New Bill (HR2749) Gives FDA Unheard-of Power over Small Farmers, Food and Supplement Producers

A new, long-awaited food safety bill is now before the US House of Representatives. It is the Food Safety Enhancement Act of 2009, or FSEA. Introduced by Reps. Henry Waxman (D–CA) and John Dingell (D–MI), the FSEA is meant to address food safety concerns. But as you will see, much of it is not about food safety at all. Food safety issues have arisen from large agricultural operations. But this bill places its harshest burdens on small food producers and supplement producers.

Take Action and let your Representative know you DO NOT support this bill

The Food Safety Enhancement Act:

• gives the US Food and Drug Administration (FDA) unprecedented scope, authority, and power over small farmers, food producers, and supplement producers, including the power to use vague language to intimidate and threaten;
• imposes unjustifiably harsh criminal and civil penalties for even administrative violations; and
• places undue economic hardship on small and mid-sized farms and food facilities (both organic and conventional), which could easily drive many of them out of business, and lead to monopoly control of food by large corporations.

Also known as the Waxman–Dingell bill, the Food Safety Enhancement Act has a number of provisions that would directly affect many of AAHF’s members. Although much of the bill’s language is vague—and, some worry, deliberately deceptive—it is clear that the FSEA provides for the following:

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An Update on our Social Media Sites!

Social Media Sites are taking the world by storm. They are transforming the way we access and receive news and information and connect and communicate with each other on a daily basis. AAHF has joined many of these new and fast-growing networks in an effort to spread awareness about our organization and to help keep members in the loop on the latest news from the alternative medicine field.

It all started with three simple words, “You’ve got Mail.” We all remember that adorable romantic comedy, where a couple fell in love, *gasp* over the internet! What was thought of as a new and revolutionary way to meet people has now become the norm. Relationships are now being established and built through connections made on social networking sites. Organizations are no longer sending letters and gaining membership through face-to-face interaction, but through “Tweeting with Tweeples.” And although this new way of communication may seem complicated and confusing, these sites are surprisingly simple and are gaining membership at an extremely rapid pace.

The basic concept behind these sites is networking. Sure, Facebook may have started out as a way for college students to express themselves and socialize with their friends online. However, organizations soon realized that those friend networks could be used to spread the word about their campaigns, creating new networks of people working to spread the word about their issues.

AAHF has created accounts for Facebook, Blogspot, Twitter and MySpace and we actively update each site and recruit new friends and followers every day. Our Facebook account, which can be found by searching for friends through E-Mail at office@healthfreedom.org --- has 563 friends and counting. On our profile, we post information about our organization, links to our campaigns, articles and photos and live-streaming updates from our Twitter. We can also send private messages to members and comment on others’ walls.

Our MySpace is another online community that helps us stay connected. MySpace provides users with an extensive profile, allowing us to share everything from what our organization’s goals are to what books and movies we would like to endorse. The site also automatically streams and links to our blog posts, Facebook activity and Twitter “Tweets,” connecting all of our Social Networking Sites easily and accessibly. You can add us by simply searching MySpace for “American Association for Health Freedom.”

Although we have had our blog for quite some time, we are now beginning to post articles twice weekly on the latest alternative health issues. We hope that the topics we choose will spark comments and start conversations and we encourage everyone to subscribe to our blog and voice your opinions there. Our blog site is http://thehealthfreedom.blogspot.com. You can chose to “Follow” our blog by clicking on the Follow button in the top left corner. This will allow you to receive updates whenever we have a new post or someone replies to one of your comments.

Finally, Twitter is currently the newest and most talked about social networking site that we have become involved with. We post server “tweets,” which are short comments that give our followers current information and news. These Tweets include updates on what’s going on in our organization and the alternative medicine community, links to relevant articles and websites, and Q and A between our twitter and another. If you don’t already “Tweet”, we strongly encourage you to join! Twitter is a great way to get information on what you are interested in, straight to your phone and computer. Twitter.com provides you with a short, simple video detailing everything you need to know to get started. To find us on Twitter, go to http://twitter.com/healthfreedom and join our 89 plus followers.

