Currently browsing posts about: FDA

We Americans like our eggs.

American egg producers provide us with about 76 billion eggs a year, which averages out to 242 eggs per capita.

But their safety can be iffy for two reasons: Salmonella and cholesterol.

Since the 1980s, more and more eggs have gotten contaminated with pathogenic Salmonella enteriditis, in part because of the increasing size of egg farms, and in part because of long delays in safety rules.

Salmonella is a preventable problem.

Producers must use clean food and water, probiotics to prevent development of pathogenic bacteria in hen intestines, and vaccines as necessary.  They also must keep eggs cold.

I discussed all this in my book What to Eat, in a chapter I called “Eggs and the Salmonella Problem.”  In it, I reviewed some history:

•  1997     Center for Science in the Public Interest petitions the FDA to do insist that egg farms follow standard food safety procedur.
• 1999     The FDA requires Safe Handling labels on egg cartons and refrigeration during storage and transport.
• 2004    The FDA proposes safety rules for on-farm egg production.
• 2009    The FDA issues rules to be implemented in 2010 for egg producers with 50,000 or more hens, and 2012 for producers with 3,000 or more.

Yesterday, the FDA issued Guidance for Industry:  Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation.

And it updated its Egg Safety home page.

Still to come: rules for producers of organic eggs that allow hens access to the outdoors.

But maybe we shouldn’t be eating so many eggs anyway?

A recent Canadian study associates eating egg yolks with formation of plaques in coronary arteries.

The egg industry doesn’t like this study much.

Eggs have been shown to have a wide range of health benefits, providing 13 essential vitamins and minerals, high-quality protein and antioxidants, all for just 70 calories.

It cites other studies giving different results.

These findings are surprising and contradict more than 40 years of research demonstrating that healthy adults can enjoy eggs without significantly impacting their risk of heart disease.

I like eggs.  I vote for everything in moderation on this one.  But having seen industrial egg facilities, I’m buying them from farmers’ markets these days—for reasons of food safety, animal welfare, and taste.

A full-page ad in Tuesday’s New York Times (July 17) alerts readers to the astonishing 18-month delay in issuing food safety rules authorized by the Food Safety Modernization Act passed by Congress at the end of 2010.

The sponsor of the ad, Make Our Food Safe, is a coalition of highly respected public health and advocacy groups working on food safety issues.

According to the New York Times report, they are baffled by the delay.

But the F.D.A. rules that are needed to carry out the law have been under review by the Office of Management and Budget in the White House since December, and consumer health advocates say there has been no explanation for what they describe as a lengthy delay.

….Before the rules become official, the F.D.A. still has to circulate them for public comment, adding more months to the process. The rules for importers were expected in January and for domestic food processors in July, advocates said.

Could the delay be due to election-year politics?  Advocates wonder if

Democrats may want to avoid the impression that government regulation is growing, a popular cause for attacks by Republicans.

The Office of Management and Budget denies this.

Moira Mack, a spokeswoman for the Office of Management and Budget, said that the agency coordinates suggestions from many institutions across the federal government, and that it is not unusual for the review process to take months. A regulation last year on dangerous snakes, for example, took about 10 months to clear, she said.

Oh come on.  These rules are about protecting the public from dangerous microbes.  They need to move.

The Make Our Food Safe website makes it easy to write President Obama to release the FDA’s proposed rules.    Add your voice!

Yesterday’s international edition of USA Today (I picked it up at Heathrow) carried a full-page ad from the Ad Council, which donates its services to worthy causes every now and then.  This one, entirely in grey and white, displays logos from the Ad Council, USDA, and the Department of Health and Human Services (DHHS), the parent agency of FDA.

In inch-high letters, all caps: DO YOU WANT THAT SAFE OR MEDIUM-SAFE?

In quarter-inch letters, also caps: USE A FOOD THERMOMETER TO MAKE SURE YOU COOK RAW MEAT AND POULTRY TO A BACTERIA-KILLING TEMPERATURE.

The ad also displays the Cook, Clean, Chill, Separate logo and the admonition to “Keep your family safer from food poisoning.  Check your steps at foodsafety.gov.”

Mind you, I’m highly in favor of following food safety procedures at home.

But most food safety problems are not due to the failure of home cooks to use thermometers.

They are caused by failures to observe food safety procedures during commercial production and preparation.

