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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?

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.

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.

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 means.  What “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.

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).

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.

On July 30, Center for Science in the Public Interest (CSPI)—in collaboration with representatives of a long list of distinguished health and consumer organizations (see below)–wrote Martha Coven of the Domestic Policy Council and Ezekiel Emanuel of the Office of Management and Budget urging them to encourage the FDA to take more vigorous enforcement action against misleading health claims on food packages.

Their petition responds to comments by the FDA’s Michael Taylor (discussed in a previous post) in a July 19 article for the Atlantic Food Channel, titled “How the FDA is picking its food battles.”   In explaining why the FDA is backing off from doing anything about unsubstantiated health claims on food products, Taylor said:

FDA must pick its battles—and set its priorities—in a way that will best benefit the public health….We have no pre-market review authority over such claims, and, under prevailing legal doctrines concerning “commercial free speech,” the evidentiary requirements placed on FDA to prove that such claims are misleading are significant and costly to meet. Moreover, meeting them requires tapping the same team of nutritionists, labeling experts, and lawyers who are working on our other nutrition initiatives.

We’re also conscious of the cleverness of marketing folks, who, once we prove today’s claim is misleading, can readily come up with another one tomorrow. Going after them one-by-one with the legal and resource restraints we work under is a little like playing Whac-a-Mole, with one hand tied behind your back.

So, we must make choices….especially considering the other high-priority nutrition and food safety initiatives that compete for FDA’s finite resources. We’ll consider all possibilities, but, in the meantime, we call on the food industry to exercise restraint, and we welcome the scrutiny CSPI and the media give to this issue.

Clearly, I was not the only one dismayed by this statement, which appears to be an open invitation to food companies to do whatever they like with health claims.  Indeed, Taylor’s statement reminded me of the Bush Administration’s FDA which, in 2003, announced that it had lost so many first amendment  health claims cases in court that it no longer intended to fight them.

But Taylor’s statement is also an open invitation to food advocates to get busy, as CSPI and the other signers of this letter have now done. The letter, dated July 30, 2010, is a follow up to a June 11 meeting on FDA/USDA Food Labeling Reform Efforts:

At Zeke’s suggestion, we are attaching a Priority List/Timetable Chart that provides an overview of the recommendations we made at our meeting and delineates how those recommendations intersect. As we discussed:

• We commend the Food and Drug Administration (FDA) for increasing the number of enforcement actions it has taken against misleading food labeling, and we urge the agency to increase those efforts. We also commend the FDA’s initiative to develop a system for disclosing key nutrition information on the fronts of food labels. However, we emphasize that the existing Nutrition Facts panel must also be modernized. In particular, nutrition information must be based on up-to-date serving sizes, a Daily Value for added sugars must be established and added to the existing Nutrition Facts panel, and “Calories per serving” must be displayed more prominently. Revisions to the Nutrition Facts panel and the development of a front-of-pack disclosure system are closely intertwined and should be developed concurrently.

• We urge the Domestic Policy Council to ask the FDA to ensure that any front-of-pack labeling scheme is not undercut by deceptive health-related claims on the fronts of food packages. Such claims, if unabated, will divert attention from any front-of-pack scheme the FDA develops. Since our meeting, the Federal Trade Commission (FTC) issued a consent order prohibiting claims that a food product could strengthen immunity because the claim lacked sufficient clinical evidence. Such claims are called “structure/function” claims by the FDA. The FDA should take a consistent position regarding the use of those claims. In addition, the FDA should address claims exaggerating the presence of healthy ingredients stressed in the U.S. Dietary Guidelines such as whole grains, fruits, and vegetables. For example, failure to remedy claims such as “Made with real fruit” on products that contain little fruit will detract from a declaration of sugar content that the FDA may specify in a front-of-pack labeling scheme, thus frustrating the Administration’s attempts to reduce childhood obesity.

• One way to remedy exaggerated claims for healthy ingredients (other than prohibiting them completely) is for the FDA to revise the ingredient list to require that the percentage of key ingredients such as fruit be disclosed in a clear, easily readable manner. FDA could also require that ingredient lists group all sources of added sugars to provide consumers with a clearer indication of the amount of added sugar in a product. The First Lady has recognized that ingredient labeling reform is an integral part of the Administration’s broader efforts to combat childhood obesity. The U.S. Department of Agriculture (USDA) is already working on new formats for ingredient labeling. We support those efforts and request the Council to encourage the FDA to follow USDA’s approach.

