Tag: FDA

Drug executive Nirmal Mulye: It’s a ‘moral requirement’ to charge patients the highest price

Seth Anderson0 comment

Social Media Drug Mart

LA Times reports:

In the category of saying the quiet parts out loud, consider this statement by Nirmal Mulye, the chief executive of drug company Nostrum Laboratories:

“I think it is a moral requirement to make money when you can … to sell the product for the highest price.”

Mulye was responding to questions posed by the Financial Times about his quadrupling the price of an essential antibiotic to $2,392 per bottle. The drug, nitrofurantoin, is used to treat urinary tract infections. It has been on the market since 1953 and is listed by the World Health Organization as an essential medicine for “basic healthcare systems.”

In his interview with the Financial Times published Tuesday, Mulye defended Martin Shkreli, the former drug company CEO who became the face of the industry’s profiteering in 2015 when he jacked up the price of a generic anti-parasitic drug needed by HIV patients by more than 5,000%.

(click here to continue reading Drug executive: It’s a ‘moral requirement’ to charge patients the highest price.)

Strange definition of morals. This douchenozzle might want to check a dictionary.

Merriam-Webster’s definition of moral:

a : of or relating to principles of right and wrong in behavior : ethical moral judgments

b : expressing or teaching a conception of right behavior a moral poem

c : conforming to a standard of right behavior took a moral position on the issue though it cost him the nomination

d : sanctioned by or operative on one’s conscience or ethical judgment a moral obligation

e : capable of right and wrong action a moral agent

 

(click here to continue reading Moral | Definition of Moral by Merriam-Webster.)

So which definition of moral were you referring to, Mr. Mulye? I think the moral response would be for the federal government to start regulating the price of drugs such as this one. 

The 23rd Commissioner of the U.S. Food and Drug Administration, Scott Gottlieb, responded

Testing of Household Materials

Seth Anderson0 comment

Star Kiss
Star Kiss

We’ve discussed this inexplicable loophole a few times before, ever since Bill Moyers tested his own body for chemicals and found over 70 different ones. We are glad that maybe something will be done, maybe. Though with the current group of knuckle-draggers and corporate sell-outs inhabiting Congress, I’m skeptical.

You can’t legally buy a drug in the United States that hasn’t undergone rigorous testing, mandated by Congress, to prove that it’s safe and effective. By contrast, that lipstick, shampoo, or deodorant you use every day may have undergone no such testing.

And there’s cause to wonder if those products are safe. More than 21,000 complaints of itching, rashes and hair loss, for instance, have been sent to the manufacturer and distributor of Wen Hair Care products. And hair-straightening products that contain formaldehyde, a known carcinogen, have caused allergic reactions, hair loss, rashes, blisters and other problems in salon workers and their customers.

A bill introduced by two senators — Dianne Feinstein, Democrat of California, and Susan Collins, Republican of Maine — would change that by requiring the Food and Drug Administration to evaluate a minimum of five chemicals used in cosmetics every year and to collect fees from the industry to pay for those reviews. The agency would also get the power to order companies to recall dangerous products and to force companies to provide it with safety data and reports of adverse health effects from consumers.

The bill has the backing of public interest groups like the Environmental Working Group and the American Cancer Society Cancer Action Network, as well as much of the cosmetics industry, including big companies like Johnson & Johnson and Procter & Gamble. But some manufacturers, like Mary Kay, oppose the bill because they argue that its provisions would be too onerous. They are pushing a much weaker measure introduced by Representative Pete Sessions, Republican of Texas, that would not require the F.D.A. to review risky ingredients and wouldn’t give the agency authority to order recalls.

(click here to continue reading Is Your Lipstick Bad for You? – The New York Times.)

See, Pete Sessions and his pals are doing their best to ensure you are poisoned by household chemicals. That’s democracy in America folks…

Let The Kiss Free!
Let The Kiss Free!

We are way behind Europe. As Bill Moyers and other pointed out, in the US, chemicals are only tested after they can be scientifically linked to problems: in Europe the chemical has to past those tests before being approved to the marketplace.  

All told, European officials have restricted or banned more than 1,300 chemicals and groups of chemicals, experts say; the F.D.A. has prohibited 11 ingredients. That shocking discrepancy makes clear how far behind the United States is in this area. It also shows that sensible regulations will not cripple companies that make cosmetics, since many of their products are already covered by European law.

 

How Vermont Got Big Food Companies To Label GMOs

Seth Anderson0 comment

Non GMO Project
Non GMO Project

If you hadn’t heard, Vermont recently passed a GMO labeling law, and Congress, since it is so dysfunctional, could not muster a response. Thus Vermont’s law will become the de facto law of the nation, at least for a while…

You’ll soon know whether many of the packaged foods you buy contain ingredients derived from genetically modified plants, such as soybeans and corn.

Over the past week or so, big companies including General Mills, Mars and Kellogg have announced plans to label such products – even though they still don’t think it’s a good idea.

The reason, in a word, is Vermont. The tiny state has boxed big food companies into a corner. Two years ago, the state passed legislation requiring mandatory labeling.

The Grocery Manufacturers Association has fought back against the law, both in court and in Congress, but so far it’s been unsuccessful.

Last week, as we reported, Congress failed to pass an industry-supported measure that would have created a voluntary national standard for labeling — and also would have preempted Vermont’s law. Which means for now, food industry giants still face a July 1 deadline to comply with the state’s labeling mandate.

And since food companies can’t create different packaging just for Vermont, it appears that the tiniest of states has created a labeling standard that will go into effect nationwide.

This statement, from General Mills’ Jeff Harmening, sums it up:

“Vermont state law requires us to start labeling certain grocery store food packages that contain GMO ingredients or face significant fines,” Harmening wrote on the General Mills blogs.

“We can’t label our products for only one state without significantly driving up costs for our consumers and we simply will not do that,” explains Harmening.

So, as a result: “Consumers all over the U.S. will soon begin seeing words legislated by the state of Vermont on the labels of many of their favorite General Mills products,” he concludes.

Chocolate giant Mars struck a similar tone in its announcement: “To comply with [the Vermont] law, Mars is introducing clear, on-pack labeling on our products that contain GM ingredients nationwide,” the company statement says.

(click here to continue reading How Little Vermont Got Big Food Companies To Label GMOs : The Salt : NPR.)

All Your Bonnie Plants Come from Non-GMO Seeds, and All Your Base are Belong to Us
All Your Bonnie Plants Come from Non-GMO Seeds, and All Your Base are Belong to Us

For the record, I’m ok with the Vermont labeling law. I don’t know if genetically modified food is good or bad, but truthfully, nobody really does. The American government’s regulatory agencies are permanently tilted towards the interests of corporations, always, and nearly without exception; the FDA cannot be trusted to protect the health of consumers. Do we really know if gene splicing pesticide resistance into apples or wheat is going to alter our bodies? The corporations pinky-swear GMOs won’t have long-term effects on cancer rates and other health-related concerns, and maybe they are right.

But maybe they are not.

Last spring, the cancer research arm of the World Health Organization declared glyphosate, the most commonly used herbicide on GMO crops, to be a probable carcinogen. And just last month, the FDA announced it would begin testing food products sold in the U.S. for glyphosate residue.

State legislators across the nation introduced 101 bills last year pertaining to GMOs. Of the 15 that passed, four had to do with labeling, according to the National Conference of State Legislatures. A bill introduced by Illinois state Sen. David Koehler, D-Peoria, requiring disclosure of genetically engineered ingredients stalled in committee.

More than 90 percent of corn and soybeans grown in Illinois is genetically modified, said Adam Nielsen, director of national legislation for the Illinois Farm Bureau.

…

The GMO crop movement took off in 1996, when Monsanto Co. introduced Roundup Ready soybean seeds, genetically modified to resist Monsanto’s glyphosate-based herbicide. Similarly marketed cotton, canola, corn and sugar beet seeds soon followed.

For farmers, glyphosate represented a safer, cheaper, more effective way of controlling weeds, thwarting pests and growing crops, Moose said. It’s since become the standard in large-scale agriculture.

The general public and the scientific community don’t tend to agree when it comes to GMO safety, according to a 2015 Pew Research Center survey conducted before the World Health Organization finding. Most consumers surveyed, 57 percent, said they considered GMOs to be generally unsafe to eat, whereas 88 percent of scientists surveyed, all of them connected to the American Association for the Advancement of Science, said GMOs were generally safe.

Genetically modified crops don’t present a health risk, but the herbicides used on them are “a big problem,” said Dr. Philip Landrigan, dean for global health at the Mount Sinai School of Medicine in New York City and an expert on environmental health concerns and children.

