Federal preemption relieves manufacturers of OTC generic ranitidine heartburn remedies of obligation to use Proposition 65 label warnings in California as alleged in a complaint, according to a state appeals court.
Federal Preemption Strikes California Prop 65 Complaint Against Generic OTC Ranitidine Firms
Case Against Zantac Marketer Could Strike Out On Faulty Research Behind Carcinogen Claim
Whether California court finds Zantac, when marketed containing ranitidine, should have had a Prop 65 label warning could be influenced by dismissal in federal court of class action complaints due to faulty research behind claims that ranitidine causes a carcinogenic substance to form post-production.
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Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.
Despite questions surrounding the SEC rule, including disputes being litigated in the US Eighth Circuit, companies must prepare to meet the new climate disclosure requirements in addition to related mandates in California and abroad. Experts emphasize opportunities beyond compliance.
Supreme Court’s Loper Bright “decision is central to this case,” says Jonathan Emord, attorney representing Alliance for Natural Health USA and Meditrend Inc. in a complaint filed in US District Court for the District of Columbia.
Filed on 20 August by Pensacola, FL-based law firm Aylstock, Witkin, Kreis & Overholtz (AWKO) on behalf of an unnamed client, the petition points to benzene study data unconnected to Valisure on unheated benzoyl peroxide products, but is light on details of how it was conducted.
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Cavazzoni, who led the drugs center four-and-a-half years, decided on her own to retire at this time, sources said. The decision may have been a preemptive move knowing her time as head of CDER would have been limited, or at the very least highly challenging, under the new administration.
Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."