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In an astonishing display of what can only be described as chutzpah* Del Monte sued the FDA for insisting on a recall last March of its cantaloupes likely to be contaminated with a toxic form of Salmonella Panama. Now Del Monte is also suing the State of Oregon.

On what grounds?

Notably, “[t]he FDA investigation ultimately found no connection between Del Monte Fresh cantaloupes and any cases of Salmonella Panama, including in Oregon,” the company says. “FDA issued a notice ending the recall on July 29, 2011.”

The CDC thinks otherwise.  Its investigations pointed to imported Del Monte cantaloupes as the source of an outbreak that affected 20 people in several states:

Twelve of 16 ill people reported eating cantaloupe in the week before illness. Eleven of these 12 ill people ate cantaloupes purchased at eight different locations of a national warehouse club. Information gathered with patient permission from membership card records helped determine that ill persons purchased cantaloupes sourced from a single farm. Product traceback information indicated these cantaloupes were harvested from single farm in Guatemala.

FoodSafetyNews reviews the history of this particular recall.  It agrees with Del Monte that tests performed in April on cantaloupe samples from the Guatemala farm came out negative for Salmonella and that the FDA has now ended the recall.  But:

Del Monte had announced the recall in March, after the suspect melons had passed their shelf-life date. It is not clear whether any of the cantaloupes tested were actually the suspect melons. In foodborne illness investigations, samples of the food from the same batch eaten may no longer available by the time the connection to an outbreak is made. Epidemiology, rather than a contaminated sample, is the evidence that points to a likely source.

For these reasons, attorney Bill Marler terms the lawsuit “frivolous.”  He is suing Del Monte on behalf of a sick client.

Public health agencies doing their jobs to protect the public now have to defend against lawsuits like this?  Putative cause is no longer enough to order recalls?

U.S. courts are not famous for understanding epidemiology or other aspects of public health and I’m wondering what effect this suit will have on public protection against foodborne illness.  What standard of proof will the courts require?

Lawsuits are chilling.  Congress has just granted the FDA the authority to order recalls.  Food producers were not happy about that provision.  This is one way to get around Congress and the FDA.

It is worth asking who gains and who loses from lawsuits like this.

*Hence: chutzpah, which if you aren’t familiar with the term, is the Yiddish word for outrageous audacity.

I’ve been rounding up information about the Cargill recall of ground turkey contaminated with Salmonella Heidelberg.  William Neuman at the New York Times related the story on August 3. Same old same old.

Cargill is a huge company with, as Bill Marler counts them, a long history of food safety problems.  Did Cargill not bother to test for pathogens?   As I explain in my book Safe Food: The Politics of Food Safety, no meat company wants to test for pathogens.  If they found pathogens, they would have to recall the products.

And where was the USDA in all of this?  Best not to ask.

The USDA was testing.  The testing found Salmonella.  The USDA did nothing.

According to the Wall Street Journal,

Federal officials said they turned up a dangerous form of salmonella at a Cargill Inc. turkey plant last year, and then four times this year at stores selling the Cargill turkey, but didn’t move for a recall until an outbreak killed one person and sickened 77 others.

How come?

Food-safety specialists said the delay reflected a gap in federal rules that don’t treat salmonella as a poisonous contaminant, even if inspectors find antibiotic-resistant forms such as the Heidelberg strain implicated in the latest outbreak.

But CDC investigations show that turkey-related illnesses have been reported for months.  Despite the reports, the USDA took its own sweet time insisting on a recall.

The rationale for the delay is—get this—the USDA believes it does not have the authority to order recalls for any contaminant except E. coli O157:H7.  It has no authority to recall meat contaminated with Salmonella or other toxic forms of E. coli.

Or at least that’s how USDA interprets the legal situation (for the history of all this, see Bill Marler’s summary.

One reason for the USDA’s foot-dragging must surely be pressure from the meat industry which wants as little testing as possible and preferably none.  The meat industry would rather leave it up to you to cook your food safely.