Shouldn’t meat and poultry be safe when you buy it in the supermarket?

This ad implies that the principal responsibility for food safety lies with the end user—you.

If you get sick it’s your fault because you didn’t use a meat thermometer?

USDA and DHHS:  how about getting the Ad Council to encourage meat and poultry producers to make sure their products are safe in the first place.

Cheers to the FDA.  It just said a firm no to the Corn Refiners’ petition to be allowed to call High Fructose Corn Syrup (HFCS) “corn sugar.”

The FDA’ s rationale:

• Sugar is solid, dried, and crystallized.  Syrup is liquid.  HFCS is liquid.  Therefore, it is syrup, not sugar.
• Corn sugar already has a regulatory definition: dextrose (glucose).  HFCS contains fructose as well as glucose.  Therefore, it is not corn sugar.

As I mentioned earlier, I filed comments to the FDA on the Corn Refiners’ petition:

The [Corn Refiners’] website quotes comments I have made to the effect that HFCS is biochemically equivalent to sucrose. It is. But I do not believe that biochemical equivalence is a good reason for the FDA to agree to a name change at this point.

It is highly unlikely that public misunderstanding of nutritional biochemistry and the differential physiological effects of glucose vs. fructose will be addressed and corrected by changing the name of HFCS to corn sugar.

…the name change is not in the public interest. Its only purpose is to further the commercial interests of members of the Corn Refiners, and that is not one the FDA should be concerned about.

I was referring here to the legal and public relations wrangling between the Sugar Association, which represents the growers of cane and beet sugar (sucrose), and the Corn Refiners.

I have complained previously about the in-your-face behavior of the Corn Refiners in attempting to protect its share of the sweetener market: its strange advertisements; its use of my quotes (they told me the quotes are in the public domain and if I don’t like it I can sue them); its aggressive lobbying; its stated intention to use the term “corn sugar” whether the FDA approves it or not.

The Sugar Association’s behavior is not much better.  It has taken the Corn Refiners to court over the naming issue.

I was amused to receive two e-mails this week from its public relations firm complaining about the Corn Refiners’ clumsy PR response to a UCLA  study ostensibly showing that HFCS makes rats “fat and stupid.”  This study, however, did not compare the effects of sucrose and HFCS and its results, even if confirmed, could apply to any source of fructose.

The second e-mail sent links to the FDA’s decision and the Sugar Association’s response.

The FDA’s ruling represents a victory for American consumers,” said Dan Callister, an attorney for the plaintiffs in the ongoing litigation. “It reaffirms what most consumer advocates, health experts and policy officials have been saying all along: only sugar is sugar. HFCS is not sugar. The next step is for the federal court to end the CRA’s misleading propaganda campaign.

Sugars, plural, are sugars.  Sucrose is glucose and fructose.  So is HFCS.

Everyone would be better off eating a lot less of both.

And that brings me to New York City Mayor Michael Bloomberg’s latest attempt to promote the health of his constituents: banning any sugary drink larger than 16 ounces from restaurants, movie theaters, and street carts.

I can’t wait to see how the Beverage Association deals with this one.

Addition June 1: Rosie Mestel of the L.A. Times has an excellent account of this in which she quotes from these comments.  Her story is accompanied by a PR photo from the Corn Refiners Association.  What are these people thinking?

• DMAA does not naturally come from a food.
• Most of it is produced synthetically
• It might not be safe.

In response to my post on tuna scrape, Professor Alan Reilly, Chief Executive, Food Safety Authority of Ireland (the equivalent of our FDA) sent this photograph of an actual tuna scrape label.

After I forwarded it to Bill Marler, he noticed that it is one of several photographs posted on the FDA’s tuna scrape recall web page).

The type is too small to read so I’ve done some cropping:

Professor Reilly asks:

What is puzzling me is why this product “minced tuna” was used in sushi products. The label (copy attached) clearly states that the product must be cooked before consumption and it is for industrial uses only (labelled not for retail).

Those are good questions, but here’s another, equally alarming.  What’s that strangely formatted Nutrition Facts label? It does not precisely follow FDA design or content requirements.

This is a red flag.  If the company is not following labeling rules, it might not be  following other rules either—safety, for example.

Safety?  Uh oh.

