by Marion Nestle

Currently browsing posts about: FDA

Sep 23 2010

Genetically modified foods in supermarkets: how many?

A reader writes that the discussion over genetically modified foods makes no sense because: “virtually every food we consume today  has been genetically  modified.”

The accuracy of this statement depends, of course, on how you define “genetically modified.”  If you include traditional genetic crosses done through plant and animal breeding, the statement is correct.

If, however, you restrict the definition of GM foods to those involving actual manipulations of DNA (rather than eggs and sperm), and the insertion of DNA from one organism into the DNA of another, then the number of GM foods approved for production in the United States is quite limited.

The FDA provides a list of such foods in its inventory of completed consultations on bioengineered foods.

The list includes GM corn, soybeans, cotton, cotton, alfalfa, canola, and sugarbeets, most of which are fed to animals or used as ingredients in processed foods.

But what about supermarket fruits and vegetables?  To answer this question requires a clear separation between approval of production and actual production.

To date, the FDA has approved production of GM varieties of plums, cantaloupe, papaya, squash, radicchio, tomatoes, and potatoes.  Note: sweet corn–the kind you eat off the cob–is not on the list.

Even if approved, the GM varieties may not be in your supermarket.  GM varieties, it turns out, are difficult to produce under field conditions.

When I was doing the research for What to Eat in 2005 or so I tried hard to find out which supermarket foods might be GM.  This was not easy.  Basically, nobody knew.  Unless you test for GM, you can’t tell, and nobody was testing.

So I did some testing.  The foods most highly suspected of being GM were papayas from Hawaii engineered to resist ringspot virus.  I sent samples of seeds from several varieties of supermarket papayas to GeneticID, a company that does such testing (at, alas, great expense).   As I recount in the book, the only papaya that tested positive was the one from Hawaii.  The one labeled organic did not and neither did any of the others.

I believe that the public has a right to know whether supermarket foods are GM varieties.  Without labeling, you can’t tell.  That is why we need GM labeling.

As I explained a year ago, the U.K. requires labeling of GM ingredients and companies making products with GM ingredients do so.  We could do this too, and we should.

Addition: The Associated Press writes about the significance of these discussions (I’m quoted).

Sep 21 2010

The GM salmon saga continues

The FDA has just concluded two days of hearings on the safety and labeling of genetically modified (GM) salmon. I’ve been collecting comments about this and will add a few of my own.

USA Today: Let’s begin with Elizabeth Weise’s clear, insightful summary of what this is about. She summarizes the situation with GM salmon in a nifty Q and A format:

Q: What happens next?

A: Nothing soon. Before issuing a decision on the application, FDA will publish an Environmental Assessment of the salmon, followed by a required 30-day comment period. The agency would then determine whether it would file a Finding of No Significant Impact or an Environmental Impact Statemen….then use those findings to make a decision on whether or not to allow the sale of the salmon. The agency has said it has no set timeline for reaching a decision. Were the agency to decide to approve the sale of the salmon, it would take two years before the first crop was ready, company officials say.

Food Chemical News (September 20):  reports that AquaBounty’s CEO has no intention of restricting GM salmon farms to Panama. At the FDA hearing, he “forecast a spread of transgenic salmon operations from a proposed site in Panama to other countries, including the United States.”

Oops. The FDA had to remind him that his company’s application is for Panama only, and any other sites would require supplemental applications from the firm.”  The FDA said it was “not interested in AquaBounty’s future business plans.”

FoodNavigator.com reporter Caroline Scott-Thomas predicts that the hearings will lead to no recommendation.

The FDA’s Veterinary Medicine Advisory Committee (VMAC) did not vote or make a recommendation at the end of the hearings, saying that it does not yet have sufficient data…After two days of hearings, a Food and Drug Administration (FDA) advisory panel has called for more research to decide whether genetically engineered salmon is safe for consumption.

The New York Times says that the advisory group favored approval of the GM salmon, but that this could take ages.

