Search results: Immunity

I was surprised by FoodNavigator-USA’s story about “SmartCandy,”—a “vitamin-infused snack.”

Could the name and contents of this candy be violating the FDA’s “jelly bean” rule?

The “jelly bean” rule refers to FDA’s fortification policy,* which aims to discourage food and beverage makers from adding vitamins to “foods of minimal nutritional value” (a.k.a. junk foods) so they can be marketed as healthy.

The policy is explicit.  The FDA does not consider it appropriate to add nutrients to candies and beverages.

Here’s what the article says about what’s in it:

Smartcandy is formulated with a blend of Vitamin A for eye health, three B vitamins to support converting sugar and carbohydrates into sustained energy, and vitamin C for immunity. The trans fat-, high-fructose corn syrup-free candies come in four varieties: sweet and sour gummies; and Froot, a proprietary snack with a candy shell and a layer of yogurt encasing a strawberry or orange center.

Here’s the Nutrition Facts label (thanks to a reader for sending).

Here’s what the website says Orange Froot candy can do:

This is the visionary leader of the snacking world, it’s the one they listen to and admire. He can make a three point shot with his eyes closed, build the best fort you’ve ever seen, or solve an algebra question like it was a nursery rhyme, this flavor packed snack will push you to achieve anything!

If SmartCandy can get away with this, won’t Coca-Cola and Pepsi be next?

Candy is candy and has an place in kids’s diets—occasionally.  But a health food that makes kids do better in school?  I’d like to see the evidence for that.

FDA: take a look please.

*Thanks to Michael Jacobson for forwarding.

Update, April 13: The New York State Attorney General has filed a complaint.

Kellogg has had a bad year on the truth-in-advertising front.

First, It took the brunt of the furor over the late and unlamented Smart Choices fiasco, when the program’s first logo turned up on Froot Loops of all things and was attacked by the Connecticut attorney general.

Next, the IMMUNITY banner on Cocoa Krispies drew fire from the San Francisco city attorney’s office.

Both boxes are now collectors’ items.

Now, FoodNavigator-USA reports that Kellogg has taken another expensive beating, this time on its health claim for Mini-Wheats.

In 2009, Frosted Mini-Wheat boxes sported this health claim:  “Clinically shown to improve children’s attentiveness by nearly 20%.”

Of course this cereal can do that, especially when kids eating it are compared to kids who don’t eat any breakfast at all—which is what this study did.

But that’s not what the adorable television advertisements imply, as shown in exhibits A and B in the summary of the class-action decision.

Last April, Kellogg settled a dispute with the FTC over this claim.  The FTC did not argue that the claim was inherently absurd because of the lack of an appropriate control group for the study.  Instead, it took the study at face value and charged Kellogg with exaggerating the results because hardly any children—only 11%—improved attentiveness by 20% or more.

Kellogg has just settled a class-action suit over this claim that will cost the company $2.75 million in order to pay customers between $5 and $15 each in compensation.  The company also will give $5.5 million to charities.

Because of city and state attorneys and the FTC, the most egregious health claims are slowly disappearing from cereal boxes.     But lawsuits do not constitute policy.  What goes on the front of food packages is FDA territory.

FDA: Get to work!

I am indebted to FoodSafetyNews for a curious item about President Obama’s food tasting problem in India.  I can understand why the White House would be concerned.  It is easy for Americans unused to the local bacteria to get food poisoning while traveling anywhere, and such things happen in India (I have some personal experience with this problem, alas).

The Indian government has recruited twelve somewhat reluctant doctors at a hospital in Mumbai to join the tasting staff that usually travels with the President.  [Aside: I wonder how one gets a job like this.  It could be a lot of fun].  The Indian doctors’ view, however:

This job is often annoying because we are not professionals and are used as guinea pigs. However, it is exciting to work for Obama,” one anonymous doctor told the Mirror. “We have already started doing our homework on what he will be eating. We will be meeting the hotel chefs tomorrow.”

“We taste samples and also store some for the cops,” explained one doctor on the assignment. “If anything goes wrong, we can use these samples for investigation.”

These physicians live in India and must have built up some immunity to the local flora.

