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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.

“Health at Gunpoint: The FDA’s Silent War Against Health Freedom”

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 by Citizens for Health’s very own VP and Senior Policy Advisor, James Gormley, in Health at Gunpoint: The FDA’s Silent War Against Health Freedom, what we at CFH 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.

Please view this new video about the book:

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, James Gormley presents a history of both the natural foods movement and of this over-reaching Federal agency and examines how the agency has changed over the years. He then looks 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 pregancy and aging) and normal discomforts (such as headaches) classified as diseases? Why are irradiated and genetically-altered foods 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.

In many European countries, nutritional supplements are now available by prescription only. If you don’t think harmonization-friendly, anti-consumer, restrictions can be put in place here, you may be in for a rude awakening.

Health at Gunpoint will help prepare you for the coming fight!

The Questions of Fluoridegate

Scandal Widens, Calls for Hearings Grow as New Revelations Highlight Science in Conflict with Officials’ Statements on Water Fluoridation Safety

Part 1 of a Series, By Daniel G. Stockin, MPH

Following the Hurricane Katrina formaldehyde trailers fiasco and the Washington D.C. lead-in-drinking water disclosures, now yet another scandal provides evidence that what is said and done by public health experts may not be as important as the reasons behind what is left unsaid and undone.

Enter Fluoridegate, a multi-faceted scandal unfolding while simultaneously a growing number of cities and water utilities have halted water fluoridation or are considering legislation to end it.

City officials in Milwaukee, New York City and Phoenix have recently discussed ending water fluoridation. Quebec and Calgary in Canada, College Station in Texas, and Pinellas County in Florida have ended it, along with numerous smaller cities and agencies.

“I think there are safety concerns and fiscal concerns causing people to rethink fluoridation,” says Wally Babb, a former Georgia water plant operator reveling in the cities’ actions, since he was fired in 2008 for his stance against fluoridation.

“But I also think prosecutors and investigative bodies are going to be very interested to ask why certain groups and individuals did not share key information about fluoridation risks,” he says.

“If any scandal ever deserved a series of investigative hearings, this is it. This is going to call some very high level people on the carpet.”

Prominent Washington D.C. product safety attorney James S. Turner concurs.

“The evidence is shocking,” he says. “It’s time to put some of the key players under oath in Fluoridegate hearings.”

The developments point to a central question: Did a group of vested interest federal and private sector officials collude to use the public health infrastructure to control what the public hears about fluoridation and divert attention from increasingly bad news about harm from fluorides?

For those still unfamiliar with the developments, here are some of the deeply troubling questions of Fluoridegate.

Controlling the Discussion and Talking Points

Water fluoridation is the long-standing practice of adding fluoride chemicals to drinking water to help prevent cavities. For decades, Americans have been told that the practice is entirely safe, though controversy about fluoridation safety has never completely disappeared.

In 2011 a Freedom of Information Act request asked for the names, titles, and job descriptions of all persons past and present inside the U.S. Centers for Disease Control and Prevention (CDC) that had input into CDC’s decision to support fluoridation. The request turned up a disturbing fact: CDC’s Oral Health Directors, acting alone within CDC for more than 35 years, had sole input and control in deciding to support fluoridation.

The revelation raised obvious questions. How were CDC’s dental professionals, with expertise in oral health, competent to assess new research and make statements about possible harmful outside-the-mouth effects from fluorides? Why did CDC not seek assistance and input from its own cancer, diabetes, and minority health professionals, and from toxicologists in its sister organization, the Agency for Toxic Substances and Disease Registry?

Were improper influence and the Oral Health Division’s close ties to the American Dental Association with its long history of denying harm from fluoridation the reasons CDC continued to deny any outside-the-mouth harm?

Interestingly, a letter from ADA had protested that it was “very disturbed” about a proposed reorganization in CDC that would downgrade the status of the Oral Health Division, folding it inside another unit. In explaining that ADA had “come to value its relationship with the (Division of Oral Health)” and describing the two organizations’ “close collaborative relationship,” ADA listed water fluoridation as its number one example of collaborative efforts with the Division.

Was it collaboration…or collusion?

