FDA Does Spit-Take Over Mouthwash Labels Saying They Fight Gum Disease

FDA Does Spit-Take Over Mouthwash Labels Saying They Fight Gum Disease: "

The FDA just smacked the taste out of the mouths of Johnson & Johnson, Walgreens and CVS over advertising that their mouthwash fights gum disease, without having science to prove it.

The swig makers routinely label their products as fighting plaque and gum disease, but there is no evidence to support that their active ingredient, good ol' fluoride, actually does. Cavities, sure, but not gingivitis.

Here is the letter the warning letter the FDA sent Johnson & Johnson:

Dear Mr. Bowden:

This letter is in reference to the Listerine Total Care Anticavity Mouthwash distributed by your firm. The label for this product makes the following claims: 'Strengthens Teeth, Restores Minerals to Enamel, Fights Unsightly Plaque Above the Gum Line, Helps Prevent Cavities, Kills Bad Breath Germs, and Freshens Breath.'

Based on these labeled claims 'Fights Unsightly Plaque Above the Gum Line' and 'Prevents Cavities,' Listerine Total Care Anticavity Mouthwash is a drug as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 321(g)) because the product is intended for use in preventing or mitigating disease, or to affect the structure or function of the body, by preventing cavities and removing plaque. Sodium fluoride 0.0221% (0.01% w/v fluoride ion) for the purpose of 'Anticavity' is the sole active ingredient listed for this product. This product is subject to the Final sole active ingredient listed for this product. This product is subject to the Final Monograph for Anticaries Drug Products for Over-the-Counter Use, 21 CFR Part 355, which covers the product's disease claim of helping 'prevent cavities,' and includes this active ingredient.

However, another claim on the label of Listerine Total Care Anticavity Mouthwash is 'Fights Unsightly Plaque Above the Gum Line.' This statement represents that the product fights plaque, a well-known precursor to gum disease, including gingivitis. Antiplaque/antigingivitis claims are not covered by the Anticaries Final Monograph. Such antiplaque/antigingivitis claims are, however, addressed in the Advanced Notice of Proposed Rulemaking (ANPR) for Oral Healthcare Products for antigingivitis/antiplaque (68 Fed. Reg. 32232 (May 29, 2003)). In that ANPR, the agency identified active ingredients under consideration for inclusion in an antigingivitis/antiplaque monograph; however, sodium fluoride is not among them.

Thus, no mouthwash with sodium fluoride as the active ingredient has been included or proposed for inclusion in any monograph for the antiplaque/antigingivitis indications claimed for Listerine Total Anti-cavity Mouthwash; that ingredient is not included among those under evaluation in the ANPR for antiplaque/antigingivitis drug products, nor does the anticaries monograph at 21 CFR part 355, which does include the active ingredient of sodium fluoride, include antiplaque claims as recognized claims. As formulated and labeled, Listerine Total Anticavity Mouthwash is not generally recognized as safe and effective for the antiplaque indications in its labeling, and it is, therefore, a new drug under section 201(P) of the Act (21 U.S.C. § 321 (P)). Under section 505(a) of the Act (21 U.S.C. § 355(a)), a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an FDA-approved application. The marketing of Listerine Total Anticavity Mouthwash without an FDA-approved application violates this provision of the Act.

In addition, the front panel of your product states the product name: 'Listerine Total Care Anticavity Mouthwash.' The violative claims described in the above paragraphs, combined with the appearance of the 'Total Care' name, suggests that the product is comprehensive in function, and will provide benefits, including antigingivitis and antiplaque benefits. We are not aware of any support for the antiplaque/antigingivitis claims or other statements suggesting that the product is comprehensive in function, providing benefits beyond those related to prevention of cavities. Thus, the product's labeling claim that it will provide all of the benefits listed, is misleading and accordingly makes it misbranded within the meaning of section 502(a) of the Act. (21 U.S.C. §352(a)).

The violations cited in this letter are not an all-inclusive list of deficiencies. You are responsible for investigating and determining the causes of these violations and for preventing their recurrence and the occurrence of other violations. You are to assure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

We note additionally that your principal display panel (PDP) describes your product as 'Sodium Fluoride and Acidulated Phosphate Topical Solution.' The Drug Facts panel lists the sole active ingredient as 'Sodium fluoride 0.0221% (0.01% fluoride ion).' These representations are inconsistent. Based on the information in your Drug Facts panel, it appears that the PDP should refer to either 'Sodium Fluoride Acidulated Phosphate Solution' or just 'Sodium Fluoride Solution.' The Sodium fluoride listed in the drug facts panel should be listed at 0.02%; not 0.0221 %.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the referenced violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Your reply should be addressed to Robert J. Maffei, Compliance Officer, at the above address.You can also read the ones to Walgreens and CVS, though they share a lot of the same language.

