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FDA Updates Draft Guidance on Medical Foods 20 Aug 2013 | 07:18 pm
On August 13, 2013, the U.S. Food and Drug Administration (FDA) published its “Draft Guidance for Industry: Frequently Asked Questions about Medical Foods; Second Edition.” The first edition of this g...
FDA Publishes Final Rule on Gluten-Free Labeling 9 Aug 2013 | 07:36 pm
On August 5, 2013, the U.S. Food and Drug Administration (FDA) issued a final rule, “Food Labeling; Gluten-Free Labeling of Foods,” that defines the term “gluten-free” and adopts requirements for its ...
FDA Considering Rulemaking for Menthol Cigarettes 30 Jul 2013 | 10:59 pm
On July 23, 2013, the U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to request information regarding the agency’s regulation of menthol cigarettes. M...
FDA Issues Warning Letters to Companies Marketing Illegal Diabetes Drugs 25 Jul 2013 | 09:40 pm
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 product...
FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products 27 Jun 2013 | 05:46 pm
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-Ment...
FDA Publishes Overview of Regulatory Requirements for Food Businesses 24 Jun 2013 | 09:53 pm
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 requ...
FDA Issues Final Rule on Prior Notice for Imported Food 4 Jun 2013 | 12:40 am
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 F...
FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App 29 May 2013 | 08:39 pm
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 medi...
FDA Investigates the Safety of Caffeine in Food 8 May 2013 | 01:04 am
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 caffeinate...
FDA Issues Warning Letters to Online Cigarette Companies 29 Apr 2013 | 08:26 pm
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 F...
