Currently browsing posts about: FDA

Jan 10 2012

Antibiotics in farm animals: FDA issues weak rule

By this time everybody knows—or ought to—that the non-therapeutic use of antibiotics in farm animals is a threat to human health. 

Using antibiotics to promote animal growth or reduce feed requirements is a bad idea.  Widespread use of these drugs induces microbial resistance, making the antibiotics ineffective against human disease.

So you would think that public health agencies would be falling all over themselves trying to reduce antibiotic use in farm animals.  No such luck.  Proposals to restrict use of antibiotics for therapeutic purposes runs up against the interests of meat and poultry industries. 

The best the FDA can do falls far short of what is needed.  Witness its pussy footing on cephalosporin drugs.

On January 4, the FDA proposed a final rule on use of cephalosporin drugs in animal agriculture.

The rule bans some “extralabel” (i.e., unapproved) uses of cephalosporin antimicrobial drugs in some food animals—cattle, swine, chickens, and turkeys. 

As the FDA’s press release explains, it is banning use of cephalosporins:

  • At unapproved dose levels, frequencies, durations, or routes of administration
  • In forms that are not approved for use in cattle, swine, chickens, and turkeys because they are intended for humans or companion animals
  • For disease prevention

These are all good things but should do much more. 

Cephalosporins are used in humans to treat pneumonia, skin and soft tissue infections, pelvic inflammatory disease, diabetic foot infections, and urinary tract infections.

If bacteria are resistant to cephalosporins, doctors have fewer options for treatment and these are less effective or more harmful.

 What is troubling is that the FDA proposed a more restrictive ban in 2008 but reversed the decision under pressure from industry veterinarians.

As Food Safety News reports, the new order, which is scheduled to go into effect in April, follows a couple of previous notices published last year. 

In November, the FDA turned down consumer petitions calling for a ban on the non-therapeutic use of a broader range of antibiotics in farm animals. 

In December, the FDA admitted that it had given up a plan first announced in 1977 to withdraw approval for penicillin and tetracyclines in animal feed.

Apparently, the FDA has decided to try to get drug companies and the meat and poultry industries to reduce the use of antibiotics voluntarily.

Good luck with that. 

Philip Brasher writes in the Des Moines Register that the new restrictions will hit hardest on the chicken industry, which uses the drugs for disease prevention. 

He says the FDA’s 2008  proposal would have blocked hog producers from treating illnesses that aren’t listed on the label.   He quotes the chief veterinarian for the National Pork Producers Council:

We are pleased that FDA balanced the need to protect animal health with their concerns about resistance.

This is not about animal health.  Nobody is trying to stop the use of antibiotics to treat animal disease.  At issue is their use as growth promoters or feed savers.

Congresswoman Louise Slaughter (Dem-NY) understandably views the FDA’s action as “tepid.”  She has introduced the  Preservation of Antibiotics for Medical Treatment Act to deal with the problem of non-therapeutic antibiotic use.  Of the FDA’s proposal, she said:

This is a modest first step by the FDA…but we’re really just looking at the tip of the iceberg. We don’t have time for the FDA to ploddingly take half-measures. We are staring at a massive public health threat in the rise of antibiotic-resistant superbugs. We need to start acting with the swiftness and decisiveness this problem deserves.

We do indeed.  Her bill deserves much support.   Public health should not be left up to the meat, poultry, and drug industries to decide.

Addition, January 12: I missed the New York Times editorial on this issue:

It’s time for the F.D.A. to consider the public’s health as carefully as it considers the interests of intensive agriculture and pharmaceutical companies.

Dec 31 2011

Looking ahead: food politics in 2012

My monthly Food Matters (first Sunday) column in the San Francisco Chronicle takes out a crystal ball…

Q: What’s on the food politics agenda for 2012? Can we expect anything good to happen?

A: By “good,” I assume you mean actions that make our food system safer and healthier for consumers, farmers, farm workers and the planet.

Ordinarily, I am optimistic about such things. This year? Not so much. The crystal ball is cloudy, but seems to suggest:

Political leaders will avoid or postpone taking action on food issues that threaten corporate interests. Sometimes Congress acts in favor of public health, but 2012 is an election year. Expect calls for corporate freedom to take precedence over those for responsible regulations. Maybe next year.

Something will happen on the farm bill, but what? Last fall’s secret draft bill included at least some support for producing and marketing fruits and vegetables, and only minimal cuts to SNAP (food stamps). Once that process failed, Congress must now adopt that draft, start over from scratch or postpone the whole mess until after the election.

SNAP participation will increase, but so will pressure to cut benefits. With the economy depressed, wages low and unemployment high, demands on SNAP keep rising. In 2011, SNAP benefits cost $72 billion, by far the largest farm bill expenditure and a tempting target for budget cutters. While some advocates will be struggling to keep the program’s benefits intact, others will try to transform SNAP so it promotes purchases of more healthful foods. Both groups should expect strong opposition.

