Currently browsing posts about: FTC (Federal Trade Commission)

The FDA held two conference calls today to announce action on caffeine-alcohol beverages. It is sending warning letters to four companies that make this collection of caffeinated alcoholic beverages:

• Core High Gravity HG Green
• Core High Gravity HG Orange
• Four Loko
• Joose
• Lemon Lime Core Spiked
• Moonshot  (This product is labeled as “premium beer with caffeine”)
• Max

The FDA says:

The manufacturers of these products have failed to show that the direct addition of caffeine to their malt beverages is “generally recognized as safe” by qualified experts.  Rather, there is evidence that the combinations of caffeine and alcohol in these products pose a public health concern….The agency has given the firms 15 days to respond to the warning letters and then may proceed to court to stop their sale. In addition, other alcoholic beverages containing added caffeine may be subject to agency action in the future if scientific data indicate that the use of caffeine in those products does not meet safety standards.

The FTC issued similar warnings to the same four companies because “marketing of such beverages may constitute an unfair or deceptive practice that violates the FTC Act.  Companies receiving letters include: United Brands Co (Joose and Max), Phusion Products (Four Loko and Four Maxed), Charge Beverages Corporation (Core High Gravity, Core Spiked, and El Jefe), and New Century Brewing Company (Moonshot).

What this is about:

Ever ahead of the game, the New York Times announced yesterday that the FDA would soon be doing something about the caffeinated alcohol beverages that have caused so much trouble on college campuses recently (see previous post on this).

Today, Four Loko says it will voluntarily take the caffeine out of Four Loko.

Why?  In a statement, Phusion Projects, the maker of Four Loko explains:

We are taking this step after trying – unsuccessfully – to navigate a difficult and politically-charged regulatory environment at both the state and federal levels….We have repeatedly contended — and still believe, as do many people throughout the country — that the combination of alcohol and caffeine is safe…If it were unsafe, popular drinks like rum and colas or Irish coffees that have been consumed safely and responsibly for years would face the same scrutiny that our products have recently faced….By taking this action today, we are again demonstrating leadership, cooperation and responsible corporate citizenship.

Yeah, right.  Irish coffees are hardly considered party drinks.

Phusion Projects is acting because it is being forced to.   FoodSafetyNews has kept score, based on data collected by the Marin Institute, which has been on top of this issue for years (thanks to Michele Simon and others).

So far, Oklahoma, Michigan, Utah, and Washington have banned drinks that combine caffeine with alcohol.  New York’s largest beer distributors have stopped selling the drinks. And several colleges have banned the drinks on campuses.

And where are the regulatory agencies in all this?  Alcohol beverages are not regulated by the FDA.  They are regulated by theTobacco Tax and Trade Bureau (TTB) of the Treasury department.  From the government’s standpoint, alcohol is about tax revenues, not health.  As Phusion Projects explains, all this is TTB’s fault:

If our products were unsafe, we would not have expected the federal agency responsible for approving alcoholic beverage formulas – the Tobacco Tax and Trade Bureau (TTB) – to have approved them.   Yet, all of our product formulas and packaging were reviewed and approved by the TTB before being offered to consumers.

Why is the FDA involved in this at all?  Because it regulates food additives—like caffeine and the other supplements put into energy drinks.

If this incident illustrates anything, it’s that alcohol beverages require the same kind of scrutiny given to any other food product and their regulation needs to move to an agency that cares about their effects on health.

Additions, November 18: The California Department of Health Services says caffeine-alcohol beverages can no longer be sold in the state.  And TTB has come out with its own warnings.

Addition, November 23: I’ve been sent the Saturday Night Live skit on Four Loko, and particularly appreciate the comment on portion size—120 servings per can!

OK, so “begging” isn’t quite the right word.  The FTC (Federal Trade Commission) has issued subpoenas to 48 food companies demanding information about their marketing practices aimed at children.

The FTC tried this once before and issued a report in 2008 based on the information it received.  But companies were not exactly forthcoming with the data.  In the present political climate, they will foot-drag this time too.

According to ThePacker.com, the FTC is asking for asked for nutritional data on the companies’ products as well as marketing information by December 1.

The FTC is quoted as saying that none of this is expected to lead to new regulations.  I guess the FTC is trying to do what it can under challenging circumstances.

But let me ask again: where is the FTC’s long-awaited report on nutrition standards for marketing products to kids?  If it can’t even get that report out, can the new subpoenas do any good?

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?