As GMO crops have become more common over the years, weeds have become resistant to glyphosate, which has led to heavier use of the herbicide, he said.

Landrigan is among scientists and health experts calling on the EPA to “urgently review the safety risk of glyphosate” and says it’s time for GMO labeling. “Not because I think genetic rearrangement is bad, but because I think consumers have a right to know what they’re eating,” he said.

(click here to continue reading GMO labeling debate puts food industry on defensive – Chicago Tribune.)

The agribusinesses are not being banned from using GMO products, only being required to be transparent if they are. Does this mean General Mills has to change their packaging? Yep. So what? They can’t be complaining about the extra ink required, only that they are being forced to alter their packaging by dictate of the people. Boo hoo. Packaging changes all the time anyway, I don’t see the harm in adding a few words to a package.

Photo Republished at Did Pharmaceutical Firms Exploit Pancreas Problems to Increase Profits? – Truthdig

eggplant0 comment

My photo was used to illustrate this post

Photo by swanksalot (CC BY-SA 2.0) Successful efforts by patient advocacy groups to require new approval standards for a particular class of drugs have resulted, perhaps inadvertently, in a sharp reduction of available products and a spike in the cost of brand name drugs to a tune of $350 million per year, Gastroenterology & Endoscopy News contributor Monica J. Smith reports.

click here to keep reading :
Did Pharmaceutical Firms Exploit Pancreas Problems to Increase Profits? – Truthdig

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Moronic FDA Rules No Wooden Boards in Cheese Aging

Seth Anderson1 Comment

Global Cheese
Global Cheese

What a stupid, short-sighted decision by the Food and Drug Administration! 

A sense of disbelief and distress is quickly rippling through the U.S. artisan cheese community, as the federal Food and Drug Administration (FDA) this week announced it will not permit American cheesemakers to age cheese on wooden boards.

Recently, the FDA inspected several New York state cheesemakers and cited them for using wooden surfaces to age their cheeses. The New York State Department of Agriculture & Markets’ Division of Milk Control and Dairy Services, which (like most every state in the U.S., including Wisconsin), has allowed this practice, reached out to FDA for clarification on the issue. A response was provided by Monica Metz, Branch Chief of FDA’s Center for Food Safety and Applied Nutrition’s (CFSAN) Dairy and Egg Branch.

In the response, Metz stated that the use of wood for cheese ripening or aging is considered an unsanitary practice by FDA, and a violation of FDA’s current Current Good Manufacturing Practice (cGMP) regulations.

(click here to continue reading Cheese Underground: Game Changer: FDA Rules No Wooden Boards in Cheese Aging.)

As a cheese-eating descender-from-monkeys1 the FDA is making a really stupid mess out things, benefitting a few corporate cheese makers like Kraft and Cabot Creamery at the expense of good cheese made by small businesses. 

In case of emergency break glass
In case of emergency break glass

And to make it even worse, the FDA is seemingly about to ban the import of most cheese from the EU, including Gruyère, and others

Wisconsin cheesemaker Chris Roelli says the FDA’s “clarified” stance on using wooden boards is a “potentially devastating development” for American cheesemakers. He and his family have spent the past eight years re-building Roelli Cheese into a next-generation American artisanal cheese factory. Just last year, he built what most would consider to be a state-of-the-art aging facility into the hillside behind his cheese plant. And Roelli, like hundreds of American artisanal cheesemaekrs, has developed his cheese recipes specifically to be aged on wooden boards.

“The very pillar that we built our niche business on is the ability to age our cheese on wood planks, an art that has been practiced in Europe for thousands of years,” Roelli says. Not allowing American cheesemakers to use this practice puts them “at a global disadvantage because the flavor produced by aging on wood can not be duplicated. This is a major game changer for the dairy industry in Wisconsin, and many other states.”

As if this weren’t all bad enough, the FDA has also “clarified” – I’m really beginning to dislike that word – that in accordance with FSMA, a cheesemaker importing cheese to the United States is subject to the same rules and inspection procedures as American cheesemakers. 

Therefore, Cornell University’s Ralyea says, “It stands to reason that if an importer is using wood boards, the FDA would keep these cheeses from reaching our borders until the cheese maker is in compliance. The European Union authorizes and allows the use of wood boards. Further, the great majority of cheeses imported to this country are in fact aged on wooden boards and some are required to be aged on wood by their standard of identity (Comte, Beaufort and Reblochon, to name a few). Therefore, it will be interesting to see how these specific cheeses will be dealt with when it comes to importation into the United States.”

