Regulatory News In Brief
This article was originally published in The Tan Sheet
Far Ocean Group in deep with FDA; Keystone Labs topicals in violation, according to warning letter; NAD nixes Alde’s antifungal nail polish claim; FDA supplement marketing notice e-submissions in the works; South Korea reorganizes, strengthens its Ministry of Food and Drug Safety.
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“For the first time you’re seeing personal-care products moving into benefits that really are more about diseases and health conditions,” Jill Bollettieri, assistant general counsel at General Mills, suggested at the Association of National Advertisers’ Advertising Law and Public Policy Conference. Claims for such products, along with natural claims, have their advantages, but firms must exercise caution, attorneys say.
Orlistat benefits outweigh risks, EMA says; J&J, Energizer to study SPF 85; Health Canada warns about Miracle Mineral Solution; Regencea recalls RegenArouse; more Regulatory News In Brief
Chief medical officer Samit Hirawat outlines R&D successes – though there have been some setbacks since it bought Celgene for $74bn last year – and the company’s commitment to clinical trial diversity.