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State AGs Urge FDA to Preserve State Authority Over OTC Hearing Aid Consumer Protections

U.S. Food and Drug AdministrationJanuary 18, 2022Connecticut Attorney General

Summary

Attorney General William Tong led a coalition of 42 states and territories to urge the FDA to preserve state consumer protection authorities for over-the-counter hearing aids, concerned that the proposed rule could preempt state laws and lack adequate age verification and labeling requirements.

Contract Impact

In-house legal teams should review vendor and customer agreements with hearing aid manufacturers, distributors, and retailers. Focus on clauses addressing compliance with consumer protection laws, warranties, returns, advertising restrictions, and professional licensing requirements. Ensure agreements do not contain broad preemption language that could waive state law applicability due to the FDA's proposed rule. May need to add provisions explicitly preserving state consumer protections or clarifying that federal OTC hearing aid regulations do not override state-specific requirements for warranties, returns, advertising, or age verification.

Contract Search Terms

preemption clausestate law complianceconsumer protection warrantiesreturn policy requirementsadvertising restrictionslicensing requirementsage verificationlabeling requirements

Violation Types

Entity Details

Entity

U.S. Food and Drug Administration

Also known as: FDA

Industry

Healthcare

Multistate Coalition

ArizonaArkansasColoradoDelawareFloridaGeorgiaGuamHawaiiIllinoisIndianaIowaKansasKentuckyLouisianaMaineMarylandMassachusettsMichiganMinnesotaMississippiMontanaNebraskaNevadaNew HampshireNew JerseyNew MexicoNew YorkNorth CarolinaOklahomaOregonPennsylvaniaRhode IslandSouth CarolinaSouth DakotaTexasUtahVermontVirginiaWest VirginiaWisconsinOhio

Official Sources

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