Valisure - Valisure, LLC. 5 Science Park, New Haven, CT 06511, 833-825-4787, www.valisure.com . May 24, 2021 . Division of Dockets Management . Food and Drug Administration . 5630 Fishers Lane, Room 1061 . Rockville, MD 20852 . Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products . Dear Sir or Madam:

 
On May 25, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which FDA generally regulates as cosmetics. Valisure analyzed 294 unique batches ... . Ufc 280 sean o

Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Every medication or supplement Valisure analyzes comes with a certificate of analysis listing important chemical properties of the samples analyzed at Valisure's lab. Valisure has ISO 17025 ...Farah Stockman discusses how the American healthcare system is built upon the widely disputed concept that generic drugs are considered equal to one another and the name brand. The piece recognizes Valisure as a leader attempting to address these issues and highlights the opportunities for change through action by large health systems. View the ...Valisure is registered with the Drug Enforcement Administration (License # RV0484814). Valisure’s mission is to help ensure the safety, quality and consistency of medications and supplements in the market. In response to rising concerns about counterfeit medications, generics, and overseas manufacturing, Valisure developed proprietary analyticalTests by Valisure, however, found concerning levels of benzene in some batches of P&G products. The most highly contaminated – two lots of an Old Spice antiperspirant called Pure Sport (Lots ...We at Valisure have been appreciative of our association with Congressman Rosa DeLauro over the years. Rosa DeLauro is the Congresswoman from Connecticut’s Third Congressional District and strongly believes in the power of biomedical research and is working to increase funding to make lifesaving breakthroughs in science and medicine.August 9, 2023 at 9:27 AM PDT. The US Department of Defense entered an agreement with Valisure, an independent lab that’s spotted dangerous chemicals in a variety of widely used pharma and ...Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom. Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene."Benzene is a chemical that, when activated with exposure to the skin, blood, or organs, can affect changes in your DNA that cause mutations for cancers," says Madhuri Chadha, M.D., founder of Dr. Madh Skin Solutions and radiologist currently working in ...Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensNov 1, 2022 · In Valisure’s study, three batches from one brand contained benzene levels of more than 100 ppm, while 11 batches from three other brands contained more than 20 ppm. Even more products were ... Valisure investigated further mechanisms relevant to the conditions in the human body and identified a broadly expressed enzyme, DDAH-1, which is known to cleave DMA from its substrate and release it, presenting a known risk of NDMA formation. 4 Valisure’s computational modelling suggest this enzymeAug 8, 2023 · Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study NEW HAVEN, Conn., Aug. 8, 2023 /PRNewswire/ -- Valisure has ... Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensNEW HAVEN, CT – NOVEMBER 1, 2022 – Valisure has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and ... Oct 26, 2022 · "Unfortunately the more we looked, the more we found," he said of Valisure's tests, which late last year petitioned the FDA for product recalls after it detected benzene in 54% of the 108 batches ... Valisure And Govzilla Announce A Collaboration Focused On Creating A Platform For Evidence-Based Quality Scores For Drug Products. September 13, 2019-Valisure.Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Nov 2, 2022 · Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ... Valisure generates some of the most impactful laboratory analyses in the pharmaceutical industry, has a talented staff, and is a highly engaging place to work. Our company is growing and expanding each year, which will provide new and challenging opportunities for every employee. With the growth of our company each year, there are always new ...On May 24, 2021, Valisure released its findings showing cancer-causing chemicals in sunscreens. Two days later, two FDA inspectors showed up at the lab, according to agency documents. They brought ...Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ...Every medication or supplement Valisure analyzes comes with a certificate of analysis listing important chemical properties of the samples analyzed at Valisure's lab. Valisure has ISO 17025 ...NEW HAVEN, CT – NOVEMBER 1, 2022 – Valisure has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of dry shampoo products, which are regulated as cosmetic products by the Food and Drug Administration (FDA). Valisure’s research, along with that of Stanford University and others, found that NDMA was the result of the “inherent instability” of the ranitidine molecule. This means that all manufacturers, brands or generic, and all lots of ranitidine-containing medications are affected and could generate very high levels of NDMA in the human body.Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ...Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Valisure is urging the FDA to recall the above products and created a petition to support its efforts. And while one might think that a recall is a no-brainer, things are a bit muddled because the ...Valisure tested hundreds of products for the chemical. Valisure says of 260 products, 21 products from 15 brands tested above the FDA interim limit. The top three tested between six- to eight ...Valisure is urging the FDA to recall the above products and created a petition to support its efforts. And while one might think that a recall is a no-brainer, things are a bit muddled because the ...NEW HAVEN, CT – MAY 25, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of sunscreen, which are considered drug products by the Food and Drug Administration (FDA), as well as in after-sun care products, which are generally regulated by FDA as cosmetics.In early November, Valisure issued a citizen petition to the FDA stating that its testing revealed benzene was present at up to nine times the emergency FDA limit of 2 parts per million in several ...For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. Valisure checks the chemical makeup of drugs before it ...On March 2, 2020, Valisure announced our detections high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches ...A car on a hot summer day could reach 140 F.) Valisure reported the results to the FDA, which took exception to the testing methods, saying that its testing at lower temperatures had resulted in ...Valisure generates some of the most impactful laboratory analyses in the pharmaceutical industry, has a talented staff, and is a highly engaging place to work. Our company is growing and expanding each year, which will provide new and challenging opportunities for every employee. With the growth of our company each year, there are always new ...Benzene is not an ingredient intentionally used in sunscreens, but the products on Valisure's list were found to be contaminated with benzene."Benzene is a chemical that, when activated with exposure to the skin, blood, or organs, can affect changes in your DNA that cause mutations for cancers," says Madhuri Chadha, M.D., founder of Dr. Madh Skin Solutions and radiologist currently working in ...Nov 2, 2022 · Valisure, a New Haven, Connecticut-based analytical laboratory, tested 148 batches from 34 brands of spray-on dry shampoo and found that 70% contained benzene. The chemical can cause certain blood ... Valisure's novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and ...Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ...On May 24, 2021, Valisure released its findings showing cancer-causing chemicals in sunscreens. Two days later, two FDA inspectors showed up at the lab, according to agency documents. They brought ...Aug 11, 2021 · Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ... Emery’s results confirmed Valisure’s findings of many times the FDA acceptable daily intake limit of NDMA for the re-tested batch. Metformin is an oral diabetes medicine that helps control blood sugar levels in patients with type 2 diabetes. More than 30 million people in the United States have diabetes, of which 90 to 95% are type 2.HBW Insight released an article titled, "Valisure’s Benzene Testing Finds Problems With OTC Sunscreens, Cosmetic Sun Care Products." The article highlights our findings of benzene in sunscreen products. View the full article via HBW Insight here.In the announcement, Valisure included a link to Valisure’s FDA Citizen Petition on Body Spray, a letter to the FDA requesting further investigation into and encouraging recalls of the products ...Aug 8, 2023 · Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study NEW HAVEN, Conn., Aug. 8, 2023 /PRNewswire/ -- Valisure has ... David Light, Chief Executive Officer of Valisure, is a biotech entrepreneur and scientist with over 15 years of broad experience in the field. A graduate of Yale University, David studied molecular biology and has worked in various scientific and business roles at start-ups like Synthetic Genomics, Ion Torrent, and Valisure.Valisure also reported that 14 sun care product lots with some of the highest contaminations are sold across four different popular brands — Neutrogena, Sun Bum, CVS Health and Fruit of the Earth.Every medication or supplement Valisure analyzes comes with a certificate of analysis listing important chemical properties of the samples analyzed at Valisure's lab. Valisure has ISO 17025 ...Aug 8, 2023 · Valisure and DoD Signed a Cooperative Research & Development Agreement to Conduct a Pharmaceutical Quality Risk Assessment Pilot Study NEW HAVEN, Conn., Aug. 8, 2023 /PRNewswire/ -- Valisure has ... The FDA has said the risk for anyone exposed to nitrosamines in drugs is small. The agency has set acceptable limits on six types of nitrosamines, which equal up to one case of cancer per 100,000 ...The FDA has said the risk for anyone exposed to nitrosamines in drugs is small. The agency has set acceptable limits on six types of nitrosamines, which equal up to one case of cancer per 100,000 ...Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry. In response to rising concerns and ... Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. Valisure petitioned the FDA for recalls on dry shampoos after research in an independent lab found that nearly 70% of samples tested had concerning levels of a cancer-causing chemical, benzene. November 04, 2022 - Last month, Unilever North America voluntarily recalled multiple dry shampoo products, citing the presence of benzene in the ...On November 4, 2021, Valisure announced the detection of high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as cosmetics. Valisure ...A new study by Valisure found that 78 sunscreens contain benzene, a known human carcinogen, which means it could cause cancer and other potentially serious health problems.Dec 7, 2022 · In a Dec. 5 letter, the agency wrote Valisure that its online pharmacy failed to take several basic steps to ensure that suspect or illegitimate medicines were investigated and that distributors ... May 12, 2022 · Photo: Getty Images. Last spring, Valisure, a small Connecticut lab, announced that it had found benzene, a known carcinogen, in Neutrogena spray sunscreens. The findings prompted Johnson ... Nov 9, 2022 · Bloomberg’s The Big Take Feature Story: A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind. National healthcare reporter, Anna Edney, covers in an in-depth article how in just 3 years, Valisure's quest to hunt down cancer-causing chemicals in everyday products has impacted pharmaceuticals and consumer goods in markets worth an estimated $9 billion that touch the lives of ... Ranitidine molecule. “Beyond Valisure’s tests, the presence of NDMA in ranitidine is supported by decades of scientific studies at institutions around the world starting as early as 1982. The data published today adds to a growing body of research that raises serious concern regarding ranitidine and its potential to form the potent ...Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ...The first came in 2019 when the lab, Valisure, found a cancer-causing substance in the blood pressure drug valsartan. Later that year, it detected a different carcinogen in the heartburn drug ranitidine and its brand name version, Zantac. Then last year, the company found benzene, also carcinogenic, first in hand sanitizers and then in several ...Nov 4, 2022 · Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ... For Valisure’s scientists, finding NDMA in ranitidine was a particularly dramatic example of the kind of discovery they make routinely. Valisure checks the chemical makeup of drugs before it ...Nov 4, 2021 · NEW HAVEN, CT – NOVEMBER 4, 2021 – Valisure LLC has tested and detected high levels of benzene, a known human carcinogen, in several brands and batches of antiperspirant body sprays, which are considered drug products by the Food and Drug Administration (FDA), as well as in deodorant body spray products, which FDA generally regulates as ... Valisure is urging the FDA to recall the above products and created a petition to support its efforts. And while one might think that a recall is a no-brainer, things are a bit muddled because the ...Valisure is an independent laboratory and partner for quality that provides increased transparency and quality assurance throughout the healthcare industry.On March 2, 2020, Valisure announced our detections high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches ... Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom. Consumer Reports took a detailed look at our detections of benzene in multiple consumer products in an article, “Benzene, a Known Carcinogen, Has Been Found in Some Spray Sunscreens, Deodorants, and Other Products.”. View the full article via Consumer Reports here. Back to Newsroom.Valisure’s hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Out of 260 samples from 168 brands sold on Amazon, at ...Valisure is registered with the Drug Enforcement Administration (License # RV0484814). Valisure’s mission is to help ensure the safety, quality and consistency of medications and supplements in the market. In response to rising concerns about counterfeit medications, generics, and overseas manufacturing, Valisure developed proprietary analytical Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure investigated further mechanisms relevant to the conditions in the human body and identified a broadly expressed enzyme, DDAH-1, which is known to cleave DMA from its substrate and release it, presenting a known risk of NDMA formation. 4 Valisure’s computational modelling suggest this enzyme Jun 5, 2021 · Valisure also reported that 14 sun care product lots with some of the highest contaminations are sold across four different popular brands — Neutrogena, Sun Bum, CVS Health and Fruit of the Earth. Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens Valisure's novel approach to independent quality assurance has had a tremendous global impact and built a foundation of thought leadership that increasingly influences academia, government, and ...In early November, Valisure issued a citizen petition to the FDA stating that its testing revealed benzene was present at up to nine times the emergency FDA limit of 2 parts per million in several ...Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing. Below is a brief overview, background and overarching objective of this pharmaceutical quality risk assessment pilot study ... Valisure is urging the FDA to recall the above products and created a petition to support its efforts. And while one might think that a recall is a no-brainer, things are a bit muddled because the ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ... Valisure, a pharmacy that batch tests medication before it reaches consumers, tested 294 different batches of sun care products from 69 different companies (find the full results here, on page 12).At Valisure, we are often asked how to safely dispose of products with suspected or known contamination, like benzene. Given benzene’s potential threat to human health and the natural environment, there are many disposal precautions for benzene-containing items, and these regulations concerning benzene disposal vary by state. Connecticut ...Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more.Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more. These services include product certification, supplier validation, advocacy programs ...

