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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FDA Releases Enforcement Policies for Medical Apparel and Gloves, Sterilizers and Purifiers During COVID-19

March 30, 2020 |FDA

The Food and Drug Administration released a pair of guidance documents detailing its enforcement policies for gowns, other apparel and gloves, and sterilizers, disinfectant devices and air purifiers, during the COVID-19 public health emergency. The guidance documents include information on how different types of these products are regulated by FDA, as well as temporary enforcement discretion policies for some of these products that temporarily liberalize FDA’s rules.

FDA Enforcement Report on Recalls & Field Corrections for March 25

March 26, 2020 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for March 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 March 24

March 25, 2020 |FDA

On March 24 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

CBP Clarifies FDA Entry Requirements for Emergency Imports to Address COVID-19 Pandemic

March 25, 2020 |FDA

Importers of some N95 respirators and COVID-19 diagnostic tests that have been authorized pursuant to a Food and Drug Administration Emergency Use Authorization (EUA) must still submit a reduced entry dataset to FDA, CBP said in a recent CSMS message. For product code NZJ (Respirator, N95, For Use By The General Public In Public Health Medical Emergencies), as well as product codes QPK, OTG, QKO, and QJR (various forms of diagnostic tests for COVID-19), importers must transmit an intended use code of 940.000 (Compassionate Use/Emergency Use) and an appropriate FDA product code, CBP said.

New and Revised FDA Import Alerts for March 23

March 24, 2020 |FDA

On March 23 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 March 21

March 23, 2020 |FDA

On March 21 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 March 19

March 20, 2020 |FDA

On March 19 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 March 18

March 19, 2020 |FDA

On March 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 March 18

March 19, 2020 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for March 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 March 17

March 18, 2020 |FDA

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