There are other, cheaper ways to fight plaque buildup and prevent gum disease, like:

* brush twice a day

* brush your tongue

* floss

* avoid sugar and eat a balanced, nutritious diet

FDA warns three companies to stop making unproven claims on mouth rinses [FDA via NPR]

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Hide Lunch From Office Thieves In Healthy Meal Boxes

Hide Lunch From Office Thieves In Healthy Meal Boxes: "

Here's a potentially even better idea for protecting your lunch from thieves in the office than the fake moldy ziploc bags. Commenter Snaptastic suggests that you stash it inside a box of 'healthy,' i.e. 'gross,' food like a Weight Watchers, or, as commenter Murph1908 recommended, a Hot Pockets.

(We don't really need to go into why Hot Pockets are Satan bullets, do we?)

See, the problem with the first idea is that coworkers, whether thieves or not thieves, might toss out your lunch thinking it's actually moldy, leaving you just as sans lunch as if it were stolen. With this method, they'll avoid your lunch entirely. But what if they're really super hungry and try to jack your lunch anyway? Then you put your sandwich inside a fake moldy bag, inside a Weight Watchers box.

PREVIOUSLY

Anti-Theft Lunch Bags Make Thieves Think Your Sandwich Is Moldy

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Star Wars flicks to see 3D re-release, starting with Episode 1 in 2012

Star Wars flicks to see 3D re-release, starting with Episode 1 in 2012: "

The Star Wars series hasn't even hit Blu-ray yet, but The Hollywood Reporter reports sources saying George Lucas definitely intends to refill his money pit in 2012 by bringing out the movies, one each year, in 3D. Unfortunately that means even if you're optimistically expecting a well done 3D conversion process Episode IV is at least five years away since the plan is to release the movies in numerical order. According to the sources, even after demoing converted 3D footage of the movies in the past, Lucas was moved to greenlight the process after experiencing Avatar and realizing that by the time the movies hit theaters, and eventually homes, there will be more than enough capable screens to watch them on. Of course, all could be forgiven if this meant there were enough petty cash floating around to convince Lucas it's time to restore and rerelease the original editions on Blu-ray, but we're not holding our breath.

Star Wars flicks to see 3D re-release, starting with Episode 1 in 2012 originally appeared on Engadget on Tue, 28 Sep 2010 22:24:00 EDT. Please see our terms for use of feeds.

Permalink | The Hollywood Reporter | Email this | Comments

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Los Angeles Farmers Markets Full Of Lies, Warehouse Produce

Los Angeles Farmers Markets Full Of Lies, Warehouse Produce: "

If you're in California and need to make a little extra cash, why not buy a bag of baby carrots from the supermarket, throw some potting soil on them, and sell them at your local farmers market as fresh-from-your-farm organic treats? Okay, maybe technically that's not permitted, but who's going to stop you? An NBCLA investigation found vendors at several farmers markets were lying to customers about their produce, and sourcing it from local warehouses instead of their own farms.

NBCLA's investigation began this summer, when we bought produce at farmers markets across the LA area, and then made surprise visits to farms where we were told the produce was being grown.

We found farms full of weeds, or dry dirt, instead of rows of the vegetables that were being sold at the markets.

The station also tailed a farmers market vendor on the day of the market and watched him drive to a warehouse and load up his truck with produce from farms as far away as Mexico. When they confronted him and asked whether he was going to sell the produce at the farmers market, he said yes.

As for pesticide-free claims, three of the five strawberry samples the station bought (all from different vendors) tested positive for pesticides, despite all promises to the contrary. NBCLA told one of the vendors about the results--her berries tested positive for four different pesticides--and asked, 'You don't know how that happened?' She answered, 'Nope.'

View more news videos at: http://www.nbclosangeles.com/video.

'False Claims, Lies Caught on Tape at Farmers Markets' [NBCLA via Metafilter]

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VIDEO: Sprint Store Laptop Filters Out Anti-Sprint Consumerist Content

VIDEO: Sprint Store Laptop Filters Out Anti-Sprint Consumerist Content: "

Consumerist reader Brian got bored while he was waiting for his friend to finish up a transaction at their local Sprint store. So he decided to kill time by trying out the in-store public laptop. That's when he discovered something of interest.

