by Marion Nestle

Currently browsing posts about: FDA

Dec 20 2011

FDA tests apple juice for arsenic, says most are OK

Perhaps in response to Consumer Reports’ charges that levels of arsenic in children’s juices are so high that more restrictive standards would be healthier (see previous post), the FDA has done its own tests, updated its arsenic home page, and strengthened its Q and A on arsenic.

The Q and A includes these questions:

Is the arsenic in apple juice predominantly organic or inorganic?  Due to limited data available to answer this question, in October 2011, FDA collected and analyzed 94 samples of apple juices available for sale in the United States. Results from this data indicate that there are relatively low levels of arsenic in apple juice, with 95 percent of the apple juice samples tested being below 10 ppb total arsenic, but that the arsenic in these samples was predominantly the inorganic form [the bad kind].

Did the FDA test any of the samples tested by the Dr. Oz Show? On September 10-11, 2011, the FDA completed laboratory analysis of the same lot of Gerber apple juice that was tested by the Dr. Oz Show [Dr. Oz complained about the dangers of arsenic in juice], as well as several other lots produced in the same facility. The FDA’s testing detected very low levels of total arsenic in all samples tested. These new results were consistent with the FDA’s results obtained in the FDA’s routine monitoring program and are well below the results reported by the Dr. Oz Show. The FDA has concluded that the very low levels detected during our analysis are not a public health risk and the juice products are safe for consumption.

Food Quality News reports that safe or not, the FDA is still “considering setting a guidance level for inorganic arsenic in apple juice and apple juice concentrate that will further minimise public exposure to this contaminant.”

As well it should.  And preferably at the lower levels recommended by Consumer Reports.

 

 

Dec 15 2011

More problems with FDA’s ability to inspect food facilities

The Office of Inspector General (OIG) of the Department of Health and Human Services, FDA’s parent agency, has just issued a report sharply criticizing FDA’s oversight of State food inspections.

This report is one more piece of evidence for how FDA’s lack of resources makes our food supply less safe.

Because it does not have the personnel to do its own inspections, FDA increasingly delegates them to State agencies.  The Salmonella outbreak from peanuts in 2009 is a prime example of why the State system is too diffuse to work.  As the report explains,

The peanut processing plant responsible for a 2009 salmonella outbreak was inspected multiple times by a State agency working on behalf of FDA. This outbreak resulted in one of the largest food recalls in U.S. history and has led to serious questions about the effectiveness of State food facility inspections.

FDA has long been unable to inspect more than a tiny fraction of food processing facilities and the situation is getting worse, not better: the overall number of facilities inspected decreased from just over 17,000 facilities in 2004 to about 15,900 in 2009 (4%-5% of the total number).

FDA increasingly goes to States to fill the gap.  In 2009, it contracted with 41 States to conduct inspections, and these conducted 59% percent of FDA’s food inspections.  In 2004, State inspections comprised just 42% of inspections.

FDA says it has good reasons for relying on States:

According to FDA officials, one reason FDA relies on States is that these inspections are conducted under State regulatory authority, which often exceeds FDA’s own authority. For example, several FDA officials noted that, under certain conditions, State inspectors can immediately shut down a facility or seize unsafe food products, whereas FDA would have to go through a lengthy legal process to achieve similar results.

But this is not enough.  The current report is only the latest of a series of OIG reports detailing problems with FDA’s food inspections.  Previous reports found that more than half of all food facilities have gone 5 or more years without an FDA inspection.

The report concludes:

Taken together, the findings demonstrate that more needs to be done to protect public health and to ensure that contract inspections are effective and prevent outbreaks of foodborne illness.

Yes, of course they do.  But how is FDA supposed to fix the problem?

Bizarrely, and at great risk to the public, FDA gets its funding from congressional agriculture appropriations committees, not health committees.

In this era of cost cutting, FDA was lucky to get a $50 million increase in funding, or so everyone says.

But this is nowhere near enough to hire and train enough inspectors to do the job right.  It’s not that the States can’t do a good job.  It’s that the dispersion of authority leaves much room for flexibility in interpretation and lack of accountability, as the OIG reports consistently show.

For reasons of politics, this may not be the time to demand a stronger food safety system.  But if not now, when?

Dec 8 2011

Consumer Reports’ arsenic-in-juice study: what to do?

I don’t often write about pesticides, plasticizers, heavy metals or other such potentially toxic substances in food because there usually isn’t enough science available to draw firm conclusions about how much of them is OK to consume.

At high concentrations they are demonstrably toxic.  But in food and water, they appear in amounts measured as parts per billion (ppb) or trillion, and it is difficult to know how harmful they may be at such levels.

The big question: is there a threshold for harm or are they unsafe at any level of intake?  The history of regulation of such substances is one of constant reduction in levels considered safe.

They derive in large part from industrial processes, and attempting to regulate them confronts large and powerful industries eager to argue that low levels are safe.

Now Consumer Reports has tested samples of juice and finds levels of arsenic  higher than allowed in drinking water:

  • 10% of the samples contained levels of arsenic that exceed EPA drinking-water standards of 10 ppb.
  • 25% contained levels of lead greater than the FDA’s 5 ppb standard for bottled water.
  • Most arsenic was inorganic, a form linked to cancer, cardiovascular disease, immune disorders, and type 2 diabetes.
  • 35% of children age 5 and younger drink juice in amounts higher than recommended by pediatricians.
  • No federal standards exist for amounts of lead and arsenic in juice.

This is a food systems issue.  Inorganic arsenic gets into food from soil contaminated with arsenic-containing herbicides and waste from animals and chickens fed arsenic-containing additives.

Consumer Reports says:

  • FDA should set a standard for total arsenic in juice at 3 ppb and 5 ppb for lead.
  • EPA should lower the 10 ppb drinking-water limit for arsenic.
  • Parents should limit juice servings to small children.

What does the FDA have to say?

The Food and Drug Administration has every confidence in the safety of apple juice…small amounts of arsenic can be found in certain food and beverage products—including fruit juices and juice concentrates….there is no evidence of any public health risk from drinking these juices…FDA has been testing them for years [see the FDA’s Q and A].

As if this were not enough to worry about, Food Quality News reports increasing concern about the amount of arsenic in rice, the dangers of such levels for pregnant women, and the need to establish better standards for safe levels of arsenic in foods.

Consumer Reports is especially concerned about a study published in the Proceedings of the National Academy of Sciences linking rice consumption to levels of arsenic in the urine of pregnant women.   It notes that children in the U.S. typically are fed rice cereal as their first solid food, making them especially vulnerable to the effects of arsenic.

Arsenic gets into rice in the same way that it gets into apples and grapes, but rice is especially efficient in taking up arsenic from soil.

I see all this as further evidence that agricultural practices are key determinants of public health and that we badly need:

  • More and better research on the effects of small amounts of arsenic, lead, pesticides, and other such toxins in food
  • Research on how to remove such toxins from soil
  • Federal safety standards for arsenic in foods and beverages; the Consumer Reports recommendations make sense
  • Regulations that restrict use of arsenic drugs in animal agriculture and of pesticides containing arsenic
  • Restrictions on the amount of juice and rice given to children

It’s great that Consumer Reports is doing this kind of research but federal agencies should be doing a lot more of it too.

Nov 9 2011

The food politics of–oysters?

The Government Accountability Office (GAO) recently released a tough report on the FDA’s dispute with the Gulf Coast shellfish harvesting industry about oyster safety: Food Safety: FDA Needs to Reassess Its Approach to Reducing an Illness Caused by Eating Raw Oysters.

To better ensure oyster safety, says GAO, FDA should work with the oyster industry to (in my paraphrase):

  • Agree on a nationwide goal for reducing the number of illnesses caused by the consumption of Gulf Coast raw oysters
  • Develop strategies to achieve that goal
  • Recognize that consumer education and time-and-temperature controls have not worked
  • Recognize that the capacity to use postharvest processing methods does not currently exist.

As I explain in my book, Safe Food: The Politics of Food Safety, the FDA for more than a decade has been trying to prevent deaths caused by Vibrio vulnificus bacteria that contaminate raw oysters grown in the Gulf of Mexico.

These “flesh-eating” bacteria proliferate in warm months and are especially deadly; they kill half of the thirty or so people who develop infections from it each year.

In 2001, the oyster industry trade association, the Interstate Shellfish Sanitation Conference (ISSC), promised the FDA that this industry would substantially reduce Vibrio infections in oysters within seven years through a program of voluntary self-regulation and education aimed at high-risk groups.

If this program failed to reduce the infection rate, the ISSC agreed that the FDA could require oysters to be treated after harvesting to kill pathogenic Vibrio.

Postharvest processing involves techniques such as quick freezing, frozen storage, high hydrostatic pressure, mild heat, or low dose gamma irradiation, any of which reduces Vibrio vulnificus to undectable levels.

By most reports, the effect of treatment on the taste and texture of oysters is slight (although raw oyster aficionados might argue otherwise).

The California actions are instructive: In 2003, California refused to allow Gulf Coast oysters from entering the state unless they had undergone postharvest processing.  The result?  Sales of oysters remained the same but oyster-related deaths dropped to zero!

In contrast, states that did not require postharvest processing experienced no change in the number of deaths, meaning that the ISSC program had failed.

Late in 2009, the FDA announced that it intended to issue rules requiring postharvest processing of Gulf Coast oysters in summer months.

But less than a month later, the FDA backed off.  Under protest from Gulf Coast oyster harvesters, state officials, and elected representatives, the FDA agreed to postpone the oyster-processing rules indefinitely.

As the GAO understates the matter,

FDA and the ISSC do not agree on a common V. vulnificus illness reduction goal….If FDA and the ISSC are not in agreement on the illness reduction goal and strategies to achieve it, it will be difficult for the Gulf Coast states to move forward to significantly reduce the number of consumption-related V. vulnificus illnesses.

The GAO report further explains:

the ISSC continues to include California’s results in its illness rate reduction calculation along with Florida, Louisiana, and Texas. Doing so overstates the effectiveness of consumer education and time and temperature controls….

My translation: Despite years of warnings and promises that it has no intention of meeting, the Gulf oyster industry has been able to stave off FDA regulations for ten years at the expense of about 15 preventable deaths a year.

This is yet another example of political pressures blocking the FDA from carrying out its mandated food safety responsibilities.

Let’s hope the GAO report induces Congress to push this industry to get its act in order and the FDA to issue those regulations.

 

Nov 8 2011

Food politics semantics: the meaning of “natural”

Are you puzzled, annoyed, or irritated beyond belief by the word “natural” on food product labels?

FoodNavigator must think so.  It conducted an opinion survey on what to do about marketing foods as “natural”.

FoodNavigator asked: Do we [food companies] need a clearer definition of ‘natural’ for food marketing?

The response options:

  • Yes. The FDA should come up with a formal definition (63% checked this one)
  • Yes. The industry should develop voluntary guidance (20%)
  • No. The FDA’s 1993 guidance is sufficient (~1%)
  • No. The term is meaningless and manufacturers should stop using it (16%)

Hello FDA.  How about it?

The FDA has never defined “natural” for labeling purposes.  But it does have an answer to the question “what is the meaning of ‘natural’ on the label of a food,” one that requires self-cancelling nots (my emphasis):

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.

By this non-definition, High Fructose Corn Syrup is “natural” even though to make it, corn refiners must extract the starch from corn, treat the starch with an enzyme to break it into glucose, and treat the glucose with another enzyme to turn about half of it into fructose.

This is “natural,” according to the FDA, because the enzymes are fixed to a column, do not actually mix with the starch, and HFCS does not contain added colors or flavors.

In contrast, the USDA is way ahead and has defined what “natural” means for meat and poultry products.  “Naturally raised” means  no growth promoters, antibiotics, animal by-products, or fish by-products.

The USDA says meat and poultry products can be labeled “natural” if they are only minimally processed and don’t have any artificial flavorings, colorings, preservatives, or other additives.

As I’ve discussed previously, Horizon Organics now has “natural” milk that does not meet standards for organic certification.  It must hope that consumers can’t tell the difference.

To do something about this confusing situation, FoodNavigator reports that  the Natural Products Association (NPA) is developing standards for use of the word “natural” in food marketing.  This will be similar to the NPA’s Natural Seal Certification for personal home-care products.  NPA is doing this to “give consumers confidence that foods featuring the seal adhere to clear set of standards.”

NPA has not yet worked out the details but says some ingredients are unlikely to qualify:  those extracted with organic solvents, modified starch, high fructose corn syrup, and partially hydrogenated vegetable oils.

Oops.  What about GMOs?  NPA hasn’t decided yet, mainly because it is so hard to find soy products that are not GMO.

This situation is a mess and runs the risk of undercutting organic standards.  And we hardly need another certification system.

It’s time for the FDA to step in and give the food industry—and the public—some guidance about what counts as “natural” and what does not.

Nov 6 2011

Food Matters: front-of-package labels again

My monthly (first Sunday) Food Matters column in the San Francisco Chronicle appears today.  This time, it’s about the fuss over front-of-package labels.

Q: I’m completely confused by all of the little check marks and squares on food packages telling me they are healthy. Do they mean anything?

A: The Food and Drug Administration feels your pain. It sponsored two studies by the Institute of Medicine to rationalize front-of-package nutrition ranking systems.

The institute released its second report last month; it advises the FDA to allow front-of-package labels to state nothing but calories and nutrients to avoid: saturated and trans fat, sodium and sugar (go to sfg.ly/sUptQR).

The institute’s proposal gives products one point for not containing too much of each of these nutrients. It suggests displaying the points like Energy Stars on home appliances with zero to three stars, depending on how well the product meets nutritional criteria.

This is a simple system, instantly understandable. I think it is courageous. The institute’s proposal benefits consumers. It does not help companies sell junk food.

Selling or educating?

No food company wants to display nutrients to avoid. For the food industry, the entire point of front-of-package labels is to market products as healthy or “better for you” no matter what they contain. Front-of-package labels are a tool for selling, not buying. They make highly processed foods look healthier.

Will companies accept a voluntary labeling scheme that makes foods seem worse? Doubtful.

Nutrition ranking symbols began appearing on food packages in the mid-1990s, when the American Heart Association got companies to pay for displaying its HeartCheck.

Food companies then established their own systems for identifying “better-for-you” products. PepsiCo, for example, developed its own nutritional standards and proclaimed hundreds of its snacks and drinks as “Smart Choices Made Easy.”

In an attempt to bring order to this chaos, food companies banded together to develop an industry-wide system. Unfortunately, their joint Smart Choices checkmark appeared first on Froot Loops and other sugary cereals. The ensuing ridicule and legal challenges forced the program to be withdrawn.

At that point, the FDA, backed by Congress and other federal agencies, asked the Institute of Medicine for help.

The institute released its first report last year. It revealed inconsistencies in the 20 existing ranking schemes from private agencies, food companies and supermarket chains. Toasted oat cereal, for example, earned two stars in one system, a score of 84 (on a scale of 100) in another, and a score of 37 in a third.

The report said labels should display only calories and to-be-avoided nutrients. Labels should not display “good-for-you” nutrients – protein, fiber, and certain vitamins and minerals – because these would only confuse consumers and encourage companies to unnecessarily add nutrients to products for marketing purposes.

Although the FDA was waiting for the second institute report before taking action, the food industry wasted no time. The Grocery Manufacturers Association and Food Marketing Institute introduced their own system.

Complicated approach

They got their members to agree to a more complicated system, “Nutrition Keys,” based on nutrients to avoid but also including up to two “good-for-you” nutrients.

Food companies immediately put Nutrition Keys’ symbols – well established to be difficult for consumers to understand – on package labels where you can see them today. Now called Facts Up Front, the symbols are backed by a $50 million “public education” campaign.

The reasons for the industry’s preemptive strike are obvious. The second Institute of Medicine report gives examples of products that qualify for stars – toasted oat cereal, oatmeal, orange juice, peanut butter and canned tomatoes, among them.

It also lists the kinds of products that would not qualify for stars, including animal crackers, breakfast bars, sweetened yogurt and chocolate milk.

So the industry argues that consumers “want simple and easy to use information and should be trusted to make decisions for themselves and their families … rather than have government tell them what they should and should not eat.”

But why, you ask, does any of this matter? I view front-of-package labels as a test of the FDA’s authority to regulate and set limits on any kind of food industry behavior. If the FDA cannot insist that food labels help the public choose healthier foods, it means the public has little recourse against any kind of corporate power.

Perhaps Facts Up Front will arouse the interest of attorneys general – just as the Smart Choices program did.

In the meantime, the industry’s pre-emption of FDA labeling initiatives is evidence that voluntary schemes don’t work. Labeling rules need to be mandatory.

Let’s hope the FDA takes the Institute of Medicine’s advice and starts rule-making right away.

Marion Nestle is the author of “Food Politics” and “What to Eat,” among other books, and is a professor in the nutrition, food studies and public health department at New York University. E-mail comments to food@sfchronicle.com.

Nov 4 2011

Front-of-package labels: a survey and reprise

Food Navigator’s “special edition” on front-of-package labeling includes the results of a new survey of readers’ attitudes and a round up of previous articles.

Front-of-pack poll results: No clear winner (except cynicism…): The results of this poll are amusing, not least because they depend—as always—on how the questions were asked.   Respondents to this one were offered five choices:

  • Facts up Front. Consumers don’t want to be told what to eat (29% picked this one).
  • The IOM scheme. Busy shoppers need more guidance (19%).
  • Other points-based schemes that include positive nutrients. eg. Guiding Stars (11%).
  • Traffic-light-type color-coding schemes (~5%).
  • We’re kidding ourselves if we think front-of-pack labels will change behavior (36%).

