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Revised FDA Import Alerts on June 8
June 10, 2011 by Elizabeth Parker|FDA and EPA

On June 8, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Draft Guide on Identifying Nanotechnology in Regulated Products
June 10, 2011 by Barbara Chaves|FDA and EPA

The Food and Drug Administration has released a draft guidance, “Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology,” to provide manufacturers, suppliers, importers and other industry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.

FDA Issues Consumer Guide on Fish Hazards and Controls
June 9, 2011 by Kelly Sly|FDA and EPA

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.

FDA Registration Systems, PNSI, Etc. May be Down Intermittently June 11
June 9, 2011 by Kelly Sly|FDA and EPA

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).

FDA Announces Seizure of Misbranded Probiotic Products
June 9, 2011 by Kelly Sly|FDA and EPA

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.

Revised FDA Import Alerts on June 7
June 8, 2011 by Elizabeth Parker|FDA and EPA

On June 7, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

Revised FDA Import Alerts on June 6
June 7, 2011 by Elizabeth Parker|FDA and EPA

On June 6, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

FDA Seizes Elderberry Juice for False Disease Treatment Claims
June 7, 2011 by Kelly Sly|FDA and EPA

At the request of the Food and Drug Administration, U.S Marshals seized elderberry juice products that have been distributed by Wyldewood Cellars Inc., based in Kansas, because the products are unapproved and misbranded drugs. According to the FDA’s complaint filed in May 2011, Wyldewood makes claims in violation of the Federal Food, Drug, and Cosmetic Act (FFDCA) that its elderberry juice concentrate cures, treats, or prevents various disease conditions, including AIDS, diabetes and flu. FDA previously issued a warning letter to Wyldewood for violating the FFDCA by promoting and distributing its products as drugs

China Man Gets 7 Years for Trafficking Counterfeit Weight Loss Drug
June 7, 2011 by Kelly Sly|FDA and EPA

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.