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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 

Ordinarily I find government plans of this type to be soporific but this one is especially well written and well thought out (with some caveats).

The report is a statement of FDA commitment to what it is going to do in the next four years in food areas that affect people and animals.  It includes many promises, among them this one of particular interest: 

Program Goal 4: Provide accurate and useful information so consumers can choose a healthier diet and reduce the risk of chronic disease and obesity

Objective 1. Update the Nutrition Facts label.

• Publish proposed rules updating the nutrition facts label and serving sizes [OK, but by when?].
• Publish final rules updating the nutrition facts label and serving sizes [Ditto].

Objective 2.  Implement menu and vending machine labeling regulations.

• Publish final menu and vending machine labeling regulations [OK, but by when?].
• Collaborate with states, localities and other partners to ensure high rates of compliance.

Objective 3.  Improve consumer access to and use of nutrition information.

• Explore front‐of‐pack nutrition labeling opportunities [Explore?  See comment below].
• Collaborate with public/private sector parties on nutrition education [Collaborate?  See comment below].
• Implement updated standards for the labeling of pet food including nutrition and ingredient information [How about a Pet Facts label for pet foods that someone might actually be able to understand?].
• Implement standards for animal feed ingredients.
• Publish final rule defining and permitting use of the term “gluten free” in the labeling of foods.

Goal-setting processes usually include dates by which the objectives are to be completed.  These do not, which suggests that the FDA can continue to delay action until 2016. 

I also do not understand what is meant by “Explore front‐of‐pack nutrition labeling opportunities.”  Explore?  The FDA has already sponsored two Institute of Medicine reports on front-of-pack labeling.  Does this mean the agency is ignoring them and intends further research?

And “Collaborate with public/private sector parties on nutrition education?”  What does the FDA have in mind for the content of such education?  You can bet that no collaborative campaign can focus on “don’t drink your calories.” 

FDA needs to deliver on these items, and sooner rather than later.  This year?  I’m not counting on it.

Yesterday, the FDA proposed long-awaited action against use of antibiotics for non-therapeutic purposes in animal agriculture.

From the outside, this might look more like inaction.  The agency is asking drug companies to voluntarily cut back on producing antibiotics for non-therapeutic purposes and to require veterinary oversight of use of these drugs.

The announcement comes in the form of three documents in the Federal Register.

• Final Guidance for Industry: The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals.
• Draft Guidance for Industry aimed at assisting drug companies in voluntarily removing from FDA-approved product labels uses of antibiotics for production rather than therapy, and voluntarily changing the marketing status to include veterinary oversight.  This is open for public comment.
• A draft of a proposed Veterinary Feed Directive regulation,  also open for public comment, outlining how veterinarians can authorize the use of antibiotics in animal feed.

In an FAQ on the announcement, the FDA answers some obvious questions:

4. What is “judicious use” and what are FDA’s recommendations?

“Judicious use” is using an antimicrobial drug appropriately and only when necessary;

Based on a thorough review of the available scientific information, FDA recommends that use of medically important antimicrobial drugs in food-producing animals be limited to situations where the use of these drugs is necessary for ensuring animal health, and their use includes veterinary oversight or consultation.

FDA believes that using medically important antimicrobial drugs to increase production in food-producing animals is not a judicious use (my emphasis).

5. Why did FDA decide to do this now?

FDA has worked with many stakeholder groups and the U.S. Department of Agriculture (USDA) to develop a strategy that will be successful in reducing antimicrobial resistance while minimizing adverse impacts on animal health and disruption to the animal agricultural industry.

In June 2010, FDA released a draft guidance document explaining its recommendations for change and in the interim period sought and received input from various stakeholders, including the animal pharmaceutical industry, animal feed industry, veterinary and animal producer communities, consumer advocacy groups and USDA.

Translation: this has been in the works for a long time and is the result of extensive discussions with the relevant industries.

As Food Safety News explains, the reaction of just about everyone to this announcement has been tepid.

• Food safety advocates object to voluntary, because it never works.
•  The meat industry insists that non-therapeutic antibiotics are essential for producing cheap meat under crowded conditions.

For example, the National Pork Producers make the usual industry arguments:

Harm to small farmers: The guidance could eliminate antibiotics uses that are extremely important to the health of animals…And the requirement for VFDs [veterinary oversight] could be problematic, particularly for smaller producers or producers in remote areas who may not have regular access to veterinary services.

Voluntary equals regulation: The guidance, which does not have the force of law but may be treated as such by FDA, is a move to address an increase in antibiotic-resistant illnesses in humans, which opponents of modern animal agriculture blame on the use of antibiotics in livestock and poultry production.

The science is “junk”: But numerous peer-reviewed risk assessments, including at least one by FDA, show a “negligible” risk to human health of antibiotics use in food-animal production.

