GSK's proposed usage for mouth spray product – reducing withdrawal symptoms, including nicotine craving – differs little from the first NRT product approved in US in 1984. Additional suggested label instructions primarily focus on stating NRTs can be used to reduce smoking or gradually stop tobacco use as opposed to quitting within a specified amount of time.

Energy and Commerce members try again on monograph; Democrats want to ensure OTC oral contraceptive access; Wyden asks for faster CBD rulemaking at FDA; and House passes FDA's FY 2020 funding.

"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."

Appropriators are "concerned that the lack of dosing information" on OTC drugs for children ages six months to 2 years "may lead to dosing errors, adverse events and inadequate treatment of fever and pain.” They also ask USDA about fraud in its National Organic Program.