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Associated Press Story: FDA Skeptical of Corn Sugar Sham

September 19, 2011

In a story posted on September 15, the Associated Press reports that in response to the Corn Refiners Association’s original request to use the term “corn syrup,” Michael Taylor, the FDA’s deputy commissioner for foods, told colleagues he was uncomfortable with changing the name and suggested that allowing it would deprive consumers of important information and invite ridicule.

Read the whole story here.

The FDA’s Plan to Cripple the Health Food Industry: Their New War Has Begun

September 13, 2011

By James J. Gormley,
Vice President and Senior Policy Advisor, Citizens for Health

According to a July 7, 2011 report from the U.S. Food and Drug Administration (FDA), Pathway to Global Product Safety and Quality, government spending on healthcare has been on the rise since at least 1990 in the world’s leading economies.

U.S. Medicare spending is projected to reach $900 billion by 2018, partly a factor of the fact that the Medicare population has been, and is expected to continue, growing at four times the rate of the “employed” population between 2000 and 2025. Public hospital expenditures alone are predicted to reach over $1 trillion by 2015.

I am sure that the FDA is aware of the study entitled, “Effect of Selected Dietary Supplements on Health Care Reduction” that was commissioned by the Dietary Supplement Education Alliance (DSEA) and updated in 2007, which found that only four specific supplements, alone — calcium with vitamin D (bone health); folic acid (neural tube defects); omega-3 fats (heart health); and lutein with zeaxanthin (eye health) — could reduce healthcare costs by over $24 billion.

These are only direct cost savings, and savings directly related to them, however. If we were able to add all indirect costs and downstream cost-of-care burden projections to these data, and if we were able to assess savings from other critical dietary supplements — such as CoQ10, multivitamins, brain health ingredients (such as Huperzine A), liver health nutrients (such as milk thistle and Picrorhiza kurroa), joint health nutrients (such as biologically active silicon), and so on —- it is likely that the ultimate healthcare savings to Americans and to society would be … staggering.

Therefore, it is mystifying to me, and to many others, why the FDA would choose, 17 years after the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994, to re-interpret the laws governing dietary supplements as evident in the agency’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” issued in July.

It is baffling as to why the FDA would, as evident in the regulatory and policy viewpoints underpinning this guidance, seek to use wholly new interpretations of “what is a dietary supplement ingredient,” “what is a dietary supplement,” “what is a new dietary ingredient,” for example, as bases for what is obvious is its new supplement review and enforcement position.

Based on the FDA’s own statements and examples in the guidance, along with a simple exercise of extrapolating from what FDA is saying to what it is they apparently intend, a vast majority of the supplements sold in the U.S. would be drastically affected by review, implementation and enforcement activities along the lines outlined in this document.

Because the guidance is for industry, not for the agency. The agency is already heading down a path that would eviscerate the dietary supplement industry and would cause lasting, irreparable harm to American consumers and healthcare in the United States.

The harm would come from “dumbed down” formulations that exclude innovative natural ingredients that will have received objection notices from the FDA. The harm would come from whole swaths of products being eliminated by responsible supplement companies that cannot afford the hundreds of thousands, even millions, of dollars that would be required in order to perform toxicology tests and to develop safety dossiers on ingredients that are already proven to be safe. The harm would come from companies reverting their supplement formulations to antiquated processing and ingredient compositions that were in place prior to 1994.

Neither American consumers nor the dietary supplement industry are going to take this unconscionable attempt by the FDA to, via various NDI-related side doors, effectively re-write DSHEA, maim the health-food industry and drastically reduce consumer choice sitting down.

In fact, a number of consumer grassroots advocacy groups and initiatives are rallying to the cause, including:

I invite all of you to join with and support the critical work being done and about to be rolled out over the coming weeks.

While the fight to pass the Proxmire Bill defined the struggle for health freedom in the 1970s, and the battle for DSHEA was our signature victory in the 1990s, our war now is to protect dietary supplements from the FDA’s concerted efforts, behind the NDI guidance, to rip apart the health-food industry and to make America profoundly less healthy and more sick.

While our first campaign will take a couple of months, FDA has made it clear that it is operating under vastly misguided and adversarial interpretations of the laws governing dietary supplements than given to them by Congress and the American people.

Our defining health-freedom battle of the first century of this new millennium has begun.

“50+ EMF Safety Tips & Insights”*

“50+ EMF Safety Tips & Insights” is an overview of cell phone and wireless technology hazards prepared for the convenience of media, physicians, health practitioners, parents, schools, and patients with chronic or unexplained illnesses by leading health and environmental activist, Camilla Rees, MBA. Read this foundational education and share!

