Tag: FDA

FDA Likes the Taste of Melamine

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Melamine – it’s what’s for breakfast!

The Food and Drug Administration said it found “trace levels” of the industrial chemical melamine in one sample of U.S.-made infant formula and in a few samples of other products like nutritional and medical supplements made by U.S. manufacturers of infant formula.

The FDA said, however, the formula and the supplements were safe to consume. “These are extremely low levels,” Stephen Sundlof, director of the FDA’s Center for Food Safety and Applied Nutrition, said. “It didn’t cause any concern at all, not from a health standpoint.”

[From FDA Tests Find Melamine Traces in Baby Formula – WSJ.com]

Yeah, why don’t you drink a big glass of melamine then, and we’ll watch.

Eight years (or longer, really) of downsizing the FDA, and similar watchdog agencies has had a real effect: the FDA doesn’t even pretend to be on the side of consumers anymore.

Dr. Sundloff said the melamine detected was tiny. Out of 87 samples, it found one sample with 0.137 parts per million and 0.140 parts per million on a verification test.

Even so, the findings are likely to upset parents who feed formula to their babies. But just how much is at stake for the manufacturers isn’t certain. Infant nutritional businesses are lucrative properties for some big U.S. drug makers, including Abbott, Wyeth and Bristol-Myers, though Wyeth doesn’t make or market its infant formula in the U.S. Mead Johnson’s revenue from its Enfamil infant formula has totaled $872 million so far this year.

Money over public health.

Are you eating GM food without knowing it

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If the FDA and its client, Monsanto, had their way, consumers would never realize if the food sold at grocery stores and restaurants was some sort of franken-food created in a laboratory, with long-term health effects unknown. Furthermore, Monsanto and a few other similar corporations would own the patents to the majority of the world’s food supply, with seeds that only lasted one year. Their nefarious plan is well on the way to being permanently in place.

CIA and the art of brussel sprout earings

Alexis Madrigal writes:

Wired Science – Wired Blogs:
The other part of the explanation is that US consumer attitudes don’t actually matter very much to the current GM food business. All Monsanto needs is for you to love Twinkies and Coca-Cola, the food machinery of this country does the rest. Monsanto’s model is business-to-business (B2B), like server sales or logistics. Monsanto is more like Oracle than Apple. To the average consumer, GM crops are invisible, especially because you don’t have to label them in the US.

The attitudes towards GMO that matter to Monsanto are those held by big agribusiness seed buyers and corporate farmers, not Joe Six Pack. And the IT managers of the farming world love Monsanto. The chart is of US GE crop adoption of their big three products, corn, soybeans, and cotton, which just happen to compose 75 percent of the revenue generated from non-fruit and vegetable cash crops.

If you’re an opponent of GM foods, here comes the scary punchline. A big chunk of all that genetically modified corn and soy go right into our processed foods and into feed for the animals we eat. So chances are, unless you are a raw or organic foodista, you ate a GM food derivative this very day.

Even organic food is probably tainted in some degree by GM food.

Plastics industry has FDA in their pocket

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Corruption in the FDA? Really? Who woulda-thunk?

A government report claiming that bisphenol A is safe was written largely by the plastics industry and others with a financial stake in the controversial chemical, the Journal Sentinel found.

Although the Food and Drug Administration will not reveal who prepared its draft, the agency’s own documents show that the work was done primarily by those with the most to gain by downplaying concerns about the safety of the chemical.

That includes Stephen Hentges, executive director of the American Chemistry Council’s group on bisphenol A, who commissioned a review of all studies of the neurotoxicity of bisphenol A and submitted it to the FDA. The FDA then used that report as the foundation for its evaluation of the chemical on neural and behavioral development. The American Chemistry Council is a trade group representing chemical manufacturers.

The FDA’s draft, released in August, found no cause for worry about bisphenol A, which is found in thousands of household products, including baby bottles, infant formula containers and the lining of aluminum cans.

That finding is at odds with the conclusions of the FDA’s own advisers from the National Toxicology Program. The NTP announced in September that the chemical is of some concern for effects on the development of the prostate gland and brain, and for behavioral effects in fetuses, infants and children. The NTP also found some concern for the neurodevelopment of young children, infants and fetuses.

