Currently browsing posts about: FTC (Federal Trade Commission)

While I’m on the subject of the FTC (see yesterday’s post), let’s congratulate the agency for going after the Nestlé (no relation) corporation for marketing a product aimed at kids with misleading, deceptive, and—according to the FDA—illegal health claims.  The FTC settlement announcement says that

from fall 2008 to fall 2009, Nestlé HealthCare Nutrition, Inc. made deceptive claims in television, magazine, and print ads that BOOST Kid Essentials prevents upper respiratory tract infections in children, protects against colds and flu by strengthening the immune system, and reduces absences from daycare or school due to illness.

Nestlé must have introduced this product in 2008 because bloggers (of the sponsored kind) were promoting its benefits in September that year.  One said:

BOOST Kid Essentials is a nutritionally complete drink intended for children ages 1 to 13.  The probiotics in BOOST Kid Essentials are embedded in a straw that comes with the drink, which was prominently featured in ads for the product.  Probiotics are live, beneficial bacteria that are found naturally in many foods, and they are known for aiding digestion and fighting harmful bacteria.

This blogger’s enthusiasm for the product—“parenting solved”—quotes two studies, one done with adults using the straw and another with kids in day care whose infant formula was supplemented with one of the bacteria used in the adult study.  Both studies look preliminary to me, as they must have to the FTC.

In February 2009, in what reads like a company advertisement, another (sponsored) blogger wrote:

BOOST Kid Essentials Drink is the only nutritionally complete drink that provides kids ages 1 through 13 with immune-strengthening probiotics plus complete, balanced nutrition. Just one daily serving of the probiotic found in the BOOST Kid Essentials Drink straw has been clinically shown to help strengthen the immune system. BOOST Kid Essentials Drink is perfect for children who are below growth percentiles, having trouble gaining weight, resisting eating enough nutritious foods, or needing extra nutrition to help maintain an active lifestyle.

But in December 2009, the FDA  issued a letter to the company warning it that it was marketing this product as a drug:

this product is misbranded under…the Federal Food, Drug, and Cosmetic Act… because the label is false or misleading in that the product is labeled and marketed as a medical food but does not meet the statutory definition of a medical food in the Orphan Drug Act…Furthermore, this product is promoted for conditions that cause it to be a drug under section 201(g)(1)(B) of the Act…The therapeutic claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

The warning letter didn’t get into the business of whether probiotics really do any good (the European Food Safety Authority certainly doesn’t think so) or whether “healthy” bacteria stay live and active in a straw stuck in the packaging of a kids’ drink.  The company must not have wanted to get into all that, so it settled.  The probiotic straw no longer comes with the package.

Nestlé is the largest food company in the world with earnings that exceed $100 billion annually.  It should have known better.

Update, July 15: Since the FTC imposed no penalties on Nestlé,  analysts expect class action lawsuits to follow in due course.  And here’s the account in the New York Times (I’m quoted).

I keep hearing rumors that food industry opposition is what is holding up release of the FTC’s position paper on nutrition standards for marketing foods to kids.

I titled my previous post on this report “Standards for marketing foods to kids: tentative, proposed, weak,” because I thought they left far too much wiggle room for companies to market products that I would not exactly call health foods.

Now, Melanie Warner points out that even so, the proposed standards will exclude a great many highly profitable food products.  Hence: food company opposition.

Susan Linn of the Campaign for a Commercial-Free Childhood quotes an executive of the food industry’s Children’s Food and Beverage Advertising Initiative: “There are very few products, period, that meet these standards, whether they’re primarily consumed by adults or children.”

The food industry has consistently opposed giving the FTC more authority over marketing of foods and supplements.  Here is another reason why this agency needs it.

Update, July 24: The missing FTC report is front-page news!  William Neuman is on the front page of the New York Times with a detailed account of the Federal Trade Commission’s lack of action on food company advertising practices.  The FTC standards were expected last week but nobody seems to know when, if ever, they will be released.

Update, July 30: Here is Colbert’s take on the delaying of FTC standards.

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).

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?

I’ve been collecting items sent to me this week about government actions at the local, state, and national level.  Here’s the weekend round up.

Santa Clara County, California, Board of Supervisors bans toys in kids meals: On April 27, the San Jose Mercury News announced that this county, clearly at the vanguard of actions to help prevent childhood obesity, passed a groundbreaking law banning toys in kids’ meals that do not meet minimal nutrition standards (the very ones I talked about in a previous post).  Companies can still give out toys in meals, as long as the meals meet those standards.  What an excellent idea.  Let’s hope this idea catches on in other communities.