With the information disclosed by the Freedom of Information request, actions by CDC were now seen in a new light. CDC had continued to offer stout assurances that more than 60 years of “extensive research” had proven fluoridation to be safe. But in 2006 the prestigious National Research Council (NRC) of the National Academies of Science issued a 507 page report on fluorides that documented a long list of fundamental, basic-in-nature whole-body research that had never been performed.

Had CDC officials been lying in saying that extensive fluoridation safety research had been performed?

CDC had also issued a widely-circulated statement that fluoridation was one of the 10 great public health achievements in the 20th century. But in a 2008 article in Scientific American, John Doull, chairman of the NRC fluoride committee, stated, “…when the U.S. surgeon general comes out and says this is one of the 10 greatest achievements of the 20th century, that’s a hard hurdle to get over. But when we looked at the studies that have been done, we found that many of these questions are unsettled and we have much less information than we should, considering how long this [fluoridation] has been going on.” He also stated, “The thyroid changes do worry me.”

Cleverly calling fluoridation one of 10 great public health achievements had worked public relations wonders. It had preemptively diverted many from a deeper investigation of fluorides. But the NRC report and other developments would bring fluorides back under the microscope.

Unnerving Information for HIV, Organ Transplant, Diabetes and Kidney Patients

In addition to dismaying information about thyroid concerns, buried within the voluminous NRC report were other unnerving admissions such as this statement: “More research is needed to clarify fluoride’s biochemical effects on the brain.”

The technical jargon and size of the report are daunting, but readers willing to wade through it learn that consumers are ingesting uncontrolled amounts of fluorides through their water supply without our scientists knowing what this does to our brains.

Because fluorides deposit cumulatively in the bones over time, the report also says it is “paramount” that research be conducted because bone marrow is where immune cells have their genesis. It points out that research could be conducted to determine “what percentage of immunocompromised subjects have adverse reactions” at various levels of fluoride in water.

News of this is understandably alarming to organ transplant patients and persons with HIV/AIDS or congenital immune diseases, but there has been little or no communication of the concerns about fluoride immune system impacts to these groups.

The NRC report also listed diabetics, kidney patients, seniors, children, outdoor workers and other groups as “susceptible subpopulations” that are especially vulnerable to harm from ingested fluorides.

What was done with these startling statements in the report? Had they been quickly acted on and formally distributed by federal officials to affected stakeholder groups such as the National Kidney Foundation, the American Diabetes Association, thyroid health advocates, HIV support groups, child health groups, etc? If so, the groups were uniformly and strangely quiet about receiving it. And why did the Environmental Protection Agency (EPA) and CDC’s parent health agency take nearly five years, and until EPA was threatened by a fluoride fumigant lawsuit, to issue a tepid recommendation to slightly lower the level of fluorides in drinking water?

Was the fix in because the dental industry, water agencies, and other groups would face tremendous legal liability if fluorides were now admitted to be potentially harmful? And were CDC and other groups working to “spin” the NRC report, to do damage control?

Fluoridation advocates cited statements within the report that its purpose was not a specific assessment of water fluoridation, implying that the process of studying fluorides produced no information useful in assessing fluoridation safety. This tactic backfired because it is akin to saying that efforts to put a man on the moon did not produce information useful for other spaceflight programs. Plus, the report designated certain groups as “susceptible subpopulations” without respect to what concentration of fluoride was in their water.

Again, the question: Did a group of vested interest federal and private sector officials collude to use the public health infrastructure to control what the public hears about fluoridation and divert attention from increasingly bad news about harm from fluorides? This is where Fluoridegate hearings will come in. Both federal and state agencies and attorneys general will find numerous avenues of fertile investigation.

Harm to Minorities: the Issue that “Has the Potential to Gain Traction”

One of the key areas for investigation will focus on fluoridation promoters’ actions concerning disproportionate fluoridation risks and harm for minority groups.

For example, why did CDC fail to openly inform the black community of news that blacks are disproportionately harmed by “dental fluorosis,” a permanent and in many cases disfiguring staining of teeth that indicates childhood overexposure to fluorides? CDC continued to not openly share the information with minority advocacy groups even after The Lillie Center in Georgia presented a detailed fluoridation ethics complaint to CDC citing the omission in 2007.