Writes Brian:

My friend was wrapping up with the clerk and I thought why not leave the Company Profile for Sprint up just for kicks. But to my surprise, the store filters out just the Sprint info from Consumerist. Stories tagged Sprint end up redirecting me to their home page. The Consumerist site worked fine for other stories and other phone companies.

So instead of getting this page, he was redirected to the Sprint homepage.

Wouldn't it have just been easier to block Consumerist.com entirely? Or maybe they want customers to read what we write about AT&T, Verizon and T-Mobile?

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Netflix Will Start Treating Americans As Well As Canadians 'Over Coming Months'

Netflix Will Start Treating Americans As Well As Canadians 'Over Coming Months': "

Making an about-face after stirring up a hornet's nest of discontent by saying Americans were too self-absorbed to notice his company was providing cheap, streaming-only access to Canadian customers, Netflix CEO Reed Hastings said he was joking and that Americans would get a similar service soon.

Hastings writes on the Netflix Blog:

My Big American Foot is in my mouth. Yesterday, I made an awkward joke with a reporter in Toronto about Americans (like me) being self-absorbed relative to Netflix pricing in Canada. I was wrong to have made the joke, and I do not believe that one of the most philanthropically-minded nations in the world (America) is self-absorbed or full of self-absorbed people. The pricing Netflix is offering in Canada, $7.99 per month, does not include any DVD-by-mail option, and that is why it is cheaper than our $8.99 USA plan which has both DVD-by-mail and streaming in one plan. We are looking at adding a streaming-only option for the USA over the coming months. My apologies to anyone offended by my self-absorbed comment.

Apologies [Netflix Blog via Engadget]

Previously: Netflix CEO: Americans Too Self-Absorbed To Notice Netflix Is Cheaper In Canada

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Woman Finds Sleeping Pills In Beef Bought At Walmart

Woman Finds Sleeping Pills In Beef Bought At Walmart: "

Butcher! There's a sleeping pill in my beef! A woman is upset after buying meat at Walmart for stroganoff, only to crack open the beef and find two sleeping pills inside.

Store managers told her that Walmart doesn't package its own beef, and the cops she called later told her that Walmart was checking it out with their supplier. The police were not going to investigate as no one was poisoned.

Walmart refunded her $15 and gave her a $40 gift card so she could try her luck again at purchasing beef.

If you buy food and find a foreign object inside it, file a report with your local health department.

Woman finds sleeping pills in ground beef purchased at Wal-Mart in Indian River County [The Palm Beach Post] (Thanks to David!)

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Netflix CEO: Americans Too Self-Absorbed To Notice Netflix Is Cheaper In Canada

Netflix CEO: Americans Too Self-Absorbed To Notice Netflix Is Cheaper In Canada: "

Earlier this week, Netflix finally did what the military hasn't had the guts to do -- invade Canada... with a streaming-only video service. But unlike most U.S. products that go across borders, the people in Canadaland are actually paying less than anyone else. But the CEO of Netflix isn't worried about causing an uproar on this side of Niagara Falls.

When asked by The Hollywood Reporter if he thought U.S. customers would be unhappy to find out that Canadians are paying only $7.99/month CAD (~$7.75 USD), more than a dollar cheaper than the lowest streaming plan in the States, CEO Reed Hastings replied:

How much has it been your experience that Americans follow what happens in the world? It's something we'll monitor, but Americans are somewhat self-absorbed.

The fact that we received this in our tipline from a few dozen readers in the last couple hours might prove otherwise...

What Netflix CEO hopes U.S. won't notice [THR]

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NBC Universal says 99-cent rentals would 'devalue' content, News Corp calls them a 'short-term test'

NBC Universal says 99-cent rentals would 'devalue' content, News Corp calls them a 'short-term test': "

ABC and Fox may have been willing to part with their TV shows for 99 cents a pop on the new Apple TV and at Amazon, but don't be surprised if NBC Universal fails to join their ranks. 'We do not think 99 cents is the right price point for our content,' said CEO Jeff Zucker at an investor conference earlier this week, noting that NBC shows are indeed present on iTunes for those willing to shell out $1.99. That's not the only bad news for video-on-demand enthusiasts, as News Corporation is apparently reconsidering its stance -- though subsidiary Fox is presently dishing out 99-cent shows, president Chase Carey called its involvement a 'short-term test.' Guess that brave new world of cheap streaming is still a ways off, eh?

