Does FTC Health Ads Guide Read Like Rulemaking, Ignore Court Decisions On Requiring RCTs?
“I'm not sure they shouldn’t have done a notice of proposed rulemaking,” says attorney Claudia Lewis. From previous guidance, “the FTC has taken it a step in the different direction that you need robust scientific evidence, in their mind robust scientific evidence means clinical data.”
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“There is no bright-line requirement that a company possess randomized, controlled clinical studies before making so-called ‘health benefit’ claims for dietary supplements,” CRN states in petition. FTC, however, says it “makes no bright-line distinctions between categories of health-related products or claims.”
‘Akin To Junk Mail,’ FTC Notices Of Penalty Offense Don't Identify Health Claim Violations – Petition
Trade group ask FTC to withdraw notices, arguing it is attempting to impose substantiation standard prohibited under FDA regulations for supplement manufacturing and marketing and are inconsistent with its own as well as FDA guidance
ANH asks for information “to investigate concerns that the FTC’s recent guidance will have the effect of limiting consumer access to vital scientific information about the benefits” of natural products. Litigation challenging guidance could follow the group’s review of information FTC provides.