And the issue of harm to black citizens continues to grow. In an April 2011 letter, leaders of the American Dental Association requested assistance from U.S. Assistant Secretary for Health Dr. Howard Koh to help deal with concerns raised by civil rights leaders Ambassador Andrew Young and Rev. Gerald Durley. The two courageous black community leaders had publicly issued letters calling for a halt to fluoridation. In the ADA leaders’ letter to Dr. Koh they explained why they were seeking his assistance to address the concerns Young and Durley had raised about fluoridation safety for minorities.

The letter from ADA leaders stated: “We believe that this issue has the potential to gain traction.”

Gain traction? Fluoridation advocates had long scoffed that fluoridation opponents’ arguments were unfounded. In fact, they said, fluoridation was especially helpful for minority and low income populations, helping eliminate oral health disparities. So what was there about the issue of minorities being harmed by fluoridation that could possibly gain traction?

Could it be that there is substance to the concerns? Does fluoridation in fact disproportionately harm minority populations?

Here we find more grist for Fluoridegate hearings. Studies and other information on fluoride exposure levels and harm had never effectively or formally been presented to minority leaders until recently, by fluoridation opponents.

For example, a fall 2009 study published in the Journal of Public Health Dentistry documented that black children are ingesting significantly more fluorides in water than white children. And CDC released information in 2005 documenting that blacks and hispanics have disproportionately more dental fluorosis than whites. CDC’s statistics were found deeply buried in the very last of 23 dizzying data tables in an article in CDC’s August 26, 2005 “MMWR” publication.

The news spread. Martin Luther King Jr.’s daughter Bernice King spoke out against fluoridation on a radio program. Her cousin, Alveda King, spoke out against fluoridation on her blog. And in the summer of 2011, the League of United Latin American Citizens passed a resolution opposing fluoridation.

Let the Litigation Begin

As part of its efforts to support community water fluoridation programs, the American Dental Association had published a long list, a compendium of organizations that had lent their names as endorsing fluoridation. Dozens of national and international health advocacy, government, and professional organizations were on the seemingly impressive list.

But now it appears that organizations on the list may be named in legal actions. Citizens and decision makers relied on the organizations’ listed names in deciding to buy-in to fluoridation. Very telling will be the groups’ responses to a simple question: Did your group do its own research into potential fluoridation risks prior to allowing your name to be used on ADA’s list, or did you provide a courtesy endorsement of fluoridation without doing your own research?

The list of persons, groups, companies, and agencies that may be sued extends beyond the organizations in ADA’s compendium list. It includes almost anyone that should have warned users of fluoride products of various concerns related to fluorides. Water utilities, bottled water providers, toothpaste sellers, government agencies, nonprofits and industry trade groups, and numerous other individuals and groups may find themselves in the lawsuit cross hairs.

Washington DC toxic tort attorney Chris Nidel said this: “I think when we look back we’ll ask why Fluoridegate didn’t surface earlier. There are serious concerns about possible conflict of interest and heavy editing of information being fed to the public about fluoride risks and impacts.”

Two fluoride-related legal cases were filed in 2011 in Maryland and California courts. Both cases encountered significant, but not unexpected challenges. It’s still early in the process of developing various types of fluoride litigation, but given the now-strongly growing interest in pursuing legal actions, the future looks to hold many fluoridation and fluoride-product-related cases. The sheer number of potentially harmed citizens — persons with dental fluorosis, kidney patients tipped into needing dialysis, diabetics, thyroid patients, etc — numbers in the millions.

Concerning upcoming legal cases and hearings, perhaps most delicious to long-time fluoridation opponents is the prospect that for the first time, key officials in government and private sector agencies can be put on the witness stand and directly questioned about harm from fluorides.

A few interesting questions may be: Why are we warned to spit out pea-sized amounts of fluoridated toothpaste, but we were told we can ingest the same amount of fluoride when it comes in a large glass of fluoridated drinking water? How can it be safe to drink as much fluoridated water as we’d like? And why haven’t Americans been told that fluorides accumulate in the pineal glands in our brains?

In 2008, the National Kidney Foundation’s board of directors quietly issued a new position statement on fluoridation, causing NKF’s name to be removed from the ADA’s compendium list of fluoridation endorsers. But why did NKF not openly announce its new statement? Was it because NKF had been a recipient of grant monies from the CDC and did not wish to risk the ire of CDC officials? Did NKF risk the health of its own constituents, most of who today do not know that the National Research Council has designated kidney patients and diabetics as especially susceptible to harm from ingested fluorides?

