Yesterday, I got a last-minute invitation to listen in on a USDA conference call announcing the release of the report of the joint USDA-DHHS Dietary Guidelines Advisory Committee (see www.dietaryguidelines.gov).

The call was remarkable for how little information it produced.  It was scheduled for half an hour, but started 12 minutes late.  Officials used most of the time to talk about how the committee was appointed, how the committee process worked, how transparent everything was, and how staff of USDA’s new Evidence-Based Nutrition Library (NEL) provided much of the research basis for the guidelines.  This left hardly any time for asking questions, and only five got asked.

From what I heard, the committee report says pretty much what previous accounts said it would (see my post on this).  If my notes on the call are correct, the committee report will recommend:

• Maintain appropriate body weight through diet and physical activity
• Shift to a more plant-based diet
• Eat more seafood; eat more low-fat dairy products; limit meat intake
• Eat less solid fats; eat less of added sugars
• Reduce sodium; eat fewer refined grains
• Follow physical activity guidelines

Is this news?  Isn’t this always what the dietary guidelines say?  Here, just for fun, are the first set of guidelines that came out in 1980.

The main difference seems to be the way the evidence was judged and in some of the details: the target for saturated fat is 7% and for sodium a gradual reduction to 1500 mg/day.

If so, that’s a lot of trouble to go through to get to basically the same place.  I summarized that place in What to Eat as “Eat less, move more, eat plenty of fruits and vegetables, and don’t eat too much junk food.”  Michael Pollen did it even more succinctly: “Eat food.  Mostly plants.  Not too much.”

So why would two federal agencies and 13 committee members go to all this trouble?

The quick answer is that the agencies have to.  Congress says they have to review the guidelines every five years.

The longer answer, which I discuss in Food Politics and What to Eat, is that every word of the dietary guidelines is fraught with politics.

According to Food Chemical News (June 14),

The document is frequently the source of much controversy in the food industry because of the way it is used to promote certain ingredients and eating habits…Observers expect some controversy this year over recommendations made with regard to salt, a subject discussed frequently in committee meetings, as well a possible suggestion to replace two servings of grain with two servings of vegetables.

Another controversy is brewing in regards to the information on which the report was based. On Friday, the American Meat Institute, the National Cattleman’s Beef Association, the Grocery Manufacturer’s Association and the Grain Foods Foundation were among 23 groups that asked USDA and HHS to provide access to the Nutrition Evidence Library, which contains all the research used by the Dietary Guidelines committee when making their recommendations. “Without access to the data from which the DGAC drew its conclusions and recommendations, the public may not be able to provide meaningful comments,” the letter states.

Right. And now let’s see what the agencies do with this report (here’s the USDA press release on what happens next and how to comment).  This report is, after all, merely advisory. Now, the real politics begins!

Additions:

Here is all the information about the Advisory Committee’s report, and the report itself (but why didn’t they put it in one easy pdf file?).

And here is USA Today’s take on it: “Panel: obesity is century’s greatest public health threat.”

Further addition, June 16: Thanks to Daniel Green (Cornell) for putting the report together in one enormous (19MB) file.

In a move that should bring cheer to anyone who cares about the integrity of organic certification, the USDA has banned the Organic Crop Improvement Association (OCIA) from certifying foods from China as organic.  According to the accounts in today’s New York Times and the USDA’s enforcement announcement, OCIA used employees of a Chinese government agency to inspect state-controlled farms and food processing facilities.

Oops.  This is sending the fox out to guard the chickens (organic, hopefully).  The Chinese government has a vested interest in selling certified organic foods and can only be expected to be lenient in enforcing rules for organic production.

Honest, reliable, consistent inspection is the cornerstone of consumer trust in organics.  If producers aren’t following the rules to the letter (and, we wish, the spirit), why would anyone be willing to pay higher prices for organics?  Since it’s impossible to prove that organics are more nutritious than conventional foods, the entire system rests on trust.  And the value of trust rests with the inspectors.

Advocates of organics have been worried for ages about the credibility of organic foods from China and whether cheap organics produced according to high standards.  Now we know, and the answer is not pretty.  With respect to OCIA’s arrangement with Chinese government inspector, the New York Times explains:

The department objected to the arrangement after a 2007 audit, saying the partnership violated a rule barring certifiers from reviewing operations in which they held a commercial interest.  The department moved to revoke the association’s accreditation and the group filed an appeal. The department’s disciplinary process is conducted in secret, and negotiations often drag on. In O.C.I.A.’s case, it took nearly three years to resolve.

This cozy arrangement has been going on for at least the last three years?

