Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
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.
CDER approves Bayer Healthcare’s azelastine 0.15% nasal antihistamine indicated for seasonal and perennial allergic rhinitis in adults and children 6 and older. Bayer says Astepro Allergy is first steroid-free antihistamine for allergies available OTC in the US and the first indicated for indoor and outdoor allergy relief.
“We created a warning wallpaper, which means it looks like one block of overwhelming warnings,” says drug labeling expert Julie Akers. Technology has changed the world with nonstop access to information on multiple devices from myriad digital sources, but DFLs remain one-dimensional, static media.