Errors Coughed Up For Dextromethorphan, Guaifenesin In US FDA Electronic Registrations
Three of seven businesses warned since February 2022 about noncompliance with FDA drug reporting requirements have been marketers of OTC cough/cold/congestion formulations made with dextromethorphan or guaifenesin.
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OTC Cough/Cold Resumes Line Extension, Launch Activity
Firms are returning to line extension activity for iconic brands such Alka-Seltzer, Robitussin, Triaminic and Vicks, some with OTC monograph ingredients added to provide new indications. Market researchers project category growth through 2014 and discuss factors affecting cough/cold product sales.
US Hemp Industry Group Rings Alarm With Congress About FDA’s Safety Conclusions
US Hemp Roundtable general counsel cautions congressional leaders about “agency’s misguided use of incomplete safety data as the basis for its continued refusal to regulate CBD as a dietary supplement or food additive.”
Details Dished On Regulatory Pathway US FDA’s Developing For Lawful Hemp In Supplements
Pathway separate from FDA’s regulation of drugs and food would include rules on content limits, labeling, disclosure of ingredients– including assurances of no contaminants, and requirements to mitigate accidental ingestion.