by Marion Nestle

Currently browsing posts about: FDA

Jan 9 2014

Are GMOs “natural?” The FDA won’t say.

I’ve written frequently about the “natural” issue—what’s natural in foods and what’s not—on this site and now must do so again.

Yesterday, FoodNavigator reported that the FDA “respectfully declined” to decide once and for all whether foods labeled “natural” can include GMOs.

To summarize what brought this on:

  • Judge Yvonne Gonzalez Rogers referred a lawsuit over “all-natural’ claims on GMO-containing Mission tortilla chips to the FDA to decide whether GMO-containing products can be considered “natural.”
  • So did two other judges in cases involving Campbell Soup and General Mills Kix cereal.

The FDA’s letter to the three judges says the agency has to make decisions like this in the context of rulemaking, not litigation.

So how about making a decision about what “natural” means once and for all?

Not a chance.  The FDA says it has better things to do:  “Because especially in the foods arena, FDA operates in a world of limited resources, we necessarily must prioritize which issues to address.”

Back to court, this one goes, or so it seems.

Dec 27 2013

More on “profligate” use of antibiotics to promote growth in farm animals

The New England Journal of Medicine has an editorial on why we need to stop using antibiotics to promote the growth of farm animals and make sure they are only used for therapeutic purposes.

Otherwise, bacteria will become resistant to them and the antibiotics won’t work in us.

This figure from the article illustrates the problem:

As writers in the Journal wrote a year ago, we know what to do about the problem: Ban antibiotic use for everything other than disease treatment.

The FDA is taking baby steps in this direction.  How about a new year’s resolution to speed up the process?

Dec 17 2013

The FDA issues guidance on animal antibiotics–voluntary, alas, but still a major big deal

I was in Washington DC last week when the FDA announced  that it was taking significant steps to address antibiotic resistance, a problem caused by overuse in raising animals for food.

The FDA called on makers of animal antibiotics to:

  • Voluntarily stop labeling medical important antibiotics as usable for promoting animal growth or feed efficiency (in essence, banning antibiotics from these uses).
  • Voluntarily notify the FDA of their intent to sign on to these strategies within the next three months.
  • Voluntarily put the new guidance into effect within 3 years.
  • Agree to a proposed rule to require a veterinarian’s prescription to use antibiotics that are presently sold over the counter (the proposal is open for public comment for 90 days at www.regulations.gov.   Docket FDA-2010-N-0155).

Voluntary is, of course, a red flag and the Washington Post quoted critics saying that the new guidance falls far short of what really is needed—a flat-out ban on use of antibiotics as growth promoters.

  • Consumers Union is concerned about the long delay caused by the 3-year window.
  • CSPI is worried about all the loopholes.
  • NRDC thinks the FDA is pretending to do more than it’s really doing and “kicks the can significantly down the road.”
  • Mother Jones points out that the meat industry can still “claim it’s using antibiotics ‘preventively,’ continuing to reap the benefits of growth promotion and continue to generate resistant bacteria.”
  • Civil Eats reminds us that the Pew Commission on Industrial Farm Animal Production (on which I served) recommended a ban on nontherapeutic use of all antibiotics.

Yes, the loopholes are real, but I view the FDA’s guidance as a major big deal.  The agency is explicitly taking on the antibiotic problem.  It is sending a clear signal to industrial farm animal  producers that sooner or later they will have to:

  • Stop using antibiotics as growth promoters.
  • Stop using antibiotics indiscriminately, even for disease treatment.

I think the FDA is dead serious about the antibiotic problem.  If the FDA seems to be doing this in some convoluted fashion, I’m guessing it’s because it has to.  The FDA must not have been able to find any other politically viable way to get at the antibiotics problem.

I see this as a first step on the road to banning antibiotics for any use in animals other than the occasional treatment of specific illnesses.

As the New York Times puts it,

This is the agency’s first serious attempt in decades to curb what experts have long regarded as the systematic overuse of antibiotics in healthy farm animals, with the drugs typically added directly into their feed and water. The waning effectiveness of antibiotics — wonder drugs of the 20th century — has become a looming threat to public health. At least two million Americans fall sick every year and about 23,000 die from antibiotic-resistant infections.

Still not convinced antibiotics are worth banning for promoting growth?

The best explanation is the Washington Post’s handy guide to the antibiotic-perplexed.  Here, for example, is its timeline of development of microbial resistance to antibiotics.  The bottom line: the more widespread the use of antibiotics, the greater the onset and prevalence of resistance.  And it takes practically no time for bacteria to develop resistance to antibiotic drugs.

nchembio.2007.24-F1

Resources from FDA

Dec 10 2013

Yes, one more post on the meaning of “natural”

At a talk I gave for CQ Roll Call in Washington, DC last week, an audience member asked about the definition of “natural.”  I thought I had said everything there was to say about it (see post from August).  Wrong.

