The FDA has warned General Mills that claims about heart benefits appearing on Cheerios boxes violate federal laws.

In particular, the company’s assertion that the iconic breakfast cereal has been “clinically proven to help lower cholesterol” effectively renders the product a drug, according to federal law.

Stephen Sundlof, the director of the FDA’s food-safety center, added that General Mills needs to file a new-drug application for Cheerios if it intends to leave the box labeling as it is.

Tom Forsythe, a gobsmacked GM spokesperson responded that Cheerios’ claim it can “lower your cholesterol 4% in 6 weeks” has been posted for 2 years, and that the labeling references a study in which Cheerios was factored into a low saturated fat, low cholesterol diet.

“The clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong,” Forsythe told the Wall Street Journal.

An unimpressed Sundlof shot back that “we try to make a bright line between what can be said about a drug and what can be said about a food.”

A less specific claim that consuming whole-grain foods can reduce the risk of heart disease risk would be permissible in certain circumstances, he added.

In a letter to General Mills, the FDA said the food-maker must “promptly” correct the violations or else it would be forced to take action, which might include seizing products.

Apparently, the FDA’s intervention was prompted by a tip from the National Consumers League.

The FDA’s love letter follows by one month a case in which the Federal Trade Commission settled a dispute with Kellogg Co. regarding claims that Frosted Mini-Wheats improved children’s attentiveness by 20%.

Adolescents that had been exposed to adult-themed TV shows between the ages of 6 and 8 are more likely to make their sexual debuts before the age of 14, according to Hernan Delgado and colleagues from Children’s Hospital in Boston.

Delgado’s team tracked TV and movie exposure in 754 boys and girls who were younger than age 12 using diaries and computer-based self-interviews, and then 5 years later, asked participants about the age at which they first had sexual intercourse.

Among the youngest kids in the study, who were 6-8 years old at the time, it turned out that for every hour per day spent viewing adult-targeted programming, the chances of having sexual intercourse by early adolescence (ages 12-14) jumped by 33%.

In all, 10% of study participants reported losing their virginity by this age.

Surprisingly, the correlation was not found among the cohort of children who were older than the age of 8 at study onset.

“We think it’s because the younger you are, the more immature you are, and the media might have more influence,” Delgado told MedpageToday.

“Older children might be learning from peers, social norms, and families . . . but when they are young, they are probably using the media as a reference to make decisions as to what being an adult entails and what an adult relationship means,” he added.
 
“Watching characters on ’90210′ or ‘Glamour Girls’ engaging in promiscuous lifestyles where there are no consequences for actions is going to convey that this is an ideal way to behave to get what you want and to be popular,” said Melissa Henson, director of communication at the Parents Television Council.

El Pollo Loco, a chain of 418 grilled-chicken restaurants based in the Southwest, is engaged in an ugly cock fight with industry giant Kentucky Fried Chicken.

Last month, KFC launched a grilled-chicken product amid great fanfare. It was the largest new-product launch in the history of the bespectacled Colonel’s storied franchise, and a lightning strike to the grill of El Pollo Loco.

It didn’t buckle the contender’s knees. In fact, El Pollo Loco’s CEO Steve Carley unleashed a furious counterattack including TV commercials challenging KFC to a taste test.

He even set up a toll-free number that the Colonel could to call to arrange a showdown.

Yum Brands’ KFC, which has 11,000 outlets world-wide, claims it wasn’t ruffled by the challenge.

“We’re certainly more focused on Kentucky grilled chicken than on any advertising or online efforts of competitors,” KFC spokesman Rick Maynard told the Wall Street Journal.

Maybe so, but when a flood of calls came in to the hot line from people claiming to prefer KFC’s entry, El Pollo Loco’s handlers determined by tracing the caller IDs that some of the calls originated from HQ over at KFC.

“We’ve been grilling our employees to see if anyone’s done any undercover dialing,” Maynard said.

For El Pollo Loco though, this was a chance to make some serious gravy. It posted follow-up videos on YouTube outing KFC’s purported sham calls and claiming it had gotten under the Colonel’s oven-baked skin.

The spat has now escalated to the grandest stage of all, as king-maker Oprah Winfrey-who in the last year alone got the other Big O elected president and quadrupled the value of Twitter—announced that viewers could download coupons from her Web site for a freebie at KFC.

Once again, El Pollo Loco was ready. The coupons, it turned out, were good through mid-May, excepting Mother’s Day.

The contender posted yet another video on YouTube.

“What does KFC have against Moms?” it asked, while offering to honor KFC’s coupons on the holy day.

The Walt Disney Company wants a bigger piece of the action in the pre-teen boy market, so it hired an anthropologist to sort through the dresser drawers of a 12 year-old.

Venturing into territory never before seen by human eyes, much less smelled by human noses other than his mother’s who–let’s face it–had no choice, Kelly Peña eventually found a Black Sabbath T-shirt scrunched into a corner on the top shelf.

When confronted with the artifact, the boy confided that “wearing it makes me feel like I’m going to an R-rated movie.” 