Bill Marler reports that the FDA “483 Inspection Report” on the Indian tuna processing facility is now available.  Read these quotes and shudder:

• Tanks used for storage of process waters have apparent visible debris, filth and microbiological contamination.
• There is no laboratory analysis for water used in ice manufacturing at the [redacted] facility to show the water used to make ice is potable.
• Apparent bird feces were observed on the ice manufacturing equipment at Moon Fishery; insects and filth were observed in and on the equipment.
• Tuna processed at your facility, which is consumed raw or cooked, comes in direct contact with water and ice.

I draw several lessons from this episode:

• Food is safer when cooked.
• Labels need to be read—and followed—carefully.
• Raw sushi is a high risk product, especially if it doesn’t cost much.
• The FDA needs to be doing a lot more inspecting of overseas facilities, and before they cause problems.

All of this means that we need a better food safety system, one that can address the enormous proportion of our food supply that comes to us from countries with weaker food safety standards.

Addition, May 17: Ben Embarek, a food safety scientist at the World Health Organization notes that the 483 report reveals that Moon’s HACCP plan did not list appropriate critical control points.  Anyone auditing the plan should have picked up the problems on paper, which is easier and less expensive to do than an on-site inspection.  But the FDA does not pre-audit international HACCP plans.  They are supposed to be cleared by exporting companies registered by FDA.  Comment: it’s hard to imagine that the current system can work, and it clearly does not.

I was riveted by an article in today’s New York Times about the latest decision of an FDA drug advisory panel.

The panel voted to approve a new weight-loss drug, lorcaserin.  The vote was mixed: 18 for approval, 4 against, and 1 abstention. The majority felt that the benefits outweighed the risks and that even if there were risks, “new tools are needed to treat a major health problem.”

The benefits are worth a look.

• People taking the drug lost an average of  5.8% of their body weight in a year, compared to 2.5% for people taking a placebo.  This difference is below the FDA’s standard for approval which requires a 5% difference.
• Among those taking the drug, 47% lost at least 5 percent of their weight after a year, whereas only 23% of those taking the placebo did so.  This meets a second FDA standard for approval.

What about the risks?  The drug:

• Causes tumors in rats (although perhaps at higher doses than might be taken by people).
• Damages heart valves (in the same way the withdrawn drug, Fen-Phen, did).

Also in the Times is a piece by Dr. Danielle Ofri on her experience with patients who want weight-loss drugs.

She quotes from an essay called “Lemons for Obesity” by Dr. Michael S. Lauer, who was a minority voter on the FDA panel that approved the weight-loss drug Qnexa earlier this year.

The weight-loss field is strewn with lemons, more so than other areas of medicine, Dr. Lauer argues. Because of the enormous potential market for these drugs — two-thirds of American adults are overweight or obese — pharmaceutical companies rush new drugs to market after conducting only small clinical trials. The F.D.A. and doctors are complicit in the process, Dr. Lauer says, leaving the population at large to act essentially as guinea pigs.

Shares of the maker of the drug nearly doubled after the decision.  The Times reported that “Arguments by investors have been passionate.”

People who cannot easily lose weight are desperate for help.

But is it ethical to put them at this kind of risk?

The Government Accountability Office is complaining again about the inadequacies of the American food safety system, and with good reason.

Its 2012 Annual Report, Opportunities to Reduce Duplication, Overlap and Fragmentation, Achieve Savings, and Enhance Revenue, says that the food safety system is:

fragmented and results in inconsistent oversight, ineffective coordination, and inefficient use of resources.

In 2007, GAO added food safety to its list of high-risk areas that warrant attention by Congress and the executive branch.

More recently GAO found that this fragmentation extends to the responsibilities across multiple agencies to defend food and agricultural systems against terrorist attacks and natural disasters…Many of these activities are everyday functions or part of the broader food and agriculture defense initiative and would be difficult for the agencies to separately quantify.

This report repeats what the GAO has been saying since the early 1990s:

there is no centralized coordination to oversee the federal government’s overall progress in implementing the nation’s food and agriculture defense policy.

Because the responsibilities outlined in this policy (HSPD-9) are fragmented and cut across at least nine different agencies, centralized oversight is important to ensure that efforts are coordinated to overcome this fragmentation, efficiently use scarce funds, and promote the overall effectiveness of the federal government.

Reminder: the present food safety system is mainly divided between two agencies: USDA (meat and poultry) and FDA (everything else).

Centralized oversight of food safety?  What a concept.