The Food and Drug Administration expects that Shengyang Zhou, aka “Tom”, age 31, of Kunming, Yunnan, China, who pled guilty in January to charges of trafficking and attempting to traffic counterfeit versions of the pharmaceutical weight loss drug known as Alli, will be sentenced on May 6, 2011. The FDA states that the counterfeit drugs contained Sibutramine, which can cause high blood pressure and stroke. The counterfeit drugs were imported by Zhou from China and sold over the internet at www.2daydietshopping.com.
The Food and Drug Administration and the Drug Information Association are announcing a May 13, 2011 seminar in Washington D.C. on the prevention of cargo and warehouse theft of FDA-regulated products, including prescription and over-the-counter medicines, vaccines, medical devices, and infant formula, as theft of these types of products pose a significant public health risk resulting from improper storage, etc. FDA also has a webpage dedicated to informing the public of cargo theft of FDA-regulated products and issued a letter to stakeholders in April 2010 suggesting steps for the trade to follow to prevent and/or respond to such threats.
The Food and Drug Administration has issued a letter to stakeholders describing the agency's progress so far on implementing the Food Safety Modernization Act (FSMA). FDA points to the two interim final rules it issued recently on prior notice and administrative detention, the new recall search engine, fish and fishery products hazards and controls guidance, public meetings on the FSMA, and its first report to Congress entitled, "Annual Report to Congress on Food Facilities, Food Imports, and FDA Foreign Offices Provisions of the FDA Food Safety and Modernization Act."
The Environmental Protection Agency has issued a final significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA), effective June 6, 2011, for the chemical substance identified generically as multi-walled carbon nanotubes (MWCNT) which was the subject of premanufacture notice (PMN) P--08--199. This action requires persons who intend to manufacture, import, or process the chemical substance for a use that is designated as a significant new use by this final rule to notify EPA at least 90 days before commencing that activity.
On May 5, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act (TSCA) for elemental mercury for use in barometers, manometers, and hygrometers/psychrometers. This action would require persons who intend to manufacture (including import) or process elemental mercury for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. Comments are due by July 5, 2011.
The Food and Drug Administration has released its final guidance to firms that manufacture, market, or distribute over-the-counter (OTC) liquid drug products packaged with cups, droppers, syringes, and spoons to measure and dispense the doses of medication. The guidance, "Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products," describes how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for OTC medicines.
On May 4, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration and the Federal Trade Commission have jointly launched the "Fraudulent STD Products Initiative," which targets over-the-counter products bought online or in retail stores that make unproven claims to prevent, cure, and/or treat sexually transmitted diseases (STDs). FDA has also issued warning letters to specific companies regarding such fraudulent products. A Q&A document regarding this initiative is available here.
The Food and Drug Administration has issued an interim final rule, effective July 3, 2011, that will amend its regulations to require an additional element of information in a prior notice (PN) of imported food, as required by the Food Safety Modernization Act1. This change requires a person submitting PN of imported food, including food for animals, to report the name of any country to which the article has been refused entry.