Another member of the audience sent me the definition of “natural” produced by, of all things, the  Treasury Department’s Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF).

Three federal agencies deal with “natural.”

The FDA

In answer to the question, “What is the meaning of ‘natural’ on the label of food?,” the FDA says:

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.

The USDA

The USDA discusses “natural” in the context of organic foods, in order to distinguish “natural” from organic:

Natural. As required by USDA, meat, poultry, and egg products labeled as “natural” must be minimally processed and contain no artificial ingredients. However, the natural label does not include any standards regarding farm practices and only applies to processing of meat and egg products. There are no standards or regulations for the labeling of natural food products if they do not contain meat or eggs.

The ATF

This agency is in charge of regulating alcoholic beverages, largely for tax-collection purposes.  Its “ATF Ruling 85-4″ does not actually define the term “natural,” but instead says when ATF takes no exception to its use.

(1) Any grape fruit, citrus or agricultural wine may be designated “natural” if it is made without added alcohol or brandy…No other type of wine may be designated as “natural.”

(2) A distilled spirit may be designated as “natural” if is solely the result of distillation, with or without mingling of the same class and type of spirits or simple filtration which does not alter the class or type of the product.

(3) A malt beverage may be designated “natural” if it is made without adjuncts (additives) other than those additives which do not remain in the finished product, either by precipitating out or by combining with other components of the product and the resulting compound precipitates or is filtered out.

I am not making this up.

CSPI thinks it’s time to phase out the use of “natural.”  OK by me.

Addition: Michele Simon, who blogs at Eat, Drink, Politics, writes (she’s not making this up either):

In fact, ATF is how housed within the Department of Justice.

Historically, ATF had all jurisdiction over alcohol (and was within Treasury), which is where that rule must have come from.

ATF still maintains jurisdiction over criminal activity, but now, the Alcohol and Tobacco Tax and Trade Bureau oversees labeling. That’s housed within Treasury.

This explains the split in 2002 (click here).

Clear as mud? So maybe you can add a fourth agency to your list!

Dec 6 2013

Monsanto has a public image problem? A surprise?

Thanks to Politico for alerting us to Monsanto’s sudden discovery:  it has just recognized—can you believe this?—that it has a public image problem.

In recent months the company has shaken up its senior public relations staff, upped its relationship with one of the nation’s largest public relations firms and helped launch a website designed to combat the fallacies surrounding genetically modified organisms.

Monsanto revealed its public image worries in its annual filing to the Securities and Exchange Commission.  The SEC requires companies to list societal factors that create risk to its profitability. Monsanto’s first three:

1.  Threats to patent rights

Efforts to protect our intellectual property rights and to defend claims against us can increase our costs and will not always succeed; any failures could adversely affect sales and profitability or restrict our ability to do business.

Intellectual property rights are crucial to our business, particularly our Seeds and Genomics segment. We endeavor to obtain and protect our intellectual property rights in jurisdictions in which our products are produced or used and in jurisdictions into which our products are imported.

2. Too much regulation

We are subject to extensive regulation affecting our seed biotechnology and agricultural products and our research and manufacturing processes, which affects our sales and profitability.

Regulatory and legislative requirements affect the development, manufacture and distribution of our products, including the testing and planting of seeds containing our biotechnology traits and the import of crops grown from those seeds, and non-compliance can harm our sales and profitability.

3. Bad public relations

The degree of public acceptance or perceived public acceptance of our biotechnology products can affect our sales and results of operations by affecting planting approvals, regulatory requirements and customer purchase decisions.

Some opponents of our technology actively raise public concern about the potential for adverse effects of our products on human or animal health, other plants and the environment. .. Public concern can affect the timing of, and whether we are able to obtain, government approvals.

Even after approvals are granted, public concern may lead to increased regulation or legislation or litigation…which could affect our sales and results of operations by affecting planting approvals, and may adversely affect sales of our products to farmers, due to their concerns about available markets for the sale of crops or other products derived from biotechnology.

Maybe if the company was less aggressive about defending itself against risks #1 and #2, public relations would be less of an issue.

Do the close calls on labeling initiatives in California and  Washington worry Monsanto?  Of course they do.  They should.

I was on the FDA food advisory committee in 1994 and witnessed Monsanto’s aggressive opposition to labeling.

If public image is a problem for the company, it has nobody to blame but itself. 

The only surprise:  Why did public demands for labeling take so long?

Dec 4 2013

Yes, the environment does influence food choice

I’m in Washington, DC this week on a bit of book tour for Eat, Drink, Vote (see Appearances for schedule).