Last week, the government of Canada declared that bisphenol A is a toxin and is banning its use in baby bottles and other products used by children.

The FDA draft finding no harm is under review by a subcommittee, which will decide if the conclusions need to be amended. That assessment is expected to be released any day and will be presented Oct. 31 in Washington

The Journal Sentinel reported earlier this month that subcommittee chairman Martin Philbert is founder and co-director of an institute that received $5 million from a retired medical supply manufacturer who said he considered bisphenol A “perfectly safe.” The donor, Charles Gelman, told the newspaper that he has expressed his views to Philbert in several conversations.

Philbert at first denied ever having been contacted by Gelman about bisphenol A. He now says that he is aware of Gelman’s views but is not influenced by them.

[From JS Online: Plastics industry behind FDA research on bisphenol A, study finds ]

Keep away from children

Not surprising, but despicable. The FDA should be ashamed, and those corrupt officials who are behind this latest travesty should lose their jobs, and be banned from working for any plastic-related corporations for 20 years.

The newspaper reviewed the body of evidence that the task force considered. It found memos with entire sections blacked out, reviews commissioned by the American Plastics Council, an arm of the American Chemistry Council, and reviews completed by consulting firms with clients who havefinancial interests in the sale of bisphenol A.

Many of these reviews of individual studies are at odds with the NTP’s reviews of the same studies.

For example, one study funded by the National Institutes of Health and the Department of Defense looked at the effects of bisphenol A on prostate development in rats.

The FDA called it “severely limited,” in contrast to the NTP’s review, which labeled it of “high utility.”

Another government-funded study, which also looked at the effects of the chemical on the prostate, again was considered of “high utility” by the NTP for its evaluation, and it was deemed “very limited” by the FDA.

Much of the science that the task force considered was 20 years old or older, including a study commissioned in 1976.

The older studies are not as sensitive as modern tests. They used high doses of the chemical and did not consider the unique effects on the endocrine system.

See also
Plastic fantastic

Clash on Safety of BPA

Plastic Soup of the Pacific

or more or even more

BPA in plastics linked to diabetes, heart disease

Seth Anderson1 Comment

But never worry, I’m sure the FDA will issue reassurances that plastic is good for you. Good enough that no FDA employee will ever use a plastic water bottle again, but we wouldn’t want to cause panic, nor cause our close friends in the plastic industry to lose any shareholder value.

Thirsty?

The chemical Bisphenol A (BPA), widely used in plastic food and beverage containers, has been linked to diabetes, cardiovascular disease and liver abnormalities, according to a study released Tuesday.

The report to be published in the September 17 issue of the Journal of the American Medical Association (JAMA) found that adults with the highest concentrations of BPA in their urine had nearly triple the odds of cardiovascular disease, compared with subjects found to have the least amounts of the compound in their systems.

Of 1,455 adults studied, those with the highest BPA levels had more than double the odds of having diabetes, the report found.

“Higher urinary concentrations of BPA were associated with an increased prevalence of cardiovascular disease, diabetes, and liver-enzyme abnormalities,” the authors wrote.

[From The Raw Story | Chemical in plastics linked to diabetes, heart disease: study]

Plastic, it’s what’s for breakfast1

NPR ran a story on the same topic, and concluded:

At this time, the FDA finds the current level of exposure to BPA through food containers safe.

[From FDA Weighs Safety Of Bisphenol A : NPR]

Don’t you feel much better now? Especially after 8 years2 of fealty to corporate profit instead of consumer safety?

Footnotes:
  1. and lunch, and dinner [↩]
  2. though, one could easily add the Clinton years here to this total, and Bush the Smarter, and Reagan. So really 28 years of the FDA and similar regulatory agencies protecting the interests of industry over the health of citizens [↩]

Kids on Statins

Seth Anderson0 comment

Ridiculous, really, there shouldn’t be a pharmaceutical solution for every health issue. Like the cliche goes, to a hammer, everything looks like a nail. The drug companies, and their lackeys in the FDA (and drug-industry corrupted doctors) want to sell more pills, no matter the consequences to long-term health of the nation, and to the nation’s healthcare system.