It’s good that USDA is taking this on now.

But USDA really needs to take a hard look at conflicts of interest in organic certification, domestic as well as foreign.  Some USDA-authorized certifying agencies are much more lenient than others.  Witness: certification of fish and pet food as organic, despite the lack of final rules for such certification.  Some certifying agencies manage to find ways to do this; others refuse.

The organic industry ought to be pushing USDA as hard as it can to establish and enforce the highest possible standards for organic certification.  I’m looking forward to reading what the Organic Trade Association—and OCIA—have to say about all this.

A reporter sent me this message from Christopher Perille, Mead-Johnson’s Vice President – Corporate Communications & Public Affairs, about the company’s Chocolate and Vanilla sweetened Enfagrow toddler formula, advertised with health claims.  It seems only fair to present the company’s defense of its products.  Here’s what he says:

Enfagrow Premium products contain a balanced blend of protein, fat, carbohydrates and other key nutrients, offered in a form designed to be appealing to even the pickiest eaters. These products were introduced in the U.S. to provide additional nutrition as part of a normal healthy diet for toddlers who have been weaned off breast milk or infant formula. While we recognize that each toddler — and his or her eating habits and nutritional needs — are different, they can often have rather narrow palettes and relatively short lists of acceptable foods. My daughter, for one, had an extended period of time during which hot dogs, chicken fingers and french fries were three of her primary food groups. Happily, her tastes eventually expanded, and she is now a healthy and happy sophomore at Washington University in St. Louis — but there was certainly a time when I was concerned whether or not she was getting all the nutrition she needed.

Enfagrow Premium vanilla has been in the marketplace for nearly a year and has elicited numerous positive comments from grateful parents. They have told us that they consider these products an important option for helping to meet their child’s overall nutritional needs, especially those who are picky or erratic eaters, so as to help provide additional assurance that toddlers achieve their recommended nutrient intake.

As we discussed, you were looking at older packaging. The current labeling for Enfagrow Premium vanilla, indicates 17 grams of total sugar, but even that is overstated due to precautionary rounding — the real figure probably falls closer to 15 (14-16). The majority (approximately three-quarters) of the sugar in our product comes from lactose (that is naturally occurring in milk). So while we do add a small amount of sugar (about 4 grams or 1 teaspoon in a 7 fl. oz. serving) to our Enfamil Premium vanilla product to improve the for finicky eaters, the sugar in our flavoring equates to about 15 calories and is less than 2% of a toddler’s daily allowance of calories.

By comparison, the chocolate-flavored version contained less lactose and required more added sugar to overcome the bitterness of cocoa to make it palatable, so the sugar from lactose accounted for just over half the total sugar.

Even with the added 15 calories of sweetness, Enfagrow Premium vanilla has a superior nutritional profile to many other beverages regularly consumed by toddlers – including apple juice, grape juice and similarly flavored dairy drinks.

Enfagrow products also have beneficial ingredients include iron to help support brain growth and antioxidants and other nutrients to help support the immune system. Additionally these products are also a source of Omega-3 DHA and prebiotics, both of which are lacking in milk. Finally, these products exceed whole milk – serving for serving – for important vitamins such as A, B1, B6, C and E.

Enfagrow Premium products – flavored and unflavored – can be part of a balanced diet, which in combination with routine physical activity and an overall healthy lifestyle, can help avoid obesity. In fact, a peer reviewed article published in April 2008 in the Journal of the American Dietetic Association – based on a study of over 7,500 children and adolescents from ages 2 to 18 – found that consumption of either flavored or plain milk is associated with a positive influence on nutrient intakes by children and adolescents. Additionally, consumption of flavored milk was not associated with adverse effects on Body Mass Index (BMI), a commonly used indicator of obesity.

Convinced?  I’ve said all I have to say about these products in previous posts.  You decide.

I keep complaining about the health claims on Enfagrow toddler formula, a sugary product aimed at children from ages one to three:

These claims, for the uninitiated, are a special kind called structure-function.  Congress authorized such claims when it passed the Dietary Supplement Health and Education Act (DSHEA) in 1994.

Structure-function claims do not say that the product can prevent or treat disease. They merely suggest that the product can help in some unspecified way with some structure or function of the body.

When Congress passed DSHEA, it meant the claims to apply to dietary supplements, not foods. Enfagrow is marketed as a food, not a supplement.  It displays a Nutrition Facts label, not a Supplement Facts label.

Over the years, the FDA has issued cease-and-desist warnings about foods that bear structure-function claims.  In recent years, it has simply stated that manufacturers are responsible for ensuring that the claims are “truthful and not misleading.”

