Currently browsing posts about: FDA

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.

German authorities now say that  sprouts grown on an organic farm in Lower Saxony are the source of their E. coli O104:H4 outbreak, now responsible for more than 30 deaths and 3,000 illnesses, 750 of them severe kidney disease.

The epidemiological studies point to sprouts after all.

Sprouts, as I mentioned in an earlier post, are a prime suspect in microbial outbreaks.   They have been implicated in many outbreaks in the United States.  This is because sprouts are sprouted from minute seeds that are hard to clean, as shown in this microscopic view:

As Food Safety News explains in a long discussion of this problem, the seeds need to be dumped in bleach to kill bacteria.  It’s also a really good idea to test the wash water to make sure it is free of pathogens.

The seeds are sprouted in water at room temperature, “a warm, moist climate — just perfect for a bacteria’s social life and subsequent reproduction.”

The FDA has been aware of this problem for a long time, as shown by this brief chronology:

• 1999: The FDA issued “nonbinding guidance” on growing sprouts.  This caused the ever-vigilant Center for Science in the Public Interest (CSPI) to file a petition arguing that guidance rules for sprouts needed to be mandatory.
• 2004: The FDA wrote a “note” to producers and shippers of sprouts stating that it was aware of 27 outbreaks of microbial illness due to sprouts and urging producers to follow the voluntary guidance procedures.
• 2004: The FDA followed up by issuing safety guidance for growing sprouts in retail establishments.  These were voluntary, of course.
• 2004: California health officials produced a slide presentation on the hazards of sprout production, urging producers to follow safety guidelines.
• 2005: The FDA announced public meeting to discuss the science of safe production of sprouts as a basis for beginning a rulemaking process for mandatory safety procedures.
• 2009: The FDA issued a warning about consuming alfalfa sprouts.

The Food Safety Modernization act passed last year finally gives FDA the authority to require food safety controls for sprouts.

The German outbreak ought to be a wakeup call for this industry in the United States.  Sellers of bean sprouts market them as health foods but say little about how unsafe they are if eaten raw.

It also ought to be a wakeup call for consumers.  If you aren’t absolutely sure the seeds come from a clean source, cook your sprouts.

I haven’t said anything about the E. coli 0104 crisis in Germany up to now because I’ve been waiting for the evidence.  Without evidence, the source of the outbreak remains uncertain.

Yesterday, the German minister of agriculture announced that sprouts are the cause.  But are they?

What  is known without question is that the outbreak is deadly serious.  Bill Marler reports these shocking numbers as of June 5:

Deaths = 22 (21 in Germany, 1 in Sweden)

Illnesses = 2,243 (2,153 in Germany, and 90 more in 10 other European nations and the U.S.)

Cases of Hemolytic Uremia Syndrome (HUS) = 627

Why shocking?  This is a devastating disease, excruciatingly painful, with a high probability of causing lifelong complications.  And the disease is almost entirely preventable by following standard food safety procedures.

The idea that the cause is sprouts, and German sprouts at that, comes as a surprise.  Why?  First, sprouts are a frequent cause of foodborne illness and should have been high on the list of suspected foods.  Second, sprouts did not turn up in the case-control studies.

Instead, investigators examined cucumbers, lettuce, and tomatoes (and, in the process, put Spanish cucumber producers out of business).  As Marler explains, the German authorities didn’t want to take a chance, given the results of their investigation.

The case-control investigation was conducted by the Robert Koch Institute, the German equivalent of our CDC.

• The cases: From May 29 to June 2, investigators interviewed 46 affected patients from Bremen, Hamburg and Lübeck about the foods they had eaten.
• The controls: They interviewed 2,100 people who were not sick but were of similar age group, sex and region of residence.
• The results:

Food Reported Eaten         % By Cases     % By Controls

Lettuce                                        84                           47

Cucumbers                                 75                           50

Tomatoes                                   80                            63

95% of the Cases had eaten at least one of the three vegetables.

This evidence strongly implicates these vegetables.  But did they not look for sprouts?

In another related study of people from a Frankfurt business company who had become ill, those who had eaten from the salad bar in the company cafeteria had a 7-fold increased risk of developing bloody diarrhea than those who had not.  No such association was seen for other foods investigated, such as dessert, fruit and asparagus.  Sprouts are not mentioned.  How come?