This aggressive new recommendation for warding off heart disease in some children has stirred a furious debate among pediatricians since the American Academy of Pediatrics issued it on Monday.

While some doctors applauded the idea, others were incredulous. In particular, these doctors called attention to a lack of evidence that the use of the cholesterol-lowering drugs, called statins, in children would prevent heart attacks later in life.

“What are the data that show this is helpful preventing heart attacks?” asked Dr. Darshak Sanghavi, a pediatric cardiologist and assistant professor at the University of Massachusetts Medical School. “How many heart attacks do we hope to prevent this way? There’s no data regarding that.”

Nor, Dr. Sanghavi added, are there data on the possible side effects of taking statins for 40 or 50 years.

Other doctors said the recommendation would distract from common-sense changes in diet and exercise, which are also part of the new guidelines.

[From Well – 8-Year-Olds on Statins? A New Plan Quickly Bites Back – NYTimes.com]

How about banning high-fructose corn syrup instead? Or removing the subsidy from its manufacture so that it isn’t added to every packaged food and beverage?

FDA Still Clueless re Food Safety

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Pippen with Cilantro

Tomatoes were apparently a false lead – the probable culprit was something used frequently in conjunction with tomotoes, but not in Italian restaurants.

Officials investigating the salmonella outbreak now are looking at jalapeño peppers as a leading suspect for spreading the bacteria that has sickened hundreds across the U.S. over the past three months, according to people familiar with the probe.

The Centers for Disease Control and Prevention initially blamed tomatoes. That led to industry losses of hundreds of millions of dollars, according to the National Restaurant Association, as consumers cut down on consumption and restaurants pulled them from menus.

But as the disease continued to spread, the investigation turned to other foods commonly eaten with tomatoes, in particular to other ingredients used to make salsa. Besides jalapeño peppers, officials are looking at cilantro and Serrano peppers.

[From Jalapeños Probed in Outbreak – WSJ.com]

Costuluto Heirloom
[Costuluto Fiorentino Heirloom Tomatoes are supremely delicious]

Restaurants, food markets and consumers are annoyed at the half-hearted pace of the investigation.

The lengthy probe of the outbreak and failure thus far to find the culprit are sowing frustration and even anger among restaurants, produce growers and supermarkets. Officials have acknowledged the slow pace, while facing growing pressure to identify the source of contamination conclusively — something the Food and Drug Administration has warned may be impossible.

[snip]

Richie Jackson, chief executive of the Texas Restaurant Association, said the CDC’s focus on salsa could confuse consumers and frustrate restaurants. The state has confirmed more than 350 cases, the highest number of any state in the U.S.

“To blame salsa brings nothing to the table,” said Mr. Jackson, whose state has about 5,000 Mexican restaurants. “Until you can define which ingredient is the culprit, I don’t think you can blame salsa and condemn it … there’s all kind of salsas.”

He said he’s not aware that restaurants in the state have removed salsa from their menus. “If you don’t have chips and salsa at the table, you’re not in Texas,” he said. “I think some of the credibility of the CDC warnings is a little more suspect after the tomato warnings,” he added.

Marijuana is a Powerful Medicine

Seth Anderson0 comment

Aron Rowe of Wired points out one of the biggest problems with our healthcare system: if a drug was not created in a laboratory, by a pharmaceutical corporation, and subsequently approved by the FDA, then no matter how effective the drug might be, the drug will have an immense barrier to entry.

Marijuana contains an amazing chemical, beta-caryophyllene, and scientists have thoroughly proven that it could be used to treat pain, inflammation, atherosclerosis, and osteoporosis.

Jürg Gertsch, of ETH Zürich, and his collaborators from three other universities learned that the natural molecule can activate a protein called cannabinoid receptor type 2. When that biological button is pushed, it soothes the immune system, increases bone mass, and blocks pain signals — without causing euphoria or interfering with the central nervous system.

Gertsch and his team published their findings on June 23 in the Proceedings of the National Academy of Sciences.They focused on the anti-inflammatory properties of the impressive substance — testing it on immune cells called monocytes and also in mice.

