The US Food and Drug Administration is considering the efficacy of oral phenylephrine-containing nasal decongestants with regulatory tools it didn’t have when it asked the same question 16 years ago.
Potential Action By US FDA On Oral Phenylephrine ‘A Lot Harder’ With Old Monograph Program
“We've had several citizen petitions. We can't ignore the data that are out there and are very new since the last time FDA had looked at this back in 2007,” says FDA OTC drugs office director Theresa Michele.

More from International
Stada launches nine new Oilatum products in Saudi Arabia including “rich moisturising creams for intense hydration, gentle body washes for daily cleansing, and baby-specific products like soothing bath bubbles and head-to-toe wash.”
Bayer Consumer Health, the Global Self-Care Federation and the Business Council for International Understanding outline in a paper how industry can work with multilateral organizations, governments, financial institutions, and stakeholders to "recognize and champion self-care as a fundamental driver of global health progress."
PAGB CEO Michelle Riddalls and ISF president emeritus David Webber have been awarded OBEs for their services to consumer health and self-care.
A round-up of the latest consumer health industry appointments: GSCF names next director general, MENAP-SCI elects chairman; Clasado hires BD director.
More from Conferences
GSCF research shows that self-care already saves the Asia Pacific region more than $30bn a year in healthcare system costs. To realize higher gains, health literacy, Rx-to-OTC switch and digitalization need to be leveraged, according to the EU-ASEAN Business Council.
APAC health agencies such as WHO and Thailand's FDA are on board with the self-care agenda, and see it as crucial to achieving universal health coverage.
Single-use packaging producers should heed the 1 October deadline in Colorado’s EPR law for paper and packaging to register with Circular Action Alliance lest they face enforcement action, said an advisor for that organization, which is leading the program’s administration, at IBA’s Cosmetics Convergence Fall 2024 Virtual Symposium.