According to a report by Elizabeth Weise in USA Today,

The reasons these bugs aren’t currently regulated are a mix of politics, money and plain biology — the bacteria are constantly evolving and turning up in new and nastier forms, making writing rules about them a bit of a nightmare. For example, the German E. coli variant that sickened more than 4,075 in Europe and killed 50…wasn’t known before this spring.

The meat industry takes advantage of this situation and argues:

“We don’t have a true baseline determining the prevalence of these organisms in the beef supply,” says Betsy Booren of the American Meat Institute (AMI) Foundation, the research arm of AMI. Without knowing how common they are, it’s impossible to say whether they should be considered adulterants, she says.

What they seem to be saying is that meat always has bacteria on it.  And just because these particular bacteria can kill people doesn’t mean the industry is responsible if anyone gets sick.  But shouldn’t the industry be doing a better job?

In Food Safety News, Michele Simon has a terrific analysis of the safety loopholes that allow this absurd situation to continue:

How did the meat industry get so powerful that it can keep USDA from doing its job? Now, instead of preventing illnesses from occurring by requiring testing with teeth, we have USDA regulations that are so lax they allow almost half the samples tested at ground turkey plants to be contaminated with Salmonella — a pretty easy standard to meet. And one that allowed this outbreak to occur.

I keep asking: how much worse does it have to get before Congress does something about ensuring safe food.  Cargill’s inability to protect the public from unsafe meat is reason alone to create a single food safety system that unites the functions of USDA and FDA.

If Congress isn’t ready to take that step, it could at least give USDA the power to act and the FDA the funding it needs to do its job.

The Berkeley group that organized a contest to redesign the food label has picked its top choices from among 24 entries.   Take a look at them on that site and vote for your favorite by midday Sunday.

Tara Parker-Pope has a nice summary on her New York Times blog along with interviews with the judges.  Lily Mihalik, cocreator of the project explains:

We asked food thinkers and design minds to come together and give advice on how they might rethink the food label and bring some insight into how design impacts choice…There are a lot of things right with the current label, but at the same time people are confused. The question is whether a new nutrition facts label could help people make more educated decisions.

Good question.  My take is that most of the entries are even more complicated than the current Nutrition Facts label and leave out a lot of useful things you might like it to do:

• State the content of calories per serving
• State the serving size
• State the content of nutrients of interest per serving (opinions can vary as to which are worth listing)
• Compare those levels to standards for daily intake
• Explain how those levels apply to a typical day’s diet
• Indicate how the food fits into diets that vary in calorie intake
• List ingredients
• List allergens
• Be accurate, noticable, understandable, and usable

Overall, the label is supposed to help consumers make more healthful food choices.  It also has to fit on food packages.

As several of the entries suggested, it would also be helpful if the label could indicate the degree of processing.  Actually, you can figure that out now by looking at the ingredient list.  Count the ingredients, see if you can pronounce them, and make sure they are recognizable as food.

If anything, this project demonstrates how difficult it is to develop a design that addresses all of these issues.   The January 6, 1993 Federal Register notice that announced the Nutrition Facts label takes up nearly 900 pages.

That notice reviewed the research that led to the current label.  The review makes it clear that nobody understood any of the available design options.   The FDA, under great pressure to meet a deadline set by Congress, chose the design that was least poorly understood.

Hence the FDA’s web pages devoted to explaining how to read and interpret the Nutrition Facts label, and its even lengthier web guide to the food industry on how to create the labels.

The FDA is currently doing the preparatory work for an eventual revision of the label, so these designs come at an opportune time.  Take a look and see what you think of them. 

The designers were brave to take this on. 

And so is the FDA.

Today is the last day to comment on the federal Interagency Working Group’s (IWG) proposed nutrition standards for marketing food products to kids.  The IWG is a joint project of four federal agencies with at least some responsibility for public health: FTC, FDA, USDA, and CDC.

As I discussed back in April, I thought the IWG standards were generous and gave food companies plenty of room to market junk foods with impunity.  Maybe, but that’s not how food companies see it.  They think it will cause so much havoc with their marketing that they are fighting back, big time.

Large food companies joined together to create the “Sensible Food Policy Coalition.”  This entity paid for an economic assessment.  On July 8, the Coalition released Global Insight’s report of this assessment—a call to arms arguing that the “administration’s misguided ad restrictions would cost 74,000 American jobs.”

The report’s point is that restricting advertising would have unintended economic consequences, particularly losses in sales and revenues, and therefore jobs.  The report estimates an astonishing loss of $28.3 billion from manufacturing and retail sales, just in the first year, translating to “at least 74,000 lost jobs.”

This makes me think that the standards may have some merit.  Campbell Soup, for example, has just announced that because its low-salt soups aren’t selling, they are putting the salt back in.  Oh.

In any case, industry pushback seems to be having an effect.  As I discussed in my post a week or so ago, David Vladeck of the FTC used his blog to discuss industry mythology about the proposed standards.  I thought his statement backpedaled on even a hint of federal regulation of food marketing to kids.

MYTH #2: The Working Group’s proposal is regulation by the back door

….This is a report to Congress, not a rulemaking proceeding, so there’s no proposed government regulation. In fact, the FTC Act explicitly forbids the Commission from issuing a rule restricting food advertising to children. So the FTC couldn’t issue a rule on this subject if it wanted to, which it doesn’t. Simply put, a report like this can’t be a rule — whether it’s delivered to Congress by the front door, the back door, or the kitchen door.

The IWG is collecting comments on its proposals through close of business today.  If you need a rationale for filing a comment, read Larry Cohen’s piece in the Huffington Post.

Comments don’t have to be long or complicated.  Just say what you think.

Go to this site to file them.

Or go to the PreventObesity site for additional suggestions.

Do this today!

The California-based Marin Institute, “the alcohol industry watchdog,” has issued an enlightening new report: Questionable Health Claims by Alcohol Companies: From Protein Vodka to Weight-Loss Beer.

According to the Institute’s press release, “Major alcohol companies are exploiting ineffective or non-existent regulatory oversight with deceptive marketing and potentially dangerous products.

Some examples described in the report:

• Devotion Vodka (“Infused with Casein”)
• Fragoli strawberry liqueur (promoted with antioxidants)
• Absolut, Skyy, and Finlandia vodkas (“infused with natural flavors”)
• Michelob Ultra, and MGD 64 beer (promoted as fitness and weight-loss aids)

Or how about vodka advertised as “no sugar, gluten free, low calorie?”  The Marin Institute points out that terms like these are “promoted as logical compliments to a healthy, fitness-oriented lifestyle, without a hint of irony.”

Irony?  Check the illustrations!

As the report concludes, such marketing messages when applied to alcoholic beverages are “legally tenuous, morally unsound, and potentially dangerous.”

But don’t blame the FDA for this one.  Alcoholic beverages are regulated by the Treasury Department because they are a lucrative source of revenue.  Health claims sell products.

Treasury benefits more when companies sell more.  This sounds to me like a clear conflict of interest.  You?

In an action highly unusual for the FDA, the agency has released a new “special report” on what it is up against as it tries to get a handle on the safety of imported foods.

Pathway to Global Product Safety and Quality points out that imported foods account for:

• Between 10% and 15% of all food consumed by all U.S. households
• Nearly two-thirds of all fruits and vegetables
• 80% of seafood

And imported foods have increased by at least 10% during each of the last seven years and are expected to increase by 15% per year for the next several years.

The New York Times notes that in 2008 the FDA would have needed “1,900 years to check every foreign food plant at its rate of inspections at the time.”

That’s not all.  According to FDA:

Manufacturers and producers…face intense pressure to lower costs and improve productivity, fueling a cycle in which the quest for efficiency leads to increased production abroad and higher volumes of imported products to regulate.

Goods entering the U.S. will come from new and different markets, flowing through long, multistep processes to convert globally-sourced materials into finished goods.

The shift in global product flows will make it difficult to identify the “source” of a product and to ensure that all players along the supply chain meet their safety and quality responsibilities.

