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!

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

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?

10,000 Signatures in 10 Days; We Can Do It!

By James J. Gormley
With Citizens for Health supporters already having generated over 11,000 letters to Congress demanding that the FDA’s NDI Draft Guidance be withdrawn, the organization is now on a mission to collect 10,000 petitions in 10 days calling for Congress to withhold FDA appropriations until this unaccountable agency is held to account: by adjuring the FDA to withdraw the supplement-killing NDI Guidance and to cease and desist from reviewing and enforcing against dietary supplements and nutritional ingredients according to its willfully adversarial re-interpretation of the laws governing dietary supplements.

To help us in this effort, Australian truth rapper and activist Jody Lloyd, aka Trillion, has re-mastered CFH’s “10,000 Signatures” video to make our call-to-arms that much more impactful!
Please sign the petition today and send out the link (and video!) to all of your contacts, friends and family, work colleagues, in short, everyone in your personal universe who cares about their rights to high-quality, innovative dietary supplements!

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!

A New Year’s Resolution: We Will Make Our Voices Heard in 2011!

By James J. Gormley

Courtesy of NOW Foods

The late William F. Buckley, Jr. ─ yes, the William F. Buckley of Firing Line, The National Review and the editorial column “On the Right” ─ once wrote:
 

“We are all increasingly anxious in America to be unobtrusive, we are reluctant to make our voices heard, hesitant about claiming our right; we are afraid that our cause is unjust, or that if it is not unjust, that it is ambiguous; or if not even that, that it is too trivial to justify the horrors of a confrontation with Authority; we will sit in an oven or endure a racking headache before undertaking a head-on, I'm-here-to-tell-you complaint.”

In addition to being hesitant to speak up about issues that are important to us ─ such as challenges to health and health-freedom on Capitol Hill ─ very often people do not know how to start or where to start in order to tackle these issues.

Here are a few of the main reasons why people don’t take action on health-freedom issues (including battles relating to dietary supplements):

1. They are not even aware of the issue.
2. They are aware of the issue, but they are not sure the source (organization or website) from which they learned of the issue is credible or well informed.
3. They are aware of the issue, and they are sure of the source, but they don’t know what the next step to take is, whether it is a phone call to a town, city, county, state or U.S. elected official.
4. They are aware of the all of the above, but they assume that “other people” will call in or write or act, so they don’t have to because others are presumably already taking action.

NEW YEAR’S RESOLUTION NO. 1:

I WILL BE AWARE OF THE ISSUES

It is our responsibility as health conscious consumers and natural products advocates to regularly visit the websites and blogs of those organizations that are the most credible (more on this in resolution number 2 and the Gormley Take-Away, below), to sign up for e-newsletters and regular updates, and to friend or “like” those organizations on Facebook and Twitter. Join these organizations’ discussion groups, and regularly participate in posting comments on issues and posts. Ask questions, learn, ask more questions. Soon you will be a super-informed advocate.

NEW YEAR’S RESOLUTION NO. 2:
I WILL GET MY INFORMATION FROM HEALTH-FREEDOM ORGANIZATIONS THAT ARE CREDIBLE AND EFFECTIVE

Aside from organizations that are shills for big money interests in one segment of industry ─ not common, to begin with, and less likely now given stricter FCC rules re blogs ─ most health-advocacy and health-freedom organizations are well-meaning although not necessarily well informed. Sometimes a health-freedom group will intentionally use scare tactics to get consumers activated on a specific issue or campaign, never a good or ethical approach. If an organization consistently (or constantly) sends out “The sky is falling” announcements and calls to action, this group may be non-credible and not trustworthy.

I remember one group’s representative with whom I sat down at the July 2005 Codex meeting in Rome coming out with a press release (and e-mail blast) saying: “All supplements are now banned!!!” I challenged the person about this after I saw the blast go out and asked why his group said that, knowing full well that this is not at all what went down. He said that his organization thought it was important to get people activated! (I assume to donate money to an emergency “battle” fund). So be selective as to which groups you get your information from, especially if they are also always asking you to donate money and are always in “crisis mode.”

RESOLUTION NO. 3:
I WILL CONSIDER TAKING INFORMED, CONSTRUCTIVE ACTION ON ISSUES AFFECTING ME, MY FAMILY, MY COMMUNITY AND MY COUNTRY

If we are linked in to credible health advocacy organizations, most likely they will regularly recommend specific actions, which will typically involve reading an issue summary and then submitting on online letter (or petition signature) to elected officials related to the question at issue. Typically, by filling out an online form with one’s Zip code and other contact information, the correct officials’ names will be automatically generated. However, another way to verify who your legislators are (at the state and national level) is to visit USA.gov. For non-elected officials (such as at the FDA or FTC), you can contact the agencies directly.

RESOLUTION NO. 4:
I WILL NOT ASSUME THAT OTHERS WILL TAKE ACTION BUT WILL TAKE ACTION MYSELF ON IMPORTANT ISSUES IN 2011
Just as with voting, being an informed, active and participatory citizen is essential to protecting and advancing democracy. As Mr. Buckley sagely noted, we must be obtrusive, we must be committed and we must be assured in claiming our rights. By being knowledgeable and informed about the issues, we do not need to worry about our message or our cause being construed as ambiguous. We must question “Authority” since authority is merely power lent to agencies and officials to carry out the public will and to fulfill the public good.

Gormley Take-Away:

Some reputable organizations to consider finding out more about include (but are not limited to):
Alliance for Natural Health/AAHF
Citizens for Health
Citizens Speaking Out for Health
National Health Federation
Organic Consumers Association

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

Anti-Supplement “Perfect” Storm Building in Washington

http://www.citizens.org/?p=1924
By James J. Gormley

As if Senate Bill 3002 (S. 3002) were not more than enough to deal with, according to The Hill Rep. John Dingell (D-Mich.) is criticizing the Senate for not moving on Senate Bill 510 (S. 510).

Unfortunately, The Pew Charitable Trust has been assisting with a coordinated lobbying effort to press Senate leaders to bring the bill to the floor. Sandra Eskin, director of Pew’s food safety campaign, told The Hill that she is “cautiously optimistic” that a vote can occur in the first half of March, before the Senate’s next recess week starts on March 29.

Regan LaChapelle, a spokeswoman for Sen. Harry Reid (D-Nev.), told The Hill that the majority leader hopes to bring the bill to the floor either during the current work period or the next, which runs from April 12 to May 28. “It’s on our list of legislative priorities,” she said. “It could be in March or the next work period. Obviously we have many issues to address.”

House Republicans were split on H.R. 2749, with 54 supporting it and 122 opposed. GOP members who backed it include Reps. Michele Bachmann (Minn.), Joe Barton (Texas), Dave Camp (Mich.) and Greg Walden (Ore.).

After the House bill passed, Rep. Frank Lucas (R-Okla.) told The Washington Post: “The federal government will tell our farmers and ranchers how to do something they’ve been doing since the dawn of mankind. It goes too far in the direction of trying to produce food from a bureaucrat’s chair in Washington, D.C.”

Twenty House Democrats opposed the bill.

Now moreso than in recent memory, it is critical that we all stay tuned to these issues, keeping an eye out for our continuing posts and opportunities for action on S. 3002 and S. 510 — and whatever else floats down the Potomac that threatens DSHEA, our supplements and our health-food stores.

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.