Since beta-caryophyllene seems to be powerful, occurs naturally in many foods, and does not get people high, it could turn out to be a nearly ideal medication. The organic compound is also phenomenally cheap. Sigma Aldrich sells it, in kosher form, for forty-two dollars per kilogram.

Unfortunately, big pharmaceutical companies tend not to seek FDA approval for natural chemicals, and most doctors are reluctant to prescribe drugs that have not received a green light from the regulatory agency. Thus, it would require a heroic effort by academic researchers to prove that beta-caryophyllene is safe and effective in humans.

[From Some Proof that Marijuana is a Powerful Medicine | Wired Science from Wired.com]

A real shame. In a fair world, natural remedies would be the first option, not an option only available to law-breakers.

Bridge of Smoke

Legal Shields for Bush Donors

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KWD-808-II Multi-Purpose Health Device
[not a Medtronic device, but some Chinese electric acupuncture stimulation machine, Kent Young, Chinatown]

Another way the Bush Administration and its Republican cronies has screwed the nation: this time by gutting consumers rights to legal redress. Bridget Robb used a faulty Medtronic device and nearly died. Robb wanted to sue for the months of medical fees, but:

her lawyer told her that is probably not an option because of a clause the Food and Drug Administration has written into its policy on what kinds of standards medical devices like hers must meet. Because the defibrillator passed the FDA’s tests and was deemed safe, the company that made it may be immune from legal action.

Since 2005, lawsuit limits like the one protecting Medtronic and other manufacturers have been included in dozens of agency rules covering everything from drugs to car parts, shielding them from consumer suits if their products are approved by federal agencies. And it has often been done at the behest of the White House, critics say, with little input from Congress.

That has prompted a debate over whether the unprecedented increase in benefits granted to product makers is fair to consumers or even constitutional.

[From Critics blast feds’ legal shields for manufacturers — chicagotribune.com]

The same impulse that shields telecom companies from having to explain why they were allowed to break the law of the land without repercussion1 created this clause. If your widget causes harm, you should have to pay the consequence. The FDA is so corrupted that having one’s widget deemed safe might be as simple as taking an FDA official out to a strip club, or promising a salaried position when the FDA official resigns. Despicable.

Consumer advocates and some law professors argue that the anti-lawsuit clauses undermine consumers’ rights and make it difficult to hold businesses accountable for faulty products. And they say the federal government should not be blocking lawsuits that are permitted by individual states.

“I’ve been here since the second Reagan administration, and I’ve never seen anything like this,” said Michael Bird, federal affairs counsel for the National Conference of State Legislatures. “This is not what the framers of the Constitution had in mind.”

An example of this arose in 2006, when a Consumer Product Safety Commission regulation on flame-retardant mattresses limited the ability of consumers to win cases under state laws if their mattresses caught on fire.

Around that time, the FDA approved a rule on drug labeling that included a similar clause. That year, parents whose son killed himself while taking the antidepressant Paxil sued maker GlaxoSmithKline for failing to disclose that Paxil increases suicide risk. They lost their case because, the judge wrote, “federal law pre-empts plaintiffs’ instant action.”

Some complain that the Bush administration pushed these regulations through the federal agencies it controls instead of trying to move them through Congress. Passing a bill requires hearings and public debate, while an agency often can change its rules with little fanfare.

In 2007, the National Highway Traffic Safety Administration began including lawsuit-protection language in its rules on door locks, safety restraints and crash protection for cars. Now NHTSA may insert such a clause in proposed standards on how strong a car’s roof must be to prevent injuries from rollovers.

Footnotes:
  1. FISA, if you’ve forgotten. We’ve discussed that travesty a number of times. [↩]

Tomatoes may not be source of salmonella

swanksalot2 Comments

tomatoes redux

Wait, after all the fulminating, and gnashing of teeth, tomatoes are maybe not to blame? Geez, can we have a competent (and fully funded) FDA please?

As the number of cases in an ongoing salmonella outbreak climbed past 800 on Friday, federal health officials said they might never find the cause—and that tomatoes might not be the culprit after all.

