U.S. Food and Drug Administration (FDA)

Catch Up on DTL’s Top Blogs From 2019!

We want to make sure you stay up to date with the hottest trade blogs from 2019. Below is a summary of what you missed by category. Enjoy!

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2019: A Year in Review!

DTL saved clients MILLIONS of dollars in 2019. It is with great joy that we finish off 2019 celebrating our fourth anniversary! We would like to thank each of you for being an integral part of making DTL a success.

This year has been filled with numerous achievements and accomplishments. We are grateful for the clients who have entrusted their trade and customs issues to us, and we look forward to assisting you in 2020!

Below we share some of our 2019 success stories with you.

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33,810 IPR Seizures in 2018!

U.S. Customs and Border Protection (CBP) is tasked with the monitoring of and enforcement of intellectual property rights (IPR). In CBP’s FY 2018 Seizure Statistics, CBP advised that it enforced trademarks and copyrights pertaining to over 17,641 active recordations, including 2,289 new recordations and 812 renewals of expiring recordations.

In fiscal year 2018, 381 individuals were arrested by CBP or ICE for violations related to IPR violations and 260 convictions related to intellectual property crimes proceeded. The total number of IPR seizures decreased by 333 seizures from the previous year. Surprisingly, while the number of seizures decreased from 34,143  in 2017 to 33,810 in 2018, the total estimated manufacturer’s suggested retail price (MSRP) of seized goods, had they been genuine, increased $1.4 billion.

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New FTC Warning Letters Issued to Companies Selling CBD Products

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The United States Federal Trade Commission (FTC) issued a press release confirming is sent three warning letters to companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD), a chemical compound derived from the cannabis plant. While the warning letters are not made publicly available, the FTC advised the warning letters were sent because the companies were advertising their CBD products could treat or cure serious diseases and health conditions, in violation of both the FTC Act (as well as U.S. Food and Drug Administration (FDA)) laws and regulations.

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Here are the Major Changes FDA is Proposing to Make to the Sunscreen Rule!

On February 26 2019, the United States Food and Drug Administration (FDA) proposed a rule that would alter the regulations associated with the manufacturing and selling of sunscreen, as well as other sun-care related products. Since the closing of the comment period on May 28th, 2019, FDA has received over one thousand comments from industry players voicing their concern over various aspects of the proposed measures.

The proposed rule was issued as part of the regulatory proceeding to put into effect a final monograph for nonprescription, OTC sunscreen drug products under the OTC Drug Review. An OTC monograph establishes conditions under which certain OTC drugs may be marketed without approved new drug applications because they are generally recognized as safe and effective (GRASE) and not misbranded. The proposed rule classifies active ingredients and other conditions as:

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