Food Chemical News (September 21) says that most speakers at the hearing on GM labeling did not want it to be mandatory. It quotes Greg Jaffe, the director of biotechnology at Center for Science in the Public Interest (CSPI), as opposing mandatory labeling. Apparently, Jaffe:

urged AquaBounty to require its customers to provide “real” voluntary labeling on food products, such as “AquaBounty salmon,” “fast-growing salmon” or “environmentally friendly salmon”….He agreed that “no ingredients from a genetically engineered source” would be acceptable language provided there’s a comparable GE product in the marketplace.

Why would a representative of a consumer organization oppose mandatory labeling?  For that, go to

Jill Richardson’s lengthy analysis of FDA’s actions, written for Grist.  She lays out some of the more complicated issues, and takes a tough look at the biases of the committee members.

Washington Post: Lindsey Layton writes about the debates over labeling (I’m quoted).

A Washington Post poll found 78% of respondents to be worried about the health and safety risks of GM salmon.

Meanwhile, in the UK, the new government has stopped a scheduled public dialogue about GM foods.  That’s one way to handle it. All those pesky consumers don’t want it? Too bad for them.

My interpretation: of course the public does not trust genetically modified foods. The foods are not labeled. If the biotech industry and the FDA want the public to trust them, they need to label the GM salmon and all the other GM foods in the marketplace.

The public wants the right to choose.  The public should have the right to choose.

The issue of GM foods cannot just be about safety.

My mantra on this one: Even if genetically modified foods are safe, they are not necessarily acceptable.

I was a member of the FDA’s Food Advisory Committee in 1993 when, under pressure from Monsanto, the agency rejected labeling of GM foods.  I wish the FDA had listened to me and the other consumer representatives on the committee, all of us convinced that labeling is essential for promoting trust, and giving the public a choice. And, we said, it’s the right thing to do.

The FDA now has a chance to redeem it’s bad decision.  I hope they take this opportunity and decide to require labeling.

Footnote: I wrote about all this in my book, Safe Food: The Politics of Food Safety, just published in a new edition in July.  In preparing the second edition seven years later, I was surprised by how little about food biotechnology had changed.  The issues have not changed.  The field is stuck.   Labeling is one way to break the stalemate.  Let the public have a choice.  I’ll bet doing that will solve a lot of problems.

Sep 20 2010

One more time: corn sugar chemistry

Thanks to alert reader Glen for pointing out that the FDA already has a regulation for Corn Sugar in the Code of Federal Regulations, under food substances Generally Recognized as Safe (GRAS).  CFR Section 184.1857 reads:

(a) corn sugar (C6H12O6, CAS Reg. No. 50-99-7), commonly called D-glucose or dextrose, is the chemical [alpha]-D-glucopyranose. It occurs as the anhydrous or the monohydrate form and is produced by the complete hydrolysis of corn starch with safe and suitable acids or enzymes, followed by refinement and crystallization from the resulting hydrolysate.

(b) The ingredient meets the specifications of the Food Chemicals Codex, 3d Ed. (1981), pp. 97-98 under the heading “Dextrose….”

(c) In accordance with 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice.

The Corn Refiners have just petitioned the FDA to be allowed to use the name Corn Sugar to apply to both glucose/dextrose and High Fructose Corn Syrup (HFCS).  But the existing definition seems to exclude HFCS.  While HFCS is about half glucose, it is also about half fructose, and its manufacture from corn starch requires one more enzyme.

A reminder about sugar chemistry:

  • Glucose is the sugar in blood, and dextrose is the name given to glucose produced from corn but biochemically they are identical.
  • Fructose is the principal sugar in fruit.  In fruit, it raises no issues because it is accompanied by nutrients and fiber.
  • Sucrose is table sugar.  It is a double sugar, containing one part each of glucose (50%) and fructose (50%), chemically bound together.  Enzymes in the intestine quickly and efficiently split sucrose into glucose and fructose, which are absorbed into the body as single sugars.
  • HFCS is made from corn starch.  It contains roughly equivalent amounts of glucose (45 to 58%) and fructose (42 to 55%).

