Tom's of Maine toothpaste made with bacteria-tainted water, FDA warns. Here are details.

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Here are details.","description":"The FDA sent a warning letter flagging \"significant violations\" of manufacturing regulations for Tom\u0027s of Maine toothpaste.","articleSection":["MoneyWatch"],"image":{"@context":"https:\/\/schema.org","@type":"ImageObject","height":630,"width":1200,"url":"https:\/\/assets2.cbsnewsstatic.com\/hub\/i\/r\/2024\/11\/19\/2b3eab89-d285-4103-9032-4012952e0b41\/thumbnail\/1200x630\/2570de10baa4f87a259d70d331f0478f\/gettyimages-57204262.jpg?v=e3aa8b4a58817620ee227c79202c9709"},"thumbnailUrl":"https:\/\/assets2.cbsnewsstatic.com\/hub\/i\/r\/2024\/11\/19\/2b3eab89-d285-4103-9032-4012952e0b41\/thumbnail\/1200x630\/2570de10baa4f87a259d70d331f0478f\/gettyimages-57204262.jpg?v=e3aa8b4a58817620ee227c79202c9709","associatedMedia":{"@context":"https:\/\/schema.org","@type":"ImageObject","height":630,"width":1200,"url":"https:\/\/assets2.cbsnewsstatic.com\/hub\/i\/r\/2024\/11\/19\/2b3eab89-d285-4103-9032-4012952e0b41\/thumbnail\/1200x630\/2570de10baa4f87a259d70d331f0478f\/gettyimages-57204262.jpg?v=e3aa8b4a58817620ee227c79202c9709"},"keywords":["FDA"],"datePublished":"2024-11-19T14:52:00-0600","dateModified":"2024-11-19T15:53:00-0600","author":[{"@type":"Person","familyName":"Picchi","givenName":"Aimee","name":"Aimee Picchi","url":"https:\/\/www.cbsnews.com\/team\/aimee-picchi\/","jobTitle":"Associate Managing Editor, MoneyWatch","description":"Aimee Picchi is associate managing editor for CBS MoneyWatch, where she covers business and personal finance. She previously worked at Bloomberg News and has been published by national news outlets including USA Today and Consumer Reports. Aimee frequently writes about retirement, and has been a National Press Foundation fellow for reporting on retirement and Columbia University\u0027s Age Boom Academy. She\u0027s also the editor of the Institutional Investor book "Cultivating the Affluent II," with noted wealth consultant Russ Alan Prince.","sameAs":"https:\/\/x.com\/@aimeepicchi","knowsAbout":["Economy","Product Recall","Finance","Stock Market","Money"],"workLocation":{"@type":"Place","name":"New York"},"affiliation":{"@type":"Organization","name":"CBS News"},"worksFor":[{"@type":"Organization","name":"CBS News"}],"publishingPrinciples":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/"}],"editor":[{"@type":"Person","familyName":"Lee","givenName":"Anne Marie","name":"Anne Marie Lee"}],"publisher":{"@context":"https:\/\/schema.org","@type":"NewsMediaOrganization","@id":"https:\/\/www.cbsnews.com\/chicago\/","name":"CBS Chicago","foundingDate":"1946-09-06","sameAs":["https:\/\/www.cbschicago.com\/","https:\/\/www.wbbm.com\/","https:\/\/www.facebook.com\/cbschicago\/","https:\/\/www.instagram.com\/cbschicago\/","https:\/\/twitter.com\/CBSchicago","https:\/\/youtube.com\/CBSChicago\/","https:\/\/en.wikipedia.org\/wiki\/WBBM-TV"],"logo":[{"@context":"https:\/\/schema.org","@type":"ImageObject","height":60,"width":600,"url":["https:\/\/www.cbsnews.com\/assets\/partner\/google\/cbs-chicago-600x60.png","https:\/\/www.cbsnews.com\/assets\/partner\/google\/cbs-chicago-darkbg-600x60.png"]}],"url":"https:\/\/www.cbsnews.com\/chicago\/","parentOrganization":{"@type":"Organization","name":"Paramount Global","@id":"https:\/\/www.paramount.com\/","sameAs":"https:\/\/www.paramount.com\/","legalName":"Paramount Global"},"actionableFeedbackPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#1d4ed2b9-ade8-4203-a4e4-115dd34c0735","correctionsPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#751608ae-9468-457c-9dbe-1f9400a7f428","ethicsPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#a0060f90-73b0-4a57-b756-ca7a7f26cc7d","Masthead":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#5fd9a80d-2c6c-4d38-8b1e-4144650d5963","missionCoveragePrioritiesPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#4ffda755-6b47-49e1-b98c-24b737906aca","ownershipFundingInfo":"https:\/\/www.paramount.com\/company-history","unnamedSourcesPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#de41886e-07ed-4887-ad05-4b2c79edf857","publishingPrinciples":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/"},"articleBody":"Tom\u0027s of Maine toothpaste was manufactured with water containing bacteria, while a \"black mold-like substance\" was found in a factory where the product was made, according to a warning letter from the U.S. Food and Drug Administration.