AAHF is harnessing the networking power of social media sites, organizing and recruiting members to help gain momentum for our cause. We hope that you will add us as your friend on Facebook and MySpace and follow our tweets and posts on Twitter and Blogspot. As always, we are working for the right of the consumer to choose and the practitioner to practice- and we need your help in spreading the word!

Is Health Care Reform Moving Too Fast?

All this talk about health care reform ... has there been adequate time and transparency to develop a comprehensive workable plan? A matter of this importance which affects every single American needs to be discussed in the public domain. Open the closed-door dealings. Deals are being struck and discussions are being had that the general public is not privy to.

Senator Enzi (R-Wyo) expressed concern over the 'focus that some Democrats have placed on meeting arbitrary deadlines over getting the legislation done right.' The deadline to meet some random politically inspired timeline could cause a glossing over of the details. Are we going to be presented a bill in the 11^th hour that will be forced through Congress without time for public comment or perhaps even a thorough review by Congress?

Press Release: NEW SCIENCE POINTS TO IMPORTANCE OF HIGH-DOSE SUPPLEMENTS

For Immediate Release:
March 3, 2009

US Contact:
Tami L. Wahl, 800.230.2762
International Contact:
Dr. Robert Verkerk, 44.1306.646.600

NEW SCIENCE POINTS TO IMPORTANCE OF HIGH-DOSE SUPPLEMENTS
Calcium, B Vitamins, and Vitamin D Play Important Roles

Three new pieces of research reveal the importance of higher supplement doses. The February 23 issue of Archives of Internal Medicine, a highly respected, peer-reviewed medical journal published by the American Medical Association, includes three studies that demonstrate the benefits of high-dose nutritional supplements, which suggests that the methods being used to determine “maximum safe dosages” in the US and Europe are greatly flawed.

The American Association for Health Freedom (AAHF) and its European counterpart, the Alliance for Natural Health (ANH), have long argued that the methodology used to determine dosage greatly overestimates the risks—and completely ignores the benefits—of higher dosages. Dr. Robert Verkerk, Executive and Scientific Director of ANH, commented, “These latest studies, all published in single edition of Archives of Internal Medicine, provide important information about the roles of B vitamins in age-related macular degeneration, calcium in cancer prevention, and vitamin D in reducing the risk of upper respiratory tract infections.”

Dr. Verkerk continued, “In all cases the levels that delivered the best results were the highest doses tested, and these levels are well over those that the European Commission (EC) wants to see banned.” The EC is pushing for very low MPLs, or Maximum Permitted Levels, for supplements sold in Europe, creating concerns that the high-dose supplements commonly consumed in Ireland, the UK, the Netherlands, and Sweden may be stripped from shelves.

AAHF Legislative Director Tami Wahl agreed: “Vitamins and supplements, combined with other healthy habits, play an integral role in the prevention of many medical conditions and diseases. Our concern is that the dosage amounts currently recommended are simply not adequate to yield protective effects.”

Dr. Verkerk added, “There is an increasing body of science, which these new papers in Archives of Internal Medicine support, that shows high doses of supplements are both safe and effective. To get some perspective on it, the levels found to be most beneficial in preventing macular degeneration were over twelve times the US’s Recommended Daily Allowance (RDA) of folate, twenty-five times the RDA of vitamin B6, and 1000 times the RDA of vitamin B12.”

In a recent presentation at a public meeting of the Food Safety Consultative Council of the Food Safety Authority of Ireland, Dr. Verkerk demonstrated that the amounts of vitamins and minerals commonly consumed in a single healthy meal are often well in excess of those that are considered to be “maximum safe levels,” and may even be exceeded in a single unhealthy meal!

AAHF Executive Director Gretchen DuBeau adds, “Recent studies—which were funded by pharmaceutical manufacturers - that questioned the benefits from supplement use have not been based on good science and create unfounded confusion for consumers who are simply trying to make the best and most informed healthcare decision. Ironically, most of the recent studies questioning the efficacy of vitamins have used minimal doses, not the potentially helpful doses tested in the three recent studies that found vitamins to be useful.”