One reason for the shift is what the Courts have ruled.  The Courts say that structure-function claims are protected by First Amendment guarantees of free speech.  The most recent case is Alliance for Natural Health USA v. Sebelius. As described in Food Chemical News (June 7), a D.C. District Court judge ruled that the FDA cannot deny health claims that link selenium supplements to reduced risk of several diseases, or require those claims to be qualified, just because the claims lack adequate scientific substantiation.

In other words, supplement makers can say anything they want to about the benefits of their products—on the grounds of free commercial speech—whether or not science backs up the claim.

Recently, the FDA issued a warning letter to Nestlé, the maker of a Juicy Juice product aimed at toddlers, which displays a claim that its content of added omega-3 DHA improves brain development.  The FDA did not take on the claim, even though research seems unlikely to find that such drinks have any special benefits for brain development.  Instead, the FDA focused on a technicality:

The product makes claims such as “no sugar added,” which are not allowed on products intended for children under 2 yrs of age because appropriate dietary levels have not been established for children in this age range.

I’m guessing—this is speculation—that the FDA is reluctant to take on Enfagrow’s brain or immunity claims because Mead-Johnson has deep pockets and might well be willing to fight this one in court as a First Amendment case.

I am not a lawyer but I thought that intent mattered in legal cases.  Surely, the intent of the founding fathers in creating the First Amendment was to protect the right of individual citizens to speak freely about their political and religious beliefs.  Surely, their intent had nothing to do with protecting the rights of supplement, food, and drug corporations to claim benefits for unproven remedies, or to promote sales of sugary foods to babies.

I think it is time to give these First Amendment issues some serious thought.  How about:

• FDA: Fire those lawyers and hire some who will protect the FDA’s ability to use science in its decisions.
• FTC: Take a look a the immunity claim on the Enfagrow Vanilla toddler formula, now that the Chocolate is off the market.
• Legal scholars: Surely there are ways to protect real First Amendment rights while restricting unsubstantiated health claims?

Other ideas are most welcome.  Your thoughts?

Mead Johnson announced yesterday that it was withdrawing its Enfagrow Chocolate Toddler Formula–just the Chocolate version–from the market:

Like all our Enfagrow Premium products, the recently introduced chocolate-flavored version has a superior nutritional profile to many other beverages typically consumed by toddlers — including apple juice, grape juice, and similarly flavored dairy drinks. Unfortunately, there has been some misunderstanding and mischaracterization regarding the intended consumer for this product and the proper role it can play in a child’s balanced diet. The resulting debate has distracted attention from the overall benefits of the brand, so we have decided to discontinue production of Enfagrow Premium chocolate toddler drink and phase it out over the coming weeks.

I can’t resist quoting the Chicago Tribune’s explanation of the origin of the debate caused by “misunderstanding and mischaracterization:”

Introduced in February, the chocolate-flavored formula was widely criticized in the blogosphere after Marion Nestle, professor of nutrition, food studies and public health at New York University, wrote that the drink would lead children to crave sugary beverages on her influential blog, www.foodpolitics.com.

Influential?  Maybe, but it seems that my comments on this formula did not go nearly far enough.  Mead-Johnson may be withdrawing the Chocolate version, but it is keeping the Vanilla (as explained by Susan James on ABCNews.com, which also quotes me).

What’s the difference?  The Vanilla has exactly one gram less sugar than the Chocolate, 18 grams per 6-ounce serving, rather than 19 grams.  In contrast, the milk in my refrigerator has 9 grams of sugar (natural, not added) in 6 ounces.

Clearly, Mead-Johnson doesn’t get that it’s the sugars, stupid.

Why do I think this is a PR stunt?  Three reasons:

• The Vanilla doubles the sugars in regular milk.
• The Vanilla has the same health claims as the Chocolate: growth, brain development, and immunity.
• Mead-Johnson’s stock went up after the announcement.

One more time: Where are the FDA and FTC on this product?  This Immunity claim is no different from the one on Kellogg’s Krispies cereals that the FTC went after a couple of days ago.

Tomorrow: Some speculation on why the FDA is reluctant to take on things like this.

Addition, June 11: Here is Melanie Warner’s take on this on her BNet Food Industry blog site (she quotes my post).

If you don’t have a small baby, or your baby is breastfed(and see note at end) you no doubt are missing the furor over “functional” ingredients that companies have been adding to infant formulas.