Here’s the press release, a a fact sheet on childhood obesity, and remarks by the president of the board of supervisors, along with recommendations from the local public health agency.  Thanks to Michele Simon for the documents.

Connecticut state legislature plays computer games: This photo, attributed to the Associated Press, arrived from Michelle Futrell.  I worried that it might be Photoshopped.  Whether it is or not, it is flying around the Internet, in versions that clearly identify each of hard-at-play legislators.

The Federal Trade Commission (FTC) teaches kids about marketing: The FTC regulates advertising, including food advertising, and it must be getting increasingly concerned about the effects of marketing on kids.  To counter some of these effects, it has created a website, Admongo.gov, an interactive site to teach kids about advertising.  After playing these games, the FTC wants kids to be able to answer these questions:

• Who is responsible for the ad?
• What is the ad actually saying?
• What does the ad want me to do?

The New York Times concludes: “Perhaps the effort comes not a moment too soon. Adweek devotes this week’s issue to “Kids” and “How the industry is striving to conquer this coveted market.” Thanks to Lisa Young for sending the links.

The FDA asks for comments on front-of-package (FOP) labeling: Patricia Kuntze, a consumer affairs advisor at the FDA sends the April 28 press release and the April 29 Federal Register notice announcing the FDA’s call for public comment on this topic.  The agency particularly wants data on:

• The extent to which consumers notice, use, and understand FOP nutrition symbols or shelf tags
• Results of research examining the effectiveness of various FOP approaches
• Graphic design, marketing, and advertising that will help consumers understand nutrition information
• The extent to which FOP labeling influences food manufacturers’ decisions about the contents of their products

The goal, says the FDA, is to make “calorie and nutrition information available to consumers in ways that will help them choose foods for more healthful diets – an effort that has taken on special importance, given the prevalence of obesity and diet-related diseases in the U.S. and of increasingly busy lifestyles that demand quick, nutritious food.”

Here is a speech on the topic by FDA Commissioner Margaret A. Hamburg, M.D.  For information about how to submit comments, click here. To submit comments, refer to docket FDA-2010-N-0210 and click here. You have until July 28 to do it.

Public comment, of course, includes the food industry and a FoodNavigator call for industry comment cites my recent commentary in JAMA with David Ludwig.  I’m glad food industry people are reading it and I hope the FDA does too.

The White House equivocates on organics: What’s going on with the White House garden?  Is it organic or not?   Michael Pollan forwards this item from the Associated Press:

Assistant White House Chef Sam Kass, an old friend of President Barack Obama’s who oversees the garden, says labeling the crops “organic” isn’t the point, even though the White House only uses natural, not synthetic, fertilizers and pesticides.

“To come out and say (organic) is the one and only way, which is how this would be interpreted, doesn’t make any sense,” Kass said Monday as he walked among the garden’s newly planted broccoli, rhubarb, carrots and spinach. “This is not about getting into all that. This is about kids.”

Uh oh.  Has “Organic” become the new O-word?  Surely, the White House is not secretly pouring herbicides and pesticides over its garden vegetables.  If not, are we hearing a small indication of big agribusiness pushback?

Food politics makes strange bedfellows.

The Associated Press reports that an organization of retired military personnel, Mission Readiness, is upset about obesity.  American youth, it says, are  Too Fat to Fight. Obesity may be a threat to personal health, but this group sees the problem as a threat to national security (see note below).

Here’s the irony.  The exact opposite was true in World War II.  Then, the army had trouble finding recruits who were not undernourished.

How did we go from lean to fat?  TV food commercials, for one thing, says Jane Brody in a review of recent studies.   Kids eat what they see.  The Rudd Center at Yale has even more recent data on the number of commercials watched by young children.

The Federal Trade Commission (FTC) is responsible for regulating advertising.  It has been making noises lately about taking on food marketing to kids.  I’ve heard rumors that the FTC is ready to release a report on the topic but food marketer’ complaints are holding it up.  Many marketers (not just of food) are worried that the FTC might move to restrict Internet marketing.

This might be a good time to ask the FTC what it is doing about food marketing to kids.

Note: Thanks to Bob Bannister for reminding me of George Saunders’ Shouts & Murmurs piece on this topic in the New Yorker.

