4 Foods That Could Disappear If New Food Safety Rules Pass

When President Obama signed into law an overhaul of the nation's food-safety regime in early 2011, it was clear that the system needed a kick in the pants. Recent salmonella outbreaks involving a dizzying array  of peanut products and a half billion eggs had revealed a dysfunctional, porous regulatory environment for the nation's increasingly concentrated food system.

The law, known the Food Safety Modernization Act, was a pretty modest piece of work when it came to reining in massive operations that can sicken thousands nationwide with a single day's output. No surprise, since Big Food's main lobbying group, the Grocery Manufacturers Association, notes on its web site that "GMA worked closely with legislators to craft the FDA Food Safety Modernization Act and will work closely with the FDA to develop rules and guidance to implement the provisions of this new law. " (Food and Water Watch summarizes FSMA here; Elanor Starmer lists some of its limitations here.)

AquaAdvantage Genetically Modified Salmon Not A Threat To Nature, FDA Says

WASHINGTON -- Federal health regulators say a genetically modified salmon that grows twice as fast as normal is unlikely to harm the environment, clearing the way for the first approval of a scientifically engineered animal for human consumption.

The Food and Drug Administration on Friday released its environmental assessment of the AquaAdvantage salmon, a faster-growing fish which has been subject to a contentious, yearslong debate at the agency. The document concludes that the fish "will not have any significant impacts on the quality of the human environment of the United States." Regulators also said that the fish is unlikely to harm populations of natural salmon, a key concern for environmental activists.

Why Isn't the FDA Stopping the Epidemic of Foodborne Illness?

All of his life, Paul Schwarz had been active and healthy. When his family imagined the various ways the decorated veteran of World War II might eventually die, they never imagined that the cause would be a piece of cantaloupe.

On Tuesday, September 13, 2011, Schwarz complained to his daughter Janice of abdominal pains and a slight fever. She took him to his doctor, who said it was likely a case of stomach flu. By Thursday the symptoms had worsened, and Schwarz had developed diarrhea. Janice took him to the emergency room. Once again flu was the diagnosis, and he was sent home. For a time, his condition improved. He called his son, also named Paul, that Sunday and cheerfully assured him that he'd eaten a big breakfast and felt a lot better.

The FDA Is Spying on Its Own Scientists

After I spoke at a pesticide industry confab a few months ago, an executive with the agrichemical/GMO seed giant Syngenta approached to politely challenge my assessment of the US regulatory agencies. I had charged that these federal watchdog groups kowtow to Big Food and Big Ag, regularly approving dodgy products or practices with little regard for how they may affect public health or the environment.

Au contraire, the Syngenta guy assured me. He insisted that the US regulatory system was full of rigorous scientists who vetted the industry's products carefully and would never let something through that might harm the public. We began a tense conversation about Syngenta's highly toxic and widely used atrazine herbicide, green-lighted by the Environmental Protection Agency despite growing evidence of harm to people and wildlife. We decided after a few minutes to agree to disagree.

Spying on Scientists: How the FDA Monitored Whistleblowers Who Raised Concerns over Radiation

The Food and Drug Administration has been found to have launched a massive surveillance campaign targeting its own scientists for writing letters to journalists, members of Congress and President Obama. The scientists were expressing their concern over the FDA’s approval of medical imaging devices for colonoscopies and mammograms that could endanger patients with high levels of radiation. The covert spying operation led the agency to monitor the scientists’ computers at work and at home, copying emails and thumb drives and even monitoring individual messages line by line as they were being composed in real time. The agency also created an enemies list. We’re joined by the FDA whistleblowers’ attorney, Stephen Kohn, executive director of the National Whistleblowers Center. "For the first time, we now have a glimpse into what domestic surveillance of whistleblowers looks like in this country with the modern technological developments," Kohn says. "The agency [sought] to destroy the reputation of these whistleblowers forever."


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FDA Takes a Baby Step on Factory Farm Antibiotics

For a few months now, Obama's FDA has been showing zero appetite for standing up to the meat industry on factory-farm livestock use. In two key decisions (here and here), the agency declined to impose real restrictions on farm drug use, promoting a "voluntary" approach instead.

But today, the FDA abruptly canned the lapdog schtick and growled like a real watchdog: It banned certain uses of the cephalosporin family of antibiotics. The FDA declared in a press release:

Cephalosporins are commonly used in humans to treat pneumonia as well as to treat skin and soft tissue infections. In addition, they are used in the treatment of pelvic inflammatory disease, diabetic foot infections, and urinary tract infections. If cephalosporins are not effective in treating these diseases, doctors may have to use drugs that are not as effective or that have greater side effects.  

