The Food and Drug Administration has released a draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” to provide manufacturers, suppliers, importers and other industry stakeholders with greater certainty about the use of nanotechnology.
On June 8, 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 has submitted a prerule to the Office of Management and Budget entitled: "Sunscreen Drug Products for Over-the-Counter Human Use; Request for Data and Information Regarding Dosage Forms."
The Food and Drug Administration reports that U.S. Marshals have seized probiotic products from UAS Laboratories, Inc. of Minnesota because the company markets the products as drugs. The seized products include DDS Acidophilus, DDS Plus, Probioplus DDS, DDS Junior, and Cran-Gyn DDS, in capsule, powder, and tablet forms. UAS Laboratories claims the misbranded products could treat or prevent colds, flu, respiratory infections, urinary tract infections, yeast infections, ulcers, and high cholesterol, in violation of the Federal Food, Drug, and Cosmetic Act.
FDA announces that due to scheduled maintenance, users of the following systems and their subcomponents may experience intermittent time outs from 5:00 AM to 6:00 AM EDT on June 11, 2011: FDA Unified Registration and Listing System (FURLS) (Account Management System, Food Facility Registration System, Drug Facility Registration System, Device Registration and Listing System, ALERT System, Shell Egg Producer Registration System, and OAA-OID); the Low Acid Canned Food System (LACF); and the Prior Notice System Interface (PNSI).
The Food and Drug Administration has issued a consumer guide, "Fish Hazards and Controls: More Than a Fish Story," which states, among other things, that the “Fish and Fishery Products Hazards and Controls Guidance” plays a key role in keeping American consumers safe from contaminated seafood. The Hazards Guide is a roadmap for commercial fishermen and processors to follow to ensure that consumers don’t become ill from parasites, pathogens (bacteria, viruses, fungi), or natural toxins (poisonous substances produced by living organisms) in the seafood they eat.
On June 7, 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 announces that Shengyang Zhou of China has been sentenced to serve 87 months (over 7 years) in federal prison for trafficking and attempting to traffic in counterfeit goods, namely counterfeit versions of the pharmaceutical weight loss drug known as Alli. During the course of the investigation, law enforcement agents identified Zhou as the trafficker and importer into the U.S. of these counterfeit and unapproved purported weight loss related drugs. Zhou also identified himself as the manufacturer of the counterfeit Alli.
The Food and Drug Administration announces that Manuel Calvelo, a citizen of Belgium, has been sentenced to 48 months in federal prison on charges of operating an Internet pharmacy that sold misbranded and counterfeit drugs as well as controlled substances. From 2005 to 2008, he and another man operated Web sites offering for sale without a prescription misbranded and counterfeit drugs to customers in the U.S. in violation of the Federal Food, Drug and Cosmetic Act.
In response to the E.coli 0104 outbreak in Europe, the Food and Drug Administration stated on June 6, 2011 that the agency is currently conducting increased surveillance of fresh tomatoes, cucumbers, lettuce and raw salads, as well as sprouts and sprout seeds from areas of concern. To date, FDA believes that this outbreak has not affected the U.S. food supply. The U.S. receives relatively little fresh produce from the EU, particularly at this time of year. Due to the short shelf life of most fresh produce and the availability of growing areas in the U.S. and Central America, the EU is not a significant source of fresh produce for the U.S.