Mar 18, 2022 · Valisure’s hand sanitizer analysis found the highest levels of benzene in small brands that popped up as demand for the product spiked. Out of 260 samples from 168 brands sold on Amazon, at ... . Renninger

valisure

Here's a list of brands, manufacturers and sunscreens with benzene, according to Valisure: Aveeno Baby Continuous Protection Sensitive Skin Sunscreen Lotion, SPF 50 Babyganics Kid's Sunscreen ...Valisure has entered into a Cooperative Research and Development Agreement (CRADA) with the Department of Defense (DoD) in order to generate objective drug quality data through independent sourcing and chemical testing. Below is a brief overview, background and overarching objective of this pharmaceutical quality risk assessment pilot study ... Feb 16, 2023 · Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ... Valisure analyzed 260 bottles from 168 brands. They found 17% of the samples contained detectable levels of benzene. And 21 bottles (8% of the samples) contained levels of benzene that were above ...Images: Reuters/AFP/Getty Images Composite: Mark Kelly. Claims by the small laboratory company, Valisure LLC, that popular consumer products contain cancer-causing chemicals have generated ...Valisure, LLC. 5 Science Park, New Haven, CT 06511, 833-825-4787, www.valisure.com . May 24, 2021 . Division of Dockets Management . Food and Drug Administration . 5630 Fishers Lane, Room 1061 . Rockville, MD 20852 . Re: Valisure Citizen Petition on Benzene in Sunscreen and After-sun Care Products . Dear Sir or Madam:On March 2, 2020, Valisure announced our detections high levels of N-Nitrosodimethylamine (NDMA) in specific lots of the drug metformin, a prescription medication used to control high blood sugar in adults and adolescents with type 2 diabetes. Valisure’s analysis of 22 companies selling metformin and a total of 38 batches revealed 16 batches ... Sarah D. Young, Reporter and Editor. • Mar 30, 2021. Some hand sanitizers have elevated levels of the human carcinogen Benzene, according to a new study conducted by Valisure, an independent ...Valisure Named Honorable Mention in Category of Fast Company’s 2022 World Changing Ideas Awards April 20, 2022 David Light Awarded Junior Achievement's Entrepreneur of The Year AwardValisure generates some of the most impactful laboratory analyses in the pharmaceutical industry, has a talented staff, and is a highly engaging place to work. Our company is growing and expanding each year, which will provide new and challenging opportunities for every employee. With the growth of our company each year, there are always new ... Valisure offers a variety of services that leverage its unique capabilities and globally-recognized leadership in independent quality assurance, including product certification, supplier validation, advocacy programs, consulting, specialty projects, and more.NEW HAVEN, CT – MARCH 24, 2021 – Valisure has tested and detected benzene, a known human carcinogen, in several batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA)."Unfortunately the more we looked, the more we found," he said of Valisure's tests, which late last year petitioned the FDA for product recalls after it detected benzene in 54% of the 108 batches ...Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in SunscreensIn Valisure’s study, three batches from one brand contained benzene levels of more than 100 ppm, while 11 batches from three other brands contained more than 20 ppm. Even more products were ...March 24, 2021. On March 24th, 2021, Valisure announced our detection of high levels of benzene, a known human carcinogen, in several brands and batches across multiple brands of hand sanitizer, which are considered drug products regulated by the Food and Drug Administration (FDA). Benzene is known to cause cancer in humans according to the U.S ... Nov 4, 2022 · Then on Monday, Valisure sent a citizen petition to the US Food and Drug Administration in which the lab described that among 148 batches from 34 different brands of dry shampoo products, 70% of ... Valisure CEO Testimony at Senate Finance Committee on the FDA’s Foreign Drug Manufacturing Inspection Process April 26, 2022 U.S. Senator Richard Blumenthal’s Reaction to Benzene in Sunscreens.

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