From India with H1N1 claims
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
FDA's continues fraudulent H1N1 enforcement
FDA continues its enforcement efforts against firms marketing products claiming to treat or prevent the H1N1 flu virus, with three new company warning letters posted to the agency Web site April 20 (1"The Tan Sheet" April 12, 2010). The warnings to three separate firms include an April 13 letter to Super Body Care, an April 13 letter to E-holistic Health and a Nov. 4 letter to Silver Soft Skin asking the firms to contact the agency with a corrective action plan to address the issues the agency identified. In each letter, the agency states that the products "have not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment or cure of the H1N1 Flu Virus." To date, FDA sent a total of 88 warning letters related to 162 H1N1 products
ESMO: Evidence Piles Up For AZ’s Tagrisso With ADAURA CNS Data
A new analysis of the ADAURA study shows that Tagrisso’s disease-free survival benefits in early stage EGFRm NSCLC are replicated for brain metastases, a common complication with a poor prognosis. Filings and OS data await.
Small Firms Get Year Reprieve From Compliance With US FDA’s Supplement Facts Label Changes
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.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: