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Consumer United States Business Strategies

DermaTend Firm Faces Re-Labeling To Keep Lotions On Market

This article was originally published in The Tan Sheet

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Executive Summary

Solace International’s recall announcement says “DermaTend is not FDA approved,” and “Using these DermaTend products instead of seeking medical attention could result in delayed diagnosis of conditions such as cancer.”

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In Brief

NAD refers Solace to FTC; ERSP chastises TriVita for testimonials; Perrigo gains second China formula distributor; CHPA comments on lobbying regulations; Acetaminophen linked to asthma in children; CSPI pushes for St. John’s wort warning

FDA Combines Supplement GMP Recordkeeping, Testing Waiver Estimates

FDA didn't change its estimates for industry's annual regulatory burden – 929,140 hours – from compliance with recordkeeping requirements in supplement GMPs, its estimates of eight hours needed to prepare a request for exemption from identity-testing requirement also in unchanged.

On CRN Challenge, Nexus Formulas Gets Lesson On Supporting Ad Claims For Supplements

So full of errors were the firm's online ads for its Plavinol supplement, the National Advertising Division noted support for some claims contained "many of the same flaws" as others. The prevalence of problems prompted NAD to go outside its "scope of review" and note unclear instructions on Plavinol labels.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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