Affecting Our Babies and Even Our Pets

Many Americans do not know that for one-time, acute exposures, fluorides are known to be slightly less toxic than arsenic and slightly more toxic than lead. But even with longer-term, lower level chronic exposures, the risks are real, especially for babies and other groups that are particularly vulnerable to harm from fluorides. The NRC report stated that on a body weight basis, infants and young children are ingesting 3-4 times the amount of fluorides as are adults.

On another front, what is fluoridated water doing to our pets and horses? This issue has received little attention until recently, but given Americans’ deep protective instincts for their pets and horses, the issue threatens to become an enormous one in its own right. News of the deaths of the fluoridated water-poisoned horses of Colorado resident Cathy Justus is quickly spreading. A growing number of stunned pet and horse owners are educating themselves further about fluorides before they continue to provide fluoridated water for Fido, the family feline, or a beloved horse.

There are so many facets to the Fluoridegate scandal that it will not be surprising if a number of attorney generals, district attorneys, politicians, investigative journalists, philanthropists, and others make their mark uncovering the harm done and the names of those responsible. Fluorides are an equal opportunity offender, so it is also not surprising that both Democrats and Republicans are joining the calls for Fluoridegate hearings or for a halt to fluoridation.

What are the other key issues? Will there be sacrificial lambs among those subpoenaed for Fluoridegate hearings and court cases? Who will point fingers at each other to try to escape blame?

Part 2 of The Questions of Fluoridegate will delve further into the numerous swirling questions.

__________________________________________________________________________________

Daniel G. Stockin, MPH, is the former manager of the EPA Western Regional Lead Training Center. He is a career public health professional with a background in toxics assessment and hazardous materials management. He is known internationally for his work at The Lillie Center Inc., a Georgia-based firm working to end water fluoridation. He may be reached at: stockin2@yahoo.com

© 2012 The Lillie Center Inc. This article may be reproduced and distributed in its entirety without modification.

The FDA Goes Back To The Drawing Board On NDI Draft Guidance!

Over 30,000 of you – Citizen for Health supporters, all – responded to the call to urge the FDA to revise or scrap the supplement-killing New Dietary Ingredient (NDI) Draft Guidance after we launched our multi-pronged campaign in September 2011.

Together with the outreach efforts of fellow health-freedom groups and the natural products industry, we were able to force the FDA to go back to the drawing board on the NDI Draft Guidance!

According to Natural Products INSIDER, “After close to a year of industry outcry, FDA apparently will issue a revised draft guidance on the topic of new dietary ingredients (NDIs).”

According to news reports, FDA’s Commissioner Margaret Hamburg, Deputy Commissioner Mike Taylor, and Assistant Commissioner Jeanne Ireland met with Sens. Orrin Hatch [R-UT] and Tom Harkin [D-IL] on June 19.

Word on the street is that, as a result of that meeting and the overwhelming outcry from the natural health and wellness community, the FDA will be releasing a revised draft guidance that the agency hopes will provide greater clarity and address concerns that the document is not in line with the intent of the original statute. However, industry observers do not expect a revised draft guidance will be released until after the election.

As mentioned, we began our campaign in September 2011, and shortly thereafter, on October 6th, Citizens for Health submitted its own organizational comments to the FDA in opposition to the NDI Draft Guidance.

In November, we launched a viral petition campaign accompanied by a video re-mastered by Australian truth rapper Jody Lloyd a.k.a. Trillion, electrifying American consumers and setting a new benchmark in grassroots advocacy: 10,000 petition signatures in 10 days!

In fact, over 12,000 of you initially made a commitment to health freedom and Citizens for Health (CFH) by signing your name to that critical petition to stop what would have been a dangerous extension of the FDA’s reach!!! We at CFH (Jim Turner and James Gormley) honored that commitment by meeting with top aides from 11 key U.S. House of Representatives and U.S. Senate offices, providing copies of the petition strengthned by 12,686 citizen activist signatures!

Here is a Thank You video tweaked by Trillion:

And we didn’t stop there.

Not only did you help us reach past our original goal and amass 25,000 signatures by February 25th – today we have 30,215 petition signatures calling on the FDA to do what is right.

While the FDA has to be watched very carefully as this process unfolds, it is certain that consumers successfully sent the agency a clear, irrefutable message. To borrow some jargon from the world of boxing, we made them “retreat to a neutral corner” for the time being.

While we still maintain the position that a complete withdrawal of the petition is what is needed, mothballing it and massively overhauling may hold some promise.

But only time will tell. In the meantime, you can (very briefly) sit on your high horse AND rest on your laurels! How many people get to do that?!

Stay tuned for updates as we move forward with this historic effort.

In Memoriam: Joe Bassett, Health-Freedom Legend

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).

During Bassett’s first term as president of NNFA from 1993 to 1995, his leadership was critical in leading efforts to pass the Dietary Supplement Health & Education Act of 1994 (DSHEA), which created a new regulatory paradigm for dietary supplements. During his second term as president, from 1997 to 1999, he continued to champion the industry’s goal of providing clear, substantiated information about the health benefits of supplements to consumers.

He was a founding member of the National Institute of Nutritional Education, president of the Mid-American Health Association, past chairman and current board member of Citizens for Health and a former member of the Board of Governors of the National Health Federation (NHF) and a current member of the NHF Advisory Board.

James Gormley, vice president and senior policy advisor of Citizens for Health (CFH), commented on Bassett’s many achievements:

“In 2010, Loren Israelsen told me that after the 1992 FDA raid of Dr. Jonathan Wright’s Tahoma Clinic for his treating patients with high-dose B vitamins, people began to think: ‘Wow, what are they prepared to do to stop us from taking vitamins.’ And this legitimate fear began to spread like wildfire across the country. On the grassroots side, Joe Bassett and the […] NNFA expanded an early incarnation of CFH in order to mobilize consumers and health-food stores against these threats. Along with Bassett were Jim Golick, Margaret Isely, Bonnie Minsky, Dr. Joan Priestley, Alex Schauss, Craig Winters and many others.”

Gormley added: “After the DHSEA victory, Sen. Orrin Hatch commented: ‘I want to cite the dedicated efforts of Citizens for Health, whose thousands of members have worked tirelessly and unselfishly to make this an informed and successful debate. There is no question in my mind that the work of this citizen army makes today’s victory possible.’”

“And that was a tribute to Joe Bassett, who was the force majeure behind these efforts. In recent years, Joe rejoined the board of Citizens for Health, and he became an inspiration today for a whole new generation of health-freedom activists.”

“Of all of the industry leaders I have met, Joe had the most love for the health-foods movement,” added Gormley.

“When health-freedom advocates would get together, Joe’s eyes would well up in tears out of joy and appreciation for the dedication to health justice and freedom that we all shared. But it was love and appreciation that we all felt back. And that love was for Joe Bassett, one of the greatest generals that grassroots advocacy ever had and one of health-food industry’s most effective, outspoken and powerful modern-day pioneers.”

Alexander Schauss, PhD, FACN, president and CEO of Puyallup, Washington-based AIBMR Life Sciences, Inc., and a co-founder of Citizens for Health, said:

“We have all lost a great spirit in the fight for health freedom. Joe was one of those rare people you meet in life one cannot forget. His spirit and achievements will live on for eternity. He was one of the most dedicated, committed, and supportive members of the natural products community [who] played [a central role] in bringing the industry and consumers together during the critical years of 1992-1994, resulting in the successful passage of DSHEA.”

“What characterized Joe Bassett most during those years was his tireless efforts to stop those who attempted to divide the industry for their own self-serving interests, and argue for the power of unity,” said Schauss. “He believed in the fundamental right of freedom of expression and the right to take care of one’s own health. He raised money to support that effort, never to enrich himself. ”

Added Schauss:

“As a co-founder of Citizens For Health (CFH) in 1991, and its first Executive Director, I remember when Craig Winters stepped aside as Chair and co-founder of the organization in March of 1992 to let Joe become Chair because Craig recognized Joe’s abilities and determination to bring people together nationwide. This brought several Midwest and East Coast citizen organizations together under one roof.”

“He brought people together to share a common desire to preserve our freedom of expression and the right to take care of their own health,” said Schauss.

“Joseph Bassett made a real difference in all of our lives,” Schauss observed, “and his spirit to protect health freedom will live on for eternity.”

