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. 28

September 29, 2015 |FDA

On Sept. 28 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. 25

September 28, 2015 |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:

New and Revised FDA Import Alerts for Sept. 24

September 25, 2015 |FDA

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

FDA Proposes Rule on Tobacco-Derived Drugs and Devices

September 25, 2015 |FDA

The Food and Drug Administration on Sept. 25 issued a proposed rule to clarify the circumstances under which tobacco products may be regulated as a drug or device (here). Under the proposed rule, a product made from or derived from tobacco and intended for human consumption would be regulated as a drug, device or combination product if (1) 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 of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. FDA said the proposed rule will “increase clarity regarding the types of claims and other evidence that make a product made or derived from tobacco subject to regulation as a drug, device or combination product”. Comments on the proposed rule are due Nov. 24.

New and Revised FDA Import Alerts for Sept. 23

September 24, 2015 |FDA

On Sept. 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 Sept. 21-22

September 23, 2015 |FDA

On Sept. 21-22 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 Sept. 18

September 21, 2015 |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 to Hold Workshop in Chicago on FSMA Preventative Controls Rules

September 21, 2015 |FDA

The Food and Drug Administration will hold a public meeting on Oct. 20 in Chicago to discuss its two recently-issued final rules on preventive controls for human and animal food (see 1509100021 and 1509100073), it said (here). “The public meeting will provide interested persons an opportunity to discuss the final rules for current good manufacturing practice, hazard analysis, and risk-based preventive controls for human and animal food and FDA’s comprehensive planning effort for the next phase of the FDA Food Safety Modernization Act (FSMA) implementation,” said the agency. Registration is free, but seating is limited so preregistration (here) is encouraged, said FDA.

New and Revised FDA Import Alerts for Sept. 17

September 18, 2015 |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:

FDA Enforcement Report on Recalls & Field Corrections for Sept. 16

September 18, 2015 |FDA

The Food and Drug Administration issued its weekly Enforcement Report for Sept. 16 that lists the status of recalls and field corrections for food, drugs, biologics, and devices (here). The report covers both domestic and foreign firms.