AAHF believes that any type of noninvasive and inexpensive treatment that assists in the prevention of life-threatening or life-changing diseases like age-related macular degeneration should be strongly encouraged and endorsed by the medical community as a whole. AAHF continues to push US regulators to accept a more rational scientific and legal framework in creating food supplement maximum doses.

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NOTES TO THE EDITOR:

About the American Association for Health Freedom (AAHF): www.healthfreedom.net.

AAHF is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.

About the Alliance for Natural Health (ANH):www.anhcampaign.org

ANH is an international, non-governmental organization, based in the UK. It was founded in 2002, and works on behalf of consumers, medical doctors, complementary health practitioners and health-product suppliers worldwide, to promote natural and sustainable health, using the principles of good science and good law.

Letter to the Editor: Vitamins are Harmful?

February 17, 2009

To the Editor:

Your February 16 article, “Vitamin Pills: A False Hope?” made reference to “high-quality” studies that supported the researchers’ conclusions. Unfortunately, these “high-quality” studies not only have inherent flaws in the methods they utilized, but are creating unwarranted confusion as well.

As noted in the article, “vitamins are essential nutrients that people ingest in their daily diets.” This, however, is actually the most significant flaw in these vitamin studies: in contrast to drug studies, which employ a placebo group, there is no way to isolate the exact cause-and-effect of vitamin supplements without knowing the precise vitamin content of the food the subjects are eating. In fact, most vitamin studies do not monitor the participants’ diets before or during the research period. Without accurate and sound testing methods, the findings are practically meaningless.

There are other flaws in vitamin studies in general: the subject population typically represents a fragment of the general population (such as an older population that is already diagnosed with some type of disease), or the control group is gender-based, or the allotted vitamin dosage is simply too low to yield any type of effect. Ethnic backgrounds are typically ignored, and most of the studies have failed to ensure that the supplements were taken consistently, since most reporting from study participants tends to be anecdotal. These lapses totally undermine the conclusions reached.

Pharmaceutical industry-funded studies inject hysteria and doubt into the discussion of natural health. We believe in a common-sense approach to optimal health: a program of exercise and a balanced diet—one that includes nutritional supplements to correct what is missing because of food processing, soil depletion, and less-than-ideal lifestyle choices.

Very truly yours,

Gretchen DuBeau
Executive Director
American Association for Health Freedom

For Immediate Release:
February 17, 2009

Contact:
Tami L. Wahl, Legislative Liaison
800.230.2762

FDA RULING PUTS WOMEN’S HEALTH AT RISK
Health Freedom Organization Urges Action to Lift Estriol Ban

The American Association for Health Freedom (AAHF) is requesting Congressional support to have the FDA-imposed ban on estriol lifted. Estriol is a hormone naturally produced by the body that has been prescribed for decades to address menopausal symptoms.

Last year, the US Food and Drug Administration (FDA) responded to a petition filed by Wyeth Pharmaceuticals asking FDA to change its policy on estriol—claiming, in part, that estriol posed “a serious threat to public health.” FDA ruled that physicians must now obtain an approved investigational new drug (IND) application before pharmacists can fill a prescription with the hormone estriol in compounded medications. According to AAHF, due to the complexity in completing an IND, the FDA has in effect banned the use of estriol.

Today, AAHF hand delivered letters and a White Paper to key political figures in an attempt to force FDA to reverse its policy change on estriol. FDA has already admitted they could not identify a single adverse event from the use of estriol in the decades it has been prescribed to women in the US, and have not yet disclosed any research that would back up its reasoning for designating estriol as a “new investigational drug.”

According to AAHF, the FDA is ignoring the realistic implications of its ruling. Gretchen DuBeau, AAHF’s executive director, stated, “The IND process could cost more than $50,000 and take a minimum of six months to complete. Doctors simply do not have the time, resources, or research expertise to complete this unnecessary, burdensome, and costly procedure to prescribe a natural hormone.”