• In regard to a timetable, the recommendations we have made are closely intertwined with efforts already ongoing at the FDA. In some cases, they are necessary to ensure that those ongoing efforts by FDA succeed. We, therefore, urge the Council to recommend that the FDA expand its food labeling reform initiatives to include these additional issues and address them concurrently. Additional efforts that complement existing FDA labeling reform initiatives should commence as soon as the first set of initiatives is published in the Federal Register. All initiatives should be finalized by October 2012. This request is based on the fact that the FDA implemented the Nutrition Labeling and Education Act of 1990 in two years. The reform efforts we request are more limited than the requirements of the 1990 Act, and the FDA should be able to accomplish them by 2012 based on the agency’s previous performance on such matters.

• Rep. DeLauro, Chair of the House Agriculture Appropriations Subcommittee, asked the FDA how many FTEs the agency would need to issue regulations to revise the Nutrition Facts panel, increase the prominence of calories per serving, require caffeine labeling, and establish a daily value for added sugars, as well as other issues. The FDA stated that approximately “10-12” additional FTE’s would be necessary to address such concerns. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 2005: Hearings Before a Subcomm. of the House Comm. on Appropriations, 108th Cong. 2d Sess. 323 (2004). While the FDA’s response at the time involved some issues not covered by our current requests, we believe that the FDA’s estimate is still reasonable, and we urge the Council and the Office of Management and Budget to work with the FDA to ensure that the FDA devotes additional resources to this effort.

We welcome the opportunity to assist the Administration and look forward to continuing our dialogue.

The letter is signed by Bruce Silverglade, Director of Legal Affairs, CSPI and representatives of Consumers Union, American Public Health Association, American Medical Association,  American Cancer Society Cancer Action Network, American Heart Association,  American Society of Bariatric Physicians, American Diabetes Association,  American Dietetic Association, Alliance for Retired Americans, Society for Nutrition Education, American Institute for Cancer Research, and Directors of Health Promotion and Education.

Let’s hope the FDA pays attention and gets busy on these issues.

Nanotechnology involves the ability to control matter at the scale of a nanometer—one billionth of a meter. The world market for products that contain nanomaterials is expected to reach $2.6 trillion by 2015.

So says a report from the Government Accountability Office (GAO): Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk. GAO-10-549, May 25, 2010.

GAO identified a variety of products that currently incorporate nanomaterials already available in commerce…[in] food and agriculture….The extent to which nanomaterials present a risk to human health and the environment depends on a combination of the toxicity of specific nanomaterials and the route and level of exposure to these materials. Although the body of research related to nanomaterials is growing, the current understanding of the risks posed by these materials is limited.

The effects of nanotechnology on the environment are regulated by the EPA (Environmental Protection Agency), which is why this report targets recommendations to EPA.

Shouldn’t some of those recommendations be directed toward FDA, the agency that regulates food safety?  Maybe GAO needs to do another report?

In the meantime, the European Food Safety Authority is preoccupied with issues related to the safety of food nanotechnology.

The risk assessment framework for nanotechnology in Europe – like so much else connected to the technology – appears to be in its infancy but developing at a rapid pace…. Nano knowledge gaps have led some to call for a ban on the use of nanomaterials in food products until their safety has been fully established. One area of concern is whether nanoparticles can migrate from packaging materials into foods.

In seeking to assess nanomaterials, the food safety body repeatedly used phrases such as “specific uncertainties”, “limited knowledge” and…“difficult to characterise, detect and measure” in relation to toxicokinetics and toxicology in food. Likely usage and exposure levels are also largely a mystery.

The European Food Safety Authority says that lack of knowledge means that risk assessment of risk assessments must be done on a “cautious case-by-case approach.”

Last April, the European Parliament’s environment committee said nanotech products should be withdrawn from the market until more is known about their safety.  In June, that committee added that nanotech foods should be assessed for safety before they are approved for use and labeled.

Doesn’t that sound reasonable?  Let’s hope it’s not too late to put such constraints in place, and in the U.S. too.