Citing concern that routine use on factory farms will push pathogens to develop resistance to these antibiotics, the FDA has banned certain uses of them. Now before I show just how limited this move is in the grand scheme, I have to stress its historical significance. For 34 years, the agency has been wringing its hands over the dangers of farm antibiotic abuse, all the while doing precisely nothing about it (save for appointing committees and issuing polite requests for "judicious" use). Now it's actually regulating. The Pew Campaign on Human Health and Industrial Farms, which advocates a ban on routine antibiotic use, praised the move Wednesday as an "important first step" in addressing the problem.

FDA Withdraws Proposal To Limit Livestock Antibiotic Use, Raising Public Health Concerns

The U.S. Food and Drug Administration announced Thursday its withdrawal of a decades-old proposal to limit the use of antibiotics in animal feed, a move experts say could have dire implications for public health.

Experts warn the common and often unnecessary practice is decreasing the effectiveness of antibiotics in human medicine and increasing the deadly threat of Methicillin-resistant Staphylococcus aureus (MRSA) and other difficult-to-treat infections.

"This is a step backwards in protecting the public from the rise in antibiotic resistance," said Avinash Kar, a staff attorney for the Natural Resources Defense Council.

Earlier this year, the NRDC filed a lawsuit to compel the FDA to fulfill a commitment it made in 1977, when the agency first acknowledged the mounting public health threat posed by the use of antibiotics in healthy livestock for growth promotion and disease prevention. A recommendation from an advisory committee at the time addressed two major classes of antibiotics that are used in both human and animal medicine: penicillin and tetracycline. The FDA was told to "immediately withdraw approval" for subtherapeutic uses of the drugs in livestock.

According to Thursday's FDA notice, Congress stepped in before the FDA could move forward with industry hearings -- a necessary step before imposing a ban. They asked the agency to refrain from taking any action until there was more research on public health risks.

A Depressing Story You Need to Read

If President Obama's health reform, the Affordable Care Act, backfires politically, one reason will be the staggering political power of the drug industry. If, for example, the health reform had used the bargaining power of the federal government to lower the cost of prescription drugs bought by Medicare and Medicaid, instead of the current system in which the government pays sticker price, there would have been far less need to find savings in Medicare and far less political backlash among voters.

But there would have been a huge political backlash on the part of the drug industry, whose benign neutrality the administration sought and got. So bulk purchase of drugs at negotiated prices was a non-starter politically.

The drug industry has also very substantially captured the Food and Drug Administration, which is far too quick to approve new, "me-too" drugs of dubious clinical value and far too slow to remove dangerous or ineffective drugs from the market or at least condition them with clear limitations and warnings. The Obama FDA is only marginally better on this front than George W. Bush's.

If you want to get a sense of just how damaging the drug industry is, you need to read Dr. Marcia Angell's blockbuster two-part article in the June 23 and July 14 New York Review of Books. Here is the punch line of part one, "The Epidemic of Mental Illness: Why?" The current generation of anti-depressant drugs, which change the way the brain absorbs a neurotransmitter called serotonin, are probably no more effective than placebos.

Yet these widely prescribed and hugely profitable drugs produce major changes in brain chemistry, are often difficult to kick, and patients can find themselves on a whole cocktail of drugs to counteract each other's effects. As Angell writes: in positing that depression was caused by too little serotonin, "instead of a developing a drug to treat an abnormality, an abnormality was postulated to fit a drug." As she adds, "Or similarly, one could argue that fevers are caused by too little aspirin."

Angell draws on three books, most notably, The Emperor's New Drugs, by Irving Kirsch. As Angell explains the system, a drug company may submit any number of clinical trials to the FDA in seeking approval for a new drug. No matter how many trials prove duds, as long the drug maker can produce two trials that show some clinically significant difference between the drug and the placebo, it generally gets the drug approved. This is rather like a student doing over exams until the right answer pops up.

Studies that show benefit are of course published and publicized. Studies that show no benefit are kept quiet. But the duds remain on file with the FDA. So Kirsch used a freedom of information request to review all of the trials that drug makers had submitted. He found that the vast majority of 42 clinical trials submitted to the FDA between 1987 and 1999 for such best selling selective serotonin reuptake inhibitor drugs as Prozac, Paxil, Zoloft, Celexa, Serzone, and Effexor, showed no improvement compare to placebos. And if you averaged all the studies, the improvement was marginal.

But then Kirsch adds another twist. Since anti-depressant drugs generally have side effects, patients often guess correctly whether they are receiving the placebo or the drug because of the presence or absence of side-effects. That, of course, ruins the "double blind" nature of the clinical trial, in which no subject is supposed to know whether they are getting the drug or a placebo.

But in some trials, according to Kirsch, scientists use "active" placebos that include a harmless drug that produces a side effect such as a dry mouth. That way, both the group receiving the drug and the group receiving the placebo believe that they are getting the drug. Guess what? In trials using an active placebo, with "side effects," there was no difference between the patient response to the drug and to the placebo.

Angell argues that much of the huge increase in reported mental illness is the result of the development and marketing of drugs.

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Source: Huffington