Addition, April 22: The rumors about food industry pressures on the FTC turn out to be true.  Margo Wootan of CSPI reports on a meeting today with representatives of the FTC:

A number of members of the Food Marketing Workgroup met with FTC Chairman Jon Leibowitz today and delivered the letter [urging the FTC to publish standards for marketing to children]. It was a good meeting.They said that the standards are not in jeopardy and should be out in the near future. All the industry opposition has caused the agencies to go through a more thorough (i.e., slow) clearance process.

If you can’t block action, you can always delay it as long as possible.

I received a flurry of “you should have attended the meeting before you said anything” messages in response to my post yesterday about the FTC forum.  They said the table that I posted did not have footnotes attached and I also had missed a key point about RACC (reference amounts commonly consumed): they are likely to be larger than current FDA serving sizes, meaning that the amounts of sugars and salt will have to be reduced to qualify.

Guilty as charged.  RACC, as I mentioned yesterday, is a new term to me.  This is because – how could anyone have missed this – I was unaware of the FDA’s Federal Register notice of April 4, 2005: “Serving sizes of products that can reasonably be consumed at one eating occasion; Updating of reference amounts customarily consumed; Approaches for recommending smaller portion sizes.”

This notice was the result of concerns about the serving sizes that had been established when the FDA issued final food labeling regulations in 1993.  Then, the FDA established serving sizes for 129 product categories for adult foods and 11 categories for infant and toddler foods.  These were derived from information about amounts commonly consumed reported in food consumption surveys from the late 1970s and late 1980s.

Either people ate a lot less back then or they were lying, or both.  As my former doctoral student, now Dr. Lisa Young, discovered during her doctoral research, standard portion sizes – half a cup of ice cream or one 2 or 3-ounce slice of pizza, for example – are smaller (sometimes much smaller) than what people seem to be actually eating.

The FDA knew this.  In 2003, it appointed an Obesity Working Group to advise the agency about several issues, among them whether to update the RACCs.  The Group filed its report in 2004.  With respect to serving size, it recommended:

* In the short-term, that FDA encourage manufacturers immediately to take advantage of the flexibility in current regulations on serving sizes that allows food packages to be labeled as a single-serving if the entire content of the package can reasonably be consumed at a single-eating occasion.

* In the long-term, that FDA develop two separate ANPRMs [Advance Notice of Proposed Rulemaking].  The first would solicit comment on whether to require additional columns within the nutrition label to list the quantitative amounts and %DV of the entire package on those products and package sizes that can reasonably be consumed at one eating occasion or, alternatively, declare the whole package as a single serving. This ANPRM would also solicit information on products and package sizes that can reasonably be consumed at one eating occasion.  The second ANPRM would solicit comments on which, if any, RACCs of food categories appear to have changed the most over the past decade and therefore need to be updated.

On that basis, the FDA’s 2005 Federal Register notice asked for comments about whether:

• Consumers might “think that an increase in serving size on food labels means more of the food should be eaten.”
• Manufacturers might repackage products in larger sizes to avoid labeling a package as a single serving.
• Manufacturers might reduce the size of single-serving packages to reduce the apparent content of undesirable nutrients.

That was nearly five years ago.  If anything further happened, I cannot find it in the Federal Register. Getting to these questions at last was apparently the point of the FTC forum.

I am told that panelists suggested raising the RACC serving size of kids’ cereals to 50 grams rather than the current 30 grams.  If so, this would require cereal companies to reduce the amount of sugars in their products.   Aha!  That could explain why, as I discussed in a previous post, General Mills chose to put its full-page ads in newspapers promising to drop the sugars to single digits.  General Mills must think changes in the RACC for cereals will require it to lower the sugars in order to be able to advertise to kids under the voluntary guidelines. Given how long the FDA’s processes take, it is understandable why General Mills failed to say when it would implement its promist.  I am also told that the salt cut-point is open for comment.

For those of us who were not at the Forum and prefer to see such things in writing, how about releasing the footnotes to that chart and giving us some examples of the proposed changes to the RACC?  Also, how about setting up a mechanism so interested people can file official comments on the proposals?  Both would help people offer more informed comments on how the FDA should handle the serving size issues.

Update, December 20: Thanks to Ellen Fried for providing a link to some food industry opinion on what all this is about and another an in-the-know source that says the proposed standards are to be published in the Federal Register and opened for further public comment in January.  The project is to be finished by July.  Ellen points out that this procedure seems administratively complicated for standards that are not regulations; they are voluntary. Do the FTC and FDA really have to go through all this to issue what is simply guidance?  Or is something else going on here that I’m not getting?