Co-Authored by Denise Calle.
On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees to OTC Drug Manufacturers and submitters of OTC monograph order requests.
The United States has been increasing its efforts to combat forced labor around the world. During the Trump Administration’s final weeks, the United States not only banned the importation of Chinese Cotton, Tomatoes, among other products, but also explicitly recognized the situation in Xinjiang as a Genocide.
Importers not adequately auditing their supply chains for use of forced labor are at risk of administrative and criminal enforcement. Imported merchandise produced with forced labor is subject to the Department of Homeland Security (DHS) enforcement. Such enforcement includes U.S. Customs and Border Protection’s (CBP) right to detain, exclude, and/or seize imported goods and Homeland Security Investigation’s potential criminal investigation. China is not only the United States’ number one trading partner but also happens to be the world’s biggest forced labor violator.
Because of its production limitations, the Caribbean has become a growing market for U.S. suppliers. As one of the most diverse regions in the world, the islands of the Caribbean attract a lot of visitors. With the development of tourism comes an increased demand for imported products from the U.S.—due in part to their perceived higher quality.
Co-Authored by Sharath Patil
Introduction
There are many factors that U.S. exporters and importers should be conscious of in their operations – including trade and customs laws, foreign market opportunities, changes in commodity prices, and currency fluctuations – just to name a few. However, one vital consideration that exporters and importers alike often overlook is trade flows. A firm’s ability to analyze and keep a pulse on trade data pertaining to that company’s product category can provide that exporter or importer with a clear vision of what’s actually happening. This perspective can empower a firm to optimize its operations and gain an edge against competitors. For example, U.S. importers who regularly track and analyze trade data can gain an understanding of how tariff and non-tariff barriers affect imports. Similarly, U.S. exporters can track and analyze trade data to glean vital intelligence about opportunities in foreign markets. In doing so, U.S. exporters can gain an understanding of which markets their U.S. competitors are selling to and which countries demand is quickly increasing. Analyzing trade data is the first step to developing a sound import or export market strategy. However, doing so once is not enough. Importers and exporters should have a regular practice of tracking trade flow developments and restructuring operations based on what the data reveals. Such a nimble posture can truly empower businesses trading internationally.
Do you want to learn more about intellectual property rights (IPR)? Do you want to understand how IPR and U.S. Customs mix (and don’t mix)? Do you want to understand how to properly protect your brand internationally and domestically and what type of enforcement action U.S. Customs can take against infringers? If so, this 3 part FREE seminar series is especially for you. Act now, and reserve your FREE seat while they last. Did we mention it’s FREE??
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.
Tasked with the protection of the nation, The Department of Homeland Security (DHS) siphons the protection of our ports to United States Customs and Border Protection (CBP). With the continuous threats to safety and integrity of the country, CBP is conducting a voluntary test to collect certain advanced data related to shipments potentially eligible for release under section 321 of the Tariff Act of 1930.
In order to cope with the e-commerce trend, CBP will allow online marketplaces, and other non-traditional partners to participate in the pilot program. If you wish to participate in the program, DTL can assist you in submitting the required application to the Department Of Commerce. While the Pilot opens on August 22, 2019, and is set to last for roughly one year, CBP may accept potential participants after the program’s commencement until a sufficient number of participants has been identified.
Why Have My Goods Been Seized?
For many companies who begin the process of importing goods there is an expectation and an underlying hope that the entire process will run smoothly. However, if your product is not compliant with U.S. laws and regulations, 19 CFR Part 162 and 19 CFR 151 authorizes U.S. Customs & Border (CBP) to either detain or seize your goods upon importation. For importers, the best moment to contact a Customs expert is at the detention phase. This will expedite the correct communication with CBP and increase the likelihood of your product not being seized. Continue Reading
We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement. Continue Reading
One might naturally think of a product like a defibrillator as a medical device, but in our business, we find many companies unsure if its products are, in fact, medical devices.
The following is the first of a two part series which you may use as a helpful guide to get you through the medical device maze. First is a description of what medical devices are, and helpful hints so that you may identify if your product is regulated as a medical device. Second is a brief overview of FDA’s regulation of medical devices. The second part of the series will discuss the classes of medical devices, and the FDA registration process.
What is a Medical Device? Continue Reading