you’re sure to be hit by the latest “news” about dietary supplements: how they don’t work, how they’re all tainted with contaminants and laced with pharmaceuticals; and how their manufacturers are out to get us!

The truth, however, is far more reassuring than the headlines make out.  Go ahead, Google “dietary supplements” with the name of any of the big networks or newspapers, anything from ABC News to the Chicago Sun-Times or CNN, you name it.

I did: and in top search listings for seven of the country’s leading newspapers and five of its major networks, nearly 70 percent of the coverage is skeptical and cautionary about dietary supplements.

In fact, our self-appointed guardians of public health (whether wielding Senatorial powers or using a journalist’s pen) almost always forget to discuss those tablets and capsules that are profoundly dangerous and largely toxic: prescription drugs. Each year, prescription drugs injure approximately 2.2 million and kill at least 100,000 Americans.

With today’s nutritionally bankrupt diet over 52 percent of Americans take dietary supplements, a rate that is expected to keep growing. So, if supplements are so popular, and good for us, why, we ask, are they getting such a bum rap? Good question.

Feeding the undeservedly bad reputation is a confluence of several factors, including: historically poor government enforcement against a small number of fringe operators; general misunderstanding of how well-regulated the dietary supplement industry actually is; and media feeding frenzies related to high-profile cases that have little, or nothing, to do with the dietary supplement industry, aside from actually showing the regulations effectively working.

Therefore, it’s up to all of us to be myth-busters on a daily, or weekly or monthly basis — so that one day our guardians of public health will have no choice but to acknowledge what we already know: the power and promise of safe dietary supplements that are produced by a responsible, well-regulated dietary supplement industry: in other words, the facts.

It’s time that conventional researchers begin to design studies that build on vitamin research of the last 50 years rather than attempt to poke holes in what we already all know: vitamins promote health, reduce disease, and help people live longer … and better.

And it’s high time that the media write a new story about dietary supplements, one based on science and facts not on cynicism and misreporting, because the story they have been writing of late is getting old fast. 

The (FDA's) Claim Game

By James J. Gormley

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

On May 26, the FDA announced the first in a series of proposals to “increase public understanding of the public health impact of FDA’s enforcement efforts,” etc., all part of the FDA Transparency Initiative that was launched in 2009.

Hate to say it, but the FDA has been the model of opacity, not transparency, in regards to dietary supplements, a perfect example of which is the mystical structure-function claim process for dietary supplements.

Section 403 [ r] (6) of the Federal Food, Drug and Cosmetic Act (21 USC 343 [r] [6]) requires that a manufacturer of a dietary supplement making a nutritional deficiency, structure/function, or general well-being claim have substantiation that the claim is truthful and not misleading. The manufacturer “shall notify the Secretary [of Health and Human Services, the FDA] no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made.”

The funny thing is that the FDA does not actually approve 403[r] [6] post-market structure-function claim submissions; it merely objects to certain ones and provides no comment on others, so companies are put in a position of using structure-function claims that were not objected to under the assumption that by not objecting the FDA is providing implicit approval.

Therefore, companies that want to know what specific structure-function claims are allowable have two choices: (1) to submit several claims, one of which is at least likely to receive an objection note from the FDA; or (2) to not submit any claims, provided they are confident that they have a robust level of substantiation.

If a manufacturer submits several claims, one of which is known to be objectionable, whatever claims are not objected to are generally considered by industry to be implicitly, although not explicitly, approved or allowed by the FDA.

The downside of including an egregious claim, says DSHEA architect and guru, Jonathan Emord, Esq.: “If you submit an egregious claim you will be scrutinized more closely by the FDA.

“The window in which FDA considers to be acceptable structure-function claims is getting narrower and narrower, yet what it considers prohibited speech or a drug claim is getting wider and wider.”

Adds Emord: “Overall, today there is no tolerance and more hostility in this current regulatory climate.”