\u00a0The November 5 letter stated that Tom\u0027s Simply White Clean Mint toothpaste contained Pseudomonas aeruginosa, a germ that can cause infections in the blood and lungs, the FDA letter said.\u00a0The FDA letter also flagged another bacteria, Ralstonia insidiosa, which was found in water sources at the factory and\u00a0has been linked to infections acquired in hospital settings. Another Tom\u0027s of Maine product, Wicked Cool! Anticavity Toothpaste, was found to include another type of bacteria, Paracoccus yeei, the letter stated. The latter has been linked to infections such as peritonitis and conjunctivitis.Tom\u0027s of Maine, which markets its products as made with \"safe and hardworking natural ingredients,\" manufactures a host of personal hygiene products, from toothpaste to deodorant. The company was bought by Colgate-Palmolive in 2006.\u00a0In a statement emailed to CBS News, Tom\u0027s of Maine said that the company is working with the FDA to remedy the issues found during the agency\u0027s May inspection of its Sanford, Maine-based manufacturing plant.\u00a0\"We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make,\" Tom\u0027s of Maine said in the statement. \"In addition, we have engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues.\"Tom\u0027s of Maine added that it is making capital investments to upgrade the plant\u0027s water system.What did the FDA find?The FDA cited an \"inadequate water system\" at the plant, and also said its investigator observed \"a black mold-like substance at the base of the hose reel and behind the water storage tank\" in one area.\"Water is a major ingredient in many of your OTC drug products,\" the FDA letter said. \"It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain and monitor the system to ensure it consistently produces water suitable for pharmaceutical use.\"According to the letter, Tom\u0027s of Maine determined that the Wicked Cool! toothpaste had P. yeei bacteria \"due to sample contamination,\" and that the batch was released after retesting, but the FDA said that conclusion was \"without sufficient justification.\"The FDA also noted that although company blamed the \"root cause\" of the P. yeei bacteria was due to a \"laboratory error,\" no lab errors were identified in its initial investigation.\u00a0\"Your response is inadequate. It does not include additional supporting evidence or testing results for the finished products,\" the FDA said.\u00a0","alternativeHeadline":"Here\u0027s what to know about bacteria in Tom\u0027s of Maine\u0027s toothpaste"} </script><script type="application/ld+json"> {"@context":"https:\/\/schema.org","@type":"NewsMediaOrganization","@id":"https:\/\/www.cbsnews.com\/chicago\/","name":"CBS Chicago","foundingDate":"1946-09-06","sameAs":["https:\/\/www.cbschicago.com\/","https:\/\/www.wbbm.com\/","https:\/\/www.facebook.com\/cbschicago\/","https:\/\/www.instagram.com\/cbschicago\/","https:\/\/twitter.com\/CBSchicago","https:\/\/youtube.com\/CBSChicago\/","https:\/\/en.wikipedia.org\/wiki\/WBBM-TV"],"logo":[{"@context":"https:\/\/schema.org","@type":"ImageObject","height":60,"width":600,"url":["https:\/\/www.cbsnews.com\/assets\/partner\/google\/cbs-chicago-600x60.png","https:\/\/www.cbsnews.com\/assets\/partner\/google\/cbs-chicago-darkbg-600x60.png"]}],"url":"https:\/\/www.cbsnews.com\/chicago\/","parentOrganization":{"@type":"Organization","name":"Paramount Global","@id":"https:\/\/www.paramount.com\/","sameAs":"https:\/\/www.paramount.com\/","legalName":"Paramount