Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

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.

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By |2021-07-22T11:27:59-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Reasonable Care, Tobacco, U.S. Food and Drug Administration (FDA)|Comments Off on Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

Dietary Supplement Labeling Do’s and Don’ts

You don’t want to miss this one! The U.S. Food and Drug Administration (FDA)’s top rationales for detention of dietary supplements include non-compliant labeling, products subject to an Import Alert, unauthorized claims, and more. Consistently, we encounter dietary supplements with outrageous claims turning the intended use of the products into “drugs” instead of Supplements. In this webinar we will explore the confusion surrounding suitable structure/function claims versus disease claims made on Dietary Supplements and the nuances involved behind the FDA’s approach of deciding what constitutes a valid claim. Participants will also what’s required on a dietary supplement label, best practices and how to handle FDA enforcement actions, and much more! Don’t delay, RSVP Today!

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By |2021-10-29T15:18:18-04:00December 5, 2018|Best Practices, Events, Import, International Trade, Speaking, U.S. Food and Drug Administration (FDA)|Comments Off on Dietary Supplement Labeling Do’s and Don’ts
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