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.

1 comment:

Stephen Fox said...

Dr. Dean could do with American health what he did in revitalizing the Democratic party and in bringing victory in 2008, by countering Big Pharma and Big Junk Food and their corrupted influence on the FDA's Regulatory processes, and that would be an achievable miracle, a 50 state strategy for
Health and Preventive Medicine, which we direly need as a nation!

see my latest article, on of many on this subject here:


[title Why Howard Dean, MD, would be the best Health Secretary or FDA Commissioner]

Stephen Fox, Contributing Editor
New Mexico Sun News