On July 23, 2013, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to 15 domestic and foreign companies that were deemed to be unlawfully marketing diabetes products in violation of the Federal Food, Drug, and …
FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products
On June 25, 2013, the U.S. Food and Drug Administration (FDA) issued substantially equivalent (SE) marketing orders for two new tobacco products marketed by Lorillard Tobacco Company, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. This is the …
FDA Publishes Overview of Regulatory Requirements for Food Businesses
On June 19, 2013, as part of Small Business Week, the U.S. Food and Drug Administration (FDA) published “How to Start a Food Business” on its website. The article provides a brief overview of the requirements that a food business …
FDA Issues Final Rule on Prior Notice for Imported Food
On May 29, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule that adopts, without change, the Interim Final Rule (IFR), entitled “Information Required in Prior Notice of Imported Food,” that was published in the Federal Register …
FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App
On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The …
FDA Investigates the Safety of Caffeine in Food
On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with …
FDA Issues Warning Letters to Online Cigarette Companies
In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the …
FDA Publishes CPG on Food Facility Registration
On April 4, 2013, the U.S. Food and Drug Administration (FDA) published its Draft Compliance Policy Guide Sec. 100.250 Food Facility Registration—Human and Animal Food. This compliance policy guide, when finalized, will provide a resource to FDA staff on the …
Company’s Operations Halted for Violating FDA Food Labeling Rules
On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of permanent injunction, enjoining a New Jersey-based food company’s operations. In particular, Butterfly Bakery Inc. (“the Company”) is prohibited from processing …
Supreme Court to Review Design Defect Case against Generic Drug Company
On March 19, 2013, the U.S. Supreme Court will hear arguments in Mutual Pharmaceutical Company, Inc. v. Karen L. Bartlett. The defendant-appellant in the case, Mutual Pharmaceutical Company (“Mutual”) appealed from a decision of the U.S. Court of Appeals for …