(click here to continue reading Cheese Underground: Game Changer: FDA Rules No Wooden Boards in Cheese Aging.)

Stilton with candied lemon peel
Stilton with candied lemon peel

Footnotes:
  1. a/k/a cheese eating surrender monkey – I’m not yet comfortable with my mom’s discovery that our ancestors included French and French Canadian folk; I’ve self-identified as Irish for so long, adding French to the mix might take a while [↩]

Scientists Condemn New FDA Study Saying BPA Is Safe

Seth Anderson0 comment

The Pope gets bagged
The Pope gets bagged

The Food and Drug Organization is still beholden to the industries it is supposed to regulate, putting us, the non-corporations, needlessly at risk in order to protect profits of industry. If we had a liberal, socialist president, perhaps this could change. However…

In February, a group of Food and Drug Administration scientists published a study finding that low-level exposure to the common plastic additive bisphenol A (BPA) is safe. The media, the chemical industry, and FDA officials touted this as evidence that long-standing concerns about the health effects of BPA were unfounded. (“BPA Is A-Okay, Says FDA,” read one Forbes headline.) But, behind the scenes, a dozen leading academic scientists who had been working with the FDA on a related project were fuming over the study’s release—partly because they believed the agency had bungled the experiment.

On a conference call the previous summer, officials from the FDA and the National Institutes of Health (NIH) had informed these researchers that the lab where the study was housed was contaminated. As a result, all of the animals—including the supposedly unexposed control group—had been exposed to BPA. The FDA made the case that this didn’t affect the outcome, but their academic counterparts believed it cast serious doubt on the study’s findings. “It’s basic science,” says Gail S. Prins, a professor of physiology at the University of Illinois at Chicago, who was on the call. “If your controls are contaminated, you’ve got a failed experiment and the data should be discarded. I’m baffled that any journal would even publish this.”

Yet the FDA study glossed over this detail, which was buried near the end of the paper. Prins and her colleagues also complain that the paper omitted key information—including the fact that some of them had found dramatic effects in the same group of animals. “The way the FDA presented its findings is so disingenuous,” says one scientist, who works closely with the agency. “It borders on scientific misconduct.”

(click here to continue reading Scientists Condemn New FDA Study Saying BPA Is Safe: “It Borders on Scientific Misconduct” | Mother Jones.)

A fan of Peapod

A fan of Peapod 

reminds me of the climate change debate, and not in a positive light:

In contrast to the FDA’s recent paper, roughly 1,000 published studies have found that low-level exposure to BPA—a synthetic estrogen that is also used in cash register receipts and the lining of tin cans—can lead to serious health problems, from cancer and insulin-resistant diabetes to obesity and attention-deficit disorder. In some cases, the effects appear to be handed down, with the chemical reprogramming an individual’s genes and causing disease in future generations.

But the agencies that regulate BPA and other chemicals have largely ignored this research in favor of industry data showing BPA is safe. A 2008 investigation by the Milwaukee Journal Sentinel revealed that the FDA had relied on industry lobbyists to track and evaluate research on BPA. It also found that the agency’s assessment of BPA’s safety was based largely on two industry-funded studies—one of which turned out to have “fatal flaws,” according to leading researchers in the field. Both studies also relied on a breed of rat, known as the Charles River Sprague Dawley, that is all but immune to the effects of synthetic estrogens like BPA.

On one hand, nearly 1,000 studies saying at the minimum, there could be potential health problems associated with the usage of this plastic; and on the other finger, 2 studies, flawed in methodology, and funded by the plastic and chemical industry that claim everything is fine as it is. In a rational world, these two studies would be marginalized. Instead, the FDA uses them as a fig leaf to protect the industry from regulation. Pathetic, and troubling.

Hmm, maybe if I started a religion that said ingesting BPA was against my core beliefs, we could take this to the Supreme Court…

How the NYT Got It Wrong on the FDA’s New Antibiotics Rules

Seth Anderson4 Comments

Wherever I Lay My Head
Wherever I Lay My Head

Not the first time, sadly.

A casual reader taking in my account and the New York Times’ account of yesterday’s big FDA antibiotics announcement might have thought we were reacting to different events. Here’s the Times lead:

Farmers and ranchers will for the first time need a prescription from a veterinarian before using antibiotics in farm animals, in hopes that more judicious use of the drugs will reduce the tens of thousands of human deaths that result each year from the drugs’ overuse.

In the Times’ reading, the FDA placed significant restrictions on antibiotics use. My take was more critical: “The plan contains a bull-size loophole—and is purely voluntary, to boot.”

What gives? In short, the Times delivered a skim-level, FDA-friendly account of the new plan. Let’s start with the loophole. Here’s the Times:

Michael Taylor, the F.D.A.’s deputy commissioner for food, predicted that the new restrictions would save lives because farmers would have to convince a veterinarian that their animals were either sick or at risk of getting a specific illness. [Emphasis added.]

The bolded part is the key. As I reported yesterday, the FDA plan intends to phase out the use of antibiotics as growth promoters, but allows them to continue to be used to “prevent” disease. That’s a major loophole—it means that farmers can continue stuffing animals together in filthy conditions and dosing them with antibiotics to keep them alive. Margaret Mellon, senior scientist at the Union of Concerned Scientists and a longtime watchdog of the meat industry’s antibiotic-gorging ways, put it like this in a Wednesday press release:

The outlined process appears to give the companies the opportunity to relabel drugs currently slated for growth promotion for disease prevention instead. Such relabeling could allow them to sell the exact same drugs in the very same amounts

None of this comes out in the Times story.

(click here to continue reading How the NY Times Got It Wrong on the FDA’s New Antibiotics Rules | Mother Jones.)

Critical Mass Griller
Critical Mass Griller

Margaret Mellon responds, angrily:

FDA to Establish Voluntary, Largely Secret Program to Reduce Antibiotic Overuse in Agriculture Statement by Margaret Mellon, Senior Scientist

WASHINGTON (April 11, 2012)—The U.S. Food and Drug Administration (FDA) today released three documents that constitute its long-awaited response to the problem of antibiotic overuse in agriculture. There is wide recognition among scientists that such antibiotic use is driving up the rate of antibiotic-resistant diseases, which are becoming increasingly severe and more costly to treat. While the documents establish a new, completely voluntary approach to reducing antibiotic use in agriculture, the Union of Concerned Scientists cautioned that the program’s shortfalls are likely to imperil its success.

Below is a statement by Margaret Mellon, senior scientist at UCS.

“The approach announced represents a bold, well-intentioned attempt by the FDA to persuade an entire industry to voluntarily abandon claims that allow them to sell a large number of lucrative products. The agency should be congratulated for finally taking action on a serious and long-neglected public health issue, but we’re deeply skeptical that the approach will work.

“We have no reason to believe that the veterinary pharmaceutical industry—which, to date, has rarely even acknowledged that antibiotic resistance is a serious public health issue—will cooperate with the agency on a plan that could reduce its profits.

“The outlined process appears to give the companies the opportunity to relabel drugs currently slated for growth promotion for disease prevention instead. Such relabeling could allow them to sell the exact same drugs in the very same amounts. The process also allows companies to avoid risk assessments for new drug approvals.

“Unfortunately, the process will also be secret. Companies will have three months to submit voluntary plans and three years to implement them. During this entire time, the public will be kept in the dark. It could be three to four years before anyone knows how well the program is working.

“Ultimately, if antibiotic use is reduced only marginally or not at all much time and taxpayer dollars will have been wasted.

“The agency doesn’t need to embark on this novel but very risky experiment in relying on companies to police their own products. It has – and should have relied upon – its  authority under the Food, Drug and Cosmetic Act to cancel unsafe uses of drugs.”

(click here to continue reading FDA to Establish Voluntary, Largely Secret Program to Reduce Antibiotic Overuse in Agriculture | Union of Concerned Scientists.)

USDA suggests Monsanto police itself

Seth Anderson0 comment

Bounty from @FreshPicks

Lovely. What’s next? Asking ExxonMobile to conduct its own environmental studies for the EPA? Asking G.E. to do its own tax audits for the IRS? We expected better than this from Obama’s administration.

The U.S. Food and Drug Administration introduced a pilot project in the Federal Register this month which would allow biotech seed companies to perform their own environmental impact studies of novel seed varieties before deregulation. The USDA’s move seems to be a response to a decision last August by Federal Judge Jeffrey White which banned the planting of genetically modified sugar beets until an environmental study assessed the impact of commercial cultivation. White ruled that the USDA’s approval of the beets violated the National Environmental Policy Act.

Proponents of the USDA’s project believe the decision will make the biotech industry less vulnerable to legal challenges and speed the registration process of new GE crops. “A big deterrent to future lawsuits would be if the USDA were to win some of them,” said Karen Batra, director of communications at Biotechnology Industry Organization, to Capital Press. “The more information the department has, the better case they can make.”

Most recently The Center for Food Safety challenged the USDA’s unregulated approval of GE-alfalfa saying the decision puts organic and conventional farmers at risk. The case is pending.

Organic advocates believe the USDA’s pilot will slow what they believe to be an already ineffective process and encourage more legal challenges.

“There’s virtually no chance, in the current political climate, that the idea of expanding the role of biotech is going to speed up approval,” said Chuck Benbrook, chief scientist for The Organic Center.  “The fact of the matter is there are many good reasons not to trust science from Monsanto.  Almost inevitably the first assessments carried out under this pilot program will be challenged in court—probably successfully.”

Bill Freese, science policy analyst for the Center for Food Safety, said the USDA’s proposal would make an already poor process worse.

“This decision would give us additional incentive to challenge a seed up for deregulation, subject to other factors,” he said. “We might actually challenge the process itself. This decision seems to go against some pretty basic scientific integrity guidelines. Letting a company do its own assessment is a pretty obvious conflict of interest.”

 

(click here to continue reading USDA suggests Monsanto do its own environmental impact studies | Farming content from New Hope 360.)

F.D.A and Dairy Industry Spar Over Testing of Milk

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R. J. Rous Wholesale Milk and Cream

Yet again, a federal agency chooses to let a regulated business make the decisions. Too bad there isn’t a consumer advocate that could demand the FDA be firm with industry.

Each year, federal inspectors find illegal levels of antibiotics in hundreds of older dairy cows bound for the slaughterhouse. Concerned that those antibiotics might also be contaminating the milk Americans drink, the Food and Drug Administration intended to begin tests this month on the milk from farms that had repeatedly sold cows tainted by drug residue.

But the testing plan met with fierce protest from the dairy industry, which said that it could force farmers to needlessly dump millions of gallons of milk while they waited for test results. Industry officials and state regulators said the testing program was poorly conceived and could lead to costly recalls that could be avoided with a better plan for testing.

In response, the F.D.A. postponed the testing

(click to continue reading F.D.A and Dairy Industry Spar Over Testing of Milk – NYTimes.com.)

The FDA even says, bluntly, that they don’t give a shit about consumers:

The F.D.A. said that it would confer with the industry before deciding how to proceed. “The agency remains committed to gathering the information necessary to address its concern with respect to this important potential public health issue,” it said in a statement.

House Passes Overhaul of Food Safety Laws – Devil in the Details

Seth Anderson0 comment

Carrots in Soho square

So the House finally passed the food safety bill that we’ve discussed dozens of times previously, but

The House of Representatives gave final approval on Tuesday to a long-awaited modernization of the nation’s food safety laws, voting 215 to 144 to grant the Food and Drug Administration greater authority over food production.

(click to continue reading House Passes Overhaul of Food Safety Laws – NYTimes.com.)

…the devil is in the details1. For instance, some of the implementation doesn’t start until five years from now, some not until 18 months from now, and with the risk that the whole thing will get changed by then since our country inexplicably elected Republicans to be the majority party in the 112th Congress

Meth Leaves

“The F.D.A. asked for and was given a very long lead time for implementation,” said Caroline Smith DeWaal, food safety director for the Center for Science in the Public Interest, an advocacy group. “But it’s still a vast improvement over what we have today.”

Ultimately, the agency’s ability to carry out and enforce the law will depend on how much money it has available to pay inspectors and maintain or increase its staff. Republicans will gain control of the House next year and have vowed to cut spending on many domestic programs. Deep cuts could hobble the F.D.A. just as it gains the new authority.

“It’s going to be crucial for the next Congress to recognize that F.D.A. can’t fulfill the promise of this new law without the resources it needs to do the job,” said Erik D. Olson, who heads food policy for the Pew Health Group, an advocacy organization.

Footnotes:
  1. whatever the frack that means [↩]

Step Forward for Genetically Engineered Salmon

Seth Anderson0 comment

Catch Anything?

Follow up on the AquaBounty Frankenfish FDA hearing held yesterday…

Still some panel members did say the studies the F.D.A. relied on to reach its own conclusion that the salmon would be safe were flawed, often using only a few dozen fish or even fewer.

