Tag Archives: fda

“100% Natural” might be deceptive as applied to food w/bioengineered ingredients

Lee v. Conagra Brands, Inc., No. 17-2131 (1st Cir. May 7, 2020) Lee alleged that Wesson’s supposedly “100% Natural” vegetable oil contained GMOs, which she regarded as “quite unnatural,” in violation of Mass. Gen. Laws ch. 93A.  She also alleged … Continue reading

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“complete” vitamin is plausibly deceptive where essential nutrients are lacking

Devane v. Church & Dwight Co., No. 3:19-cv-09899-BRM-LHG, 2020 WL 998946 (D.N.J. Feb. 28, 2020) Plaintiffs brought consumer protection claims based on Church & Dwight’s purportedly false labelling of several multivitamins, including L’il Critters Multivitamins, Vitafusion Women’s Complete Multivitamins, and … Continue reading

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FDA/FTC Workshop on a Competitive Marketplace for Biosimilars

FDA Licensure Process and U.S. Biosimilar Markets   [I entered in media res] · Eva Temkin, Acting Director for Policy, Office of Therapeutic Biologics and Biosimilars,  CDER, FDA   · Christine Simmon, Executive Director, Biosimilars Council, AAM: barriers to entry for … Continue reading

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labeling grandfathered drug in standard format doesn’t misrepresent it as FDA-approved

Belcher Pharms., LLC v. Hospira, Inc., — F. Supp. 3d –, No. 8:17-cv-2353-T-30AAS, 2020 WL 102744 (M.D. Fla. Jan. 7, 2020) “Epinephrine—a drug that is a medical necessity—has been in short supply on and off for nearly a decade.” Hospira … Continue reading

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court enjoins bar on “fake meat” labels; implications for FDA standards of identity?

Turtle Island Foods SPC v. Soman, No. 4:19-cv-00514-KGB (E.D. Ark. Dec. 11, 2019) Unsurprisingly, the court here enjoins provisions of Arkansas law that tried to restrict the use of “meat” terms for meatless alternatives. The worrying part is that the … Continue reading

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implied claims of FDA approval actionable under Lanham Act

Kurin, Inc. v. Magnolia Medical Technologies, Inc., 2019 WL 5422931, No.: 3:18-cv-1060-L-LL (S.D. Cal. Oct. 23, 2019) Kurin developed the Kurin Lock, a “specimen diversion device that reduces the risk of blood culture contamination and associated false positive blood culture … Continue reading

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pharmaco gets summary judgment against compounder on falsity/unlawfulness

Allergan USA, Inc. v. Imprimis Pharmaceuticals, Inc., 2019 WL 4545960, No. 17-cv-01551-DOC-JDE (C.D. Cal. Mar. 27, 2019) The parties compete in the market for ophthalmic drugs. Imprimis sells its ophthalmic drugs pursuant to Sections 503A and 503B of the FDCA … Continue reading

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