And I can’t figure out how the tasting would work.  It often takes some hours after eating before the effects of food poisoning to show up.  Just because a food is safe early in the day does not necessarily mean it would still be safe after sitting around for some hours.

I’m guessing the President has to follow the same food safety rules as the rest of us when traveling in tropical countries with questionable water supplies:

• Do not drink tap water and do not use it to brush your teeth.
• Do not drink bottled water if the seal on the bottle has been broken.
• Do not use ice unless you’re sure it’s made from purified water.
• Do not drink milk or eat dairy products that have not been pasteurized (heated to a temperature that kills all germs).
• Do not eat raw fruits or vegetables unless they can be peeled and you are the one who peels them.
• Do not eat cut-up fruit salad.
• Do not eat lettuce or other leafy raw vegetables (such as spinach).
• Do not eat raw or rare (slightly cooked) meat or fish.
• Do not eat food from people who sell it on the street.

I hope he enjoys his trip.  The food is likely to be supremely delicious—as soon as it cools down enough to enjoy.

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.

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).

My most recent column in the San Francisco Chronicle appeared later than usual (March 14) so I forgot to post it when it came out.  It deals with Listeria in pregnancy:

A guide to avoiding Listeria

Nutrition and public policy expert Marion Nestle answers readers’ questions in this monthly column written exclusively for The Chronicle. E-mail your questions to food@sfchronicle.com, with “Marion Nestle” in the subject line.

Q: I miscarried at 19 weeks of pregnancy. My doctor said my placenta was infected with Listeria, only her second case in 20 years of practice. I am your typical Bay Area food lover. I thought if I knew the sources of most of my food, I’d be safe. What is safe for pregnant women to eat in the post-Michael Pollan era?

A: Thanks for allowing your personal tragedy to alert others to this hazard. Losing a wanted pregnancy is a heartbreak. Losing one to a food-borne illness is especially tragic. Such illnesses should be preventable.

Food should be safe before it gets to you. That it sometimes is not is a consequence of our inadequate food safety system, which does not require food producers to test for harmful bacteria. The House of Representatives passed legislation that does so last summer, but the Senate is sitting on it. As an individual, you cannot easily protect yourself against invisible hazards in food. Congress must pass that legislation.

Without federal requirements, you are on your own to keep yourself and your unborn infant safe from food pathogens, especially Listeria. Much as I hate to add to what the French sociologist Claude Fischler calls “Listeria bacteria hysteria,” I must. Listeria preferentially affects pregnant women. If you are pregnant and want to stay pregnant, you must avoid Listeria.

This will not be easy. Listeria is widely dispersed in foods. Infections from it may be rare, but they are deadly. Listeria kills a shocking 25 percent of those it infects and is particularly lethal to fetuses.

Most people, including pregnant women, are immune to Listeria and do not feel ill when infected. But unlike most bacteria, Listeria penetrates the placenta, and fetuses have no immunity. The first sign of an infection can be a miscarriage or stillborn infant – too late for antibiotics.

How worried should pregnant women be about Listeria? Given our ineffective food safety system, I’d advise caution. The Centers for Disease Control and Prevention report 2,500 cases a year and 500 deaths. These numbers are minuscule – unless your pregnancy is affected.

Cases occur mainly among the young, the old and others with poor immunity. But the cause of miscarriages is not typically investigated, and I’m guessing that fetal deaths from Listeria are badly underreported.

Animals and people often excrete Listeria from their digestive tracts, even when they show no signs of illness. The bacteria get into food from infected animal waste and unwashed hands.

As a result, unpasteurized milk products and contaminated raw vegetables are frequent food sources. Other sources depend on yet another of Listeria’s nasty features – Listeria grows, reproduces and flourishes at refrigerator temperatures that stop other bacteria cold.

This explains why the CDC strongly advises pregnant women not to eat potentially undercooked foods stored in refrigerators: hot dogs, lunch meats, deli meats, patés, meat spreads and smoked seafood (salmon, trout, lox, jerky); soft cheeses such as feta, Brie, Camembert, those with blue veins, and especially Mexican “queso blanco fresco”; and raw milk or foods containing unpasteurized milk.