FDA “Protectin?g” the Public from Locally Grown, High Quality Food: An Interview with Deborah Stockton

Powerful corporate interests  have become proficient in colluding with the state to shield themselves from having to compete in the free market. In this podcast, Deborah Stockton, Executive Director of the National Independent Consumers & Farmers Association speaks with Michael Ostrolenk about how the heavy-hand of government over-regulation is forcing many small, independent farms across the United States to close.  The FDA labyrinth of  “food safety” rules do not actually protect the public but rather protect the corporate farming industry from competition while restricting consumers’ access to high-quality, locally-grown food.

Listen now – click here!

Take Action! Senate Bill Addresses Antibiotics in Animal Feed

Urge Congress to Preserve Antibiotics for Medical Treatment

by Helena Bottemiller, Food Safety News (action links added)

A bipartisan group of senators re-introduced a bill late last week aimed at preserving the effectiveness of medically important antibiotics by limiting their use in food animal feed. In the face of the rising threat of antibiotic resistance, public health experts and activists have pushed for regulation to limit the subtherapeutic use of antibiotics in animal agriculture.

Recent estimates indicate around 80 percent of all antibiotics in the U.S. are given to food animals.

Senator Dianne Feinstein (D-CA), the primary sponsor of The Preservation of Antibiotics for Medical Treatment Act, otherwise known as PAMTA, reintroduced the measure to address “the rampant overuse of antibiotics in agriculture that creates drug-resistant bacteria, an increasing threat to human beings.”

Click Here to Contact Congress NOW!

“The effectiveness of antibiotics for humans is jeopardized when they are used to fatten healthy pigs or speed the growth of chickens,” said Senator Feinstein.  “This is a basic food safety initiative that would phase out the misuse of these drugs so that food in supermarkets across America will not spread strains of drug-resistant bacteria.”

Senators Susan Collins (R-ME), Jack Reed (D-RI), Barbara Boxer (D-CA), all collaborated on the legislation.

According to Feinstein’s office, in 2010, the senator was contacted by the Don family of Ramona, California.  Their son, Carlos, “a bright and athletic 12-year old,” became gravely ill with an infection while at summer camp and did not respond to antibiotics.

“It took doctors 48 hours to find a medication that could kill the Methicillin-resistant Staphylococcus aureus, or MRSA, that had infected his body.  By that time, Carlos’ lungs, kidneys, liver, intestine and heart had failed.  With only some brain activity left, Carlos lost his life because the antibiotics that hospitals have relied on for 80 years no longer worked,” said Feinstein’s office in a statement late last week.

“No parent should ever undergo the heartbreak and the tragedy that the Don’s went through,” said Feinstein.  “My bill makes important changes to the use of antibiotics and ensures that operations on a farm do not negatively impact the health and well being of families across the nation.”

The bill Feinstein is championing, PAMTA, mirrors a bill introduced by Congresswoman Louise Slaughter (D-NY), the only microbiologist serving in Congress. The legislation:

— Phases out the non-therapeutic use of medically important antibiotics in livestock;
— Requires new applications for animal antibiotics to demonstrate the use of the antibiotic will not endanger public health;
— Does not restrict the use of antibiotics to treat sick livestock or to treat pets.

“PAMTA will limit the agricultural use of seven types of antibiotics that have been identified by the Food and Drug Administration as critically important in human medicine to ensure that antibiotic-resistance is not inadvertently accelerated,” according to Feinstein’s office.

The Senate version of the legislation has 17 cosponsors and the House version has 60. Slaughter has been introducing a version of the bill since 2007.

The animal agriculture industry maintains that antibiotics are a critical tool for preventing disease and promoting animal health and welfare, casting doubt on the link between the sector’s use of antibiotics and human health issues.

Click here to send your message to Congress NOW!

Will the Food Safety Bill Make Food Safe?

By Alison Rose Levy

With a vote likely imminent on the Food Safety Bill S510 this week, many of us want to call our Senators and weigh in on the impending vote, which will affect food quality, safety and price for years to come.

But we aren’t sure exactly how to weigh in because confusion about this bill is so rampant. Most agree that something needs to be done about industrial suppliers whose unhealthy livestock farming practices led to the recent salmonella outbreak and recall of eggs. But the question is what?

The bill’s many proponents (including Consumer’s Union, General Mills, Kraft Foods and others) assert that broader and deeper authority and an increased budget will allow the FDA to monitor safety measures and demand accountability to assure food safety, finally getting a handle on the behemoth of industrial food production.

