EAPA Litigation

Under the Enforce and Protect Act, CBP investigates whether a company is evading particular antidumping and countervailing duty orders. Litigation on determinations made under the relatively new statute have centered on due process protections for respondents, CBP's evidentiary basis for its decisions and the interplay of decisions made on the scope of the applicable AD/CVD orders from both CBP and the Commerce Department. The Court of Appeals for the Federal Circuit issued a key decision for all EAPA cases in Royal Brush Manufacturing v. United States, when it found CBP to have violated a respondent's due process protections by failing to provide it with access to the business proprietary information used in the proceeding.

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New and Revised FDA Import Alerts for Sept. 25

September 26, 2019 |FDA

On Sept. 25 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Sept. 25

September 26, 2019 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Sept. 25 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Sept. 20

September 23, 2019 |FDA

On Sept. 20 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Sept. 19

September 20, 2019 |FDA

On Sept. 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Proposes New Requirements for Tobacco Premarket Applications

September 20, 2019 |FDA

The Food and Drug Administration is proposing new regulations on premarket tobacco product applications (PMTAs). FDA’s proposed rule would codify general procedures FDA would follow when evaluating PMTAs, including application acceptance, application filing, and inspections, and would also create postmarket reporting requirements for applicants that receive marketing orders. It would also require that manufacturers maintain records establishing that their tobacco products are legally marketed. While FDA has been evaluating PMTAs for years, the new regulations would clarify requirements for applicants and reduce the costs of having to file follow-up submissions when their original applications aren’t accepted by FDA. Comments are due Nov. 25.

New and Revised FDA Import Alerts for Sept. 18

September 19, 2019 |FDA

On Sept.18 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA Enforcement Report on Recalls & Field Corrections for Sept. 18

September 19, 2019 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Sept. 18 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for Sept. 17

September 18, 2019 |FDA

On Sept. 17 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

New and Revised FDA Import Alerts for Sept. 16

September 17, 2019 |FDA

On Sept. 16 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

FDA to Hold Public Meeting on Future Approaches to Food Safety

September 17, 2019 |FDA

The Food and Drug Administration will hold a public meeting Oct. 21 to seek input to shape its “Blueprint for a New Era of Smarter Food Safety,” FDA said in a notice. At the meeting, FDA will “foster a dialogue” with a wide range of stakeholders, including domestic and foreign regulators, industry and consumers, on topics including the use of new technologies in traceability through the international supply chain, evolving business models and the creation of “food safety cultures.” Attendees must register by Oct. 11. Comments on topics related to the meeting are due Nov. 20.