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Oral Care, Topical Product 'Natural' Claims Paint Bullseye For Class Action

 
• By Malcolm Spicer

Class action complaints alleging misleading "natural" claims for food products have been stayed pending completion of FDA's look at whether it should formally define the term for use in food, but there is no parallel FDA consideration of how the term is used for oral care products and topicals.

Open season for litigation challenging "natural" claims could go on longer for oral care products and topicals than for food and dietary supplements due to the greater likelihood of FDA exercising oversight on labeling in the food space.

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Are Bigger Ad Policy Changes Coming After US FDA’s Drug Promotion Office Hit Hard By Layoffs?

 
• By Sue Sutter

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US FDA Cites Taiho’s Lytgobi Healthcare Provider Website For Misleading Efficacy Claims

 
• By Sue Sutter

Results from a single-arm study cannot support representations on overall survival, progression-free survival and disease control rate for the cancer drug, the Office of Prescription Drug Promotion said in another “untitled” letter implicating the agency’s CFL guidance.

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By Sue Sutter

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

Ad/Promo: Improved Adherence Claim For Dexcel’s Hemady Not Supported, US FDA Says

 
• By Sue Sutter

A retrospective analysis does not support a claim that multiple myeloma patients are more adherent to Hemady than generic dexamethasone, OPDP said in an "untitled" letter suggesting increased enforcement focus on promotions leveraging the agency’s 2018 CFL guidance.

More from Compliance

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

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US FDA Finds ‘Significant’ Data Integrity Breaches In CRO Raptim Studies

 
• By Urtė Fultinavičiūtė

The US FDA has deemed certain in vitro bioequivalence studies conducted by CRO Raptim Research “not acceptable” and raised concerns over its in vivo study methods.

US Pharma Tariff Reprieve May Be Ending

 
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Sector-specific tariffs, including on pharmaceuticals, could be announced as early as this week.