And it is not just legal activity that poses challenges for the FDA. Increasingly, the agency must contend with ever more sophisticated threats of fraud, product adulteration, and even terrorism.

The FDA illustrated its report with terrific graphics.  My favorite is the supply chain for canned tuna:

What will the FDA do about this problem?  It says it will:

1) Assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2) With these coalitions, develop a global data information system and network.

3) Expand capabilities in intelligence gathering and use.

4) Allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

The FDA released its report on practically the same day that the Health and Human Services Inspector General’s office released a report highly critical of the FDA’s ability to monitor the safety of imported foods.

Because FDA’s food recall guidance is nonbinding on the industry, FDA cannot compel firms to follow it and therefore FDA cannot ensure the safety of the Nation’s food supply.

FDA did not always follow its own procedures to ensure that the recall process operated efficiently and effectively.

This kind of criticism is not new.  Just last month, the GAO issued a critical report on the FDA’s problems regulating the safety of imported seafood.  The FDA’s difficulty with recalls is that until Congress passed the food safety act last year, FDA did not have the authority to order recalls.  It had to “pretty please” ask companies to recall unsafe foods.  Now it has the authority, but Congress did not grant new resources to carry out that authority.

The New York TImes explains the reason for the FDA’s lack of oversight:

Audits of the F.D.A.’s oversight of the nation’s food system routinely find the agency’s efforts wanting, in part, the agency says, because its budget for such activities has long been inadequate. And although the new food safety law gave the agency extra supervisory powers, it is not clear how much it will be able to do, given that House Republicans have proposed cutting its budget for protective measures.

The FDA official in charge of food safety, Michael Taylor, has been discussing the vexing resource question in recent speeches.  He points out that the FDA:

Has a a huge workload. And even though public health officials are working hard, the agency will likely not meet all of its deadlines. On top of the backlog, FDA has no idea what its budget will be for fiscal year 2012.

An agriculture appropriations bill that cleared the House last week would cut food safety programs $87 million below fiscal year 2011.

The current budget situation does paint a challenging picture…a patchwork of continuing resolutions to keep the government funded — as we saw in 2011 — makes it nearly impossible to plan ahead.

When Congress gives us our budget over half way through the fiscal year it’s very difficult to use that money in as orderly a way as possible. You can’t use that money to hire the experts you need because the hiring process is such that you won’t get them hired until the end of the fiscal year

When it comes to food safety, we only have one food supply, and it is global.  That was the whole point of my book Pet Food Politics: The Chihuahua in the Coal Mine—a case study of how melamine in China got into American, Canadian, and South African pet foods.  If it could happen to pet food, it could happen to ours.

To monitor the safety of imported foods, the FDA neeeds to be stronger, not weaker.

The Environmental Working Group (EWG) has just published its 2011 guide to the most and least pesticide-laden fruits and vegetables.

The #1 “dirtiest”?  Apples.  The remedy?  Buy from the EWG “clean 15” list or buy organic.

The “dirty dozen” list, in order: Apples, Celery, Strawberries, Peaches, Spinach, Imported nectarines, Imported grapes, Sweet bell peppers, Potatoes, Domestic blueberries, Lettuce, Kale/collard greens.

The “clean 15” list of foods with the least pesticides: Onions, Sweet corn, Pineapples, Avocados, Asparagus, Sweet peas, Mangoes, Eggplant, Domestic cantaloupe, Kiwifruit, Cabbage, Watermelon, Sweet potatoes, Grapefruit, Mushrooms

How much should you worry about pesticides on foods?  As one reader asked,

Is it better to eat conventional fruits (cherries, berries and apples) and other veggies (peppers) that are on the “dirty” vegetable list or forego them altogether?

