Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
CDER notes in update to COVID-19 enforcement and other actions that Umbrella Labs made unlawful claims to prevent and treat the virus. Announcement didn’t note those claims weren’t first among violations identified in a warning letter to the firm.
In investor conference presentations, CEO Kessler says “we have a very strong case that the way we filed those taxes was correctly and the assessment should be 0,” and bringing its European consumer health brands to the US is “finally starting to really happen.”
Changes for supporting OTC labeling for drugs currently available Rx-only and indicated for chronic, more complicated conditions, aren’t minor and won’t happen within limits of one-dimensional text media printed on OTC drug containers, packages and inserts.
Harbor-UCLA Center for Clinical Pharmacology director Eric Brass says FDA should change DFL requirements, considering container labels as part of OTC labeling and reconsidering what information should be included on labels and threshold for consumer comprehension of labels.
Psychologist Anthony Grant operates “Resonator.UK” and sells a device that vibrates on the 30kHz frequency at 30,000 times a second. Claims including “the only safe way to destroy a virus is to shake it to pieces” challenged by MHRA and consumers.
BBB National Programs’ appeals panel decision “includes factual and substantive inaccuracies, is not in accordance with NARB procedures, and misstates Colgate’s positions and arguments,” Colgate says. Panel upheld findings agreeing with P&G’s challenge of “removes 10 years of yellow stains” claim.