From India with H1N1 claims
This article was originally published in The Tan Sheet
FDA warns an online firm based in India, 1www.ayurvediccure.com, it is marketing herbal products as unapproved drugs because they claim to prevent or treat the H1N1 flu virus. The agency's Jan. 26 warning letter says the noncompliant products include tinospora cordifolia, holy basil and ginger capsules. FDA has not approved the products to diagnose, mitigate, prevent, treat or cure H1N1, according to the letter posted on FDA's Web site April 7. The product claims on the firm's Web site included, "Regular uses of these medicines are helpful in controlling the signs and symptoms of deadly swine flu and help in early treatment of influenza." FDA says until the firm removes unapproved claims, it will include the firm's name in a list on the agency's Web site with other businesses that received warning letters about unapproved H1N1-related products
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FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.