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]

Comments

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  1. sirwired says:

    And this, ladies and gentlemen, is why we have an FDA. However, note that this product conspicuously does NOT have an ADA label either, so the ADA probably rejected those claims also.

    As a side note, regular Listerine IS listed as an anti-gingivitis (although not anti-plaque) product and is reasonably effective for that purpose, although it does not prevent cavities like this other rinse does.

    • FatLynn says:

      I thought any company could buy an ADA endorsement.

      • sirwired says:

        No. The ADA reviews all packaging and advertising prior to the product obtaining an ADA seal. (The FDA only has packaging/claim review power once the product is out the door.) The most notable denial was the ADA refusing a seal for Plax.

    • EarlNowak says:

      Well now, regular listerine it doesn’t contain fluoride, which is potent for anti cavity action. But dollars to donuts your toothpaste has more than enough fluoride to prevent cavities.

  2. El-Brucio says:

    See, I always thought they got around that by using weasel words that a lawyer could argue in court. “Sure it fights plaque …. but it loses. No one claimed it *won*.” “It helps prevent cavities…..but it didn’t help enough.”

    It is nice to see regulatory agencies actually doing something about this.

  3. Loias supports harsher punishments against corporations says:

    Way to deal with this a decade after it’s been going on. Even if the labeling is removed, millions of Americans already think this stuff fights gingivitis and will pass that believe erroneously to others.

    I love the purpose of the FDA, but not it’s methods.

    • GuidedByLemons says:

      This product (Listerine Total Care) hasn’t been around that long. Regular Listerine is effective in preventing gingivitis.

    • jessjj347 says:

      I’m also confused about why this letter is coming at this point…
      I assume it’s because this “total care” products that Listerine, Walgreens, and CVS have are somehow advertising themselves in a way that is different than the older lines and the FDA can now technically classify them as drugs…

  4. Tim says:

    I used this mouthwash (or its generic alternatives), but it’s mostly for the fluoride and the bacteria-killing qualities of the alcohol (which almost all Listerine products have).

    • scratchie says:

      The fluoride ones don’t have alcohol and the alcohol ones don’t have fluoride. You should take a closer look at the info label.

    • sirwired says:

      21.something% diluted alcohol does NOT have any particular useful effect on your mouth (the alcohol has trouble penetrating the biofilm.) In regular Listerine, the alcohol is in there to dissolve the Menthol and Eucalyptol which DO provide the disinfectant action. (If you look at the label, you will see that those are the active ingredients, the alcohol is not.

      Not sure what it’s doing in this stuff other than providing a “fresh” feeling since evaporating alcohol has a cooling effect.

  5. jessjj347 says:

    Haha I just bought some of the stuff pictured. It’s much more expensive than regular Listerine, probably because of the claims that it makes on the label.

    Best ingredient in mouth wash? Good old alcohol….

  6. Jeff_Number_3 says:

    I’m always wondering what mouthwash I should be using. I currently use the normal deathmint style of Listerine, but there’s also Total Care, Whitening, and maybe a couple others.

    They all have different formulations, so there’s not really an overlap between them in what they do.

    Is there something in the actve ingrediants that causes them to react when they’re mixed together? I know that the kinds that have hydrogen peroxide for whitening have to be kept in the opaque bottles as that compound is photosensitive. Why can’t they just mixed them all together and have ‘Wonderwash’ or something?

    Should I be making my own mouthwash at home?

  7. H3ion says:

    You probably get enough fluoride to prevent cavities simply by using your community’s tap water. Most toothpaste products add enough to make products like this one overkill for cavity fighting purposes. That said, the alcohol in most mouth wash products do have an anti-bacterial effect but so does the alcohol in wine and beer.

    • Harmodios says:

      the problem is that the alcohol will give you mouth cancer. I use ACT, which does not have that.

      • Clyde Barrow says:

        That study was done in the late 80s and never proven. And the study stated that alcoholics were the ones that tended to get mouth cancer because they drank and used Listerine.

    • sirwired says:

      It’s the menthol and eucalyptol in Listerine that prevents gingivitis, not the alcohol. (The alcohol helps these oils dissolve in water.) This is why Scope, et al., are not listed as anti-gingivitis products.

  8. Beeker26 says:

    SPANKED!

  9. balderdashed says:

    Good for the FDA. I have in fact been purchasing this Listerine product, which is comparatively expensive (and tastes unusually unpleasant) specifically because of Johnson and Johnson’s gum-disease-related claims. What should happen now? For starters, I and everybody else who bought the product based on Johnson and Johnson’s fraudulent labeling and marketing should get their money back, and all product sitting on the shelves that contains such claims should be taken off the shelves. Clearly, this is not the worst example of a corporation knowingly making false medical claims to bilk gullible customers; in fact, its all too typical. But if you lie to consumers and know you’re doing so, there ought to be consequences — only when the penalties are swift enough, and substantial enough, will corporations calculate that it is in their best interest not to make false claims that violate federal law.

  10. nyscof says:

    Fluoride mouth rinses don’t reduce tooth decay, anyway, studies show.

    The Robert Wood Johnson Foundation reported the following in 2001: “One of the most surprising and controversial findings of the National Preventive Dentistry Demonstration Program concerned the lack of effectiveness of fluoride mouth rinsing and fluoride tablets in preventing tooth decay in children.”
    http://www.rwjf.org/files/publications/books/2001/chapter_09.html

    This 2004 review of studies shows that fluoride mouth rinses have no beneficial effect on children who use fluoridated toothpaste
    http://informahealthcare.com/doi/abs/10.1080/00016350410001658?journalCode=ode

  11. dave says:

    great. the cost of Listerine is going to go up by a buck now.

  12. Hi_Hello says:

    please provide references to this claim:

    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

    • Marshmelly says:

      common sense comes to mind

      • Hi_Hello says:

        Some common sense are myths. I didnt want to say anything because I was hoping someone can prove. Brushing your tongue doesn’t not prevent plaque build up or gum disease.

        Some people need to brush it because of bad breath. The tongue is a self cleanning. It also has some good bacteria on it.

        My dentist recommend the brushing and flossing. The diet part is important too that people seem to neglect when talking about teeth and gums

        And I dont’t even want to get into the sugar part…

  13. Saltpork says:

    I use the old death brown Listerine. It burns and it tastes bad, but it does the job.
    I also dunk my toothbrushes in it for 20 minutes or so once a week to remove any particles or kill anything living on my toothbrush.
    I also use it in my water pick to help clean out my gum line.

    It does the job and isn’t fancy. It’s not supposed to be. Mouthwash is meant to kill germs and freshen your breath.
    Fighting cavities is up to my toothbrush and floss habits.

    You should also add seeing a dentist to your list up there guys. Somewhat important to get your teeth looked at by a professional.

  14. iParadox{InLove} says:

    My Dentist just recommended this product to me during my cleaning this morning, even gave me a promo sample bottle.

    But damn, this stuff burns your mouth like crazy!

  15. Oranges w/ Cheese says:

    I can’t use Listerine for more than 10 seconds. IT HURTS LIKE HELL