New Proposal on Antibacterial Soaps

On Tuesday, December 17, 2013, FDA published a proposed amendment to the tentative final monograph for topical antiseptic/antimicrobial products (http://tinyurl.com/qbatlul). The proposed rule addresses the formulation of “consumer antiseptic products intended for use with water” or in laymen’s terms, antibacterial hand and body washes. Products [...]

2022-11-29T16:33:20-07:00December 19, 2013|

FTC and Two Well-controlled Clinical Studies

In their settlement with Dannon over claims on DanActive and Activia, the FTC again evoked its standard of “two well-control clinical trials” to support structure function claims.  This standard was previously applied to Nestlé’s Boost® Kids Essentials drink and POM Wonderful Pomegranate Juice (POM is [...]

2022-11-29T16:33:33-07:00December 17, 2010|

Warning Letter & Draft Guidance on Clinical Trials

The FDA has been busy lately, issuing many guidance documents and warning letters.  Two that are of particular interest to the dietary supplement industry are a series of warning letters to companies marketing chelation/detoxification products and a new guidance on when FDA permission is required [...]

2022-11-29T16:33:33-07:00October 20, 2010|
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