At my Politics & Prose bookstore event last night, I got asked why I think the food environment matters so much in dietary choice.  Isn’t food choice a matter of personal responsibility?

It is, of course, but the food environment greatly influences personal choice.

Two examples:

Large portions: just about anyone presented with a large portion of food with eat more from it, take in more calories (larger portions have more calories!), and underestimate the calories consumed by a much greater proportion than from a smaller amount.

Salt intake: Because 80% or so of salt in the American diet comes from processed and restaurant foods, people eating in restaurants have no control over the amount of salt they take in.

To make it easier for people to take in fewer calories and less salt requires changes in the food environment: serve smaller portions and reduce the salt in restaurant foods.

FDA: Get to work!

Nov 26 2013

The hooks and lines of the farm bill: Catfish inspection

As I am endlessly complaining, the farm bill is so detailed, complicated, and opaque that no rational person can possibly understand it, let alone a member of Congress.

To wit: catfish inspection.

As Gail Collins noted in her New York Times column a week or so ago, some members of the House want the USDA to inspect catfish, not the FDA (which ordinarily is responsible for fish inspection).  The current FDA inspection office costs $700,000 per year.  The USDA office, established by the 2008 farm bill, costs about $14 million a year, even though the USDA has not gotten around to issuing rules or actually inspecting catfish.

What is this about?  Not fish safety, really.  It’s about protecting catfish farmers in the South and setting up “more rigorous” safety criteria that will exclude competitive foreign catfish imports, especially from Vietnam.

The House version of the farm bill calls for repeal of USDA catfish inspection as a cost-cutting measure (the Senate farm bill does not mention catfish inspection, which means it leaves the USDA office in place).

Thad Cochran, Republican Senator from Mississippi, wants the House to delete the repeal provision, keep USDA in charge, and, thereby, protect the Mississippi catfish industry from foreign catfish imports.

Politico Pro quotes a member of Cochran’s staff:

Sen. Cochran has made it clear that his priority is to complete the new farm bill and get it signed into law. It sounds like there are some who have a deep under-appreciation of the diversity of Mississippi’s agriculture industry and the importance of this bill to the state’s farmers, foresters, hunters, and those in need of nutrition assistance.

The New York Times also points out that although some watchdog consumer groups support tougher safety standards for catfish (because of lower foreign standards for antibiotics and other chemicals), a Government Accountability Office report in May 2012 called imported catfish a low-risk food and said an inspection program at the Agriculture Department would “not enhance the safety of catfish.”

Now, says the Times in another article, a coalition of budget watchdog groups and a seafood trade group are lobbying to repeal the USDA’s inspection program.

All of this is in the House version of the farm bill, but unless you are a lobbyist for the catfish industry, you would never know it from the bill itself.  Here’s the relevant section from the  House bill.

catfish

As Gail Collins puts it,

See, this is what I like about the farm bill. The agriculture parts harken back to the golden era when Republicans and Democrats could work together to promote stupid ideas that benefited the special interests in their districts. And then go out and get inebriated in bipartisan drinking sessions. Now everybody is in the gym and then shutting down the government.

Nov 7 2013

Trans-fat: FDA proposes to eliminate GRAS status

The FDA has just announced a proposal to withdraw GRAS (Generally Recognized As Safe) status for trans-fat.

My first reaction: Isn’t trans-fat already out of the food supply?  Hasn’t this been one of the food industry’s greatest public health achievements?

Once the FDA started to require trans-fat to be listed on food labels, food companies quickly stopped using partially hydrogenated oils (the source of trans-fat) and found healthier substitutes.  That’s why most food labels list zero grams trans-fat.

But the FDA allows food labels to say zero trans-fat if its amount is below 0.5 gram per serving.

Some manufacturers are still using a little.  This new initiative will encourage them to get rid of those last little bits.

Contrary to the New York Times headline, this is not exactly a ban on trans-fat.  If trans-fat is no longer GRAS, manufacturers can still file a food additive petition to continue using partially hydrogenated oils.

The Federal Register notice asks for input for the next 60 days.

I say congratulations to all:

  • To food companies who worked hard to find ways to substitute healthier fats for trans-fats.
  • To the FDA for finally taking care of the trans-fat 0.5-gram loophole.
  • To Center for Science in the Public Interest for bringing health problems with trans-fat to public attention.
  • To all of the researchers who did the science linking trans-fat to higher LDL-cholesterol levels and to heart disease risk.
  • To the New York City health department for banning trans-fats from use in city restaurants.

Americans will be healthier as a result of all of your efforts.

Resources

At the moment, the FDA has not yet posted its Federal Register notice on the GRAS status of trans-fat. When it does, the notice should be available here.

CSPI’s home page on trans fat

The FDA trans-fat home page

FDA consumer materials

FDA guidance for industry

Research

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