Malcolm Spicer, Managing Editor – US
Latest From Malcolm Spicer
While FDA continues posting announcements of recalls of hand sanitizers made by firms in Mexico and found to contain methanol, its latest recall records update also show Michigan Herbal Remedies recalled a total of 5,938 bottles of hemp oils due to elevated lead levels.
Final rule amends FDA regulation on gluten-free labeling to provide alternative means for the agency to verify compliance. It will determine whether a firm is compliant from records it must maintain, and make available for inspection and copying, of the fermented or hydrolyzed supplements and food products bearing the claim.
The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.
Sales of its segment leaders Ocuvite and PreserVision vision health supplements, Lumify OTC eye drops and other consumer lines were down a reported 13% to $321m in the second quarter.
As draft guidance receives OMB review, FDA’s determination of no economic significance reflects its official position that the thousands of supplements, food and personal care products containing CBDs available in the US are unlawful.
Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.