Proposed rule introduces two exemptions agency would allow from needing IND clearance for clinical investigations to evaluate food, supplements or cosmetics. Both begin with basic requirement of trial not intended to support drug development plan or labeling change that would make a food, dietary ingredient or cosmetic an unlawfully marketed drug.

Final guidance presents same descriptions of six "categories of homeopathic drug products ... potentially posing higher risks to public health” agency stated in 2019 revised draft. Agency adds reference to monograph reform in explanation of how homeopathics aren't GRASE.  

AHPA urges chairs and ranking members of Senate HELP and House Energy and Commerce committees not to pass mandatory product listing legislation or make other changes to FDA regulation of industry before the 117^th Congress ends. NPA board members lobby lawmakers about the topic.

Emergent BioSolutions’ announcement of FDA accepting sNDA for an OTC 4-mg naloxone nasal spray marks another recent step in agency’s response under Commissioner Califf to Capitol Hill pressure to expand availability of topioid antagonist to help curb opioid overdose death epidemic.

Substantially more consumers in 2022 report sleep issues, allergies and skin problems than in 2018 while using quit smoking aids has dropped, according to CHPA’s latest “Value of OTC Medicines” survey. Average annual household spending on OTCs is $645.

FDA “understands that manufacturers expect availability to continue to increase in the near future.” CHPA is working with members “focused on safeguarding the US supply by maximizing capacity to produce and direct product to where it is needed most.”