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the Hosmer-Proxmire Vitamin Bill in the 1960s and 1970s, USDA Organic and DSHEA in the 1990s, and the recent NDI Draft Guidance (so far at least).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

Health at Gunpoint: Expo West Book Signing Coming Up!

By James J. Gormley

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

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

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

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

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

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

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

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

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

Dieticians and Efforts to Monopolize Nutrition

By James J. Gormley

There are many healthcare professionals who provide dietary advice. One subset is “Registered Dietitians” or RDs, a private credential offered by the private trade association, the Academy of Nutrition and Dietetics (AND), formerly known as the American Dietetic Association, or ADA.

RDs typically provide government-sanctioned dietary advice, such as the USDA dietary guidelines. There is a large other set of professionals – fully 2/3 of the nutrition community!– more commonly referred to as “nutritionists” who typically take a very different approach to dietary advice (not constrained by government-imposed guidelines), and there are many other professionals who use nutrition as part of their practice.

Despite an urgent need for more nutrition therapy and advice (not less), nutritionists claim that the dietician lobby has engaged in a campaign to monopolize nutrition advice through regulatory capture, specifically state nutrition licensing laws and federal regulations.

Regulatory capture of health professions is nothing new. But this attempt is said by nutritionists to be particularly egregious, because the ‘scope’ of the so-called ‘dietetics and nutrition’ profession is not a set of competencies unique to a particular health care provider (like an MD or a nurse).

It does not involve substances that the law otherwise forbids the public to use (such as a medical license permitting the prescription of pharmaceuticals). This is the purveying of advice with regard to a substance freely available to all and consumed every day: food.

The dietician lobby seeks to not just prevent laypeople from providing dietary advice, but non-RD health professionals as well! The crux of the problem is this:

Unlike many health professions, “nutrition advice” is not a single profession, but is a tool-set legitimately used by many professionals (and the public). Those professionals include dietitians, nutritionists, medical doctors, chiropractors, naturopaths, acupuncturists, health coaches, and many more. Thus, it is much more difficult to reduce nutrition to a uniform regulatory scheme than it is for a discrete profession, such as nursing, for instance. It is like trying to license “exercise advice” – which is a tool used by many professions, not the domain of a single profession.

The dietician licensing bills make it a crime for those who give nutrition advice without a license. These laws prevent the vast majority of non-RDs from providing nutrition advice and artificially constrain the number of nutrition advisers and practitioners. In over half of states in the U.S. these one-sided licensure laws have passed, and entire segments of nutrition practitioners – such as naturopaths, nutritionists, herbalists and many others – are often barred from providing advice.

The sole beneficiaries of the dieticians’ drive for monopoly are its Registered Dietitians. And they are by no means the most highly qualified. The RD credential requires a bachelor’s degree, while several other nutrition credentials require a Masters or Doctoral level. What the dietician lobby does have is far greater financial resources.

According to the American Nutrition Association (ANA), the dietician lobby is acting as legislator, executive, judge, and jury:

1. It has attempted to insinuate itself into federal regulations, so that only members of its professional trade group are permitted to be reimbursed for nutrition counseling.
2. It has been fairly successful at getting state laws passed, substantially similar to North Carolina’s, that criminalize the provision of nutrition advice. This at a time when their own data show a shortage of nutrition professionals relative to the demand
3. Those dietician-friendly state laws enshrine Registered Dietitians as the dominant force on each of these state licensing boards.
4. The state licensing boards play a large role in determining who can and cannot obtain a license, first by drafting ‘rules’ that spell out the details of licensure requirements (which mimic the dietician group’s requirements), and second by being the gatekeeper for applicants for licensure.
5. The association then encourages its members to file complaints with the state licensing boards
6. Then the Registered Dietitians in the state, encouraged explicitly by the dietician lobby to police the field, report unlicensed practitioners to the state’s licensing board, which are referred for prosecution.
7. Hearings and settlements during the course of such prosecutions are conducted by or in close contact with the particular licensing board.

Progress in Illinois
While Current Illinois law has been a near-monopoly for dietitians, I am pleased to announce that the American Nutrition Association’s bill to open up access to nutrition practitioners is up for a vote, likely by tomorrow morning, November 29^th. If you are in Illinois or have a family member, friend or colleague in the state, I urge you to pass along the this link asap!

The ANA has approval of the bill sponsor, Sen. Iris Martinez, many other legislators, and the Illinois Department of Professional Regulation, on an amended bill that would:

• Change current law from an RD-only law, to one that permits a wider variety of nutrition education and allows other nutrition exams and credentials (the CNS, CCN, and DACBN).
• Strengthen exemptions protecting acupuncturists, health food stores and other businesses and employees who respond to consumer questions regarding nutrition and dietary supplement information.

According to the ANA, “This bill doesn’t correct every provision of current law we sought to change. However, the significance of rolling back a monopolistic RD practice law to one which includes other nutritionists and exemptions, is immense.”

Ending a dietetics monopoly and ensuring protection for a diverse range of nutrition care providers for Americans is underway. This is a huge step in the process, and I look forward to, along with Citizens for Health, working with all of you to roll back these nutrition monopolies in other states!

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.

Promo Video for "Health at Gunpoint: The FDA's Silent War Against Health Freedom"

In Memoriam: Joe Bassett, Health-Freedom Legend

In Memoriam: Joe Bassett, Health-Freedom Legend

Joseph M. Bassett

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

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

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

Petition to Demand that the FDA Withdraws the NDI Draft Guidance!

By James J. Gormley

Let's call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

That's why we created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:

"I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA."

Will you sign this petition? Please click here.

Thanks!

America, Let's Tell the FCC That The Internet Must Stay Free

By James J. Gormley
Courtesy of American Chronicle

On August 23rd, Verizon's lobbyist Tom Tauke gave a speech at a trade forum sponsored by the Information Technology Industry Council (ITI) where he, according to Free Press, defended his company's recent net neutrality pact with Google.

According to FreePress.net, "Tauke claimed that the two companies proposal fulfills the president's campaign promise of non-discrimination and transparency on the Internet, but the pact," said Free Press, would exclude all wireless internet connections, and would even bar the Federal Communications Commission (FCC) from "having any authority to make and enforce net neutrality rules, instead requiring it to defer to a third-party industry group."

"Verizon is simply dead wrong in claiming their farce of a framework would fulfill President Obama's net neutrality promises," said Free Press research director S. Derek Turner in a statement. "Verizon can't hide the fact that, if enacted, this pact would mark the end of the open Internet era."

"The Google-Verizon deal contains no protections for wireless access, which accounts for nearly one-third of all Internet connections, giving Verizon and other ISPs [internet service providers] the green light to block or degrade content on their wireless networks," added Turner. "In addition, it would allow internet service providers to discriminate online by offering private Internet services alongside those on the 'public' Internet. As a candidate, Obama himself opposed the two-tiered Internet this proposal would create."

"The simple fact is Verizon and Google cooked this scheme to carve up the Internet among themselves and other industry giants because they fear competition on the free and open internet," Turner said in conclusion. "It's up to [FCC] Chairman Genachowski and the FCC, not Verizon or Google, to fulfill President Obama's promises to preserve net neutrality."

Other groups criticized the new talks, as well. Instead of more industry discussions, the FCC should move to pass formal net neutrality rules, said Andrew Jay Schwartzman, senior vice president and policy director at the Media Access Project, in the August 24th edition of CIO in an article by Grant Gross. "FCC chairman Julius Genachowski has pushed for formal net neutrality rules after an appeals court in April struck down the agency's attempt to enforce informal principles after Comcast (CMCSA) slowed customers' access to a peer-to-peer service," Gross wrote.

