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 Nov. 12

November 13, 2019 |FDA

On Nov. 12 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 Nov. 8

November 12, 2019 |FDA

On Nov. 8 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 Dec. 7

November 8, 2019 |FDA

On Dec. 7 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 Nov. 6

November 8, 2019 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Nov. 6 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 Nov. 6

November 7, 2019 |FDA

On Nov. 6 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 Nov. 5

November 6, 2019 |FDA

On Nov. 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

OMB Reviewing FDA Rules on Drug Importation, ACE Filing for Veterinary Devices

November 6, 2019 |FDA

A proposed rule that would allow importation of drugs intended for foreign markets is now under review by the Office of Management and Budget, according to the OMB website. Though OMB doesn’t say what exactly the rule would do, the Food and Drug Administration has said it would soon publish a proposal to allow pilot (or demonstration) projects developed by states, wholesalers or pharmacists to import certain drugs from Canada that are versions of FDA-approved drugs that are manufactured consistent with the FDA approval (see 1907310018).

FDA Extends Grace Period for Co-Manufacturers to Comply With FSMA Supply-Chain Program Requirements

November 6, 2019 by Brian Feito|FDA

The Food and Drug Administration will continue its policy of enforcement discretion for food facilities that have co-manufacturing agreements with brand owners and must comply with certain Food Safety Modernization Act requirements for supply-chain programs, it said in a Nov. 6 constituent update. The policy was set to end Nov. 6, but FDA has "learned of additional challenges industry is facing in trying to meet the supply-chain requirements," it said. Under the policy, FDA is not taking enforcement action against co-manufacturers that are not in compliance with certain supply-chain program requirements related to supplier approval and supplier verification. Industry has expressed concerns that confidentiality clauses in existing contracts prevent co-manufacturers from obtaining information about suppliers. FDA did not say for how long the policy would be extended, but said it would soon announce the extension in the Federal Register.

New and Revised FDA Import Alerts for Nov. 4

November 5, 2019 |FDA

On Nov. 4 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 Nov. 1

November 4, 2019 |FDA

On Nov. 1 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: