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

Originally published on Diaz Trade Law Blog

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.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA — Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Why Should Industry Register for the Webinar?

Warning Letters in 2021:

• Just yesterday, FDA teamed up with the Federal Trade Commission (FTC) to publicly admonish 5 companies with warning letters for illegally selling dietary supplements claiming to treat infertility because FDA advised the products are unapproved drugs.
• Since the beginning of 2021, alone, the FDA has already issued 260 warning letters. 55 of those warning letters were issued against firms, including cosmetic firms, for selling unapproved drugs that are misbranded or adulterated or selling unapproved and misbranded products related to COVID-19.

Import Alerts in 2021:

• FDA has 208 active import alerts. Since the beginning of 2021, the FDA has already updated 74 import alerts to add new violators. 4 of the 74 import alerts are specifically for unapproved drug violations:

Import Alert — Number Import — Alert Name

66–40 “Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs”

66–41Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.

66–57“Detention Without Physical Examination Of Foreign manufactured Unapproved Prescription Drugs Promoted to Individuals in the U.S.”

99–34DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION

• FDA has updated Import Alert 66–41 a total of 274 times since the beginning of 2021, with the most recent update on May 6, 2021. This import alert lists 379 violative cosmetic products which are (because of their claims) unapproved drugs. This import alert will be discussed in detail at the webinar. The speedy increase in the number of firms subject to the this import alert indicates that manufacturers, importers, and distributors of cosmetic and over-the-counter drugs must review their labeling and pre-compliance protocols to avoid being targeted by the FDA.
• Important to note that on February 25, 2021, FDA published Import Alert 62–08, which allows for the “Detention Without Physical Examination of Alcohol-Based Hand Sanitizers Manufactured in Mexico.”

This one-hour webinar will provide an overview of FDA regulatory enforcement actions. Our international trade attorneys will discuss top labeling dos and don’ts to lower your risk of FDA enforcement, while offering best practices. You will learn about FDA regulations and laws pertaining to over-the-counter (OTC) drugs and cosmetics marketed in the United States. The presentation will discuss real case scenarios. The objective of the webinar is to teach manufacturers, importers, and the like, how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of Over the Counter (OTC) drugs or cosmetic products are encouraged to attend our one-hour webinar, “Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions” either live on June 9, 2021 at 12:00 PM, or on demand thereafter.

Diaz Trade Law’s president, Jennifer Diaz, accompanied by DTL’s Associate Attorney Denise Calle, will be our featured speakers. Importers, exporters, brokers, and others interested in trade policy are encouraged to attend. REGISTER HERE!