Biden Administration Commits to Modernizing Regulatory Review

Co-Authored by Sharath Patil

Background on Regulatory Review

U.S. federal laws come from a wide array of sources. They are generally organized under the following order of authority:  1) the U.S. constitution, 2) statutes passed by Congress, 3) treaties ratified by Congress, 4) case law, 5) executive orders, 6) regulations, and 7) agency guidance. After Congress has provided a federal agency with a policy mandate, an agency is empowered to promulgate regulations to provide detailed and binding rules on those matters.

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FDA Import Alert on Mexican Hand Sanitizer

For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.

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UK Joins Kimberley Diamond-Trading Process

Co-Authored by Sharath Patil

What’s the Kimberley Process?

Established in 2003, the Kimberley Process (“KP”) is a multilateral trade regime created to prevent the flow of conflict diamonds. Conflict diamonds, also known as “blood” diamonds, are rough diamonds used by rebel movements or their allies to finance armed conflicts aimed at undermining legitimate governments. Under the Kimberley Process Certification Scheme, participant states implement safeguards on shipments of rough diamonds and certify them as “conflict-free.” The regime is credited with removing 99.8 percent of conflict diamonds from the global supply chain. The Process comprises 83 countries, and a number of civil society organizations and industry associations. The participants include all major rough diamond producing, exporting and importing countries.

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BIS Publishes First Military End User List

In a Final Rule, published on December 23, 2020, the U.S. Commerce Department’s Bureau of Industry and Security (“BIS”) amended the Export Administration Regulations (“EAR”) by creating a “Military End User (MEU) List”. The list includes the first tranche of 103 entities consisting of 58 military end-users in China and 45 in Russia. BIS determined that these companies are ‘military end users’ for purposes of the ‘military end user’ control in the EAR that applies to specified items for exports, reexports, or transfers (in-country) to China, Russia, and Venezuela when such items are destined for a prohibited ‘military end user.’

Prior to this final rule, exporters, reexporters, or transferors were responsible for identifying these entities as ‘military end users’ themselves, assuming they were not otherwise individually informed. The MEU List (which is now searchable on the consolidated screening list) allows the public to be informed of BIS’s determination so all potential exporters are informed simultaneously.

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FTC issues a Record Breaking $1.2 Million Penalty

Co-Authored by Denise Calle

Chemence Inc., a glue maker, is once again in a sticky situation with The Federal Trade Commission (FTC) for allegedly making deceptive claims that its products are made in the United States. In a proposed Consent Order, Chemence agreed to pay $1.2 million for its violation of the FTC Act for violating a 2016 federal court order to cease deceptive marketing tactics, as well as mandated an annual compliance report. The FTC now seeks Public Comment on the proposed consent agreement. The comment period closes on February 8, 2021. Thereafter, FTC will decide whether it should withdraw from the agreement or make it final and force Chemence to pay the $1.2 million penalty.

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