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Citizens for Health Launches Campaign Against FDA’s NDI Guidance

September 20, 2011


Contact: James J. Gormley, VP and Senior Policy Advisor, Citizens for Health
Phone: 202.695.2027; email:

Washington, D.C. – Citizens for Health (CFH) today launched an action campaign to join with our 100,000 supporters and the rest of the health freedom movement in opposing the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”. The agency issued the guidance, mandated by the food “safety” law passed earlier this year, in July, purportedly to clarify requirements for filing new dietary ingredient (NDI) submissions.

However, the FDA is going way beyond simply clarifying existing requirements. It is attempting to drastically change existing law by saying that finished product manufacturers must make a submission for every product that contains an NDI or whenever a formula is changed, if an NDI is present.

James Gormley, Vice President and Senior Policy Advisor for CFH, notes:

“Quite simply, the FDA is ignoring Section 413 [21 USC §350b] of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which says an NDI submission is not required if ‘there is a history of use or other evidence of safety’ supporting its inclusion, use and marketing prior to 1994. Essentially, the FDA is making NDI submissions product-specific rather than ingredient-specific, which contravenes the spirit and the letter of DSHEA.”

Gormley adds:

“In addition, the FDA’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and is in violation of the law on the basis of this alone.”

While much has been written regarding the FDA’s guidance since its introduction, CFH made a strategic decision to “let the dust settle” and do a thorough analysis before adding its voice to the clamor for its withdrawal, given the massive impact to the dietary supplement industry implicit in the guidance. CFH is also calling for the comment period to be extended to July, 2012 so that more industry and policy experts, as well as the public, can be sufficiently heard on the issue. (Industry leaders have succeeded in pressuring the FDA to extend the comment period once already, until December of this year).

Click here to send a letter urging Congress to put pressure on the FDA to withdraw the guidance.

In the coming days and weeks CFH will offer further analysis and talking points on the guidance, as well as opportunities to take action. In fact, CFH will be conferring with consumer advocates and health-food industry leaders this Friday at the Natural Products Expo East trade show in a meeting sponsored by Jarrow Formulas, Inc.

CFH asks you to join them, industry leaders, the health freedom community and concerned Americans everywhere in the campaign to get the guidance withdrawn. Furthermore, ask Congress to rebuke the FDA and demand that the agency state, for the record, that they will no longer attempt to deviate from the plain and intended meaning of DSHEA.

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.

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

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.

Why Frito-Lay’s Move Towards “Clean Labels” Is Smart Marketing

By Melanie Warner via

Frito-Lay has decided to reformulate its snacks so that by mid-2011 more than half of the company’s sales will come from products without things like MSG and artificial colorings and flavorings. The move illustrates why PepsiCo (PEP), Frito’s corporate parent, is the most savvy and proactive of the major food companies when it comes to health and nutrition.

Recent ill-conceived remarks about obesity aside, PepsiCo executives are taking the lead in responding to Americans’ increasingly sophisticated concerns about the healthfulness of food. A Deloitte survey done in March found that 31% of respondents said “over-processed food” was among their top concerns. And 29% said they were highly concerned about the “possible use of chemical ingredients that are detrimental to long-term health.”

It’s this kind of consumer sentiment that’s inspiring major manufacturers, Pepsi among them, to ditch high fructose corn syrup and replace it with sugar, which is thought to be more natural.

Clearly, Pepsi can’t stop making processed food any time soon, but it can make its products a bit healthier and more closely resembling actual food. In the age of Michelle Obama, that’s what every major packaged food company (restaurants are a different story) wants to do, and virtually all them have pledged to cut back on some combination of sodium, calories and/or saturated fat.

But Frito-Lay’s full-fledged embrace of what the industry likes to calls “clean labels,” which was announced at the company’s annual meeting last week, takes the endeavor to a whole new level. It’s a rare acknowledgment that the healthfulness of a product depends not just on easily manipulated things like calories and fat, but on the quality of the ingredients that go into the product. Artificial food colorings, which can cause hyperactivity in children and are linked to cancer in lab rats, and MSG, which causes some people to have allergic reactions, are the kind of things that make food products sound more like a chemistry experiment than something made from things that once grew in soil or from a tree. According to that Deliotte survey, a majority of consumers — 55% — say they understand half or less of the ingredients in food these days.

The fact that Frito-Lay is already making products without chemical additives in its line of so-called natural snacks will no doubt help make the transition easier. The company has already figured out how to make Cheetos, for instance, without yellow 6, MSG and partially hydrogenated soybean oil that was extracted using hexane, a neurotoxic and highly flammable chemical.

The big challenge will be taking out all this “dirty” stuff without raising prices significantly, since Frito Lay’s core customers are accustomed to getting their snacks for cheap.

Image by Flckr user Merry~Blues