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The agency applied the four-factor framework set out in 21 CFR 216.23(c), covering physical and chemical characterisation, safety, evidence of effectiveness, and historical use

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While the FTC could not comment on its lawsuit or the specific practices of any given company, the commission is advancing new rules about telehealth companies using whats commonly called a negative option. As described in a recent FTC Advanced Notice of Proposed Rulemaking (ANPRM), a negative option is a common form of marketing in which the absence of affirmative consumer action constitutes consent to be charged for goods or services. In other words: drugs prescribed and shipped without patient consent, credit cards charged without direct authorization, inscrutable cancellation policies, and other automatic opt-ins that seem to typify telehealth frustrations

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