Global"},"actionableFeedbackPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#1d4ed2b9-ade8-4203-a4e4-115dd34c0735","correctionsPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#751608ae-9468-457c-9dbe-1f9400a7f428","ethicsPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#a0060f90-73b0-4a57-b756-ca7a7f26cc7d","Masthead":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#5fd9a80d-2c6c-4d38-8b1e-4144650d5963","missionCoveragePrioritiesPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#4ffda755-6b47-49e1-b98c-24b737906aca","ownershipFundingInfo":"https:\/\/www.paramount.com\/company-history","unnamedSourcesPolicy":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/#de41886e-07ed-4887-ad05-4b2c79edf857","publishingPrinciples":"https:\/\/www.cbsnews.com\/news\/cbs-news-publishing-principles\/"} </script><script type="application/ld+json"> {"@context":"http:\/\/schema.org\/","@type":"WebPage","name":"Tom\u0027s of Maine toothpaste made with bacteria-tainted water, FDA warns. 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data-update-time="1732118523000"> <header class="content__header "><div class="item--asset-wrapper"> <a href="https://www.cbsnews.com/moneywatch?ftag=CNM-16-10abg0d" class="item--asset-label is-topic" data-invalid-url-rewritten-http="">MoneyWatch</a> </div> <h1 class="content__title ">Tom's of Maine toothpaste made with bacteria-tainted water, FDA warns. Here are details.</h1> <div class="content__meta-wrapper">  <a class="content__topic-link " href="/moneywatch"> <img width="60" height="60" class="content__show-logo" alt="moneywatch" src="/assets/show/moneywatch/logo-square-32.svg" loading="lazy"></a>  <p class="content__meta content__meta--byline byline"> By <a href="https://www.cbsnews.com/team/aimee-picchi/" class="byline__author__link" data-invalid-url-rewritten-http="">Aimee Picchi</a> </p> <p class="content__meta content__meta--byline byline"> Edited By <a href="https://www.cbsnews.com/team/anne-marie-lee/" class="byline__author__link" data-invalid-url-rewritten-http="">Anne Marie Lee</a> </p> <p class="content__meta content__meta--timestamp "> <time datetime="2024-11-19T15:53:00-0600">Updated on: November 19, 2024 / 3:53 PM CST</time> / CBS News </p> <ul class="sharebar"><li class="sharebar__button-container sharebar__button-container--service "> <a href="http://www.facebook.com/sharer.php?u=https%3A%2F%2Fwww.cbsnews.com%2Fnews%2Ftoms-of-maine-toothpaste-bacteria-water-black-mold-fda-details%2F" class="sharebar__button sharebar__button--type-facebook lazyload" title="facebook" target="_blank" data-component="popups" rel="noopener"> <svg viewbox="0 0 32 32" class="sharebar__icon sharebar__icon--facebook" aria-hidden="true"><use xlink:href="#icon-social-facebook"></use></svg></a> </li> <li class="sharebar__button-container sharebar__button-container--service "> <a href="https://twitter.com/intent/tweet?related=cbsnews,CBSchicago&via=CBSchicago&text=Tom%27s%20of%20Maine%20toothpaste%20made%20with%20bacteria-tainted%20water%2C%20FDA%20warns.%20Here%20are%20details.&url=https%3A%2F%2Fwww.cbsnews.com%2Fnews%2Ftoms-of-maine-toothpaste-bacteria-water-black-mold-fda-details%2F" class="sharebar__button sharebar__button--type-twitter lazyload" title="twitter" target="_blank" data-component="popups" rel="noopener"> <svg viewbox="0 0 32 32" class="sharebar__icon sharebar__icon--twitter" aria-hidden="true"><use xlink:href="#icon-social-twitter"></use></svg></a> </li> <li class="sharebar__button-container sharebar__button-container--service "> <a href="https://share.flipboard.com/bookmarklet/popout?v=2&utm_source=www.cbsnews.com&utm_medium=article-share&utm_campaign=tools&title=Tom%27s%20of%20Maine%20toothpaste%20made%20with%20bacteria-tainted%20water%2C%20FDA%20warns.%20Here%20are%20details.