DHA (an omega-3 fatty acid) came first.  As I discuss in my book, What to Eat, infant formula companies could not wait to add it.  They knew they could market it on the basis of preliminary evidence associating DHA with visual and cognitive benefits in young infants.    Although evidence for long term benefits is scanty, the companies also knew that they could charge higher prices formulas containing DHA.

The FDA approved the use of DHA in infant formulas on the grounds that it is safe, but did not require the companies to establish that DHA makes any difference to infant health after the first year.  Because of its marketing advantage, virtually all infant formulas now contain DHA.  Surprise!  They also cost more.

Companies now want to add other ingredients, such as prebiotics, probiotics, lutein, lycopene, and betacarotene, which also can be marketed as healthier and at higher prices.

In response, the Center for Budget and Policy Priorities (CBPP), has issued a report on the lack of evidence for the benefits of functional ingredients and the substantial harm they will cause to the economic viability of the WIC program, the USDA’s assistance program for low-income mothers and children.

WIC buys about half the infant formula sold in the United States each year.  WIC is not an entitlement program, meaning that the number of participants is limited by available funding (a GAO report explains how this works).

The CBPP report says:

As pressure mounts to limit federal discretionary spending, it is critical to ensure that WIC not spend funds on foods with functional ingredients that do not deliver clinically significant benefits. WIC spent approximately $850 million on infant formula last year, and a recent USDA study found that more than ten percent of that spending ($91 million annually) is attributable to higher-priced formulas with functional ingredients.  Under current law, the additional cost to WIC of providing foods with these ingredients is likely to grow substantially as such foods proliferate.

As the report explains, formula companies do not have to demonstrate that the added–and more expensive–ingredients do any good:

There is no mechanism within the national WIC program that requires USDA to review the research evidence on the claimed benefits of these functional ingredients or to base decisions about whether to offer foods containing such ingredients on their benefits and the specific needs of WIC participants. Currently, instead, infant formula manufacturers themselves decide whether WIC offers infant formulas with new functional ingredients, while state WIC programs decide whether WIC should offer other foods with such ingredients.

As I keep saying, functional foods (and ingredients) are about marketing, not health.  If companies are going to add functional ingredients–and charge higher prices–they need to have some convincing scientific evidence to back up their claims.

Postscript: Laurie True of the California WIC program writes:

Congressman George Miller, Chair of the House Education and Labor Committee, is writing the bill that reauthorizes the WIC Program this week. He should include a provision requiring independent scientific review of the efficacy of these “functional ingredients” before USDA allows them in WIC foods and infant formula.

Note:  Lori Dorfman sends a Berkeley Media Studies Group issue paper on how to advocate for hospitals and workplaces to make it easier for moms to breastfeed.

The FTC has imposed new advertising restrictions on Kellogg because of the Immunity claim on Rice Krispies.  The company is not to make claims about “any health benefit of any food  unless the claims are backed by scientific evidence and not misleading.”

Under a previous order dealing with Frosted Mini-Wheats, Kellogg was not supposed to make claims about benefits to cognition on any of its cereals or snack foods unless the company could prove that the claims were backed by real science. This new decision extends that ruling to include any claim at all.

OK, but I’m confused about several aspects of this decision:

• How come the FTC is doing this and not the FDA?  At some point years ago, regulatory responsibility was split between FDA and FTC.  Since then, the FDA regulates claims on food package labels, whereas the FTC regulates advertising claims.  I realize that food labels are a form of advertising, but it’s unusual and surprising for the FTC to get involved in FDA-regulated matters.
• As FoodNavigator also wonders, why didn’t the FTC fine the company and, instead, write a harsh letter? [see update below]
• Why is the FTC doing this?  Kellogg agreed months ago to withdraw its Immunity claim ( see my November 5 post about the withdrawal).  The Immunity boxes gradually disappeared from supermarket shelves and I haven’t seen one for a long time.

So what’s going on here?  Is the FTC getting serious about regulation (and about time, too)?  Or is FDA sitting back and letting the FTC do its enforcement work?

Could this be why the FDA hasn’t sent a warning letter to Mead-Johnson, the maker of the chocolate toddler formula with three health claims aimed at kids ages 1 to 3.  I posted about this product on April 26, but haven’t heard whether the FDA is doing anything about it.  Can the FTC be on this case but waiting for investigations to be completed before taking action?

Kellogg, it seems, is under fire on all fronts.  CSPI’s Margo Wootan sent me the recent decision by the Children’s Advertising Review Unit of the Better Business Bureau that Kellogg must stop advertising Pop-Tarts to kids:

CARU was concerned that the product packaging, which features berries and states “Made with Real Fruit” for several of Kellogg’s Pop-Tarts®  products that have fruit in their names, impliedly represents to children that the products contain substantial amounts of fruit.

