Warning Letters

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 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.

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