NBC Universal says 99-cent rentals would 'devalue' content, News Corp calls them a 'short-term test' originally appeared on Engadget on Wed, 22 Sep 2010 22:29:00 EDT. Please see our terms for use of feeds.

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More People Buying Mexican Coca Cola

More People Buying Mexican Coca Cola: "

Perhaps it's the glass bottles. Or it could be the lack of high fructose corn syrup. Maybe it just tastes better. Whatever the reason, a growing number of folks on the north side of the Rio Grande are drinking Coca Cola bottled in Mexico.

One of the major reasons is the aforementioned absence of HFCS is Mexican Coke, which still uses cane sugar as its sweetener. While the debate continues over whether or not HFCS is any worse for you than sugar, there are many who say there is a marked difference in the taste of the two sweeteners.

Mexican Coke also provides those soda shoppers with something to sip on during those months when Kosher for Passover Coke isn't on sale.

DailyFinance spoke to Coke's vice president and general manager of Importation and Commercialization (try to fit that on a business card), who added that the growing Hispanic population in the U.S. is contributing to the increase in imported pop:

When purchasing Coca-Cola from Mexico, Hispanics are purchasing a bit of nostalgia -- it's like getting a piece of home... Some of that feeling may have to do with the packaging and the fact that it is imported.

Of course, many people who prefer Mexican Coke have to pay extra to do so. Here in New York, a 12 oz. bottle of the imported stuff will cost you around twice as much as a same-size can of the domestic.

If Coke made a cane sugar version in the U.S., would you buy that instead of the HFCS version?online surveys

Mexican Coca-Cola Is Finding Sweet Success in the U.S. [DailyFinance.com]

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Price Chopper Supermarket Emails Customer's Employer, Demands Disciplinary Action For Negative Tweet

Price Chopper Supermarket Emails Customer's Employer, Demands Disciplinary Action For Negative Tweet: "

Last week, a customer at Price Chopper in upstate New York tweeted a relatively mild insult about the store: "Every time I go to @PriceChopperNY I realize why they r not @wegmans. Tonight -bare produce areas & this sign 4 ex http://yfrog.com/2tfj9sj.' In return, Price Chopper contacted the man's employer and complained about him.

A professor at Syracuse University started a Tumblr blog about the issue. He says the customer who was targeted was his friend, and that he therefore has a first hand an account of what happened after his friend posted the tweet. He says someone at Price Chopper obtained the customer's employer information and proceeded to contact people there. (To clarify, the professor says that the customer does not work for a company that has a business relationship with Price Chopper.)

Although Price Chopper did reply to the customer directly, they did not wait for a response before dragging the individual's employer into the mix. In an email addressed to a seemingly random list of executives at the customer's workplace, including the customer's supervisor, Price Chopper labeled the individual as destructive and negative. They suggested that this individual's distaste for their stores could jeopardize the relationship between Price Chopper and the company where the individual is employed, and they requested action be taken against the individual.

Once the Tumblr page went up, the director of Price Chopper's PR department jumped on to comment, and said that they were reaching out to the customer to apologize for what happened. Then the rogue employee who targeted the customer left a public apology as well. It reads in part:

I took matters into my own hands. And though well-intentioned, I clearly went over the line - without the knowledge of our consumer insights people or my direct supervisor, the Vice President of Public Relations and Consumer and Marketing Services. I was trying to understand and engage a disgruntled customer and clearly lost sight of my goal.

I'm not sure how contacting someone's employer and requesting disciplinary action--over a tweet posted from a private Twitter account, no less--can be considered 'well-intentioned' by even the loosest definition, and from her apology I get the impression that this employee learned nothing except to be more subtle when she tries to punish a customer next time. But hey, at least her behavior was exposed.

And remember, if you want to shop at Price Chopper, make sure you use an anonymous Twitter account before you complain about their barren produce section or dumb store signage.

pricechopperfail.tumblr.com [via All Over Albany] (Thanks to Steven!)

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Just How Massive is Google, anyway?

Just How Massive is Google, anyway?: "

Infographic by computer school.org

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Passengers Tossed Like Ragdolls Inside Storm-Stricken Cruise Ship

Passengers Tossed Like Ragdolls Inside Storm-Stricken Cruise Ship: "

CCTV video has recently resurfaced showing what happened inside a Pacific Sun cruise ship during a severe storm. Passengers smack to the floor and locomote from port to sideboard and back again like ragdolls on ice, cling desperately to anything they can get a hand on, and try to dodge the piles of furniture caroming around. Cruise ships can be fun, but out there on the open seas Mother Nature can have her own ideas about what constitutes a good time.