Even though some of these foods were cooked or pasteurized to begin with – blue cheese, for example – they can become contaminated after processing. Days or weeks of refrigeration give Listeria ample time to reproduce. Just about any food sitting around in a refrigerated package can be a source, with meat, fish and dairy foods especially suspect.

The CDC advises following safe food handling procedures to the letter at home. Avoid cross-contaminating raw and cooked foods, and use refrigerated perishables right away.

Listeria infections were virtually unknown 25 years ago, so view this hazard as collateral damage from the consolidation and centralization of our industrialized food supply.

Do not despair. There is some good news. Cooking kills Listeria. Pregnant women still have plenty of options for good things to eat that are safe.

Anything cooked hot is safe. So are hard cheeses, semisoft cheeses like mozzarella, pasteurized processed cheeses, and cream and cottage cheeses. These were cooked or are now too dry and salty for bacterial growth. Anything canned – patés, meat spreads, smoked fish, other fish – also is safe.

When it comes to food hazards during pregnancy, Listeria is unique. A sip of wine every now and then is not going to induce fetal alcohol syndrome, nor will your baby get mercury-induced brain damage from an occasional tuna sandwich. The risks from such hazards accumulate with amounts consumed over time.

But the risk from Listeria is acute. With so much at stake, and so many other food choices available, why take chances?

Just last month, the Food and Drug Administration reported recalls of queso fresco, blue cheese and bean sprouts because of possible Listeria risk. The FDA is doing its best, short of legislation. To keep Listeria out of the food supply, Congress needs to act. Write your representatives now.

Marion Nestle is the author of “Food Politics, “Safe Food” and “What to Eat,” and is a professor in the nutrition, food studies and public health department at New York University. E-mail her at food@sfchronicle.com and read her previous columns at sfgate.com/food.

I’ve been fretting about the immunity and brain claims on Nestlé’s Juicy Juice for quite some time now, but completely missed the FDA’s December 4 warning letter about them.  Thanks to Hemi Weingarten at Fooducate for keeping track of such things.

If you give these products a moment’s thought, you can quickly figure out that feeding DHA- or antioxidant-fortified juice drinks to kids is unlikely to have much effect on how smart they are or whether they can resist colds or swine flu.  But never underestimate the power of food marketers.   Adding a little DHA or a few antioxidants to juices sells products.  Health claims, as I keep pointing out, are about marketing, not health.

In warning the company to cease and desist, however, The FDA did not take on the health issues.  Instead, it invoked labeling regulations:

The Food and Drug Administration (FDA) has reviewed the labeling for several Nestlé Juicy Juice products…Based on our review, we have concluded that these products are misbranded…. because [their] labeling includes unauthorized nutrient content claims. Except for statements that describe the percentage of a vitamin or mineral in relation to a Reference Daily Intake (RDI), a nutrient content claim cannot be made for a food intended for use by infants and children less than 2 years of age….On October 30, 2009. we also reviewed your website….The labeling found on your website makes an additional unauthorized nutrient content claim, which further misbrands the product. The website claims that Juicy Juice Brain Development Fruit Juice Beverage is “naturally lower in sugar”…[but] no nutrient content claims can be made for a food intended specifically for use by infants and children less than 2 years of age unless specifically permitted by FDA regulations.

Additionally, we have reviewed the labeling of your Nestle Juicy Juice All Natural 100% Juice Orange Tangerine and Nestle Juicy Juice All Natural 100% Juice Grape products. These products are misbranded…because their labels are misleading. The label of the Orange Tangerine product is designed to imply that the product is 100% orange/tangerine juice, and the label of the Grape product is designed to imply that product is 100% grape juice…neither orange/tangerine juice nor grape juice is the predominant juice in the products….

Nestlé (alas, no relation) is the largest food company in the world with $102 billion in sales last year.  It should know better.

Just for the record, the misbranded products are still displayed on the Juicy Juice website.

The FDA also warned Nestlé that its Boost Kids Essentials products are misbranded. Why?  Because their labeling does not follow the rules for medical foods, those aimed at alleviating specific conditions – in this case “failure to thrive.”   Oops.  The Boost Kids Essentials website is now under revision.