All somewhat puzzling given this statement by Google's Eric Schmidt way back in 2006:

"The Internet as we know it is facing a serious threat. There's a debate heating up in Washington, DC on something called 'net neutrality' – and it's a debate that's so important Google is asking you to get involved. We're asking you to take action to protect Internet freedom. In the next few days, the House of Representatives is going to vote on a bill that would fundamentally alter the Internet. That bill, and one that may come up for a key vote in the Senate in the next few weeks, would give the big phone and cable companies the power to pick and choose what you will be able to see and do on the internet.[...]

"Today the Internet is an information highway where anybody – no matter how large or small, how traditional or unconventional – has equal access. But the phone and cable monopolies, who control almost all Internet access, want the power to choose who gets access to high-speed lanes and whose content gets seen first and fastest. They want to build a two-tiered system and block the on-ramps for those who can't pay."

It would be hard to disagree with what Google said in 2006, although consumer advocates are rightly concerned that in August 2010 Google and Verizon have just drafted a "new policy framework" on net neutrality that would support an "almost free" internet in which wired broadban would be free whereas wireless – the real future of the internet – would not be free.

According to Anthony Carranza in the Examiner.com, "Among those who strongly criticized this proposal was Senator Al Franken when he summed up that the maneuvers from these major corporations such as Google and Verizon are going to trample the first amendment of the constitution since it would oppress freedom of expression online."

Video from Sen. Franken's talk can be found here:
http://www.youtube.com/watch?v=hjYpz5TQSlE&feature=player_embedded

It is time for Americans who want net neutrality to speak up and tell the FCC what it needs, which is to support President Obama's vision of a truly free, not an almost free, internet.

On or before September 20, 2010, consumers can file comments on the FCC web site in reference to "WC Docket No. 09-197." According to the FCC, comments may be filed using the Commission´s Electronic Comment Filing System (ECFS) or by filing paper copies. Comments may be filed electronically using the Internet by accessing the ECFS.

And remember, those who wish to support a free internet should consider denying the request of internet wireless (i-wireless) to be exempt from (or to "forbear from") the net neutrality freedoms that the rest of the internet would have.

Those who wish an almost free internet, well you know what to do – just visit those corporate sites to find out.

Health Freedom Nation: Consumers Take Control

By James J. Gormley
[Courtesy of NOW Foods]

Consumers and the health-food industry may have stopped S. 3002 in its tracks, but S. 510 and other threats to health freedom remain. Nevertheless, a new slate of bills, along with a re-invigorated health-freedom movement, offer new hope for the future.

Since the health-food movement’s earliest origins in New Hampshire in the 1790s, there have been many champions of health freedom.

The one who immediately springs to mind, at least for me, is Frank Murray, who happened to be my first boss before I became editor of Better Nutrition magazine in 1995.

In 2006, Frank was the recipient of the Natural Product Association (NPA) President’s Award for “long-time contributions to the natural products industry.”

He was for many years editor of Health Foods Retailing, the health-food industry’s very first trade publication and the official magazine of the NPA for 50 years, from the late-1930s until the mid-1980s.

More Than One Slingshot
A bestselling health-book author, Frank has been one of the industry’s most articulate, enthusiastic and tireless crusaders, having stood arm-in-arm with Milton Bass, Max Huberman and NPA in successful opposition to the Vitamin Volstead Act from 1966 through 1976, when the Proxmire Vitamin Bill was signed into law.

His book, More Than One Slingshot, which was written for the association, tells the history of the health food industry from its origins in the late 1890s up through the early 1980s.

The book has this great, dated cover that I love, one which depicts David and Goliath, a popular representation of the battle between the health-food industry and the U.S. Food and Drug Administration (FDA).

Today, in early 2010, we face many of the same threats to health freedom even if the names of the bills and the players have changed.

Today’s Threats to Health Freedom
In March of 2009, Sen. Richard Durbin (D-IL) introduced S. 510, the Food Safety Modernization Act, a bill that would hand over extensive, unwarranted powers to an agency, the FDA, that has shown that it cannot objectively and properly fulfill its mission regarding dietary supplements since it constantly works to undermine the Dietary Supplement Health and Education Act of 1994 (DSHEA) through coordinated suppression of supplement companies and health information regarding products sold by legitimate manufacturers.