In trying to figure out what’s going on here, a BBC World News report raises even more questions (my emphasis):

The agriculture minister for Lower Saxony, Gert Lindemann, said there was a clear trail of evidence pointing to a plant nursery south of Hamburg [as the source of the contaminated sprouts].

The nursery has been closed, though officials say the outbreak’s source cannot yet be definitively confirmed.

…Mr Lindemann said epidemiological studies all seemed to point to the plant nursery in Uelzen in the state of Lower Saxony, about 100km (62m) south of Hamburg – though official tests had not yet shown the presence of the bacteria there.

“Further evidence has emerged which points to a plant nursery in Uelzen as the source of the EHEC cases, or at least one of the sources,” he said.  [What evidence?]

…Gert Hahne, a spokesman for the Lower Saxony agriculture ministry, earlier told the Associated Press news agency that many restaurants in which people ate before becoming ill had recently taken delivery of the sprouts. [Guilt by association]

He said authorities would still maintain a warning against eating tomatoes, cucumbers or lettuce.

The health ministry in Berlin said it was still waiting for results from tests on the beansprouts, Germany’s DPA news agency reported.

And the head of the Robert Koch Institute (RKI), Germany’s national disease centre, was also reported as saying that the cause of the outbreak could not yet be confirmed.

So: are sprouts the cause?

By this time, the outbreak is slowing down as the contaminated foods make their way through the food supply.

Could this happen here?  You bet.

If ever there was a time to give the FDA more resources, now is it.  The FDA now has the authority to impose standard food safety procedures on food producers and to require safety measures for the foods we import.   But Congress wants to cut the agency’s budget, and badly.

Now would be a good time to let congressional representatives know that we need a stronger FDA.   And while you are at it, let the USDA know that you think it would be a good idea to regulate other forms of toxic E. coli as adulterants in the same way they regulate E. coli 0157:H7. There is plenty government could do right now to protect us from outbreaks like this one.

A word about sprouts:

How come sprouts are such frequent sources of food safety problems?

Sprouts are grown from tiny seeds that are impossible to wash thoroughly enough to ensure that they are free of harmful bacteria.  The seeds are sprouted in water that must be changed several times a day.  This water is an excellent growth medium for bacteria.  That is why FDA guidance says sprout producers ought to test the wash water for harmful bacteria.

Under the new legislation, the FDA has the authority to enforce this guidance.  But does it have adequate personnel?  Unlikely, given the current stance in Congress.

This just in:  No, it’s not sprouts, according to this bulletin from Food Chemical News:

The latest news, reported this morning by both the Associated Press and BBC, is that 23 of 40 samples of organic sprouts taken from the Gaetnerhof farm in the Lower Saxony region of Germany have tested negative for the bacteria. Tests on the other samples have yet to be returned.

Utne reader has just announced the most interesting contest: redesign the food label.

The contest is sponsored by Good magazine and the UC Berkeley Graduate School of Journalism’s News21 program.  It is called the Rethink the Food Label project.

Anyone can enter.  Just think of some way that would make the label more useful.

The FDA is currently working on doing just that, and for good reason.  The label is so hard to use that the FDA devotes a lengthy website to explaining how to understand and use it.

This too is understandable.  The Nutrition Facts label is the result of regulations in response to the Nutrition Labeling and Education Act of 1990.  When the FDA started writing regulations to implement the Act, it tested consumer understanding of a bunch of potential designs.

The result?  Nobody understood any of them.  The FDA, under pressure to complete the regulations by the congressional deadline, chose the option that was least poorly understood–the best of a bad lot.

Surely someone will come up with something better than this?  The deadline for submission: July 1. One of the judges is Michael Pollan. Give it a try!

The L.A. Times has one of the better stories I’ve seen lately about genetically modified (GM) foods.  I don’t usually write much about this topic because there is so little new to say about it.

I’ve been writing about GM foods for 20 years now and I’d call it a stalemate.  The industry says:

• GM foods are absolutely necessary to feed the world.
• Farmers love them.
• They are harmless.

Farmers do like using them because they do not have to do as many pesticide applications or worry as much about weeds.

But the first and third points are highly debatable, as the article discusses.

I worry most about two aspects of GM foods:

• They encourage corporate control of the food supply and monoculture (never good ideas)
• They do not give consumers choices because they aren’t labeled.

The LA Times illustrates both points in one terrific graphic:

The states are starting to act, but this is really the FDA’s issue.  It’s time to get the FDA to reverse its 1994 decision not to label GM foods.