The Food and Drug Administration is inviting tobacco product importers, manufacturers, and distributors, among others, to participate in its Tobacco Product Manufacturing Facility Visits program. The program is intended to provide FDA staff with the opportunity to observe tobacco product manufacturing operations and learn about manufacturing practices and processes as they implement the tobacco provisions of the Food, Drug and Cosmetic Act. Parties interested in participating should send requests by Oct. 15.
The Food and Drug Administration warned three tobacco product vendors that they face civil penalties and/or refusal of their products at the border if they continue to offer flavored and “modified risk” cigarettes for sale in the U.S. In warning letters sent to Karl Bergman (here) (pennycigarettes.com and saveonfags.com) and Dumitru Chitoroaga (here) (juicynewt.com), both of Moldova, the FDA said the companies sold cigarettes branded as apple, cherry, and mint flavored, which are either adulterated if actually flavored or misbranded if not. Additionally, both companies sold cigarettes described as “light” or “ultra-light” cigarettes, which as “modified risk” tobacco products are prohibited for sale in the U.S. A similar warning letter sent to cigs360.com of Australia (here) also alleged sale of “modified risk” cigarettes in the U.S.
In a June 14 warning letter recently posted to its website, the Food and Drug Administration said Chinese drug manufacturer Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd.’s products may not be allowed entry into the U.S. until the company renews its registration. Zhongnuo had previously been notified of its lapsed registration in an FDA letter dated March 26, but the FDA said it continued to find imports of Zhongnuo’s drugs even though the company hadn’t registered in 2011 or 2012. FDA said Zhongnuo is required to submit registration information annually by electronic means for each foreign establishment it owns or operates that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug that is imported or offered for import into the U.S. Failure to register is a prohibited act under Section 301(p) of the Food, Drug and Cosmetic Act.
The Food and Drug Administration announced it will hold the Fall 2012 Regulatory Education for Industry Conference for small businesses Sept. 19-20 in Washington, DC. At the conference, held by FDA’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH), attendees will be able to network, engage with FDA experts, and learn more about FDA’s regulatory requirements for drugs and medical devices. Advance registration is required, but is free and includes training materials only, FDA said. Registration and more information on the conference available here.
The Food and Drug Administration announced the availability of a draft guidance entitled “Necessity of the Use of Food Categories in Food Facility Registrations and Updates to Food Categories,” as provided by Section 102 of the Food Safety Modernization Act (FSMA). FSMA amended Section 415 of the Food, Drug and Cosmetic Act, which requires both domestic and foreign facilities that manufacture, process, pack or hold food for human or animal consumption in the U.S. to register with the FDA.
On Aug. 14 the Foreign Agricultural Service issued the following GAIN reports:
The Foreign Trade Zones Board issued the following notices for Aug. 15:
The Court of International Trade affirmed the International Trade Commission’s final negative determinations in the second sunset reviews of the antidumping and countervailing duty orders on hot-rolled flat-rolled carbon-quality steel products from Brazil and Japan, which resulted in revocation of the AD and CV suspension agreements for Brazil (A-351-828 / C-351-829) and the AD order for Japan (A-588-846). The domestic plaintiffs contested nearly every element of the ITC’s analysis, including the ITC’s decision not to cumulate the volume and effect of subject imports between the countries subject to the sunset review (which included Brazil, Japan and Russia), the likely volume and price effects of imports if the agreements and order were revoked, the vulnerability of domestic industry, and the likelihood of adverse impact, but CIT said the ITC’s determinations in each of these analyses were supported by substantial evidence. As such, CIT deferred to the ITC, and dismissed the challenge.
The Court of Appeals for the Federal Circuit affirmed the Court of International Trade’s 2011 ruling against Shell’s duty drawback claims for Harbor Maintenance Tax and Environmental Tax payments. In June 2011, CIT said the claims were time barred because duty drawback claims may only be filed within the three years after exporting the substitute merchandise. Shell had filed duty drawback claims in 1995 and 1996, within the three-year window, but its claims only requested drawback on import duties, and not on the HMT and ET payments. Shell didn’t file new duty drawback claims for HMT and ET payments during the six-month grace period for untimely drawback claims offered by Congress’ 1999 amendments to the drawback statute, either.
Immigrations and Customs Enforcement reported another seizure of drugs from a vessel arriving at the Port of Norfolk. The seizure of two kilograms each of cocaine and heroin, concealed in the ceiling of a bathroom on the vessel, comes on the heels of the report last week that a joint task force had seized about 35 kilograms of cocaine at the Port of Norfolk in separate drug smuggling ventures. On July 27, the task force seized 32 kilograms of cocaine off of a vessel arriving into the Port of Norfolk, ICE said. On Aug. 4, the task force seized three kilograms of cocaine from a container vessel that was due into Hampton Roads. No arrests have been made and no crew members are suspected of being involved, ICE said.