FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in patients.
FDA routinely scans websites and social media platforms in the United States and around the world, as well as product labels, other labeling and promotional materials to ensure that companies are not representing their products as safe and effective for COVID-19, use for which they have not been approved by FDA and that they do not make claims that misbrand the products in violation of the FD&C Act.
If your company is not located in the United States, please note that products that appear to be misbranded or unapproved new drugs are subject to detention and refusal of admission if they are offered for importation into the United States.
We advise you to review your websites, product labels, and other labeling and promotional materials. Otherwise, your company will probably receive one of the following letters, before or after an FDA inspection.
Failure to immediately correct the violations cited in these letters may result in seizure and injunction, without further notice.
Your company failed to conduct a hazard analysis as required, develop, maintain, and follow a Foreign Supplier Verification Program (FSVP). Verification activities under FSVP may include reviewing food safety records, onsite inspections, testing and sampling shipments of imported products, among other appropriate supplier verification activities.
FDA Compliance services are available 24/7, when needed.
If you receive an FDA notice, read it immediately and carefully!
ITB HOLDINGS LLC
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