Childhood obesity will be the flash point for fights about limits on food marketing. The Lancet recently summarized the state of the science on successful obesity interventions: taxes on unhealthy foods and beverages, restrictions on marketing such items, traffic-light front-of-package food labels, and programs to discourage consumption of sugar-sweetened drinks and television viewing. Expect the food industry to continue to get Congress to block such measures, as it did with U.S. Department of Agriculture school nutrition standards (hence: pizza counts as a vegetable).

The Federal Trade Commission will postpone release of nutrition standards for marketing to children. Although Congress asked for such standards in the first place – and the standards are entirely voluntary – it just inserted a section in the appropriations bill requiring a cost-benefit analysis before the FTC can release them. Why does the food industry care about voluntary restrictions? Because they might work (see previous prediction).

The Food and Drug Administration will delay issuing front-of-package labeling guidelines as long as it can. The FDA asked the Institute of Medicine for advice about such labels. The institute recommended labels listing only calories, saturated and trans fat, sodium and sugars – all nutrients to avoid. Although the institute did not mention traffic-light labels, it did recommend check marks or stars, which come close. The food industry much prefers its own method, Facts Up Front, which emphasizes “good-for-you” nutrients. It is already using this system. Will the FDA try to turn the institute recommendations into regulations? Maybe later.

The FDA will (still) be playing catch-up on food safety. The FDA got through the 2011 appropriations process with an increase of about $50 million for its inspection needs. This is better than nothing but nowhere near what it needs to carry out its food safety mandates. The FDA currently inspects less than 2 percent of imported food shipments and 5 percent of domestic production facilities. The overwhelming nature of the task requires FDA to set priorities. Small producers think these priorities are misplaced. Is the FDA going after them because they are easier targets than industrial producers whose products have been responsible for some of the more deadly outbreaks? Time will tell.

On the bright side, the food movement will gather even more momentum. While the food industry digs in to fight public health regulations, the food movement will continue to attract support from those willing to promote a healthier and more sustainable food system. Watch for more young people going into farming (see Chronicle staff writer Amanda Gold’s Dec. 25 article) and more farmers’ markets, farm-to-school programs, school meal initiatives, and grassroots community efforts to implement food programs and legislate local reforms. There is plenty of hope for the future in local efforts to improve school meals, reduce childhood obesity, and make healthier food more available and affordable for all.

And on a personal note: In April, University of California Press will publish my co-authored book, “Why Calories Count: From Science to Politics.” I’m hoping it will inspire more thinking and action on how we can change our food system to one that is better for people and the planet.

Happy new year!

 

Dec 29 2011

Food safety: it’s déjà vu all over again

In preparation for the holiday season, Secretary of Health and Human Services Kathleen Sebelius and Agriculture Secretary Thomas Vilsack held a press conference  to promote the departments’ efforts on food safety.

They announced release of the administration’s progress report from its Food Safety Working Group.

They also highlighted additional places to get government information about food safety at home:

I didn’t pay much attention to these announcements until I read the slightly snarky account in Food Chemical News (December 22). 

The Obama administration patted itself on the back today with a new report that both lists the accomplishments over the past three years of its Food Safety Working Group (FSWG) and identifies the group’s top priorities for the coming year.

Released just minutes before a short media call that served as more of a pep rally, The Federal Food Safety Working Group Progress Report, a 31-page document, summarizes for stakeholders a host of activities that have taken place at government agencies over the past three years related to detecting foodborne pathogens, enhancing surveillance, responding to food safety problems, improving food safety at the retail level and educating consumers.

The list of the administration’s food safety accomplishments is long and detailed, and many are impressive.

But what the report does not say is telling.  Neither the USDA nor FDA have the resources or power to require the industries they supposedly regulate to produce safe food.

As Mark Bittman explains in his Opinionator column in the New York Times, politics defeats even the most rational and thoroughly science-based safety measures, leaving the FDA unable to do much more than politely request “voluntary guidance” of industry.

Bittman focuses on the political barriers to doing what the FDA has been asking for since 1977:  a ban on the use of antibiotics for non-therapeutic purposes, in this case to make food animals grow faster.   The result: “Bacteria 1, FDA 0.”

Here’s the nut: The F.D.A. has no money to spare, but the corporations that control the food industry have all they need, along with the political power it buys.

That’s why we can say this without equivocation: public health, the quality of our food, and animal welfare  are all sacrificed to the profits that can be made by raising animals in factories….Animals move from farm to refrigerator case in record time; banning prophylactic drugs would slow this process down, and with it the meat industry’s rate of profit.

Lawmakers beholden to corporate money are not about to let that happen, at least not without a fight.

For more than 20 years, the Government Accountability Office has called for creation of a single food safety agency that unites the safety oversight functions of the FDA and USDA and has the authority to require food to be produced safely.

In this Congress?  Hopeless.

But Congress can be changed—and that’s a worthy thought for the new year.

 

 

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.

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