Tag Archives: fda

FDA preemption/preclusion after Pom Wonderful: still powerful for drugs

Exela Pharma Sciences, LLC v. Sandoz, Inc., 2020 WL 5535026, No. 19-cv-00318-MR (W.D.N.C. Sept. 15, 2020) Exela sued Sandoz for unfair and deceptive trade practices in violation of North Carolina law; tortious interference with prospective business advantage; and Lanham Act … Continue reading

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I can’t believe it’s not (vegan) butter: First Amendment invalidates standard of identity for butter as applied to vegan product

Miyoko’s Kitchen v. Ross, No. 20-cv-00893-RS (N.D. Cal. Aug. 21, 2020) Eric Goldman’s far more anti-regulatory take is here. The California Department of Food and Agriculture told Miyoko’s not to call its “vegan butter” product “butter” (it challenged certain other … Continue reading

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context matters: “mineral-based” sunscreen with chemical-based active ingredients is plausibly deceptive

Prescott v. Bayer Healthcare LLC, 2020 WL 4430958, No. 20-cv-00102-NC (N.D. Cal. Jun. 31, 2020) (magistrate) Plaintiffs alleged that defendants deceived consumers by labeling their sunscreens as “mineral-based” when the sunscreens contain active chemical ingredients. As the court explains,   … Continue reading

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“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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