Claims Other Than COVID-19 Surface But Contaminated Sanitizer Spreads In US Warnings
FDA inspectors in the eastern US took their turn recently at finding violations for dietary supplement manufacturing marketing unrelated to COVID-19. Agency also warned two more Mexican businesses that exploited its temporary loosening of regulations for producing alcohol-based hand sanitizers.
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World Nutrition, Eagles Song Health and Wellness and Natural Sprout Co. received warning letters in late October from FDA's ORA Operations Division West identifying violative claims including “greens are alkalizing to the body, disease won't thrive in an alkaline body," and “alfalfa may help reduce cholesterol.”
Four warnings, like previous letters FDA submitted to Mexican firms making methanol-containing hand sanitizers, which have been linked to deaths and other adverse events, indicate the targeted firms apparently entered US market for the products after the agency loosened manufacturing controls.
Action responds to methanol contamination in hand sanitizers manufactured in Mexico and marketed in the US under numerous brands that followed a loosening standards for the products to drive a swift increase in production and meet surging demand during the coronavirus pandemic.