As this bill was reviled by consumers and farmers across the country, it appeared to fall by the wayside, that is until Sen. John McCain introduced S. 3002, the Dietary Supplement Safety Act of 2010.

Senate Bill 3002 was said to be about athletics ─ trying to protect athletes from spiked or doped supplements (although one would think the athletes would know what they were taking, especially if they themselves ordered these products from shifty chemists and fly-by-night pharmacists), but it included a whole host of anti-supplement provisions that almost made S. 510 pale by comparison.

A firestorm of consumer outrage ensued: many tens of thousands of letters were sent to the Senate thanks to powerful grassroots advocacy campaigns organized by Citizens for Health, the Alliance for Natural Health and the NPA. In early March, Sen. McCain decided to withdraw his support of the bill, with the caveat that certain provisions should be carried over to S. 510, most of which are already in S. 510 as it now stands.

Consumers, and the natural products industry, must be especially vigilant now and throughout 2010 ─ regarding S. 510 so that the bad provisions in this bill are dropped or drastically revised, and that nothing even worse from the dry-docked S. 3002 winds up being added to S. 510.

Tomorrow’s Health Freedom Opportunities
As to bills that offer a ray of hope, there are currently three main ones: H.R. 4913, H.R. 3394 and H.R. 3395.

On March 23rd, Rep. Jason Chaffetz (R-Utah) and Rep. Jared Polis (D-CO) introduced the Free Speech about Science Act (H.R. 4913); since then, Rep. Dan Burton (R-Indiana) has signed on as a co-sponsor. The bill allows producers of healthy foods and dietary supplements to cite legitimate scientific studies on the health benefits of their products.

Similar in title to H.R. 4913, the Freedom of Health Speech Act (H.R. 3394), which was introduced by Rep. Ron Paul on July 29, 2009 and co-sponsored by Rep. Dan Burton and Dana Rohrabacher (R-Calif.), is geared to prevent the FTC from taking action against any advertiser that communicates a health benefit for a product unless the FTC first establishes, based on clear and convincing evidence, that the statement made is false and that its communication causes harm to the public.

The Health Freedom Act (H.R. 3395) is designed to remove FDA's power of prior restraint over all nutrient-disease relationship claims.

According to Constitutional lawyer Jonathan Emord, under the bill “FDA may not prohibit any statement concerning a nutrient affecting a disease (including treatment effects) from being made in the market and may only act against a statement once made if it possesses clear and convincing evidence that the statement is false.”

Gormley Take-Away: The powerful advocacy campaigns against S. 3002 (which generated tens of thousands of letters), in addition to meetings and conference calls with Sen. McCain and his staff, effected a partial yet still very important victory. The momentum and informed action that allowed consumers and the natural products industry to achieve this win must be maintained so that objectionable provisions of S. 510 are removed or drastically revised. Other bills that offer opportunities for informed action should be kept on our radar screens, including H.R. 4913, H.R. 3394 and H.R. 3395.

Orrin Hatch Letter to John McCain About S. 3002

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

NPA Alerts Health-Food Stores to Dangers of S. 3002

According to the Natural Products Association (NPA) in an e-mail alert issued today, here is how S. 3002 would affect health-food stores:

• All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.
• For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.
• Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.

Act now!

 

Take Action on S. 3002 Now!

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

The DEA Should Take Over All Sports Doping Enforcement

By James J. Gormley

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The Dietary Supplement Excuse

[With the DSSA bill, S. 3002, now up for vigorous debate, it's worth taking a look back to this article of mine from 2007, as most of the same issues still apply]

By James J. Gormley

On November 15th, 2007, home-run legend Barry Bonds was indicted for allegedly lying under oath to a grand jury about his use of performance-enhancing steroids.

In the New York Daily News coverage of the story, Victor Conte, founder of the Bay Area Laboratory Cooperative (BALCO) that allegedly supplied numerous world-champion athletes with performance enhancers, was quoted as speculating that “Bonds could have tested positive due to a contaminated dietary supplement.”

Right. Perhaps Conte was borrowing an excuse from nearby San Diego. On October 31st, The Canadian Press reported that San Diego Padres’ center fielder, Mike Cameron, was suspended for 25 games after testing positive a second time for a banned stimulant. Cameron reportedly said that he thinks he took a tainted supplement.

On October 5th, Olympic gold medalist, Marion Jones-Thompson, pled guilty to charges of making false statements to federal agencies in connection with two investigations, one of which was related to the BALCO steroid cases.

A Checkered Past
According to the Seattle Post-Intelligencer, the BALCO timeline extends back as far as 1988, when Conte was providing free blood and urine testing and dietary supplements to a group of athletes he referred to as the “BALCO Olympians,” whom he joined at the 1988 Summer Olympics in Seoul, Korea.

After 1996, Conte formed what he called the ZMA Track Club, which, according to the Seattle Post-Intelligencer,“served as a marketing tool and claimed among its athletes Marion Jones and Tim Montgomery.” According to the paper, “Bonds’ arrival in 2000 signaled even greater opportunities.”

According to USA Today, 2002 was when the federal investigation of BALCO began, followed by a raid of BALCO’s offices in September 2003 and a 42-count indictment against four men (including Conte) alleging a conspiracy to distribute anabolic steroids and misbranded drugs, in addition to money laundering.

In the midst of all of this, in February 2003, Baltimore Orioles’ pitcher, Steve Bechler, died due to “a constellation of risk factors,” according to Broward County medical examiner, Dr. Joshua Perper, including: “being significantly overweight and not well conditioned”; “not yet being acclimatized to the warm climate of Florida” and “having hypertension and abnormal liver function.”

These extremely important facts were not mentioned at the time by Rep. Henry Waxman (D-CA) when he used this case as leverage for his anti-supplement intifada now, were they? In fact, according to April 2003 comments by attorneys Marc Ullman and Seth Flaum that were submitted to the FDA regarding the agency’s proposed rule for dietary supplements containing ephedra alkaloids:

“This information was left out of many of the news reports that followed Mr. Bechler’s death and has never been acknowledged by any FDA official.”

Picking up the doping follies again in December 2004, grand jury testimony appeared in the San Francisco Chronicle in which the paper said Bonds “admitted to unknowingly using steroids during the 2003 season. In July 2005, Conte pled guilty to steroid distribution and money laundering. Reports emerged in January 2007, said USA Today, that Bonds tested positive for amphetamines during the 2006 season.

"Oh, Those Tainted Dietary Supplements" or The Dietary Supplement Excuse
Which brings us back to the present, where we apparently have entered a new age, the age of "The Tainted Dietary Supplement Excuse," an excuse that almost anyone now who is caught improperly using spiked products cooked up in some lab can apparently take advantage of.

Many of these product abusers would have us believe that they are hapless fools, doe-eyed innocent pawns of diabolical masterminds who nefariously sabotage the benign nutritional products that are foisted upon them. Hardly.

Maybe we should suggest that users of heroin could claim that they used an opium poppy extract unknowingly tainted with morphine?

Perhaps people busted for cocaine possession could claim that the Erythroxylon shrub extract they were taking was tainted with cocaine alkaloids?

Who cares about athletes exercising personal responsibility and playing by the rules when stadiums are packed to the rafters and team (or even national) glory is at stake? Isn’t it that much easier for coaches or commissioners to look the other way when championship rings or gold medals are being handed out?

It’s not about dietary supplements but about greed, money, politics and power. The pharmaceutical lobby is very powerful. The money at stake behind sports is staggering. Our need for sports heroes is also very compelling.

America needs a scapegoat. How convenient that dietary supplements continue to be easy targets. Why don’t we blame pharmaceuticals? At least, we know they harm and kill people in droves.

Oh right—sorry. Forgot about all the pharma ads in newspapers, magazines and TV and their stranglehold on Congress and the FDA.

We’ll have to come up with another idea.

Swine Flu: What To Do?

By Dr. Frank Lipman, Integrative Physician

Summer is over and the question I am being asked most frequently in my practice is, “what do I do about Swine flu?” My patients are wondering whether or not they should get vaccinated and the simple answer I give most of the time is ..NO!

From what you may have read, you might think that the swine flu vaccine is the answer to swine flu. Unfortunately this is not true and until we know that the vaccine is safe, I cannot in good conscience recommend it to most of my patients.

From the outset, let me say, I am not anti all vaccinations, rather I am pro vaccine safety and freedom of choice.

This is why am I not recommending the swine flu vaccine:

1) At this stage, for the most part the swine flu seems benign.

Over a million people in the US have already come down with swine flu, many of them without even knowing that they had it. The vast majority of people who get the swine flu recover after a week or so of high fever, aches, and respiratory distress. It’s not pleasant, but except in rare circumstances, it is not fatal. Most people who’ve been infected by swine flu think so little of it, they believe they just had a really bad cold or a regular flu. So unless the swine flu evolves to a much more virulent form, there’s no need for mass vaccination

2) We don’t know if the vaccine will be effective.

Vaccines are only useful against the specific viral strain that was available at the time of their manufacture. But influenza viruses mutate quickly, and as the WHO has already said, the real concern with H1N1 swine flu is that it will combine with seasonal flu in the Fall, creating a new strain that will of course be immune to all available vaccines.

3) We don’t know if the vaccine is safe.

The FDA has authorized an expedited approval process for the swine flu vaccine but we don’t know yet if it is safe. Even GlaxoSmithKline, one of the vaccine manufacturers has said, “The total population studied in clinical trials will be limited, due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.”

In other words, the only thing that is safe, is to say that no one knows. Since it’s never been used before and they have not had time to conduct any sufficient human testing, by getting vaccinated you are being a human guinea pig.

4) Vaccine manufacturers have been insulated from liability by the government.

The Department of Health and Human Services Secretary Kathleen Sibelius has granted legal immunity not only to the makers of the 2 drugs being used to treat swine flu, Tamiflu and Relenza, but also to the swine flu vaccine makers, for damages due to their use against swine flu. By effectively manipulating the legal system, the Pharmaceutical Industry through their powerful lobbyists have acquired almost complete and total insulation from any liability for their vaccines and adjuvants, which are additives added to generate a stronger immune response. It is believed that it is these adjuvants which often cause the problems. The last time the government embarked on a major vaccine campaign against a new swine flu was in 1976. Thousands filed claims for side effects such as paralysis caused by the vaccine and a number of people died. I am sure that the researchers know more now than they did last time and no one can say for certain that bad things will happen again or that you will suffer dire consequences if you get vaccinated. But this time you have no legal recourse even though this vaccine involves new factors, which makes it therefore experimental and unpredictable.

By shielding the manufacturers from any responsibility for any harm caused, the pharmaceutical firms have no financial incentive to make the safest product. In fact, they have a negative incentive to test it for safety, because if they are aware of problems, then they could potentially be held liable for willful misconduct.

Instead I advise my patients to build up and strengthen their immune systems to prevent viral infections.

Here are my top 10 recommendations:

1) Optimize your vitamin D levels.

Adequate levels of Vitamin D are essential for our immune systems to function optimally. Unfortunately there are no significant dietary sources of Vitamin D, most of our intake comes from exposure to sunlight. If you live far from the equator, you simply don’t get enough sun through Fall and Winter to make all the vitamin D you need. So unless you supplement during this period, your innate immunity will be compromised. Vitamin D plays such a crucial role in so many aspects of your body’s functioning, that supplementing with it makes sense whether you decide to get the flu shot or not.

We know that influenza always gets worse during the winter months. Now there is good evidence to suggest that this is because as sunlight hours lessen during the winter, the people living in the northern hemisphere become vitamin D deficient and are susceptible to influenza infections of all kinds. Here’s a great article available at NIH pertaining to this topic.

There is also some evidence that supplementation with a sufficient amount of vitamin D can help to prevent the onset of a flu or cold.

The current recommendations from the Food and Nutrition Board of the U.S. Institute of Medicine: from 200 to 600 IU/day depending on one’s age, are way too low. These values were originally chosen because they were found to prevent osteomalacia (bone softening) and rickets. It is now recognized that vitamin D has many additional physiological functions, for which these levels are totally inadequate. A number of scientists are therefore calling for the Food and Nutrition Board in the U.S. and its counterparts abroad to reassess their current recommendations.

To optimize your vit D levels, you will need to:
* Take at least 2,000 IU of a Vitamin D3 supplement daily.
* Get your 25 hydroxy Vitamin D level checked by your doctor (if that is not an option, you can self test your level with ZRT labs)

Although the current normal range is between 20 and 50ng/ml, this is much too low for optimal health. You want your level to be between 50 and 70ng/ml. This is the most important step you can take to prevent the flu!! It may require a number of months taking 5,000 to 10,000 IU of Vit D3 daily (especially during winter) under a doctor’s supervision, to optimize your blood level. Monitor your 25 hydroxy vitamin D status every 3 months until you are in the optimal range, then cut back to a maintenance dose of at least 2,000 IU a day.

2) Get adequate sleep, this is an indispensable requirement for a strong immune system.

3) Get adequate exercise, this keeps you robust.

4) Take actions to lower your stress levels.

Do breathing exercises, meditate, practice yoga, spend time doing something that makes you happy. Feeling spent, overwhelmed, and/or mentally run down has a causal relationship to your physical health.

5) Wash your hands frequently but not excessively.

It decreases your likelihood of spreading a virus to your nose, mouth or other people. Be sure you don’t use antibacterial soap because of the risk of creating resistant bacteria. Rather use a simple chemical-free soap.

6) Avoid sugar and processed foods as they decrease your immune function dramatically.

7) Eat phytonutrient rich meals (lots of colorful salads and dark greens)

8 ) Eat lots of garlic, it works as a broad spectrum antibiotic.

9) Take a probiotic daily (look for one with 10-20 billion organisms). A strong immune system relies heavily on having a strong foundation in the gut.

10) Keep a supply of antiviral herbal supplements on hand.

As opposed to antiviral drugs, antiviral herbs do not cause resistant strains because they are multifaceted and contain literally thousands of different medicinal compounds. Thus they are able to attack viruses with a full spectrum of synergistic substances. Andrographis, olive leaf extract, grapefruit seed extract and elderberry extract, all have antiviral properties. Use one or a combination of some of them as a prophylactic measure, for ex.whenever you travel (airports) or enter a potentially compromised environment such as a large office, auditorium, stadium, theater etc.

And if you really want to go all out, here are 4 more tips:

11) Take 1-2 grams (1,000-2,000 mg) of fish oils daily, its beneficial for immune function.

12) Take 2 grams (2,000 mg) of Vitamin C daily, yes it does help.

13) Stock your home pharmacy with an immune building formula. Look for one that contains Cordyceps and Astragulus. Take it throughout the flu season.

14) Keep homeopathic Oscillococcinum on hand

Take it at the earliest sign of a cold or flu. Early intervention is essential. If you are exposed to someone with the flu directly, you can take one dose twice a day for two days. You can also take one vial once a week throughout the winter, and two or three times a week during flu season, as a preventative measure.

Frank Lipman MD, is the founder and director of the Eleven Eleven Wellness Center in NYC a center whose emphasis is on preventive health care and patient education. His personal blend of Western and Eastern Medicine combined with the many other complimentary modalities he has studied, has helped thousands of people recover their energy and zest for life. He is the author of the recent SPENT: End Exhaustion and Feel Great Again (2009) and Total Renewal: 7 Key Steps to Resilience, Vitality and Long-Term Health (2003).