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Master Criminal Steals $11,000 From Walmart Over The Phone

Master Criminal Steals $11,000 From Walmart Over The Phone: "

Time was, a burglar needed a gun or a knife to hold up a store. But kids today, they got all sorts of new-fangled ways of pulling heists, like the Walmart in Ohio that is now short over $11,000 because of a phone call.

According to police in Columbus, OH, someone called up a local Walmart around 1 a.m. on Sunday morning and 'tricked a clerk' into activating money cards over the phone and giving the suspect the activation numbers.

When all was said and done, the criminal had helped themselves to $11,054.60 in money cards.

While we certainly don't condone retail crime, this is certainly a more inventive use of the phone than the Wendy's robber who later called the restaurant -- twice -- to complain about the pittance he stole from the till.

Suspect Steals $11K With Phone Call To Walmart [NBC4i.com]

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McDonald's Serves Customer A Used Burger

McDonald's Serves Customer A Used Burger: "

If car companies and Ikea can make money selling pre-owned products, why not McDonald's? Oh yeah... that would be disgusting. Just ask the Arkansas man who was sold a pre-owned, pre-bitten burger.

According to a local news report, the customer and his wife purchased a pair of angus burgers at a McDonald's drive-thru. But when he opened up his burger box, he saw he'd been served a cold sandwich with a big chunk missing from it.

So he went back to the McDonald's and spoke to the manager, who he says told him, 'I'd like to go into the kitchen and find out who did this and talk to him.'

The customer says the manager then confessed that his burger had previously been sold and returned by an unhappy customer earlier in the day. The manager apologized for the error.

As proof of the gross gaffe, the customer had the manager sign his name to the refund slip.

'I have several avenues in mind of making this the most expensive hamburger they ever sold,' said the customer, who in addition to being a minister, 'was in the restaurant business for twenty-five years, and my concern is that they not do this to anyone else. It's a health concern.'

Among the avenues the customer has in mind is sharing his story with the Arkansas Department of Health. He also plans to take his concerns to McDonald's corporate level.

'I wish I could just throw it in the trash, but then I'd feel bad if it continued to happen and someone got sick because I didn't speak up,' he says. 'There's enough negativity in this world without spreading more, so we try to stay positive; but this McDonald's has been a mess for years.'

Not lovin' it! [LovelyCitizen.com]

Thanks to Henry for the tip!

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Pack Like A Pro

Pack Like A Pro: "

This guy show off a cool 'clown-car' technique for packing a lot of clothes into your luggage.

The key is to place the the shirts and pants into the luggage with the arms and legs sticking out. Alternate the sides the legs and arms are coming out of. Only after all the shirts and pants are in do you fold all the arms and legs into the bag.

Since the bulk of the material is in the torso of the shirt, or the hips to knees of the pants, you can stuff more clothes in your luggage.

Handy! I'll have to try this next time I take a trip.

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Is It Time For Starbucks To Get Rid Of Tall, Grande and Venti?

Is It Time For Starbucks To Get Rid Of Tall, Grande and Venti?: "

The topic of Starbucks' drink sizes has once again been in the news lately. And it's brought up the discussion of the coffee company's insistence on sticking with size names like 'tall,' 'grande' and 'venti.'

While many would say that the tall is actually a small, others would say that the 'short' -- not listed on the menu -- is the true small size. But maybe the tall is really the small and the short is extra small or junior size?

If tall is medium, then what is grande? Is that large? And if so, does that make the venti extra large?

Would all this be solved by Starbucks just going with less interesting size names? What about a compromise that would involve Starbucks employees from not glaring at you when you order a 'large coffee'?

Have your say in the poll:





Is It Time For Starbucks To Ditch Tall, Grande and Venti?customer surveys

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Lady Bites Into McDonald's Burger Bursting With Maggots

Lady Bites Into McDonald's Burger Bursting With Maggots: "

An Iowa woman got more than a mouthful when she bit into a McDonald's burger. She also got some extra protein, thanks to the maggots crawling around inside it.

The restaurant determined the insects came from inside a pickle container. Their quality control department says a fruit fly somehow got into the pickles, and created a larva, which hatched maggots.

Despite maggots being completely harmless, the restaurant manager said he took the matter 'very seriously' and would be working towards a 'resolution.'

Report: Maggots found in burger served at Sioux City restaurant [KTIV] (Thanks to Emily!)

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