Submitting Voluntary Self-Disclosures to Bureau of Industry & Security
Diaz Trade Law is enthusiastic to announce Bloomberg Law published another one of our articles, “Submitting Voluntary Self-Disclosures to Bureau of Industry & Security”! Below is the article reproduced with permission for your reading pleasure. We’d love to hear your feedback!
You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.
We’d love to hear your feedback!
Diaz Trade Law 
The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.
