The US Food and Drug Administration’s regulatory policy for homeopathic drugs is targeted in a challenge to the agency’s authority leveraging the Supreme Court’s decision striking the Chevron doctrine of deference.
Challenge To US Homeopathic Drugs Regulation Rings Post-Chevron And OTC Monograph Bells
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.
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It wasn’t a quick decision for Xlear to accept DoJ attorneys’ offer to dismiss the case. “I want the I want the FTC to change its policy and its behaviors,” says Xlear president Nathan Jones.
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Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.
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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.
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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.
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“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.
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Sleep, pain, allergy and women's intimate health among the categories that the UK Department of Health and Social Care would like to see manufacturers submit Rx-to-OTC switch applications for.
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Electronic product information should be “fully operational” within four years after the entry into force of the revised EU pharma legislation and should precede the phasing out of paper leaflets, proposes the Inter-Association Taskforce (IATF) on ePI. Once the new system is up and running, ePI should be implemented across the EU in a harmonized way, with all EU member states adopting the same standard, it says.