The public outcry over FDA’s action has been significant. FDA received over 70,000 comments from patients, doctors, and pharmacists in response to Wyeth’s petition, and over 10,000 comments since the ruling.

AAHF Legislative Liaison Tami Wahl said, “Not only has the ruling deprived thousands of women from access to estriol, but two bigger concerns now loom. The first is the impact on the physician-patient relationship. Physicians have the right—and the ethical duty—to practice medicine in a manner that meets a patient’s particular needs. And the right of millions of women to choose their method of healthcare has been significantly compromised. The second concern is that this may be the first of many policies by the FDA to restrict a physician’s ability to prescribe compounded bioidentical hormone replacement therapy (BHRT).

”Senator John Cornyn (R–TX) and Representative Mike Ross (D–AR), along with the support of sixty other members of Congress, introduced a concurrent resolution last session for the FDA to “reverse its policy that aims to eliminate patients’ access to compounded medications containing estriol,” citing physicians as being in the best position to determine which medications are most appropriate for their patients.

Executive Director DuBeau continued, “Pharmacy compounding is a legal, long-standing practice that allows for customized medication to treat a patient’s specific needs. Thousands of women benefit from physician-prescribed bioidentical hormone replacement therapy. For the FDA to issue this ruling without any evidence of adverse effects is a clear indication of abuse and mishandling of the IND process.”

Additional side effects of the ruling include insurers now denying reimbursement for compounded medications containing estriol, and extensive litigation between pharmacies and the FDA questioning FDA’s jurisdiction to issue such a ruling. The 5th and 9th Circuit Courts are now split—frustrating the application of the law—which leaves the legality of compounding in a very precarious situation. The FDA is not the regulatory authority for this traditional pharmacy practice, yet this ruling has the same effect.

AAHF is also investigating the possibility of improper influence in issuing the policy change. A Freedom of Information Act request was submitted to track communication and financial ties between Wyeth and FDA. As Legislative Liaison Tami Wahl pointed out, “Wyeth Pharmaceuticals is a giant drug manufacturer and was the only entity to request that estriol be removed from the market. Wyeth alleged that estriol posed ‘a serious threat to public health’ despite the fact that Wyeth itself markets estriol products in Europe. Perhaps Wyeth’s bottom line from the sale of synthetic hormones was being affected by women’s use of estriol, the natural hormone?”

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NOTES TO THE EDITOR:

About the American Association for Health Freedom (AAHF): www.healthfreedom.net. The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.

WOMEN’S MULTIVITAMIN STUDY DANGEROUSLY FLAWED

For Immediate Release:
February 12, 2009

US Contact:
Tami L. Wahl, 800.230.2762
International Contact:
Dr. Robert Verkerk, 44.1306.646.600

Studied Not Representative of General Population;
Study Excluded Dosages Above RDA Guidelines

Today the American Association for Health Freedom (AAHF) criticized a study published by the American Medical Association in the Archives of Internal Medicine (Feb. 9, 2009), which concluded that multivitamin use has little or no influence on the risk of common cancers, cardiovascular disease, or total mortality in postmenopausal women. “This is very, very weak science—if it can be called science at all,” said Gretchen DuBeau, executive director of AAHF.

The Alliance for Natural Health (ANH) also decried the research. Dr. Robert Verkerk, executive and scientific director of ANH, said, “We were astonished to find that, with no reasons given, the study specifically excluded multivitamin and mineral supplements that exceeded the US Recommended Daily Allowances (RDA), which are known to be far too low to yield useful heart disease and cancer protective effects. Also, any multivitamin with fewer than ten nutrients was excluded from the ‘stress supplements’ group, and this would have included some of the highest-dose, limited-combination products that would have been most effective.”

The observational study, led by Dr. Marian Neuhouser of the Fred Hutchinson Cancer Research Center in Seattle, monitored a group of 161,808 postmenopausal women between the ages of 50 and 79 over an eight-year period. The study concluded that there was no difference in disease outcome, whether from cancer or heart disease, for the 42% of women who used multivitamin supplements as for those who did not.