Disney hopes these and other penetrating psychological insights into a most assuredly confused demographic can help it recreate a time when Davy Crockett drove millions of boy-dollars its way, while hopefully counteracting its reputation as a provider of girl-friendly fare like (ew!) Hannah Montana.

Early results of Peña’s work are apparent on Disney XD, a new cable channel and Web site featuring urban skateboard parks populated by unassuming, nonthreatening boys, and on its TV hit “Aaron Stone,” where one character is quite average as a basketball player.

Peña had suggested to producers that today’s boys relate with characters that are trying to grow and improve themselves. “Winning isn’t nearly as important to boys as Hollywood thinks,” she told the New York Times.

Boys in the 6 to 14 age range drive $50 billion in global sales per year, according to market researchers, but it’s a tough market to crack, a fact to which News Corporation can attest after its Fox Kids Network failed famously in the late 1990s. 

Despite Pena’s intrepid work to date, results have been modest. Disney XD has bumped its prime-time audience by 27% among kids between 6-14 years of age, but most of that has come from girls. Viewership among the boys is up 10%.

Just don’t tell that to the boys!

IBM is putting the finishing touches on a computer program that will compete against human contestants on “Jeopardy!” 

Comparing such an achievement to Deep Blue, the venerable tech company’s chess-playing program that beat world champion Garry Kasparov in 1997 is like comparing checkers to chess.

Chess is a game of simple statistical probabilities, a lot of them it’s true, and pieces with clearly defined powers.

“Jeopardy!” presents more daunting challenges for computers, which must weigh nuances of language including double entendres, puns, and analogies faster than Ken Jennings on crack.

The machine has been dubbed Watson in honor of IBM founder Thomas Watson. It is the culmination of a 3-year project involving a team of 20 with expertise in language processing, information retrieval and machine learning.

“The big goal is to get computers to…converse in human terms,” said David Ferucci, an AI scientist and the team’s leader.

In the contest, Watson will receive questions as electronic text, whereas the human contestants will, as usual, see the question and hear it spoken by host Alex Trebek.

Watson will use a synthesized voice to respond and select follow-up categories.

It will not be connected to the Internet during the contest, instead rendering answers from text that had been processed and indexed in advance.

Harry Friedman, the show’s executive producer, indicated he might invite Jennings to carry the flag for humans.

In 2004 Jennings won 74 consecutive contests and collected $2.5 million along the way.

In prepping for the contest, Watson will have stored a large chunk of the Web as indexed by Google, but it’ll mean nothing if the machine can’t understand the context of each clue.

For example, the sentence “I never said she stole my money” can have seven meanings depending on which word is stressed.

“We love those sentences,” Eric Nyberg said. “Those are the ones we talk about when we’re sitting around having beers after work.” The computer scientist from Carnegie Mellon University is on the development team.

Big Pharma cut DTC spending by 8% in 2008. It was the first such reduction in the 10 years since the FDA eased restrictions on the practice. DTC spending dropped from $4.8 billion in 2007 to $4.4 billion last year, according to IMS Health.

The drop-off has been chalked up to reductions in new drug introductions and a bit of ill-will directed at the industry by the public and congress.

Critics claim the advertisements, which are proscribed in most countries, inflate costs by encouraging people to request brand-name drugs in lieu of less expensive alternatives.

In response, PhRMA, Big Pharma’s trade group, points to a 6 year-old FTC statement claiming the ads inform consumers about medication options and have not been proven to cause health care cost escalations.

And Pfizer spokesperson Sally Beatty insisted to the Wall Street Journal that its ads raise awareness of health conditions.

“Erectile dysfunction… can be a signal for other serious medical issues, including high blood pressure, diabetes and cardiovascular disease,” she said.

Big Pharma adds that DTC constitutes only 40% of its marketing expenses for prescription drugs.

The remainder targets physicians.

Merck and the Plough, which jointly market Vytorin, shaved their DTC spend on the cholesterol buster from $114 million to $47 million, according to IMS.

That came after Michigan congressmen John Dingell and Bart Stupak denounced the companies for pushing the drug while delaying release of a study that showed Vytorin was no better for most patients than generic equivalents.

“We felt this temporary suspension was appropriate in light of the news coverage,” a Merck spokesperson told the Journal.

Even Abraham Lincoln, in his new role as Rozerem pitchman, took a hit.

Takeda cut DTC advertising for the sleeper by 90% to $14 million. We’re going to miss you too, Abe.

Last week, 2 lunkheads employed by Domino’s Pizza in Conover, North Carolina decided it would be a hoot to do a video in the chain’s kitchen, in which one prepared sandwiches while stuffing cheese into his nose and swabbing his snot on the sandwiches while the other did a play-by-play.

“In about five minutes…somebody will be eating these…little did they know that cheese was in his nose and there was some lethal gas that ended up on their salami,” chirped the narrator.

Then last Monday, the inspired pair decided to post the video on YouTube.

Domino’s found out on Tuesday. It immediately fired the lunkheads and jettisoned all opened food containers from the ground-zero franchise. On the PR side, the company decided to lay low and wait for the dust to settle.