This is not an easy question to answer.  EWG recognizes that the science linking pesticides to health problems is limited (this is an understatement).  EWG bases its rankings on data published by USDA and FDA.  It considers:

• Percent of samples tested with detectable pesticides
• Percent of samples with two or more pesticides
• Average number of pesticides found on a single sample
• Average amount (level in parts per million) of all pesticides found
• Maximum number of pesticides found on a single sample
• Total number of pesticides found on the commodity

EWG explains that its

Shopper’s Guide is not built on a complex assessment of pesticide risks but instead reflects the overall pesticide loads of common fruits and vegetables. This approach best captures the uncertainties of the risks of pesticide exposure and gives shoppers confidence that when they follow the guide they are buying foods with consistently lower overall levels of pesticide contamination.

Most available research supports the health benefits of eating fruits and vegetables regardless of their pesticide loads.  Ken Cook, the president of EWG says:

We recommend that people eat healthy by eating more fruits and vegetables, whether conventional or organic,” says Ken Cook, president and founder of Environmental Working Group. “But people don’t want to eat pesticides with their produce if they don’t have to. And with EWG’s guide, they don’t.”

By EWG calculations, you can lower your pesticide intake by 92% if you avoid the dirty dozen.  No wonder.  How’s this for an observation: “Hot peppers had been treated with as many as 97 pesticides, followed by cucumbers (68) and greens (66).”  Who knew?

Where is the produce industry in all of this?  EWG reports that produce trade associations are working hand-in-glove with the pesticide industry to attempt to keep information about these chemicals out of the public eye.

I wish more research existed on the dose-response effects of pesticides and on their long-term effects on health, especially in children.  I cannot imagine that pesticides are good for health.  In high doses, they are demonstrably harmful to farm workers.

But what about the low doses on fruits and vegetables?  Here, the evidence for long-term harm is weak, uncertain, and unhelpful.

What to do?

On the personal side: if you want to avoid eating pesticides, you can stick with the EWG 15.  Washing produce before eating it is always a good idea even if it doesn’t get rid of all of the chemicals (USDA studies are done on washed produce).  When in doubt, buy organic.

As for the political, if ever there was a situation where more research was needed, this is it.  And isn’t it time for industrial food producers to find ways to use fewer pesticides?  Let the produce trade associations know that you don’t like their defense of potentially harmful chemicals and that you much prefer organic.

Addition, June 16: For anyone interested, here are the USDA’s pesticide announcements for the new data:

Press release

Consumer factsheet

Report executive summary

For years, as Tom Philpott recounts on his new food and agriculture blog for Mother Jones, public health advocates have fretted about the use of arsenic-containing drugs to kill intestinal parasites and promote growth in chickens.

One such drug is roxarsone, made by Pfizer. Its arsenic is in the organic (carbon-containing) form, which is less toxic than the inorganic form.

But, as the New York Times explained, evidence has been accumulating that the organic form can change into the more toxic, inorganic form, a known carcinogen.

As reported in Food Safety News,  the Center for Food Safety, the Institute for Agriculture and Trade Policy, and several other consumer and agriculture groups petitioned FDA to ban the drug three years ago.

Last week, the FDA announced that the agency had done its own feeding tests.  Chickens fed organic roxarsone had higher levels of inorganic arsenic in their tissues.  The FDA got Pfizer to “voluntarily” withdraw the drug from the market.

The surprise here is not the FDA’s delay in dealing with this drug.  The big surprise is that the FDA did its own testing.  As the Times put it:

The F.D.A. once routinely conducted its own studies of animal and human drugs, but limited budgets led the agency to eliminate much of its scientific and laboratory capacity over the years. The roxarsone study is a triumph for agency scientists but one unlikely to be repeated very often. The agency asked for $183 million in additional funds for food safety efforts next year, but House Republicans have instead proposed cutting $87 million.

Drug companies cannot be expected to do their own testing if there is any chance that the tests will show something not in their best interest.  If independent federal agencies don’t do these kinds of studies, who will?

I can remember when the FDA housed a group of researchers doing outstanding work on food allergies in the 1990s.  The FDA closed down that lab when it was given additional responsibilities by Congress with no additional funding.

The FDA is a public health agency.  Its job is to protect the public against unsafe food contaminated with bacteria or antibiotics such as roxarsone.  The agency gets high marks for taking this on.  And Congress needs to support the FDA’s research mission.