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 May 23

May 24, 2017 |FDA

On May 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

OMB Accepting Comments on FDA's Prior Notice Requirements for Imported Food

May 24, 2017 |FDA

Comments are due June 26 to the Office of Management and Budget on information collected through the Food and Drug Administration’s prior notice requirements for imported food, FDA said in a notice (here). FDA has submitted its proposed extension of approval for prior notice requirements to OMB, it said. FDA estimates 10 minutes per new prior notice submission through the Automated Broker Interface and 23 minutes for each new submission via the FDA Prior Notice System Interface, 15 minutes for each cancellation of a prior notice in both systems, and one to eight hours for prior notice requests for review and post-hold submissions, for a total of 2,907,576 burden hours. FDA itself sought comments on prior notice requirements in January (see 1701040015).

New and Revised FDA Import Alerts for May 22

May 23, 2017 |FDA

On May 22 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 May 19

May 22, 2017 |FDA

On May 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 May 18

May 19, 2017 |FDA

On May 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 May 17

May 19, 2017 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for May 17 that lists the status of recalls and field corrections for food, drugs, biologics and devices (here). The report covers both domestic and foreign firms.

New and Revised FDA Import Alerts for May 17

May 18, 2017 |FDA

On May 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 May 16

May 17, 2017 |FDA

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

FDA Seeks More Comments on Regulation of Tobacco as Drug or Device

May 17, 2017 |FDA

The Food and Drug Administration seeks more comments on a final rule that clarifies when products made or derived from tobacco are subject to regulation as a drug, device or combination product, it said (here). Under the final rule, issued Jan. 9, a product made or derived from tobacco is regulated as a drug, device or combination product: “(1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000" (see 1701060011). Originally effective March 21, 2017, FDA recently delayed the effective date until March 19, 2018 (see 1703170030). Comments on the final rule, as well as a request FDA has received to reconsider the new regulation, are now due July 18.

New and Revised FDA Import Alerts for May 15

May 16, 2017 |FDA

On May 15 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: