Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Tuesday, March 10, 2009

Guest Memo: Satire From The Onion - 'FDA Approves Salmonella'

FDA director Stephen Sundlof okays the bacteria for eating, drinking, and applying directly to the skin. [the Onion. March 10, 2009.]

On The Lighter Side

From the Natural~Specialty Foods Memo (NSFM) Editor's Desk: As we're all too aware, the food-borne pathogen salmonella is a tough one to shake. In 2007 it showed up in salad greens in the United States. In 2008 it appeared in fresh peppers and Roma tomatoes. And now -- its peanut butter. Salmonella appears to be the enterobacteria that keeps on giving when it comes to appearing in various parts -- and products -- of the U.S. food supply chain.

And try as it might, the U.S. Food and Drug Administration (FDA) just hasn't been able to figure out how to stop these frequent and very serious food safety issues centered around Salmonella contamination in a host of very different foods and food products.

Perhaps the satirical publication "the Onion" has the right approach in a piece it published today. In that piece, "FDA Approves Salmonella," "the Onion" offers an "if you can't beat it embrace it" approach to the Salmonella contamination issue.

We reprint the humor piece from "the Onion" below (in italics). Remember -- it's satire:

WASHINGTON—Calling it "perfectly safe for the most part," and "not nearly as destructive or fatal as previously thought," the Food and Drug Administration approved the enterobacteria salmonella for human consumption this week.

The federal agency, which has struggled in recent years to contain the food-borne pathogen, and repeatedly failed to prevent tainted products from reaching store shelves, announced Monday that salmonella was now completely okay for all Americans to enjoy.

"Rigorous testing has shown that salmonella is...fine," FDA director of food safety Stephen Sundlof said. "In fact, our research indicates that there's no need to pull any more foodstuffs from the market. Not raw chicken. Not contaminated spinach. Not thousands of jars of harmful peanut butter. Not anything."

"It's approved," Sundlof continued."Healthy, delicious salmonella is finally approved."

Following the announcement, the FDA released a 20-page report, which included evidence that salmonella is barely more dangerous than other live-culture products such as yogurt, and results from a clinical trial which found that participants who ingested salmonella were totally fine for up to three minutes.

The report also concluded that salmonella has been around American kitchens for centuries now, and must therefore be at least harmless, if not actually good for us.

"Of course, as with everything, we encourage moderation," lead FDA researcher Phillip Millar said. "Don't just eat a whole pint of salmonella in one sitting. It's like ice cream or, for example, E. coli in that respect."

Added Millar, "A little bit goes a long way."

According to FDA officials, the intracellular bacterium will be commercially available in a variety of forms. Plans are already in the works to offer salmonella as a flavorful topping, food spread, powdered drink mix, dessert gelatin, and as a "no frills" yellow liquid guaranteed to enhance one's overall eating experience.

With hundreds of possible applications, the newly approved gram-negative microbe will also open the door for many innovative and exciting products.

"This is thrilling news," Hellmann's CEO Robert Reichert said. "We've been waiting for the federal go-ahead to produce salmonella for decades now. In fact, we have an entire line of lukewarm, sun-soaked, and partially turned mayonnaises that we just know Americans will love."

A variety of products containing the newly approved food-borne microbe will hit non-refrigerated shelves this month. [the Onion. March 10, 2009.]

One of several new foods to feature the motile microorganism is Salmonell-Os—an O-shaped breakfast cereal packed with hearty typhoid clusters—which is expected to hit grocery stores by April.

Other products currently in development include Salmonella Helper, Kraft's Extremely Painful Mac, 'Nella Wafers, and peanut butter.

"Now that salmonella's been approved, we're working overtime to get our products to market," said David Wellbrook, head of sales for Oscar Mayer, the nation's leading producer of bologna-based goods. "I've never seen so many orders come through in a single year, much less a single day. It's incredible."

News of salmonella's approval also comes as a relief to many homemakers, who, until now, had been cautioned against letting the bacteria spread.

"It used to be such a pain to have to sanitize my kitchen," Chicago resident Margaret Thewles said. "Now all I need is one cutting board. I'll cut raw poultry on it, prepare my salad veggies on it, and then use it to serve dessert when I'm done."

Salmonella is said to contain the seven essential forms of bacteria growing infants need. [the Onion. March 10, 2009.]

Michael Weinback, a California native and father of two young children, agreed with Thewles."

This is…arrghhh…great," Weinback said from the bottom of his living room stairs. "Oh, Jesus…here it comes agai—uuuuhhhhh, Christ. Get hel…just get…aarrghh.

[Natural~Specialty Foods Memo (NSFM) Editor's Note: NSFM thanks"the Onion" for permission to reprint the satirical story above. Click here to read the original satirical piece at "the Onion" Web site.

Thursday, November 13, 2008

Food Safety Memo: U.S. Federal Government to Detain All Chinese Milk-Based Food and Beverage Products at the Border Until Shown to Be Safe

On Tuesday, November 11, we wrote this story, " Food Safety Memo: U.S. President-Elect Obama Said to Plan On Beefing Up FDA Enforcement, Regulations; Speculation Rampant On New FDA Chief about plans by the incoming U.S. President Barack Obama and his administration to take action to beef up the regulatory powers and enforcement activity of the U.S. Food & Drug Administration (FDA) once he assumes office in 72 days.