Though fresh tomatoes have a “strong association” with many of the cases and remain a top suspect, health officials have not confirmed that the fruit carried the rare Salmonella Saintpaul strain.

Of 1,700 domestic and international tomato samples collected so far, none have tested positive, said David Acheson, associate commissioner for foods with the Food and Drug Administration.

Officials would not divulge if, or what, other produce was being seriously investigated, only saying they would “continue to keep an open mind about the possible source.”

[From Tomatoes may not be source of salmonella — chicagotribune.com]

I took the opportunity to eat heirloom tomatoes instead1 and roll my eyes at the incompetence of our national food inspectors.

Footnotes:
  1. Of course, I eat as many heirloom tomatoes as I can every summer [↩]

Makers of Baby Bottles Sued

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Deregulation of government has real effects.

Four parents have filed a federal lawsuit against makers of baby bottles, claiming the bottles were made from a harmful chemical that led to Congressional hearings and prompted the world’s largest retailer to phase out the products. The complaint, filed in Federal District Court in Columbus, alleges the companies knew that a chemical known as bisphenol A was associated with health problems but did not disclose the risk. It cites scientific studies that conclude BPA, as the chemical is also known, seeps from bottles and sippy-cups into liquid.

[From National Briefing – Midwest – Ohio – Makers of Baby Bottles Sued – NYTimes.com]

Public perception is that the FDA is corrupted, and only cares about profits of industry. I haven’t seen much evidence contradicting this perception.

Bad Cow Disease

Seth Anderson0 comment


"The Jungle: The Uncensored Original Edition" (Upton Sinclair)

Paul Krugman notes, correctly, the reason for so many food safety issues – the conservatives long-term goal of stripping regulatory agencies of any real power to regulate (coupled with staffing of regulatory agencies with officials with conflicted interests)

How did America find itself back in The Jungle?

It started with ideology. Hard-core American conservatives have long idealized the Gilded Age, regarding everything that followed — not just the New Deal, but even the Progressive Era — as a great diversion from the true path of capitalism.

Thus, when Grover Norquist, the anti-tax advocate, was asked about his ultimate goal, he replied that he wanted a restoration of the way America was “up until Teddy Roosevelt, when the socialists took over. The income tax, the death tax, regulation, all that.”

The late Milton Friedman agreed, calling for the abolition of the Food and Drug Administration. It was unnecessary, he argued: private companies would avoid taking risks with public health to safeguard their reputations and to avoid damaging class-action lawsuits. (Friedman, unlike almost every other conservative I can think of, viewed lawyers as the guardians of free-market capitalism.)

Such hard-core opponents of regulation were once part of the political fringe, but with the rise of modern movement conservatism they moved into the corridors of power. They never had enough votes to abolish the F.D.A. or eliminate meat inspections, but they could and did set about making the agencies charged with ensuring food safety ineffective.

They did this in part by simply denying these agencies enough resources to do the job. For example, the work of the F.D.A. has become vastly more complex over time thanks to the combination of scientific advances and globalization. Yet the agency has a substantially smaller work force now than it did in 1994, the year Republicans took over Congress.

[Click to read more of Op-Ed Columnist – Paul Krugman – Bad Cow Disease – Op-Ed – NYTimes.com]

Unfortunately, one can’t eat solely from Farmer’s Markets. Remember to thank a Republican next time you hear of a food-safety crisis, or next time you get salmonella.

Clash on Safety of BPA in Plastic Items

Seth Anderson0 comment

Do Not Attempt This At Home

So an industry-funded report found no problem? How novel! And the FDA firmly supporting the industry? How novel!

Government experts and lawmakers clashed at a hearing Tuesday over the safety of a chemical used in plastic baby bottles, as the science indicating health risks seemed not conclusive enough to meet the burden of proof required for a U.S. ban.

The chemical, bisphenol A, or BPA, makes plastic hard and shatterproof and helps prevent corrosion in cans. It is used in hundreds of consumer products, including plastic baby bottles, plastic food containers and soda cans.

The latest concern about BPA emerged in April when the Department of Health and Human Services’ National Toxicology Program released a draft report concluding that small amounts of the chemical could be linked to health and developmental problems. Those problems include early puberty, changes in the prostate gland and behavioral changes found in animal studies that warranted “some concern” for exposure to fetuses, infants and children.