HFCS raises several issues, health and otherwise:

  • Quantity: the U.S. food supply provides to every American (all ages) about 60 pounds of sucrose and another 60 pounds of HFCS each year.  This is way more than is good for health.  Sugars of any kind provide calories but no nutrients.
  • Fructose: increasing evidence suggests that the metabolism of fructose–which differs from that of glucose–is associated with abnormalities.  This means that it is best to reduce intake of fructose from table sugar as well as HFCS.
  • Farm subsidies: these go to large corn producers and have kept down the cost of HFCS relative to that of sucrose.  The use of corn to make ethanol has raised the relative price of HFCS.
  • Genetic modification: Most corn grown in the United States is genetically modified to resist insects or herbicides.

From a health standpoint, it makes no difference whether the sweetener is sucrose or HFCS.

As for agave sugar as a substitute: it can have much higher concentrations of fructose than either sucrose or HFCS but its labels do not give percentages so you have no way to know how much.

Given all this, what’s your guess about what the FDA will decide?

Sep 7 2010

International food politics: Carving up the UK’s Food Standards Agency

FoodProductionDaily.com has done an analysis of who does what under the new UK scheme for dividing food responsibilities and taking power away from the pesky Food Standards Agency, which had the nerve to actually try to regulate the food industry.

At a time when it is increasingly obvious that food regulations would be better served if under the authority of a single food agency, the UK is doing just the opposite.

Here in America, we have enough problems with food regulations divided between FDA and USDA.  The UK has done us one better.    It now has three agencies in charge.  See if you can make sense of any of these new responsibilities:

The Food Standards Agency

  • Scientific advice on the food safety aspects of date marking
  • Assessment and labeling of ingredients/foods with food safety implications (e.g. allergens, glycols, high caffeine, high glycyrrhizinic acid)
  • Food safety aspects of organic food and of foods controlled by compositional standards
  • Treatments and conditions of use with food safety implications (e.g. quick frozen foods, raw drinking milk and pasteurization, food contact materials)
  • GM and novel foods (including use of nanotechnology)
  • EU General Food Law regulation, including traceability of food
  • Codex Committees on Food Hygiene, Methods of Analysis and Sampling, Food Additives, Contaminants in Foods

Department for Environment, Food and Rural Affairs (a mix of our FDA, USDA, and EPA)

  • General lead on food labeling legislation and relevant EU negotiations
  • Lead on the EU Food Information proposal
  • Country of origin labeling
  • Food composition standards and labeling such as fruit juice and fruit nectars, jams and bottled water
  • Technical advice on compositional standards for food without specific legislation, such as soft drinks and cereal products
  • Fish labeling
  • Use of marketing terms e.g. natural, fresh, clear labeling, vegan and vegetarian labeling
  • Food authenticity program
  • Codex Committees for: Food Labeling, Processed Fruits and Vegetables, Fresh Fruits and Vegetables, Fats and Oils, Fish and Fishery Products, Europe, General Principles
  • Lead on Codex Alimentarius Commission, General Principles and Coordinating Committee for Europe

Department of Health

  • Nutrition related aspects of the EU food information regulation
  • Front of pack labeling
  • Food for particular nutritional uses (PARNUTS)
  • Infant formula and follow on formula
  • Health and nutrition claims
  • Food supplements
  • Calorie information in catering establishments
  • Codex Committee on Nutrition and Foods for Special Dietary Uses

This sounds to me like an ironclad guarantee that nothing will ever get accomplished.  But that, of course, was very point of taking so many responsibilities away from the Food Standards Agency.  That agency, alas, was actually trying to regulate the food industry, something no conservative government is willing to tolerate.

Let’s hope our FDA pays no attention.

Sep 2 2010

Fish fight: FDA to hear comments on GM salmon

The FDA has scheduled meetings September 19-21 to hear advice about whether the agency should approve GM (genetically modified) salmon.

These, you may recall are Atlantic salmon bioengineered by AquaBounty Technologies.   Atlantic salmon only grow for a few months per year; they do not produce growth hormone in non-growth months.  AquaBounty scientists combined growth hormone genes from an unrelated Pacific salmon with DNA from the anti-freeze genes of an eelpout fish.

The result is that the GM salmon produce growth hormone throughout the year and grow at twice the rate of non-GM salmon.

In preparation for these hearings, a coalition of 31 advocacy groups issued a statement urging the FDA not to approve the fish.