“To lose Joe and just two years ago, Craig Winters, is a difficult blow to bear, as we all worked day and night for the same noble cause, as warriors for health freedom,” added Schauss. “The price of freedom is vigilance, as Joe would often say. He never stopped being vigilant, and hence why passage of DSHEA was only the beginning, not the end.”

“Joe has left an indelible mark on the hearts of many, as well as the entire industry he served so valiantly,” remarked Danny Wells, head of Vacaville, California-based natural products industry consultancy, Danny Wells & Associates.

Jim Turner, chairman of Citizens for Health, said:

“Joe Bassett was an inspiration to all who worked with him especially those of us at Citizens for Health.  We will redouble our efforts for health freedom as a tribute to Joe and to his motivational leadership.”

Bassett is survived by his wife; three children, Joseph Jr., Sabrina and Charmaine; seven grandchildren; and three great grandchildren. The  Bassett family has asked that in lieu of flowers,  donations may be made to Nemenhah Press.

Tell Your Senators What You Think of Their Vote on the Durbin Amendment!

We alerted you on Wednesday, May 23rd, that Sen. Richard Durbin [D-IL] was going to propose an amendment  (S.AMDT 2127) to the  pending FDA Safety and Innovation Act (S.3187) that was a partial resurrection of his 2011 bill, The Dietary Supplement Labeling Act.

Thanks  to the efforts of CFH and its supporters, as well as allies in the  health freedom movement, that bill was soundly defeated last year.

We are happy to announce that you did it again! In a vote the day after we alerted you to this threat, the  U.S. Senate responded to our collective voice and voted 77 to 20 to  table the amendment, removing it from consideration in the overall bill. (The bill moves to a debate in the House of Representatives next week).

Click here to see how the votes broke down.

Tell Your Senators What You Think Of Their Votes! (based on your Zip Code, a thank you or a rebuke letter will be offered to you for submission to your Senators)

While it is always important to take action on issues that are important to us, our families and our health freedoms, it is also extremely important to thank our legislators for doing the right thing (when they listen to their constituents) and to reproach them (respectfully) when they do not—as this is the essence of participatory democracy.

Stay tuned for further calls to action if this amendment is re-inserted on the House side and for other issues (where we we will ask for your support or opposition, as the case may be).

Special thanks to Senator Orrin Hatch [R-UT] who noted in comments on the Senate floor prior to Thursday’s vote that Durbin’s amendment was  “based on the misguided  presumption that the current regulatory  framework for dietary  supplements is flawed and that the FDA lacks  authority to regulate these  products.” Hatch went on to say that the amendment “serves to punish  all responsible companies with its overreaching mandates.”

Tell Your Senators What You Think Of Their Votes!

You Did It!! Durbin’s Anti-Supplement Amendment Was Killed!!

Thousands of members of the natural health community called and wrote Senate offices between yesterday and today, calling on their Senators to oppose an anti-supplement amendment, Amendment No. 2127, from Senator Dick Durbin (D-IL) that would have ridden the coattails of the FDA Safety and Innovation Act (S. 3187), also known as the FDA User Fee bill (S.3187).

And you won!!!

Durbin’s amendment that was defeated today would have created a new law that would have circumvented or ignored: the guidelines outlined even in the fatally flawed NDI Draft Guidance; the facility registration rules already in place under the Bioterrorism Act of 2001; and the over 35,000 product labels already on file with the FDA and the US National Library of Medicine.

The failed amendment would have been a product registration nightmare creating burdensome and unnecessary registration of all safe dietary supplements, moving supplement labeling submission requirements that much closer to drug-like regulations that we see in Canada and Europe today.

Tens of thousands of products would have had to be removed from store shelves in order to be made compliant with new, completely unwarranted 30-day post-market product and label registration requirements.

This legislation was defeated today via a motion to table the amendment by supplements champion Senator Tom Harkin (D-Iowa) and Senator Orrin Hatch (R-Utah).

Our thanks to both Senators and to all of you!!

Our victory today reminds us of how important our health freedoms are, and how extra-vigilant we need to be every day.

The price of freedom is eternal vigilance!

 

 

Tell Your Senators to Vote NO TODAY on Durbin’s Amendment No. 2127!

By James J. Gormley and Frank Herd, Jr.