This last is tempting.  Front-of-package labels, as I keep insisting, are about encouraging sales of one processed food product over another.  They have little to do with encouraging healthier food choices.

Front-of-pack labeling in pictures: Healthier choices at a glance or more nutritional wallpaper?: Red lights, green dots, ticks, stars, healthy seals, nutrients to encourage, nutrients of concern, smart choices… The aim of front-of-pack labels is simple – to help us make healthier choices (or at least more informed ones) – fast. But how best to achieve this has prompted a storm of controversy on both sides of the Atlantic….

IOM front-of-pack labels are step in right direction but need more work, says Guiding Stars advisor: The Institute of Medicine’s (IOM’s) proposed front-of-pack (FOP) labeling scheme is a positive step forward, but “needs much more work”, according to supporters of one leading FOP scheme already up and running in the marketplace….

IOM front-of-pack labeling scheme: It’s bold, it’s simple and I love it. But is it fair?: The Institute of Medicine (IOM) certainly didn’t pull any punches in its front-of-pack labels report yesterday….

IOM calls for ‘fundamental shift’ in approach to front-of-pack food labeling: Front-of-pack (FOP) labeling schemes should “move away from systems that mostly provide nutrition information without clear guidance about healthfulness and toward one that encourages healthier food choices”, according to a high-profile report from the Institute of Medicine (IOM)….

Not a word from the FDA about the IOM’s front-of-package report.  What will FDA do?  What can FDA do?  It’s a voluntary scheme and companies can voluntarily refuse to use it.  Hence: those useless (except to food companies) “Facts Up Front.”

Oct 31 2011

The latest fish story: this time it’s Boston-area restaurants

When I wrote What to Eat, a book devoted to discussion of food issues using supermarkets as an organizing device, I needed five chapters to discuss issues related to fish.  By the time I was through, I considered the fish sections of supermarkets to be the Wild West of the food industry: anything goes and the buyer had best be wary.

Fish regulation, I pointed out, is divided among at least four federal agencies: USDA for marketing, NOAA (National Oceanic and Atmospheric Administration) for ocean fisheries, EPA for fish caught for sport and recreation, and FDA for fish safety.  This alone should tell you that this is a virtually unregulated industry.

Now the Boston Globe presents the latest evidence for this dismal view.  Investigative reporters examined fish served in Boston-area restaurants.  Oops.  They found widespread bait and switch.  In many restaurants—even good ones—the fish served are not what customers think they paid for.

On the menu, but not on your platefish at restaurants were mislabeled about half the time, sometimes deliberately.  The site takes some work to scroll through but is worth the effort.  Here is one example:

At East Bay Grille in Plymouth, what was advertised as native scrod or haddock was actually previously frozen Pacific cod. A general manager said the restaurant hadn’t yet updated the menu. The revised menu, however, still describes the fish as “fresh day boat scrod.”

From sea to sushi bar, a system open to abusefish is a largely unregulated industry and problems are pervasive.

Suppliers such as Goldwell use the names interchangeably, contributing to a little-known but pervasive problem in the international seafood industry: lower-quality and less expensive fish mislabeled as desirable species. Some distributors do this unknowingly, while others intend to deceive. Lax government oversight, industry indifference, and consumer ignorance allow mislabeling to flourish.

Fish misidentification is especially common at sushi restaurants, partly because they use various names for the same fish. The confusion can be compounded by packaging labels written in other languages that are incorrectly translated into English.

Bertucci’s tries to right a wrong: How hake ended up as cod on the menu at 94 Bertucci’s restaurants.

Scrutiny vowed on fish labeling: state officials vow to improve oversight of seafood sales.

Good luck to state officials.  They will have their hands full trying to get on top of this industry.  Here’s what I wrote in What to Eat:

Much of this industry acts like it is virtually unregulated and as if all it cares about is selling fish as quickly as possible at as high a price as the traffic will bear.  Out of ignorance or, sometimes, unscrupulousness, the more profit-minded segments of this industry bend the rules to their own advantage any time they can get away with it.  No wonder “fishy” translates as “suspicious.”  If you want to buy fish, you need to watch out for labels that are sometimes untruthful and often misleading” (p. 232).

Thanks to the Boston Globe for exposing this fish scandal. 

And thanks to Consumer Reports for doing a similar story in its December issue.  Its investigation found 20% of 190 samples to be mislabeled.  And the only fish consistently labeled correctly were Chilean sea bass, coho salmon, and bluefin and ahi tuna. 

Regulation anyone?

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