According to a food safety expert I spoke to, “The bill is rare in having broad bipartisan support because it hits a “sweet spot” in the middle,” targeting concerns of legislators on both sides of the political spectrum.

Yet many people and groups, like the Organic Consumers Association, want concrete assurances that the bill won’t apply the regulations explicitly crafted to regulate large industrial facilities (factory farms and industrial agriculture and manufacturers) to small businesses (family farmers, organic growers, farmer’s markets, food artisans and local suppliers).

I read the bill and the proposed amendment and spoke with leading experts from organizations that support — and others that oppose — the bill to answer a few basic questions:

Are small and/or local suppliers exempt from onerous provisions that would drive them out of business?

A number of groups have been working behind the scenes, knee deep in legislative policy discussions aiming to achieve flexibility for the burgeoning consumer-driven industry in healthier, locally grown foods, supplied by small to medium size operations.

As of now, the so-called Manager’s Package, a refinement of the bill, unveiled last summer, states that “raw agricultural commodities that the Secretary has determined are low risk and do not present a risk of serious adverse health consequences or death” may at the discretion of the FDA Secretary be asked to comply to modified regulations only. In addition, this new version omits “any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990…” This is a step forward for organic and smaller growers.

However, the proposed Tester Amendment (up this week for a vote for inclusion in S510) would, if included, go even further. It would definitely make small providers adhere to more modest reporting requirements, and exempt them from the extensive ones required of larger companies. The flexibility would also extend to food products sold locally.

Concerned consumers can write their Senators to request inclusion of the complete language of the Tester Amendment, which would also exempt home gardens.

Even with this language, James S. Turner, Chairman of Citizens for Health isn’t reassured. “We have the most contaminated food supply of any industrialized country because of the way FDA applies laws,” says Turner, who I interviewed this week (listen here). “The problem is that the words written on paper and the way the FDA typically enforces are two different things.”

Few have followed and monitored the activities of the FDA for as long as Turner has. He’s been at it since 1968. He points out that former Monsanto vice president for public policy, Michael R. Taylor, as the newly appointed FDA food czar in his role as the Deputy Commission for Foods, will be the one to oversee the Food Safety Modernization Act’s implementation. Says Turner, “the FDA enforcement pattern has been to ignore, placate or make a deal with the giants, and then turn around and pick on the growers it can outsize and intimidate — the medium and small ones. Add to that, the new inclusion police powers imposing criminal terms of five to 10 years for any violations, this bill will come down like a hammer on small suppliers,” Turner believes. Here’s a list of campaign contributions made by groups, supporting, and opposing the S510.

How exactly will S510 make food safer?

Additional confusion about the bill stems in part from the different ways different people understand the word “safety.”

To some, “safety” means safer food cultivation practices that are likely to create healthier fruits, vegetables and animals. To others, “safety” means more antibiotics, more food irradiation and more “controllable” food. In the latter approach to safety, which focuses on the presence of micro-organisms, a vegetable that has been boiled at high heat and vacuum packed in a can is inherently “safer” than a raw vegetable.

As such, in its focus on safety, the FDA’s stated aim will be to enforce labeling, tracking and monitoring practices, not safer growing practices. In addition, S510 aims to coordinate with Homeland Security to decrease any perceived risks of terrorism impacting the U.S. food supply.

S510 neither mandates nor mentions the safer practices that health consumers and small, farm-friendly groups typically ask for, such as a ban on the use of:

  • Concentrated animal feeding operations (CAFOS)
  • Genetically modified organisms
  • Use of hormones, pesticides or endocrine disruptors
  • Food irradiation
  • Antibiotic use in livestock

Given that industrial practices are now rampant, how do we make the foods arising from that production, safer while still leaving breathing room for the growers of healthier foods? Would healthier growing practices and concerns be better addressed by a farm bill? Will S510 clear the way for such provisions, or will it institute practices that the consumer health and agriculture movements oppose?

I  look forward to hearing your responses. For health insight, action and radio, visit healthjournalistblog.com

Cloned Salmon – Labeling Is Not the Issue: Safety and Ethics Are

Two days of public hearings have passed on the approval of the first genetically engineered (GE) animal intended for human consumption, the AquAdvantage GE salmon — including a U.S. Food and drug Administration (FDA) hearing today to discuss whether or not these GE fish should be labeled as such if they are approved; a 60-day public comment period on the labeling issue will be open until November 22, 2010. But the question of labeling presupposes that allowing is a done deal, despite the fact that the FDA has made up its mind in the absence of proof of any kind, much less anything resembling definitive evidence of safety: for salmon, for the environment and for humans.