Starting at 2:00 p.m. today, May 24th, the Senate will vote on 17 amendments to the Food and Drug Administration Safety and Innovation Act (S. 3187) –  also known as the FDA User Fee bill (S.3187) – followed by a vote on final passage, including anti-supplement Amendment No. 2127 from Senator Dick Durbin [D-IL].

Call Your Senators Now and ask them to Vote No on Durbin’s Amendment No. 2127!

Sound familiar? It should – you helped us defeat this move last year when an expanded version of it appeared as S. 1310, Durbin’s Dietary Supplement Labeling Act of 2011. Please use the link below to call your Senators right away and urge them to oppose Durbin’s amendment when it’s introduced, and to focus instead on holding unscrupulous food companies accountable to our existing system of consumer protections.

Last year’s S. 1310 was a misguided response to marketing tactics by  unscrupulous food companies trying to circumvent FDA standards – and so is Sen. Durbin’s Amendment No. 2127 to be voted on today.

This amendment would create a totally new law!

Call Your Senators Now and ask them to Vote No on Durbin’s Amendment No. 2127!

That’s right, a new law that would circumvent: the guidelines outlined even in the fatally flawed NDI Draft Guidance; the facility registration rules already in place under the Bioterrorism Act of 2001; and the over 35,000 product labels already on file with the FDA and the US National Library of Medicine.

The product registration nightmare of this new law would require burdensome and unnecessary registration  of all safe dietary supplements, moving supplement labeling submission requirements that much closer to drug-like regulations that we see in Canada and Europe today.

Call Your Senators Now and ask them to Vote No on Durbin’s Amendment No. 2127!

Tens of thousands of products would have too be removed from store shelves in order to comply with new, completely unwarranted 30-day post market product and label registration requirements!!

Leave a voicemail, or a message with an aide saying that you have learned that there will be a vote today on Senator Durbin’s amendment to S. 3187, one that unfairly targets makers of dietary supplements and that your Senator should oppose it.

Please also ask your Senator to focus instead on holding accountable the duplicitous companies looking to circumvent existing regulations.

Keep an eye on your email box and on www.citizens.org for updates as this issue develops.

The FDA’s DMAA Gamble

By James J. Gormley

Courtesy of the SupplySide Community

On April 24th, 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 6th, 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?

Continue Reading

Getting to the Heart of the Matter With Dr. Ding

QUESTION: Why is it that heart disease seems to affect more women than men?

DR. DING: There are certain social differences as well as inherent biological differences. However, there is need for clarification about the gender difference in heart disease…. Although women have fewer heart attacks than men, women are more likely to die of heart attacks than men. Part of it is differences in diet and lifestyle (e.g., men eat often more red meat and saturated fat), but also that women’s heart attacks are often less obvious, such as the fewer overt chest pains at onset of heart attacks compared to men. Additionally, women also perceive a lower risk of heart attacks than they actually have, which decreases their chance of seeing the doctor. Moreover, even if a  woman knows she has heart disease and sees a doctor, research has shown that women (compared to men) are less likely to receive ECGs, less likely to get angiograms, less likely to get bypass and stent procedures, and less likely to receive cholesterol-lowering medications. Moreover, biologically, drugs like aspirin that strongly prevent heart attacks in men, are less effective against heart attacks in women. And finally, a woman with diabetes is more likely to die of heart disease than a similar man with diabetes. Altogether, these all lead to higher heart disease mortality for women than men.

QUESTION: What are the most important things a woman can do to decrease her chances of heart disease?

DR. DING: Exercise regularly (30 minutes a day), maintain an optimal BMI of 18.5-25 and don’t smoke.

I rank sugar sweetened beverages (SSBs) as one of the worst causes of heart disease. It’s not the sugar per se, but rather liquid sugar intake such as in soda and sweetened juices, because liquid sugar is partially “invisible“ to our hunger control system. Indeed, the difference between liquid sugar and solid sugar is best seen in an experiment between sugary beverages vs. jelly beans (with same number of calories). While jelly bean eaters become full and ate less food later in the day, liquid sugar drinkers were not fully satiated and become hungrier sooner and consumed more calories at the end of the day (compared to solid sugar eaters).

This is why sugary beverages (but not sugar) are inherently dangerous (read my recent piece for more info: http://www.huffingtonpost.com/eric-ding-phd/sugary-beverages-harmful-effects_b_1103758.htm). For the same reason, parents should not give too much SSB to their children.

