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 Jennifer Diaz|2021-07-29T12:06:29-04:00May 27, 2021|Cosmetics, E-Cigarette, Food, FSMA, Gluten Free, Import, Import Alert, International Trade, Medical Devices, Pre-compliance, Tobacco, U.S. Food and Drug Administration (FDA)|0 Comments

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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What: Dietary Supplement Labeling Do’s and Don’ts
When: December 11th, 2018, 12:00PM-1:00PM EST

RSVP TODAY!

In this webinar you will learn:

What is required on a Dietary Supplement Label
How to market your dietary supplement and comply with FDA labeling requirements
How to make FDA compliant claims on your dietary supplement products
How to distinguish between structure function claims and disease claims
How to implement a process to accurately label your dietary supplement products according to current Good Manufacturing Practice (cGMP) and labeling regulations
What to do to avoid FDA enforcement actions
What to do if FDA detains your dietary supplement
What to do if your product is on an Import Alert list

Who Should Attend?

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By Jennifer Diaz|2022-07-07T13:13:29-04:00December 5, 2018|Best Practices, Events, FDA Issues, Import, International Trade, Speaking|0 Comments

19 Antibacterial Soap Ingredients to be Banned by the FDA!

Co-authored by Jennifer Diaz and Kristina Hernandez-Tilson, an attorney in Miami, Florida, practices in state and federal court, litigating matters of civil and administrative law.

Do you assume that when shopping for soaps or body washes, consumers will often times reach for products labeled “antibacterial” in hopes that those products will keep them and their families safer? If so, you would be right. The popularity of antibacterial products has grown tremendously since they first appeared on the market. According to a 1998 Gallop Study of Consumer Awareness and Perception of Antibacterial Products, 33% of those surveyed expressed the need for special antibacterial products to protect their homes from bacterial and viral pathogens. A similar study conducted by Gallop in 2010 revealed that an overwhelming 75% of those surveyed said they preferred to purchase products with antimicrobial protection.

Popular as antibacterial products may be, beginning September 2017, many of them may no longer be marketed as such, based on a Final Rule (78 FR 76444) issued by the U.S. Food & Drug Administration (FDA) on September 6, 2016. This Final Rule comes after several years of an FDA investigation into the effectiveness and potential hazards of antiseptic agents in personal care products. The most popular antiseptic agent in these products is triclosan, which, along with eighteen (18) other antiseptic agents under this Final Rule, is now banned when used for antibacterial purposes in hand and body washes. […]

By Jennifer Diaz|2022-07-07T11:50:26-04:00November 17, 2016|Customs Expert, FDA Issues, International Law, Pre-compliance, U.S. Food and Drug Administration (FDA)|0 Comments

Drugs

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