Valisure
| Type | Private |
|---|---|
| Founded | 2015 |
| Founders |
|
| Headquarters | New Haven, Connecticut |
| Key people | David Light Chip Phillips (CEO) |
| Website | valisure |
Valisure is an American independent laboratory focused on testing the purity and safety of pharmaceutical drugs and consumer products.[1] Valisure was founded in 2015 in New Haven.[1]
History
[edit]Valisure was founded in 2015 by Adam Clark-Joseph and David Light.[2] After taking an anticonvulsant medication and experiencing negative side effects due to the poor quality of the drug, Clark-Joseph contacted Light about establishing a business testing pharmaceutical products.[2] Valisure was originally established as a pharmacy, which, unlike typical pharmacies, tested drugs before distributing them.[1] Valisure divested of the pharmacy business in 2021, opting instead to focus on testing.[1]
In 2019, Valisure reported that it had tested Zantac and generic equivalents and discovered that they contained N-Nitrosodimethylamine, which is thought to be a carcinogen.[3] In September of that year, Valisure submitted a Citizen Petition to the U.S. Food and Drug Administration seeking withdrawal of ranitidine products after its laboratory testing reported extraordinarily high levels of the carcinogenic nitrosamine NDMA;[4] however, in subsequent litigation, the federal court's review of the scientific evidence found substantial problems with the methodology underlying Valisure's results, including evidence that the elevated-temperature testing procedure could itself generate NDMA from ranitidine,[5] and ultimately excluded the plaintiffs' expert testimony on general causation as scientifically unreliable.[6][7]
In 2021, Johnson & Johnson recalled sun tan lotions after Valisure discovered they contained high levels of benzene.[3][8][9]
In February 2024, Valisure announced Chip Phillips as their new CEO, succeeding David Light. They also announced funding from AlleyCorp and Connecticut Innovations.[10]
Clients of Valisure include Kaiser Permanente and the United States Armed Forces.[2][11]
References
[edit]- 1 2 3 4 Edney, Anna (9 November 2022). "A Tiny Lab Finds Danger on Drugstore Shelves While the FDA Lags Behind". Bloomberg.com. Retrieved 5 December 2023.
- 1 2 3 Edney, Anna; Griffin, Riley (5 December 2023). "The Pentagon Wants to Root Out Shoddy Drugs. The FDA Is In Its Way". Bloomberg.com. Retrieved 5 December 2023.
- 1 2 Smyth, Jamie (4 September 2022). "US lab at the centre of legal fight over Zantac and cancer". The Financial Times. Retrieved 6 December 2023.
- ↑ "FDA Citizen Petition #2: NDMA Carcinogen in Ranitidine (Zantac) & Nizatidine (Axid)". Valisure. September 13, 2019.
- ↑ "FDA Updates and Press Announcements on NDMA in Zantac (ranitidine)". U.S. Food and Drug Administration.
- ↑ In re Zantac (Ranitidine) Products Liability Litigation, 644 F. Supp. 3d 1075 (S.D. Fla. 2022).
- ↑ In re Zantac (Ranitidine) Litigation (Supreme Court of Delaware July 10, 2025), Text.
- ↑ Erman, Michael; Steenhuysen, Julie (16 July 2021). "FDA investigating how a known carcinogen wound up in J&J sunscreen". Reuters.
- ↑ Perkins, Tom (18 March 2022). "Carcinogenic chemical benzene found in hundreds of US personal care products". The Guardian. Retrieved 6 December 2023.
- ↑ "New Haven-based Valisure names new CEO, announces 'substantial investments'". Hartford Business Journal. Retrieved 2024-06-06.
- ↑ Griffin, Riley; Anna, Edney (16 August 2023). "Not All Generic Drugs Are Created Equal". Bloomberg.com. Retrieved 5 December 2023.
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