“I do get heartburn when we’re going to allow post-market surveillance to finalize our safety evaluation,” said one committee member, Michael D. Apley, a pharmacology expert at Kansas State University.

The criticisms could add to the time needed to approve the salmon. It could also provide grist for consumer and environmental groups, many of which testified on Monday that the salmon should not be approved.

Approval of the salmon could pave the way for other such biotech animals to enter the food supply, like a pig developed in Canada that has more environmentally friendly manure.

(click to continue reading Step Forward for Genetically Engineered Salmon – NYTimes.com.)

Fish head surprise

Humanity has been modifying food since agriculture was invented, but grafting apple saplings or breeding milk cows is not quite the same as modern techniques. It could be absolutely harmless, but I don’t see the need to rush the salmon to market without conducting comprehensive, exhaustive tests. Especially because the reality of a laboratory is much different than the reality of a factory farm, especially after a decade of production.

The company said that fish would not escape because they are grown inland in facilities with containment mechanisms. If any did escape, it said, the rivers outside the Canadian and Panama facilities would be too salty or warm for the fish to survive. And the fish would all be female and almost all would be sterile, so they would not interbreed with wild salmon.

But some committee members, as well as some environmental groups, said the government’s environmental assessment should evaluate what would happen if the salmon were grown widely in many facilities.

“The F.D.A. must consider issues related to realistic production scenarios,” said Anna Zivian, a senior manager at the group Ocean Conservancy.

One test showed a possible increase in the potential to cause allergic reactions that was almost statistically significant even though only six fish were used in each group in the study.

More tests please…

Toothless FDA Nibble on Frankenfish

Seth Anderson1 Comment

Unlabeled genetically engineered salmon: such a crowd pleaser that the FDA is working overtime to change the subject and make excuses, and the AquaBounty “fish” isn’t even on the market yet. Too bad we don’t have any regulatory agencies that are concerned with public opinion, and public safety.

Fresh Copper River Sockeye Salmon

The FDA’s apparent readiness to approve the AquaBounty salmon has inflamed a coalition of consumer, environmental, animal welfare and fishing groups, who have accused the agency of basing its judgment on data compiled from small samples supplied by the company, rushing the public portion of the review process and disclosing insufficient information about the fish.

The FDA does not have an approval process designed specifically for genetically engineered animals and is evaluating the salmon under the process used for new veterinary drugs. That means that much of the data provided to FDA to demonstrate the safety of the fish is considered a trade secret.

The process doesn’t allow enough public participation, doesn’t give the FDA enough leeway to consider environmental factors and doesn’t give the agency enough power to withdraw the salmon from the market if something should go wrong, said Greg Jaffe, director of the Biotechnology Project for the Center for Science in the Public Interest and a member of the FDA advisory committee that will evaluate the agency’s findings.

(click to continue reading FDA advisors to vote on genetically engineered salmon – latimes.com.)

So is this frankenfish safe to eat or not? I couldn’t tell you, but I’d sure like the FDA to conduct more tests instead of rushing this beast to market.

Fishy Fishy Fish

Egg Inspectors Failed to Raise Alarms

Seth Anderson0 comment

Surprise, surprise, another federal regulatory agency more concerned with the industry it is supposed to oversee than with the public it is allegedly supposed to protect and serve. If the USDA was a person, it could be jailed for crimes, but…

You Are Beautiful with Amish Meat

U.S. Department of Agriculture experts found growing sanitary problems including bugs and overflowing trash earlier this year on the Iowa farm at the center of the national egg recall, but didn’t notify health authorities, according to government documents and officials.

The problems laid out in USDA daily sanitation reports viewed by The Wall Street Journal underscore the regulatory gaps that may have contributed to delays in discovering salmonella contamination. Tainted eggs sickened at least 1,470 Americans.

Wright County Egg of Galt, Iowa, recalled 380 million eggs in mid-August, but people likely began getting ill around May 1, according to the Centers for Disease Control and Prevention.

Robert Arnold said he reported problems at Wright County Egg when he worked there, but was ignored.

The USDA was the only federal body with a regular presence at Wright, but it says it wasn’t responsible for safety. USDA graders were at a Wright egg-packing plant seven days a week to oversee designations such as “Grade A” on egg cartons.

The Food and Drug Administration, which has overall responsibility for egg safety but didn’t inspect the Wright facility until this August, says it never heard from the USDA about problems such as dirt and mold. The two agencies have a formal understanding about the USDA giving the FDA notice over sanitary issues, but the USDA declined to give details.

The USDA said it didn’t give notice because “the conditions at the egg plant packing facilities were routine.”

(click to continue reading Egg Inspectors Failed to Raise Alarms – WSJ.com.)

Routine. Yikes. That makes me feel like eating 50 eggs!


“Cool Hand Luke” (Warner Home Video)

Growing Concern About Tainted Eggs After Recall

Seth Anderson0 comment

Why is food safety such a low priority in Washington? How many people have to be sickened by agribusiness and factory farming methods before reform is undertaken? Are farm lobbyists really so powerful that the Senate has been sitting on Durbin’s Bill S. 510 for years? Unconscionable.

Holding My Life in My Hand

The latest action — the third recall announcement in two weeks for eggs — is bound to shake the confidence of consumers rattled by a succession of food safety scares in recent years, most prominently for foods like beef and lettuce.

The idea that half a billion suspect eggs have been circulating in the food supply comes as an embarrassment for the egg industry and federal regulators. New egg safety rules went into effect in July that the Food and Drug Administration had said would prevent tens of thousands of salmonella illnesses a year.

“You have to treat eggs with the assumption that they’re contaminated with salmonella,” said Carol Tucker Foreman, a food safety expert of the Consumer Federation of America. “We may all object to the fact that we have to treat food like toxic waste, but if we don’t want to get sick, and especially if you have someone in your house that’s immune-suppressed, you have to handle things carefully and demand that the standards be set higher.”

(click to continue reading Second Iowa Producer Recalls 170 Million Eggs – NYTimes.com.)

The FDA has been too lax for too long, and needs to be inculcated with a new mission, namely protecting consumers instead of the industry it purportedly regulates.

Herbal Supplements Often Have Contaminants, FDA Shrugs

Seth Anderson0 comment

Ru-oh. Yet again the FDA is ignoring problems instead of figuring out a plan to fix them, shirking its responsibility, and Washington co-signs.

Healthy or insane shelf 2

Nearly all of the herbal dietary supplements tested in a Congressional investigation contained trace amounts of lead and other contaminants, and some supplement sellers made illegal claims that their products can cure cancer and other diseases, investigators found.

The levels of heavy metals — including mercury, cadmium and arsenic — did not exceed thresholds considered dangerous, the investigators found. However, 16 of the 40 supplements tested contained pesticide residues that appeared to exceed legal limits, the investigators found. In some cases, the government has not set allowable levels of these pesticides because of a paucity of scientific research.

(click to continue reading Herbal Supplements Often Have Contaminants, Study Finds – NYTimes.com.)

Don’t understand why the FDA doesn’t take the time to test supplements for pollutants. What’s the downside? Is the American Chemical Council afraid of the answers? Namely, that pesticides and pollutants are in nearly every single item we consume, including vitamins and herbs?

This troubles me.

Senator Herb Kohl, a Wisconsin Democrat who will preside over Wednesday’s hearing of the Senate Special Committee on Aging, said that while improvements had been made in recent years in the oversight of supplements, “the F.D.A. needs the authority and tools to ensure that dietary supplements are as safe and effective as is widely perceived by the Americans who take them.”

Among the witnesses at the hearing will be Dr. Tod Cooperman, president of ConsumerLab.com, a company that has tested over 2,000 dietary supplements made by more than 300 manufacturers and has found that one in four have quality problems. According to Dr. Cooperman’s written testimony, the most common problems are supplements that lack adequate quantities of the indicated ingredients and those contaminated with heavy metals.

Travis T. Tygart, chief executive of the United States Anti-Doping Agency, wrote a letter to the committee saying that some athletes have been rendered ineligible for international competitions because they took supplements that contained steroids not listed on the products’ labels. There are thousands of supplements available for sale that contain steroids or other harmful ingredients, he wrote.

But this really troubles me:

In recent years, a vast majority of supplement suppliers have located overseas — principally in China. Nearly all of the vitamin C and many other supplements consumed in the United States are made from ingredients made in Chinese plants. Those plants are almost never inspected by the F.D.A. because the agency is not required to do so, has little money to do so and does not view the plants as particularly risky.

Made in China often means profit over quality, and lax oversight. Scary, if you consider the amount of vitamins and supplements that Americans consume.