ANH’s medical director, Damien Downing, a medical doctor who has practiced nutritional medicine for twenty-five years, called the research “childish naïveté.” He continued, “The findings could not be applied to the general public because the study involved only less-than-healthy, overweight, postmenopausal women taking trivial amounts of multivitamins and minerals, with no data on their earlier lives when disease causation would have been initiated.”

ANH’s published critique of the study centered on the lack of relevance of the study group to the general population, the doses of supplements used, the frequency of intake, the forms of nutrients taken, and the course of the diseases studied in relation to the time and duration of supplementation.

Gretchen DuBeau pointed out that the vitamin study’s evidence was entirely anecdotal. “The women in the study were not even given identical supplements to take.” And all reporting was left up to the subjects themselves, which is never done in a proper scientific study.”

In response to the sweeping headlines that multivitamin supplements are a waste of time, DuBeau added, “A research project based on such questionable methods—which did not even monitor whether the supplements were natural or synthetic—casts doubt on the entire study and its findings.”

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NOTES TO THE EDITOR:
About the American Association for Health Freedom (AAHF): www.healthfreedom.net.The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant

Children’s Dental Devices Contaminated with BPA

For Immediate Release:
February 6, 2009
Contact:
Gretchen DuBeau, 800-230-2762

American Association for Health Freedom Petitions FDA

Today the American Association for Health Freedom (AAHF) petitioned the FDA about Bisphenol-A (BPA), an organic compound found in polycarbonate plastics. They have asked the FDA to issue a statement encouraging Americans to request BPA-free dental sealants and devices for their children until studies prove conclusively that BPA presents no health risks.
The petition also asks the BPA Task Force to study the risks to children from exposure to BPA not only through dental applications specifically, but also through food, food containers, water, the environment, or any other means cumulatively. The BPA Task Force is an agency-wide task force created by the FDA last year to facilitate cross-agency review of all FDA-regulated products containing BPA.

There have been a significant number of reports about potential health risks from exposure to BPA—diabetes and cardiovascular disease in particular. This exposure can come though many different sources—food, the environment, food containers, baby bottles, dental applications, and medical devices, to name a few.

Canada is moving forward with legislation that bans the importation, sale, and advertising of polycarbonate baby bottles, and has issued a health warning to its citizens not to use any product containing BPA if it is to be heated or warmed. Health Canada proposed classifying the chemical as “toxic to human health and the environment.” Here in the U.S., a panel convened by the National Institutes of Health determined that there is clear evidence for concern about BPA’s effects on fetal and infant brain development and behavior. In addition, there are concerns that BPA could interfere with the sexual development of children.

In her statement released today, Gretchen DuBeau, AAHF’s executive director, said, “BPA is a known toxic substance. With safe alternatives on the market, parents need to be aware that BPA-free dental applications are available for their children.”

Despite the actions of other world governments in banning BPA, the FDA is standing by their position that “FDA-regulated products containing BPA currently on the market are safe and that exposure levels to BPA from food contact materials, including for infants and children, are below those that may cause health effects” (FDA, Alderson Statement to US Senate, 5-14-08). According to AAHF, however, the FDA’s findings are to a large extent based on the chemical industry’s own studies, and ignores numerous independent scientific research findings.

The BPA Task Force is currently reviewing additional research studies to determine what level of exposure to BPA creates a health risk; however, a public release date for any new findings has not been set.

“At this juncture,” DuBeau added, “with known links between exposure to BPA and adverse health effects, common sense dictates that we should proceed cautiously and request BPA-free dental applications. These products exist and are readily available on the market.”
The FDA Petition is available at:

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NOTES TO THE EDITOR:

About the American Association for Health Freedom (AAHF): www.healthfreedom.net
The American Association for Health Freedom (AAHF) is a 501(c)4 nonprofit organization that protects Americans’ rights to access integrative medicine and dietary supplements. AAHF protects the right of the consumer to choose and the practitioner to practice by lobbying Congress and state legislatures; educating the public, press, and decision-makers on integrative medicine; initiating legal activities; and joining and forming significant coalitions.