On Tuesday we also wrote this analysis piece, "Food Safety Memo: Maybe the Chinese Government Needs to Look to its Minority Muslim Population for Food Safety Advice and Expertise?" suggesting a potential solution for the Government of China to its chronic and serious food safety problems.

Late today both of our Tuesday stories sort of came together from a public policy standpoint. To the surprise of many observers, the U.S. federal government announced today it would start detaining all imported food products from China that contain milk, such as candy, snacks, bakery goods, pet foods and other Chinese products that contain milk, and hold there there until tests demonstrate the products aren't contaminated with melamine or anything else.

Below are a number of news reports on the surprise announcement by the U.S. federal government:

~New York Times, November 13, 2008: FDA Detains Chinese Imports for Testing

~Washington Post, November 13, 2008: US Blocks Chinese Milk

~Others: The Citizen Daily - BBC News - CNN International - The Epoch Times

This development could have some serious political and economic implications between the U.S. and China. After all, China is buying most of the government securities the U.S. is issuing as fast as the government printing presses can produce the notes to pay for the nation's $700 billion financial industry bailout, the economic stimulus package, two wars and a host of other programs and operational activities. China in affect is currently the United State's number one banker.

The way China earns the money to be the banker to the U.S. is from exporting goods. And the U.S. is China's number one market. As a result, China might not be pleased about the new U.S. policy of detaining its exported food and beverage products containing milk at the border. Bankers can get angry without much provoking these days, especially when that banker has a silent agreement with the nation's superpower, the U.S., to be its financier in return for lax trade enforcement policies.

We agree with the U.S. federal government's move though. After all, why risk death and illness from these tainted milk products, which have killed four children in China and sickened thousands there and in other Asian nations. Numerous countries like Japan and Australia have slapped complete bans on Chinese milk-based products in fact because of the melamine contamination.

We also think the move by the U.S., which will anger China initially, will act as a shot in the arm in terms of further motivating the Communist government to fix its food safety system. That's something that's overdue for the world's fastest-growing economy.

Tuesday, November 11, 2008

Food Safety Memo: U.S. President-Elect Obama Said to Plan On Beefing Up FDA Enforcement, Regulations; Speculation Rampant On New FDA Chief


USA: Election 2008 Special Report

For the last few years under the administration of President George W. Bush, the United States has experienced food safety after food safety problem, with both domestically-grown fresh produce and imported foods.

For example, there have been the major salmonella outbreaks from domestically-grown fresh produce -- first in bagged spinach and lettuce greens, then in Roma tomatoes and peppers. Numerous people died from these outbreaks and many more fell ill.

Then there's been the host of food safety problems from imported foods. The most recent one being Chinese-produced powdered and fluid milk intentionally contaminated with melamine, along with products like candy made in China with the adulterated milk. Additionally, there have been many others as well, including contaminated snack foods from China and candy from Mexico with high lead content, to name just two incidents.

None of the adulterated Chinese powdered milk made it to U.S. shores. But some of the melamine-laced candy did. Fortunately it has thus far been discovered and pulled off the shelves of Asian food stores in the U.S. before it could harm consumers.

Milk laced with higher than trace amounts of melamine, like the Chinese milk and milk-related products have been, can cause serious kidney damage, particularly in small children. As of yet there haven't been any reported deaths or cases of serious illness in the U.S. from the milk-based candy containing melamine.

Most experts and observers -- including many agricultural and food industry companies -- blame the rash of food safety problems in both domestic and imported foods in the U.S. on the deregulation policies over the last eight years of the Bush Administration, along with a lack of proper funding of the U.S. Food & Drug Administration (FDA) by both the President and Congress.

The lack of enforcement is likely to change under the new administration of President-Elect Brarack Obama though, Neera Tanden, a senior Obama advisor, tells the Associated Press (AP).

Food safety will be a priority for Obama's FDA, she says. "He (Obama) thinks this is a fundamental role of government to ensure that people's food is safe and he has been concerned that we are not in a position to ensure that."

Read the AP's full report (in Italics) below:

Obama expected to bolster FDA oversigh for domestic, imported foods
By Ricardo Alonzo-Zaldivar
October 10, 2008

The Food and Drug Administration (FDA), bedeviled by a salmonella outbreak and tainted medicine and milk from China, is likely to monitor imports and fresh produce more closely under an Obama administration.

With President Bush no longer a roadblock, health officials also can expect new powers to control tobacco, from cigarettes to the recently introduced smokeless products called snus.

President-elect Obama, a former smoker struggling to avoid relapse, is a sponsor of legislation giving the FDA authority to control, but not ban, tobacco and nicotine.

Long seen as the government's premier consumer protection agency, the FDA stumbled under Bush. Recurring drug and food safety lapses came against a backdrop of shrinking budgets and long periods without a permanent leader. In Congress, a senior Republican complained the FDA had gotten too cozy with industry.

