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American customers are paying big bucks to import tiny tubes of toothpaste
Illustration by Thoka Maer
On the r/LegalAdvice subreddit, readers can ?ask simple legal questions? like how to handle a $60,000 inheritance, or what to do when your car is repossessed, or whether an individual has legal recourse if an ex deletes a college thesis. On January 7, 2016, a poster sought advice on the shipment of unsanctioned contraband. ??the company refuses to sell it here,? wrote Reddit user orochiman. ?Just wondering if the feds will come shoot my dog if I order it from Europe.? The substance in question? Toothpaste.
Sensodyne Repair & Protect with NovaMin has established a cult following among those seeking to treat tooth sensitivity. Alex*, a 45-year-old who works in IT in France, says he discovered the toothpaste in 2012 while living in Romania. (*Alex requested anonymity for this article, as did several other Reddit users contacted for this story.)
?I was having a lot of trouble with cracks and holes in my tooth enamel and the dentists were saying the only solution is crowning a lot of my teeth,? Alex said over Reddit direct message. After using this toothpaste, he said, ?I was a new man. Not only did my teeth stop hurting but the enamel damage seemed to be repaired. The NovaMin was filling in the cracks.? Alex said he?s ?basically addicted? to the toothpaste, as the cracks return after a week without the product.
In a NovaMin-inspired Twitter thread, PC Magazine senior features writer Chandra Steele praised the toothpaste, saying that the product was ?endorsed by my teeth after having used it for a month. (They look fabulous.)? Glowing reviews pop-up across the internet: from subreddits r/Dentistry and /r/LifeProTips, to mentions on Quora, Y Combinator?s Hacker News, Twitter, and specialized sites like dentalhypotheses.com and Ceramics.org. On Amazon, a reviewer called it the ?best toothpaste ever? and the few negative reviews tend to focus on the size of the packaging ? there?s not enough of the stuff! ? or complaints about counterfeits. When YouTube celebrity Casey Neistat asked his followers if he had anything to worry about from too much seltzer water consumption, Leo, a user who requested anonymity for this piece, recommended NovaMin. Leo told Elemental he keeps a cache of the product on hand.
?Usually when my wife or myself travel, we?ll pick up a few tubes.? he said. Leo says his dentist says his teeth look fantastic.
But for consumers in the United States, the hyped product is often accompanied by a crucial caveat: Sensodyne Repair & Protect with NovaMin is not available for sale there, meaning that customers have to pay as much as $10 for a 75ml tube to be shipped from overseas.
So is Sensodyne Repair & Protect with NovaMin as radically good as its fans think it is? And if so, why isn?t it being sold in the U.S.?
To understand what Sensodyne Repair & Protect with NovaMin does, you first have to understand teeth. The outer layer of our teeth contain dentinal tubules, or tiny canals ? up to 50,000 per square millimeter. These canals travel from the outside of the tooth to the inner ?pulp,? where the nerves are located. When dentinal fluid is pushed through these canals by pressure, hot and cold liquids, or food, it can trigger the nerves and cause pain, according to the hydrodynamic theory on dentinal hypersensitivity.
That?s where a material called bioactive glass ? the supposedly revolutionary material underlying NovaMin ? comes in. Bioactive glass, or bioglass, was developed by the late Larry Hench, a Department of Defense contractor. According to his 2006 article, ?The Story of Bioglass? in the Journal of Materials Science, Hench was attempting ?something new, to discover a material that would not form an interfacial layer of scar tissue but instead would form a living bond with the host tissues.? Hench turned to vanadium phosphate glasses, a material used in semiconductors.
Dr. Grayson Marshall, a dentist in the Division of Biomaterials and Bioengineering in the Department of Preventative and Restorative Dental Sciences at the University of California, San Francisco, says that initially, bioglass was thought to be ?bioconductive,? and simply provided the necessary components for tooth tissue to form. However, says Marshall, it was later found to be ?bioinductive,? in that it actually ?alters gene expression? and makes the tooth more effective in repairing itself. This means bioglass can serve as a building block to cover dentinal tubules, decreasing tooth sensitivity in the process.
In the mid-1990s, two University of Maryland dentists put bioglass into toothpaste, in the form of calcium sodium phosphosilicate, and saw dramatic results for treating tooth sensitivity. By 2007, the two had developed a marketable toothpaste, which the Washington Examiner covered in a story titled ?Additive helps teeth rebuild enamel.? The product and company was called NovaMin, which sat under a larger company called US Biomaterials. In 2010, GlaxoSmithKline (GSK) bought NovaMin for $135 million. In 2011, the toothpaste was introduced across Europe.
?To know that our invention will now have a positive impact globally on dental pain and help those individuals suffering from sensitive teeth is very rewarding,? said Gary Hack, DDS, the co-inventor of NovaMin, in a 2011 announcement.
But eight years later, Sensodyne Repair & Protect with NovaMin is still not available in the U.S. Asked if and when GlaxoSmithKline applied for FDA approval for NovaMin, a spokesperson for the company said, ?GSK Consumer Healthcare is unable to answer this question due to scientific research and commercial strategy confidentiality.? The spokesperson also added that ?toothpaste with NovaMin and without fluoride has been cleared by FDA as a medical device for in-office use.?
An FDA spokesperson also weighed in, saying, ?We cannot comment on why a product is not approved in the U.S. The company would need to discuss their marketing.?
There are a number of reasons ? economic, social, technological, ecological, and legal ? why a company might introduce a product in one market, but not another. But the company?s tight-lipped explanation has fueled speculation, and conspiracy theories, around the absence of Sensodyne Repair & Protect with NovaMin from the U.S. shelves.