Inadequate intake of fruits and vegetables is another major cause of heart disease in America. Only a small segment of the population gets 5 servings of fruits and veggies a day — and this actually includes French fries, which nutritionists don’t really consider a vegetable [But how did the starch French fries get classified as vegetable by the USDA? It’s not hard to imagine what industry group had successfully lobbied the USDA for the ‘French fry’ vegetable classification!].

Cocoa flavonoids are good against heart disease: from multiple systematic reviews of dozens of randomized trials, cocoa flavonoids are shown to lower BP, lower bad LDL, raise good HDL, improve insulin sensitivity, and improve blood flow. Recent reviews of multiple long-term cohort studies have also shown benefits of cocoa for lowering heart disease. However, interestingly, the benefits in the trials were observed with doses of around 400-500 mg/day, equivalent to 33 bars of milk chocolate or 8 bars of dark chocolate. Thus, because it is unreasonable to consume all the calories, sugar and fat to achieve these levels of cocoa flavonoids through just chocolate bars alone… supplements with concentrated cocoa flavonoids are helpful for garnering the benefits discovered (supplements available commercially, e.g. CocoaWell supplements in 400 mg.  dosage). The key is getting the benefits of cocoa flavonoids for heart disease while avoiding the calories, and for that, chocolate bars are not the solution – supplements are a better option.

Additionally, beyond SSBs and French fries, generally, high glycemic load refined starches are a cause of heart disease. Therefore look for whole grains instead of white bread, brown rice instead of white rice, and steel cut oats instead of instant oatmeal. And avoid mashed and baked potatoes, which have an incredibly high glycemic index and glycemic load, equivalent to almost pure table sugar in spiking one’s blood sugar (and elevating heart disease risk).

Avoid trans-fats at all cost. Many years ago, before the nutrition and medical community realized the dangers, the emphasis had been on avoiding butter — and instead people were recommended to consume margarine instead. However, the Department of Nutrition at Harvard School of Public Health discovered that trans-fats, high in margarine sticks, were even worse than the saturated fat in butter for increasing heart disease risk. This eventually led to trans-fat bans from restaurants in NYC, and then the rest of the country. Trans-fats are inherently bad for both their ability to increase bad LDL cholesterol, lower good HDL cholesterol, and increase inflammation – all of which increase heart disease substantially.

QUESTION: Is heart disease hereditary?

DR. DING: Only partly hereditary – while over 80% is preventable.  As shown in several large studies at Harvard, a combination of lifestyle factors can prevent 82% of heart disease and 90% of diabetes (a major cause of heart disease mortality).

QUESTION: Can you offer any health studies on natural products/dietary supplements and their proven benefits for Heart/Cardiovascular health?

DR. DING: Emerging studies and systematic reviews suggest that:

–Vitamin D may hold promise not only for cancers but also for prevention of coronary heart disease. As well as potentially diabetes.

–As noted earlier, cocoa flavonoids, from multiple systematic reviews of dozens of randomized trials, are showing great heart health results.  See information above re supplements like CocoaWell.

–Niacin lowers bad LDL, but it causes flushing.

–Potassium supplements strongly lower BP, but be careful of overdosing.

–Folic acid among LOW folate individuals may lower stroke risk, but folate is not beneficial in most people, since the US now has folate fortification in most grain products.

–Magnesium may modestly improve glucose and lower CVD risk.

–Algal oil supplement was shown in a recent meta analysis to lower triglycerides and raise HDL, but it slightly increased LDL.

–Grapefruit enhances the effects of Cholesterol lowering statin medications, effectively requiring less meds to achieve same effects at lower drug dose. But one should inquire with your doctor. And don’t ever drink alcohol with grapefruit.

QUESTION: What research are you currently working on? What kinds of research projects would you most like to do?

DR. DING: I believe in the importance of evidence-based translational medicine…there is so much fluff and false claims in the nutrition world that I want to make sure all claims are justified with a strong body of consistently supported scientific evidence. That is why I enjoy conducting large systematic reviews and meta-analysis (which I have taught at Harvard for the last 6 years). I’m an epidemiologist and nutritionist – so I like to focus on evidence based medicine in the realm of disease prevention… because an ounce of prevention is worth a pound of cure.