That proved to be a mistake. By Wednesday, the video had been watched more than a million times. Five of the top 12 results on the Google search for “Domino’s” referenced the ghastly spectacle and on Twitter the tweets were louder than ravens at a Bodega Bay school house.

By Wednesday evening, the offending video had been removed, and Domino’s had created both a Twitter account and a YouTube video of its own.
 
“We got blindsided by two idiots with a video camera and an awful idea,” Domino’s spokesman Tim McIntyre told the New York Times. Even people who’ve been with us as loyal customers for 10, 15, 20 years are second-guessing their relationship with Domino’s. That’s not fair.”

At last report, the lunkheads were simmering in a Conover lock-up facing felony charges for delivering prohibited foods, and an impending civil lawsuit from the aggrieved fast food chain.

The FDA has told 14 pharmaceutical companies to bag certain drug ads that accompany search results generated by Google because they don’t include adequate risk information and sometimes suggest non-approved uses.

The directive represented the first salvo in what will likely become a new regulatory frontier, as Big Pharma has begun a major push to redirect marketing dollars towards Internet advertising.

The ads in question are known as “sponsored links.”

These short teasers appear alongside search lists generated in response to keyword strings that include certain diseases or drug names.

Biogen Idec has received notice from the FDA regarding its MS drug Tysabri, for example.

The drug has been linked to progressive multifocal leukoencephalopathy, an often fatal viral infection of the brain.

One sponsored link for Tysabri asks “(are you) satisfied with your MS medication or looking for something different?” The ad mentions nothing about PML.

This “casual approach to Tysabri treatment is extraordinary in light of the potentially lethal risks of the drug and the stringent controls over its distribution,” wrote the FDA in a letter to Biogen that was obtained by the Wall Street Journal.

Biogen spokesperson Naomi Aoki said her company is working to resolve the situation, and that it takes seriously its responsibility to convey the truth about the risks and benefits of its drug.

The Biogen ad includes a link to the Tysabri Web site which does provide ample risk information, but the FDA was having no part of it. The link “does not mitigate the misleading omission of risk information from these promotional materials,” it wrote.

Sanofi-Aventis received a similar letter for Plavix, its anticlotting blockbuster. Pfizer was cited for 6 of its drugs including the antismoking drug Chantix and Celebrex, an arthritis drug.

Newspapers have served as a primary information resource and a key watchdog against abuses of power by government and private interests since hacked-off Bay Staters threw British tea into Boston harbor.

But now they are on the bullet train to oblivion.

The most recent casualty was the Seattle Post-Intelligencer, which had been printing for 146 years.

Two weeks before that, Denver’s Rocky Mountain News turned out the lights, and the Tucson Citizen is on life support.

At least these cities still have a daily, for now. Most observers believe it won’t be long before some major American cities have none at all.

The San Francisco Chronicle lost a $1 million per week in 2008.

The Chicago Tribune, LA Times, New Haven Register and Philadelphia Inquirer are all owned by companies in bankruptcy. Chicago’s Sun-Times and the Miami Herald are for sale and no one’s buying.

The major problem is collapsing ad revenue. It’s dropped 25% in the last 2 years, which is actually a steeper decline than that posted by America’s Big Three automakers over the same time period.

Craigslist and similar online sites have blown up a 2-century-old business model just like that.

The papers’ efforts to balance the books have led to draconian workforce reductions that compromise the final product. The LA Times’ news staff is half what it was a decade ago, for example. 

“I can’t imagine what civil society would be like (without newspapers),” Buzz Woolley told the New York Times. The San Diego businessman has been a long time critic of the city’s Union-Tribune, and now backs VoiceofSanDiego.org, an internet news site.

“I don’t want to imagine it. A huge amount of information would just never get out.”

By all accounts, Cerrie Burnell has the skills and make-up to be terrific in her new role has co-host for Cbeebies, a BBC children’s show aimed at kids 6 years old and under.

It’s just that Burnell was born with one hand, and the plainly visible disability has roiled some British parents who worry what impact the gestalt might have on their children.

BBC Spokesperson Katya Mira said the network has received at least 25 “official” complaints since Burnell joined the show in January, and that’s not counting dozens more negative comments posted in chat rooms and blogs.

One father complained for example that the hostess forced him to discuss disabilities with his child before he would have preferred.

Mira was quick to add that the BBC has “received 99 appreciations of (Burnell),” according to CNN.

Before joining Cbeebies, Burnell had worked as an actress for theater companies in Manchester, England and Brazil.

BBC’s January news release introducing Burnell did not mention her disability, although it was accompanied by a PR photo in which the right sleeve of her sweater was rolled up leaving the missing lower limb in plain sight.

Burnell has heard the criticism and remains unperturbed.

“It can only be a good thing that parents are using me as a chance to talk disability with their children. It just goes to show how important it is to have positive, disabled role models on CBeebies and television in general,” Burnell told CNN.

And BBC controller Michael Carrington voiced strong support for Burnell. “Cerrie is warm and natural and we think that, in time, all moms and dads and children will love her as much as we do,” he said.