Obama is being urged to move quickly to appoint an FDA commissioner. Already more than a half-dozen names are in circulation: outside critics such as Cleveland Clinic cardiologist Dr. Steven Nissen; insiders such as Susan Wood, a former director of the FDA's women's health office; and public health advocates such as Dr. Joshua Sharfstein, Baltimore's health chief.

Food safety will be a priority for Obama's FDA. "He thinks this is a fundamental role of government to ensure that people's food is safe and he has been concerned that we are not in a position to ensure that," said Neera Tanden, a senior campaign adviser.

Obama will be working with a Democratic-led Congress, including lawmakers who have written legislation to bolster import inspections.

Only a fraction of imported food is inspected now. Foreign drug manufacturing plants can go years without an FDA visit. Democrats had considered fees on industry to pay for more FDA inspectors, but could not persuade the Bush administration to go along. They expect Obama to be receptive.

Tanden said Obama is open to the idea of requiring a tracing system for fresh produce. That became an issue during this summer's salmonella outbreak, after the FDA spent weeks hunting for tainted tomatoes only to find the culprit might have been hot peppers.

"An Obama administration would swing the pendulum back more to protection of public health," said William Hubbard, a retired FDA official who held top posts. "This bodes well for greater regulation in the food safety area, on imports, and on drug safety."

Under the tobacco proposal, the agency would be able to order changes in tobacco products to make them less toxic and addictive, but could not ban tobacco or nicotine. The bill passed the House and Senate with bipartisan support, but a veto threat from Bush kept it from getting out of Congress.

Aides to Sen. Edward M. Kennedy, D-Mass., co-author of the tobacco bill, say there is strong interest in getting the legislation passed soon after the new Congress convenes in January. Obama is a co-sponsor.

Natural~Specialty Foods Memo Issue Analysis

As the AP story also discusses, speculation is rampant over who President-Elect Obama will name to head the FDA. The names are all informed speculation right now. But one thing we know for sure is Obama won't carry the current Bush Administration FDA chief over into his administration like some are suggesting he might do with Defense Secretary Robert Gates.

The stories linked below further discuss and offer some analysis about the speculation on who Obama might name to head the U.S. Food & Drug Administration, including naming names:

Scientific American - November 7, 2008: Speculation swirls about Obama's EPA and FDA heads....Baltimore Sun - November 7, 2008: Baltimore's Sharfstein mentioned as possible FDA commissioner....Bloomberg - November 6, 2008: Woodcock Gains Support From Drugmakers for US FDA's Top Job. [Note: We think former Senator and Democratic candidate for President in 2004 Howard Dean, who is a medical doctor and announced yesterday he plans to leave his position as chairman of the Democratic Party when it is up next year, could be a candidate as well for FDA Commissioner, although we peg him more likely for Suregeon General if President-Elect Obama names him to a post in the administration.]

The Obama Administration isn't likely to get much opposition to strengthening the regulation of domestic and imported fresh produce and other foods from America's agriculture and food industries. For the last couple years the industries has been lobbying the Bush Administration for stronger enforcement of regulations , and higher FDA budgets, because the numerous food safety problems have not only hurt sales, they've also damaged the reputation of the food and agriculture industries among consumers.

In fact, earlier this year, the Bush Administration added a a couple billion dollars to the budget of the FDA as a reaction both to the numerous food safety problems as well as in response to requests directly from the industry to do so.

There's a particular across the board concern about stopping the food safety problems from goods imported into the U.S. -- and China just happens to be the country that time and again has had the most serious problems.

The U.S. (and the world) is locked in a financial and credit crisis, the U.S. is in an economic recession and the U.S. government has a record deficit and debt.

So far Since $700 billion has been appropriated -- $700 billion the U.S. doesn't have in real money -- to bail out America's banks and financial institutions.

Another nearly $100 billion has already been spent for a economic stimulus package (tax rebates to citizens). Those checks went out months ago and have seemed to do little to help the U.S. economy.

Congress is now talking about another stimulus package of $100 -to- $125 billion, perhaps enacted before the year is over.

Add just these three items together and you are talking about one trillion dollars. And there is more spending to come.

And of course, the U.S. doesn't have this trillion dollars. Rather, it just fires up the government printing presses, already running 24 hours a day, prints the currency, and then sells government-backed securities to the Chinese, Saudis, Japanese and Europeans to back the new money, greater a bigger deficit.

With the financial crisis and economic recession situation so pressing, we wonder how fast the Obama Administration will want to and be able to move on beefing up the FDA, which will cost at least a couple billion more to start? The new President can issue an immediate order right away though when he takes office on January 20, telling the agency the days of lax regulation enforcement are over, which should help if it does nothing else but sends a clear message to the tens of thousands who work at the FDA.

It's clear the economy is domestic priority number one for the President-Elect, who becomes the 44th U.S. President in 72 days. And that is how it should be. But it's also clear food safety will be pressed on the new President as a top concern as well -- from consumer advocates, health officials and even the food and agricultural industries.

It's going to be a tough, and expensive, 2009. But that's what HOPE is all about -- along with some good plans and strategies -- and a whole lot of good luck along with them.