In fact, according to CARU, Pop-Tarts contain less than 6% fruit and less than 2% of the fruit shown in the advertising. Kellogg claimed that its marketing was not aimed at kids, but lost that one.

It’s great that regulatory agencies like FTC and FDA (and voluntary agencies like CARU) are regulating but it’s hard to keep track of who is doing what.   Nothing to do but wait and see what happens next.  Stay tuned.

Update, June 8: CSPI’s Margo Wootan writes that FTC can’t impose fines because it does not have the authority to issue civil penalties.  Ted Mermin of Public Good Law concurs.  He says:

Companies fight hard to make FTC (and similar) orders as narrow as possible, in large part to avoid precisely the situation in which they are held responsible for violating an existing injunction/order.  Since (in the Commission’s view, at least) Kellogg hadn’t violated an existing order, the FTC did not have the authority to fine them without first going to the US Department of Justice to get DOJ to take the case (a matter of a 45 day delay, if DOJ takes it at all).  The burden of that delay (and of needing to get authority from DOJ in the first place) is precisely what is driving the congressional charge for enhanced FTC authority as part of the financial reform legislation.

If the House version of financial reform legislation had been in effect, the FTC would have had the authority to seek civil penalties (i.e., fines) and the outcome here might have been different.  As it was, the fact that Kellogg had stopped the practice…kept the Commission (at least the three commissioners in the “majority”) from focusing on any remedy other than injunctive relief–that is, a broadening of the existing order from the Mini-Wheats case, with the threat of that $16,000 per violation (and an expanded area of prohibited activity) running into the future.

Update, June 11: In an editorial titled “Snake oil for breakfast,” the New York Times explains why health claims matter so much.  If you can’t believe health claims, what part of the food label can you believe?:

Businesses have been making dubious claims about their products at least since the 17th century, when the British clergyman Anthony Daffy sold Daffy’s Elixir as a cure for scurvy as well as agues, gout, rheumatism, rickets, worms and other ailments. Hucksterism — no matter how implausible the claim — lives on…[for example] POM Wonderful claimed its pomegranate juice helps treat, prevent or cure hypertension, diabetes and cancer.  This might be par for the course for an era of swift-boating political ads and a torrent of television commercials plumping for myriad wonder drugs (sudden death may result). It leaves the consumer in a quandary: what part of the label can be believed?

Today’s New York Times has an op-ed, “Crying over raw milk“, about the political fights over raw milk in Wisconsin.  The Wisconsin legislature has introduced a bill allowing dairy farmers to sell raw milk directly to consumers.  The conventional dairy industry is not happy about that.

The author of the piece, Michael Feldman, is dubious about the purported health benefits of raw milk but is quite clear about its economic benefits: “you can’t get $6 a gallon for pasteurized milk.”

Crass economics is behind much of the politics of raw milk these days.  The conventional dairy industry is in trouble: too many cows, too much milk, and not nearly enough regulation of supply.  In contrast, raw milk has passionate advocates willing to pay premium prices.

Not fair, says the dairy industry, which wants raw milk to be regulated:

In a letter to two senior members the Senate Committee on Health, Education, Labor and Pensions, the dairy groups called for a measure obliging all facilities producing raw or unpasteurized milk products for direct human consumption to “register with FDA and adhere to the tried-and-true food safety requirements that are followed by all other facilities producing milk products”.

As for the safety of raw milk, it is useful to take a look at Seattle attorney Bill Marler’s website: “Real Raw Milk Facts.”   There, he summarizes recent cases of illness caused by toxic E. coli and Salmonella contaminants in raw milk.  These constitute a full employment act for attorneys like Marler who represent victims of foodborne illness.

My position on raw milk has long been that people have a right to drink it but it had better be produced safely.  I believe that all foods–no exceptions–should be produced under well designed and carefully followed HACCP plans (or their equivalent) with pathogen testing at intervals commensurate with the level of risk.

But food safety experts tell me that raw milk can never be tested frequently enough to be confident it is safe.

Raw milk carries a greater risk of bacterial contamination than pasteurized milk and people who buy it should know what those risks are.  The risk may be small, but it is finite.  Putting a child at risk of hemolytic uremic syndrome from toxic E. coli just doesn’t make sense to me.

Like Michael Feldman, I’m dubious about the claims made for the health benefits of raw milk.  No question, it tastes better and that may be reason enough to want it.  But until I can be sure that the producer is scrupulous about safety, my personal choice favors pasteurization.

But that’s just me.  You?