My interpretation:

The FDA’s position on non-therapeutic use of antibiotics in animal agriculture is quite clear.  The agency recognizes that based on the science, the use of antibiotics as growth promoters in animals poses a serious risk to human health.

I’m guessing this is the best the FDA can do in an election year.

This move looks to me like a direct challenge to drug companies and meat producers to clean up their acts and take some responsibility for the effects of their misuse of animal antibiotics on public health.

It’s also a challenge to food safety advocates to make sure that the FDA monitors the effects of its voluntary guidance and, if the industries don’t cooperate, that the FDA gets busy on real regulations.

Addition: The account in today’s New York Times explains why the FDA is starting with voluntary efforts:

The reason for the reliance on voluntary efforts is that the F.D.A.’s process for revoking approved drug uses is lengthy and cumbersome, officials said. The last time the F.D.A. banned an agricultural use of a medically important antibiotic against the wishes of its maker, legal appeals took five years. In this case, hundreds of drugs are involved, each with myriad approved uses in various animals.

“You and I and our children would be long dead before F.D.A. could restrict all of these uses on its own,” Ms. Rogers [of the Pew Foundation]said.

Apparently as a result of a need to cut costs, the USDA is changing the way its inspectors oversee chicken processing.

As Dana Milbank of the Washington Post puts it, this is

a proposal to allow chicken slaughterhouses to inspect themselves — eliminating those pesky federal monitors who have the annoying habit of taking diseased birds out of the food supply.

Even if the Obama administration were inclined to bring down capitalism with an orgy of overregulation, there isn’t enough money in the budget to enforce the rules on the books.  That’s what the chicken fight is about: Spending cuts…are a form of de facto deregulation (my emphasis).

The New York Times account of this policy change notes that inspectors:

had observed numerous instances of poultry plant employees allowing birds contaminated with fecal matter or other substances to pass. And even when the employees try to remove diseased birds, they face reprimands….

The Agriculture Department proposal allows poultry plants to speed up their assembly lines to about 200 birds per minute from 140, hampering any effort to examine birds for defects.

But that’s not all.  The Center for Livable Future at Johns Hopkins  reports that meal made from chicken by-products (in this case, feathers) contains arsenic and antibiotics such as fluoroquinolones that have been banned by the FDA for use in poultry.

A study published in Environmental Science & Technology found fluoroquinolone antibiotics in 8 of 12 samples of feather meal collected from six states and China.

A second study found arsenic in every sample of feather meal tested.

These findings indicate that poultry producers are using these drugs, even though they are not allowed to.

The U.S. poultry industry raises about 9 billion chickens and 80 million turkeys for human consumption each year.  Meal made from their feathers is commonly added to feed for chickens, pigs, cattle, and fish.  This could be a reentry route into the human food supply for such drugs.

Nicholas Kristof explains in the New York Times that these studies also found feather meal to contain

an antihistamine that is the active ingredient of Benadryl…[and] acetaminophen, the active ingredient in Tylenol.  And feather-meal samples from China contained an antidepressant that is the active ingredient in Prozac.

Poultry-growing literature has recommended Benadryl to reduce anxiety among chickens, apparently because stressed chickens have tougher meat and grow more slowly. Tylenol and Prozac presumably serve the same purpose.

Such findings indicate some of the worst problems with industrial poultry production.  They result from pressures to produce chickens cheaply.  The faster chickens can be pushed to grow, the less feed they consume and the cheaper they are to raise.

I don’t know what the best system for inspection might be, but I’m quite sure that leaving food safety oversight to the discretion of the packers is not a good idea.  Neither is speeding up the line.  And neither is feeding chickens drugs that can affect human health.

Here is even more evidence for the need for an overhaul of our food safety system.

A single food safety system anyone?

Today’s New York Times has a long investigative piece on White House interference with FDA decision-making.

The FDA is supposed to make regulatory decisions on the basis of science. When President Obama came into office, he pledged to make decisions based on science and facts rather than ideology:

The truth is that promoting science isn’t just about providing resources—it’s about protecting free and open inquiry…It’s about ensuring that facts and evidence are never twisted or obscured by politics or ideology. It’s about listening to what our scientists have to say, even when it’s inconvenient—especially when it’s inconvenient.

The Times article documents instances in which the administration failed to keep that pledge.  Most of the instances concerned FDA-regulated drugs and devices, but one involves calorie labeling on restaurant menus.

Recall that when President Obama signed the health care reform act in 2010, he signed menu labeling into law.  This required chain restaurants and vending machines to post calorie labels.

The F.D.A.’s first draft of the guidelines — approved by the Department of Health and Human Services and the White House — included rules for movie theaters, lunch wagons, trains and airlines.

But when the FDA released its proposed regulations a year ago, these venues were exempted.

