GMPs, DMHA Spell FDA Warning For Revital U International
Executive Summary
Plano, TX, own-labeler's Smart Caps declared dietary ingredient "Octrodine," also known as 1,5-dimethylhexylamine, or DMHA. Revial's two responses failed to satisfy the agency's concerns about its GMP compliance.
You may also be interested in...
Sales Of Drug-Spiked Supplements After Warnings Show Stronger US Regulation Needed – Study
"FDA should consider ways to ensure that prohibited drugs are removed from supplements, perhaps by testing products sold after warning letters and mandating recalls whenever products remain adulterated,” say Pieter Cohen and colleagues in JAMA study.
DMHA Gets FDA Attention At Alternative Labs, CBD Noticed While There
Warning doesn't reference any noncompliant claims for CBD-labeled Green Roads, but FDA explains the basis for which it has stated for two years it could warn every firm marketing products that are labeled as or found containing CBD.
Abbott's ‘Bedrock Of Good Health’ Nutritionals Business Faces Mounting Infant Formula Litigation
Nutritional product business had 5.1% Q1 sales growth and is like Abbott’s other segments, “super well-aligned to the global demographics and trends in health care,” says CEO Ford. But as it defends complaints of damages from powder formulas made at facility found with unsafe levels of bacterial contaminants, Abbott’s also targeted in litigation alleging failure to warn about risk of infants born prematurely developing necrotizing enterocolitis if fed cow’s milk-based formula.