Currently browsing posts about: FDA

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.

The FDA has just released a classy new report on Global Engagement, summarizing its efforts to deal with issues raised by the globalization of drugs, medical devices, and foods.

This is a big deal.  In 2009, 300,000 foreign facilities in more than 150 countries exported $2 trillion worth of FDA-regulated products to the United States.

Given these numbers alone, the FDA has some challenges.

In 2011, one out of every six FDA-regulated food products in the U.S. came from abroad.  Imports of fresh fruits, vegeta­bles, coffee, tea, and cocoa have more than doubled since 2000.

We import:

• 80 percent of seafood
• ~50 percent of fresh fruit
• ~20 percent of fresh vegetables

As the report explains,

• Many products entering the United States are made or grown in countries that lack the necessary regulatory over­sight to ensure their quality and safety.
• Greater numbers of suppliers, more complex products, and intricate multinational supply chains introduce risks to product safety and quality, including more oppor­tunities for economic adulteration and the spread of contaminated products.
• FDA can only realistically inspect a small percent­age (less than 3 percent) of the enormous volume of food products arriving at U.S. ports of entry, making it crucial that the Agency focus on ensuring that food products meet U.S. standards before they reach the United States.

To deal with this problem, the FDA has opened offices in:

• China: Beijing, Shanghai, and Guangzhou
• India: New Delhi and Mumbai
• Latin America: San Jose, Costa Rica; Santiago, Chile; and Mexico City, Mexico
• Europe: Brussels, Belgium; London, United Kingdom; and Parma, Italy
• Asia-Pacific: FDA headquarters
• Sub-Saharan Africa: Pretoria, South Africa
• Middle East and North Africa: Amman, Jordan

The FDA seems seriously concerned about its global initiatives and the safety problems posed by our globalized food supply.

The volume seems impossible to manage.  Let’s hope the FDA’s efforts do some good.

A reader writes:

Here’s what I don’t understand.

Everyone who is scared of raw says they want their dog’s food to be cooked, to kill salmonella.

But here is kibble, which by definition is cooked to the point of losing most of its original nutrients, but STILL has salmonella.

I don’t see how this is possible.  If it’s cooked enough to be “kibbled,” how can it possibly still have salmonella? It just seems like the worst of all possible worlds.

This question refers to the recent recall of dry dog food manufactured by Diamond Pet Foods.

As the CDC explains, Michigan public health officials found Salmonella in an unopened bag of a Diamond kibble product during routine testing.  This particular Salmonella strain had been found to infect at least 14 people.

CDC investigators connected the dots between the illnesses and dog food through interviews:

Seven of 10 (70%) ill persons interviewed reported contact with a dog in the week before becoming ill.

Of 5 ill persons who could recall the type of dog food with which they had contact, 4 (80%) identified dry dog food produced by Diamond Pet Foods that may have been produced at a single facility in South Carolina.

In my book, Pet Food Politics: The Chihuahua in the Coal Mine, I tell the story of the massive pet food recalls of 2007 due to contamination with the industrial chemical, melamine.  And in Feed Your Pet Right, my co-authored book about the pet food industry, I explain how pet foods are manufactured and why they are so subject to contamination and recall.

Canned pet foods are sterile.  Dry kibble is not.  It may be sterile at the point of extrusion, but it is a perfect growth medium for bacteria.  It is nutritionally complete.  Although some nutrients are lost during processing, the product formulas compensate for such losses.  That is why dogs can survive on “complete and balanced” dry foods.

If the factory is contaminated with Salmonella, the bacteria can fall into the production lines and get packaged into the kibble bags.

Dogs are relatively resistant to Salmonella and usually do not show signs of illness from eating contaminated kibble.

But humans who handle the food or the dog can acquire the bacteria and get sick.

This makes dry dog food a potentially hazardous product, one best kept away from people with weak immune systems such as young children and the elderly.

People like feeding dry food to pets because it is convenient and cheap.

My point in Pet Food Politics was that pet food is an indicator of problems in food safety regulation.  If pet foods are not forced to be produced under strict food safety measures, humans and the human food supply are also at risk.

Resources

• Products recalled by Diamond Pet Foods
• FDA’s main Diamond recall page
• FDA’s recall announcement, puppy food
• FDA’s recall of Chicken Soup for Pet Lover’s Soul
• Food Safety News account of the recalls
• Food Safety News post on what dog owners should do 
• AmericanVeterinary Medicine Association’s list of previous pet food recalls