As I said at the time, “Uh oh. Food is sold everywhere these days as anyone who has been to a drug store lately can attest.”

According to the Times’ account, a White House health adviser insisted on these exemptions out of fear that Fox News might view labels on movie popcorn

as an especially silly example of the government intrusions that conservatives often mocked as the nanny state… This was the era of Glenn Beck, and the White House was terrified that Beck would get up and say this is all part of the nanny state.

That’s bad enough but I noticed other key omissions in the FDA’s proposed rules.  For one thing, they allow impossibly large ranges such as the 200-to-800 calories that Chipotle posts, for example.

For another, they say nothing about alcoholic beverages.  As I explain in Why Calories Count, alcohol calories count and alcohol is almost as calorie as fat (7 per gram).  The FDA is ducking this ostensibly because it does not have jurisdiction over alcohol (the Treasury Department does).

The FDA needs to take a good hard look at these issues.

It has not yet propose final rules.  Maybe the Times’ article will give the FDA some breathing room and allow it to do the right thing this time.

And the FDA needs to get the rules out fast.  If the Supreme Court strikes down health care reform, will that mean the end of menu labeling as well?

FoodNavigator.com has issued a collection of its recent articles on “natural” and processing.  At issue is the meaning of “natural,” which many people perceive as equivalent to organic or healthy.  As I’ve said before, it isn’t.

Natural has no regulatory meaning.  The FDA merely says (note obfuscating double negatives):

From a food science perspective, it is difficult to define a food product that is ‘natural’ because the food has probably been processed and is no longer the product of the earth.

That said, FDA has not developed a definition for use of the term natural or its derivatives. However, the agency has not objected to the use of the term if the food does not contain added color, artificial flavors, or synthetic substances.

One thing is clear: “natural” sells food products.

Selling processed foods in a whole food world? Authenticity is key: Consumers increasingly are choosing whole and unprocessed foods – so is it the end of the line for processed food manufacturers? Not if they move with the times, say ingredient suppliers.

Who is driving the clean label agenda, and what does ‘clean’ really mean? Attempts to link clean-labeling policies with the healthy eating agenda have been so successful that research now shows shoppers equate ‘healthy’ with ‘natural’ or ‘minimally processed’ foods.

‘Natural’: The most meaningless word on your food label?  Consumers, the marketers all tell us, want foods that are ‘wholesome’, ‘authentic’, and above all ‘natural’, although few of them can articulate what this means.

‘Processed’ foods are often high in sodium – but what’s a processed food? About 75% of the sodium in our diets comes from processed foods. It’s a regularly cited figure – but what exactly is a ‘processed’ food? Consumers might be surprised.

Processing is a dirty word – but we’ll need more of it to feed the world. Processing has become a dirty word, but we are going to need more processing, not less, in order to feed a growing population, according to professor and head of food science at Penn State University John Floros.

FDA: get to work!

USA Today has picked up the various Internet petitions—SignOn, FoodDemocracyNow, CredoAction, etc— to fire Mike Taylor, the head food safety person at the FDA. 

When the FDA hired Mike Taylor nearly three years ago, I wrote a long post reviewing his complicated employment history: Monsanto, FDA, USDA, Monsanto, private sector, university, FDA—a classic example of the “revolving door.”.    

He was at FDA, although recused, when the agency approved GM foods and denied labeling. 

But at USDA, he was a public health hero to food safety advocates.  He was responsible for installing food safety oversight systems that have greatly reduced contamination outbreaks from meat and poultry.

 He was hired at FDA to do the same thing, which is why I thought his appointment made sense at the time.  I thought he ought to be given a chance.

 He has now become the flashpoint for public anger at FDA over issues that include GM foods but go well beyond them:

• Failure to require labeling of GM foods
• Failure to recognize the scaled-down safety needs of small farmers
• Failure to enforce and punish food safety violations by large producers
• Unfair enforcement of food safety procedures against small producers
• Clamping down on raw milk producers

As I explained to USA Today, I’m a big fan of MoveOn and grass-roots political action, and I’ve been advocating for GM labeling since I was on the FDA Food Advisory Committee in 1994 (if only they had listened to me).

But I don’t exactly get where the “fire Monsanto Mike” movement is coming from nearly three years after he was hired.   Why make the political so personal?

As I told USA Today,

What would firing Mike Taylor do? It would show the muscle of the anti-corporate food movement, says Nestle, “and there’s much to be said for that.” However, she questions whether Taylor leaving would do anything to advance the goals of this loose coalition of activists. “Will it make the FDA listen more carefully to demands that it keep its priorities where the most serious food safety problems are? I don’t know.”

All of the issues mentioned in the petitions are important.  All are complicated.  All deserve serious thought and attention to political goals.  Will firing Mike Taylor advance those goals? 

I don’t see how.

What am I missing here?