One theory claims GSK is in the pocket of ?Big Dental.? In turn, the company is withholding NovaMin so that consumers have to pay for more expensive in-office procedures. Another theory argues that the FDA approved NovaMin for use in over the counter toothpaste, but had qualms with the term ?Repair? in the name of the product.
?GSK couldn?t market the ?Repair? part because bioglass isn?t really repairing the enamel, just protecting it beyond fluoride,? says Leo. In a December 2016 post on Reddit?s Q&A section r/IamA, a technician claiming to work in a toothpaste factory repeated the theory.
?NovaMin didn?t make it into U.S. markets due to regulatory obstacles, though my guess is Sensodyne/GSK is working on that. Making the label claim that the toothpaste restores enamel will really challenge the way toothpaste is currently registered/regulated by the FDA whereas the MHRA in the EU is very relaxed on toothpaste,? said user PasteGuy. (PasteGuy?s identity was not verified.)
Leo notes that at different times, Burt?s Bees and Dr. Collins both sold toothpaste products that contained the NovaMin compound under it?s nonbranded name, calcium sodium phosphosilicate. A 2010 press release from Burt?s Bees confirms the existence of the product, and a 2014 blog from HuffPo lamented that it had been taken off the market. Today, a discontinued four pack of 4-ounce tubes of the stuff sells for $49.99 on Amazon.
Terry* has been using toothpaste with NovaMin since 2015 and is a convert. ?I have had no new cavities or needed any major dental work in that time. I had a few cavities filled prior to that, but I can?t recall right now how many filings I actually have,? she said over direct message on Reddit. Terry is based in the U.S., and buys her Sensodyne with Novamin from Amazon or Ebay.
Terry doesn?t know why the toothpaste isn?t sold in the U.S., but says, ?I?m sure money is involved somehow. Possibly more money to be made through ?remineralizing? treatments in dental offices versus an at-home solution??
For Terry, the absence of Sensodyne from drugstore shelves is a question of justice. ?I?m not passionate about toothpaste but I get heated about pharmaceutical companies and using restrictive patents/copyrights to jack up prices for medications/products which could improve people?s health and lives.?
Conspiracy theories in dental care are not uncommon. A recent Atlantic feature detailed how one dentist bilked customers for tens of thousands of dollars with superfluous treatments, as well as procedures charged for but never actually performed. Patients that have been taken advantage of are more likely to turn to conspiracy theories and self-guided research. For instance, a small but vocal community has long believed that water supplies around the country are fluoridated in order to control the public?s behavior ? a completely unfounded accusation.
Though none of the dental professionals I spoke with knew why Sensodyne Repair & Protect with NovaMin was not being sold in the United States, they suspected more benign reasons.
?I can?t imagine they?re making much money off of it keeping it so exclusive,? says Daniel Jeremy Lopez, a registered dental hygienist in New York, and a moderator of a dentistry and dental hygiene subreddit. But, he adds, ?I don?t understand big pharmaceutical company motives.?
In an interview with Elemental, Hack likened the product to a cure-all that could undermine a billion dollar dental industry. But when pressed, he says, ?I believe that it is possibly a business decision on the part of the manufacturer.?
Dr. Matthias Zehnder, head of the Division of Endodontology at University of Zrich, is puzzled by the obsession with the toothpaste, and, in an email correspondence, called the topic ?somewhat enigmatic.? He referred to two articles from Ceramics.org that theorized why the product was not on U.S. shelves, and added his own take.
?It may be speculated that, because this Sensodyne toothpaste contains fluoride and bioglass 45S5 (NovaMin), it is considered to be a medication in the U.S. and thus the manufacturer refrained from keeping it on the market as such.?
?The toothpaste industry is a strange club,? he added. ?They put all kinds of stuff in toothpaste and hope it helps. :-)?
Other medical professionals I spoke with questioned the supposed miracle powers of NovaMin. Dr. William Landis, PhD, a professor and Interim Division Chair in Department of Preventative and Restorative Dental Sciences in the University of California, San Francisco School of Dentistry, says, ?Whether bioglass is as effective in its applications with teeth as it is with bone is conjectural? There are literature reports that bioglass is efficacious in some applications with teeth, but others that it is no more efficacious than products containing fluoride alone.?
Asked if he?d recommend NovaMin to his patients, Dr. Landis says ?My outside perspective is that I am not aware of a risk, but I would also not recommend the product for remineralization compared to other products already on the U.S. market that contain fluoride. I believe the latter do a very good job in their own right without the need for an additional additive such as NovaMin.? In other words, he?s just as likely to recommend a NovaMin toothpaste as a standard tube of Colgate.
And though the internet is glowing with positive reviews for the stuff, not all NovaMin users will find relief.
Lopez first heard of NovaMin in dental school in 2012 and has followed the hype since. He says he would only recommend using the product ?in extreme cases where other options have proved ineffective.? He is not an evangelist for Sensodyne with NovaMin.
?Novamin can only block up dentinal tubules, which means it really only works for inhibiting cold/fluid sensitivity. It does nothing to actually address irritable pulp/nerves. Only potassium nitrate can do that,? he says.
Lopez also points out that different treatments have different effects on different people. ?There isn?t one magic compound that solves everyone?s problem,? Lopez said. He knows from personal experience. Lopez says he has tooth sensitivity, which he attributes to sensitive pulp. He has used NovaMin products for ?a few months at a time.? He never felt relief.