Each year millions of farmed salmon escape from open-water net pens, outcompeting wild populations for resources and straining ecosystems…We believe any approval of GE salmon would represent a serious threat to the survival of native salmon populations, many of which have already suffered severe declines related to salmon farms and other man-made impacts….FDA’s decision to go ahead with this approval process is misguided and dangerous, and is made worse by its complete lack of data to review…FDA has been sitting on this application for 10 years and yet it has chosen not to disclose any data about its decision until just a few days before the public meeting.

According to press accounts, salmon are only the first in a long line of potential GM fish and animals.  AquaBounty also raises GM trout and tilapia.  Other companies are working on GM pigs and cows.

AquaBounty lost no time in responding to the Coalition’s objections:

This press release is inaccurate, deliberately misleading, and intended to create fear and misunderstanding. AquAdvantage salmon are, quite literally, the most studied fish in the world. In addition, the U.S. Food and Drug Administration has spent the last fifteen years creating a robust regulatory process to ensure these fish and other transgenic animal applications are appropriately evaluated and regulated.

Comment: In the early 1990s, I was one of four consumer representatives on the FDA’s 30-member Food Advisory Committee.  This was the time when the FDA was considering approval of the first GM crops.   All four of us voted to delay the decision until more information became available or to make sure that GM foods were labeled as such.  Obviously, the FDA did not listen to our excellent advice.

Indeed, when our term on the committee was up, the head of the FDA’s Center for Food Safety and Applied Nutrition explained to us that our committee had not really been advisory.  The FDA had already decided the issues that it brought to the committee for discussion.  All the agency wanted from the committee was some indication of the kind of public reaction its decisions might raise.

Is this still the case with FDA advisory hearings?  I really don’t know, but I hope the FDA will listen carefully to concerns about these fish.

Aug 27 2010

FDA proposes rules for menu labeling

When President Obama signed the health reform bill last February, he also signed national menu labeling into law.  The FDA is now proposing rules for how calorie labeling will work in practice.  The proposed rules are posted on the FDA website and in the Federal Register.  The FDA is seeking public comment on its Draft guidance for industry.

The law says that restaurant chains with more than 20 units nationally must post by March 23, 2011:

  • The number of calories in each standard menu item “as usually prepared and offered for sale” (the calorie disclosure must be “clear and conspicuous” and “adjacent to” the name of the standard menu item)
  • A statement that puts the calorie information in the context of a total daily caloric intake, and
  • A statement regarding the availability of the written nutrition information.

In my previous posts and writings about calorie labeling, I’ve been concerned about several problems I’ve observed in the implementation of New York City’s calorie labeling program.  Here’s how the FDA proposes to address them.  FDA’s rules are in black italics.  Mine are in red:

Not displaying calories at all: a “menu” or “menu board” is “the primary writing of the restaurant or other similar retail food establishment from which a consumer makes an order selection. FDA considers primary writing to include all forms of primary writing, such as dessert menus, beverage menus, or other specialty type menus. I think this means that if a restaurant has a menu board, it has to post calories on the board.  If it only has menus, the calories have to be on the menus.

Displaying calories in absurdly precise numbers: calorie disclosure should be expressed in the nearest 5-calorie increments for menu items containing up to and including 50 calories, and in 10-calorie increments above 50 calories, except that amounts less than 5 calories may be expressed as zero. This is fine.  Measuring calories isn’t all that precise anyway.

Displaying absurdly large ranges of calories: FDA will not require posting calories of variable menu items and combination meals until FDA issues a final rule. FDA will provide recommended language in the proposed rule. Uh oh. The FDA must be having a hard time figuring out what to do about this one.

Displaying incorrect values for calories: a restaurant shall have a reasonable basis for its nutrient content disclosures, including nutrient databases, cookbooks, laboratory analyses, and other reasonable meansWhat “reasonable” means is debatable but this ought to work within a an error of 10% or so.  We will have to see how this one plays out.

If you want to weight in on these proposed rules, now is the time to comment. You can do this easily at Docket FDA-2010-N-0298.