“The possibility that bisphenol A may alter human development cannot be dismissed,” said John Bucher, associate director of the National Toxicology Program, at Tuesday’s hearing.

The program’s findings contradicted some earlier industry-funded animal studies that found minimal concern.

[From Clash Arises on Safety of BPA in Plastic Items – WSJ.com]

Here is where Senator Clinton can help the nation: pass this bill

Led by New York Democratic Sen. Charles Schumer and supported by fellow New York Democrat Hillary Clinton, the senators want their BPA-Free Kids Act of 2008 to be part of a larger bill that would reform the Consumer Product Safety Commission.

Bills to overhaul the CPSC were passed by the House and Senate in differing forms late last year and earlier this year following a string of recalled children’s products that put the agency under fire. If signed into law, the overhaul would provide the agency with more funding and greater authority, while making data more transparent and boosting fine limitations for manufacturers.

Part of the clash in how the hundreds of BPA studies are viewed stems from the manner in which they were conducted. Many have been small and weren’t conducted according to regulatory standards, critics say.


“SIGG – Green Traveler Classic Water Bottle” (SIGG)

Food Labs Corrupt

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Dog Food

FDA has been caught with its head in the proverbial sand again, sort of a don’t ask, don’t tell policy for food safety. Venue shopping, in other words.

A congressional committee is investigating whether some private U.S. laboratories were instructed to withhold samples of tainted food so that importers could get their goods into the United States.

In a May 1 letter to 10 labs, the House Committee on Energy and Commerce suggests they may have been encouraged by importing companies to discard test results that had failed Food and Drug Administration standards.

“We’re gathering information from both the FDA and private industry about the labs almost being complicit in helping importers game the system,” said Rep. Bart Stupak (D-Mich.), chairman of the Oversight and Investigations subcommittee that is investigating the labs and food companies. “Someone told us you pay for the result you want to get from the labs.”

The committee’s letter reiterates Stupak’s suspicion that testing on some samples was conducted repeatedly until the food passed.

In other instances, the letter says, importers whose food failed tests at one laboratory would hire a different lab to continue testing until they got a positive result. “This repeated testing is done without alerting FDA that potentially dangerous food has been imported into this country — a practice which we find deplorable,” the letter states.

The committee asked 50 multinational food companies for a wide range of recall- and food-import records dating to 2000. A May 8 letter from the committee to the companies asks about instances when food was found to be contaminated with chemicals or bacteria such as E. coli, salmonella or listeria. “We wish to assess the extent of microbiological and/or chemical contamination occurring during the processing of food and the extent to which controls have failed to prevent or eliminate contamination in food,” the committee wrote.

Three Chicago-area corporations— Kraft Foods Inc., Sara Lee Corp. and the Wm. Wrigley Jr. Co.—are included in the second request.

[From Suspicions deepen on food labs — — chicagotribune.com]

Sounds like a pretty big loophole to me: too bad the FDA’s mandate is to protect the business interests of food manufacturers, and not consumers, or else the FDA would run its own laboratories, conducting its own tests. Privatization is usually not the best solution to address public health concerns.

Last autumn the FDA issued an alert on five types of Chinese seafood: eel, shrimp, catfish, basa and dace. The warning was recognition of the fast-growing Asian aquaculture industry and its frequent use of antibiotics banned in the United States.

To import those seafoods, companies affected by the alert must prove that their products don’t contain banned substances. Conducting tests to prove it is one of the jobs the private labs perform.

So far, just 2 of the 10 labs targeted by the House committee have complied with the records request, according to committee staffers. Amir Jalaeikhoo, president of one lab that did comply, Imperial Private Laboratories Inc. of Miami, said that his firm reports negative test results to the FDA. Imperial mostly tests for pesticides in produce imported from Central and South America, Jalaeikhoo said. “Sometimes we lose clients because our standard operating procedure is that basically if something is … in violation, we submit it,” he said. “Some importers don’t like that policy.”

The nation can’t afford to ensure the quality of its citizen’s food – there are wars in the desert to fund!