&url=https%3A%2F%2Fwww.cbsnews.com%2Fnews%2Ftoms-of-maine-toothpaste-bacteria-water-black-mold-fda-details%2F" class="sharebar__button sharebar__button--type-flipboard lazyload" title="flipboard" target="_blank" data-component="popups" rel="noopener"> <svg viewbox="0 0 32 32" class="sharebar__icon sharebar__icon--flipboard" aria-hidden="true"><use xlink:href="#icon-social-flipboard"></use></svg></a> </li> </ul></div> </header></div> <section class="content__body"><p>Tom's of Maine toothpaste was manufactured with water containing bacteria, while a "black mold-like substance" was found in a factory where the product was made, <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/colgate-palmolivetoms-maine-inc-687043-11052024" target="_blank" rel="nofollow noopener">according</a> to a warning letter from the U.S. Food and Drug Administration. </p><p>The November 5 letter stated that Tom's Simply White Clean Mint toothpaste contained Pseudomonas aeruginosa, a germ that can cause infections in the blood and lungs, the FDA letter said. </p><p>The FDA letter also flagged another bacteria, Ralstonia insidiosa, which was found in water sources at the factory and<strong> <br></strong>has <a href="https://www.sciencedirect.com/science/article/abs/pii/S1341321X22001866" target="_blank" rel="nofollow noopener">been linked</a> to infections acquired in hospital settings. Another Tom's of Maine product, Wicked Cool! Anticavity Toothpaste, was found to include another type of bacteria, Paracoccus yeei, the letter stated. The latter has been <a href="https://www.hartmann-science-center.com/en/hygiene-knowledge/pathogens-a-z/pathogens-16/paracoccus-yeei" target="_blank" rel="nofollow noopener">linked</a> to infections such as peritonitis and conjunctivitis.</p> <p>Tom's of Maine, which markets its products as made with "safe and hardworking natural ingredients," manufactures a host of personal hygiene products, from toothpaste to deodorant. The company was bought by Colgate-Palmolive in 2006. </p><p>In a statement emailed to CBS News, Tom's of Maine said that the company is working with the FDA to remedy the issues found during the agency's May inspection of its Sanford, Maine-based manufacturing plant. </p> <div id="mpu-plus-outstream-middle" data-ad="mpu-plus-outstream-middle" class="ad-mpu-plus-outstream-middle ad-wrapper " data-ad-unit='"mpu-plus-outstream-middle"'> </div> <p>"We have always tested finished goods before they leave our control, and we remain fully confident in the safety and quality of the toothpaste we make," Tom's of Maine said in the statement. "In addition, we have engaged water specialists to evaluate our systems at Sanford, have implemented additional safeguards to ensure compliance with FDA standards, and our water testing shows no issues."</p><p>Tom's of Maine added that it is making capital investments to upgrade the plant's water system.</p><h2><strong>What did the FDA find?</strong></h2><p>The FDA cited an "inadequate water system" at the plant, and also said its investigator observed "a black mold-like substance at the base of the hose reel and behind the water storage tank" in one area.</p><p>"Water is a major ingredient in many of your OTC drug products," the FDA letter said. "It is essential that you employ a water system that is robustly designed, and that you effectively control, maintain and monitor the system to ensure it consistently produces water suitable for pharmaceutical use."</p> <div id="leader-plus-inc3" data-ad="leader-plus-inc" class="ad-leader-plus-inc ad-wrapper " data-ad-unit='["leader-plus-inc",3]'> </div> <p>According to the letter, Tom's of Maine determined that the Wicked Cool! toothpaste had P. yeei bacteria "due to sample contamination," and that the batch was released after retesting, but the FDA said that conclusion was "without sufficient justification."</p><p>The FDA also noted that although company blamed the "root cause" of the P. yeei bacteria was due to a "laboratory error," no lab errors were identified in its initial investigation. </p><p>"Your response is inadequate. 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Tom's of Maine toothpaste made with bacteria-tainted water, FDA warns. Here are details. - CBS Chicago