Aug 23 2010

The egg recall saga continues

The massive egg recalls so dominate the news today that it’s hard to talk about anything else.

For one thing, FDA Commissioner Margaret Hamburg took to the tube and appeared on three morning shows:

“We need greater abilities to trace back products to their source,” Hamburg told NBC’s “Today” show this morning. “We need better abilities and authorities to put in place these preventive controls and hold companies accountable.”

She pointed out that it is now one year after the peanut butter recall prompted calls for increased regulation, but the FDA still has limited authority to order recalls, among other things.

What she did not say, is that the Senate continues to tie the FDA’s hands by not passing S. 510.  Fortunately, other commentators (besides me) are making that point loud and clear:

With elections looming, Washington insiders saw little chance that the Senate would complete the bill this fall – until now. The recall of about a half-billion eggs in a salmonella scare may have given new life to the legislation….At the moment—even with salmonella eggs–the FDA can’t force a company to take its products off the market. (If an egg producer violates safety standards, the FDA does have authority to divert shell eggs to a pasteurization process, which egg producers would rather avoid).

In the meantime, the industry-sponsored  Egg Safety Center says:

Consumers are reminded that properly storing, handling and cooking eggs should help prevent food-borne illness. The Egg Safety Center and the Food and Drug Administration recommend that eggs should be fully cooked until both the yolks and the whites are firm, and consumers should not eat foods that may contain raw or undercooked eggs.

Wouldn’t it be nice if this group also said: “Producers are reminded that properly taking care of hens and diligently following food safety plans should help prevent food-borne illness. The Egg Safety Center urges egg producers to immediately implement the FDA’s new regulations for preventing Salmonella that went into effect on July 9.”

And here is USA Today’s take on it (I’m quoted).

Aug 19 2010

Salmonella in eggs is old news. But 380 million?

Yesterday, the FDA announced yet another voluntary recall of eggs produced by Wright County Egg in Galt, Iowa.  The first announcement on August 13 covered 228 million eggs.  This one adds 152 million for a grand total of 380 million—so far.

In that first announcement, the Wright company said: “Our farm strives to provide our customers with safe, high-quality eggs – that is our responsibility and our commitment.”

That, however, is not how the New York Times sees it.  According to today’s account, Wright has a long history of “run-ins with regulators over poor or unsafe working conditions, environmental violations, the harassment of workers, and the hiring of illegal immigrants.”

OK, so where are we on safety regulation?  The FDA, after many, many years of trying, finally introduced safety regulations for shell eggs.  These supposedly went into effect on July 9.

I recount the history of FDA’s persistence in the chapter entitled “Eggs and the Salmonella problem” in What to Eat. Check out the table  listing the key events in this history from 1980 to 2005.  It’s not pretty.

Preventing Salmonella should not be difficult.  The rules require producers to take precautions to prevent transmission, control pests and rodents, test for Salmonella, clean and disinfect poultry houses that test positive, divert eggs from positive-testing flocks, refrigerate the eggs right away, and keep records.  These sound reasonable to me, but I care about not making people sick.

Problems with Wright County Eggs started in May before the FDA’s mandatory rules went into effect meaning that the procedures were still voluntary.  The recalls this month are after the fact.  Chances are that most of the recalled eggs have already been eaten.

The CDC is tracking this recall and has logged about 200 reports of illness associated with it so far.  It has plenty to say about Salmonella and its hazards.

According to FoodSafetyNews, the first lawsuits have been filed.

As for food safety legislation that would give the FDA the authority to handle these incidents more efficiently—and, let us hope, maybe even prevent them—it is still sitting in the Senate.  For S.510 watchers, Bill Marler has a helpful new analysis.

The recall, by the way, affects eggs sold under many different brands: Lucerne, Albertson, Mountain Dairy, Ralph’s, Boomsma’s, Sunshine, Hillandale, Trafficanda, Farm Fresh, Shoreland, Lund, Dutch Farms, and Kemps in the first round, and now also James Farms, Glenview, and Pacific Coast.

The good news is that cooking kills Salmonella.  I’m buying eggs at farmers’ markets these days.

Addition: Tom Philpott of Grist on Wright County’s unsavory history.