Heavier FTC Scrutiny Puts Pressure On Consumer Health Product Claims
This article was originally published in The Tan Sheet
Attorneys say marketers should make structure/function claims with knowledge that no claims are safe from FTC scrutiny. During the Food & Drug Law Institute annual meeting, stakeholders commented on how FTC’s stance on Bayer Health Care’s Philips Colon Health will impact other claims.
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On behalf of the FTC, DoJ alleges Bayer violated a 2007 settlement to substantiate supplement claims and asks a court to require the firm to provide two RCTs for dietary supplement claims for Phillips’ Colon Health. Trade groups rally behind the firm, arguing the requirement is unfair and illegal.
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FDA’s OTC Monograph User Fees Are Existential Threat To Small Contract Manufacturers, Cosmetics Brands
OMUFA reauthorization should include small business considerations for the US FDA’s OTC Monograph Drug User Fee Program, which established in 2020 a ‘one-size-fits-all’ facility and monograph order request user fee system which could lead to more contract manufacturer exits, a manufacturing bottleneck for OTC cosmetic products, and fewer product choices, says IBA.