Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
RAAS Nutritionals tells FDA “it proceeded without an IND because it believed that if it was legally able to sell its nutritional supplements ... it should be able to test and observe the effects of those supplements without an IND.”
Firms making OTC monograph drugs won’t have to pay facility fees twice during FY2021, says Theresa Michele, FDA Office of Nonprescription Drugs director.
FDA makes withdrawal effective on 31 December, also the deadline for firms manufacturing or compounding alcohol-based hand sanitizer products, and making alcohol for those products under temporary guidances, to cease production.
"Fewer people are manufacturing the products ... That seems to be a sort of a natural reaction to I think the decreased consumer demand," says Donald Ashley, compliance chief in FDA’s drug center.
One of two US firms among five warned recently about problems with OTC sanitizers is a petroleum product business. Two of the other three warnings went to firms in Mexico, by far the predominant source of adulterated OTC sanitizers found in US since early 2020.
CFSAN launched “C2Z” initiative in April following widespread reports of contamination of baby food products. Agency officials will outline C2Z plan including a four-stage approach for continual improvement and additional work related to levels of toxic elements in food.