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HTMLThe Food Safety Modernization Act -- where do we stand 20 months after its enactment?
T.H. Lyda, Edwin B. Palmer; Burns White LLC;
Legal Alert/Article
March 18, 2014
The Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, is the most significant expansion of food safety requirements and the Food and Drug Administration’s (FDA) food safety authority in over 70 years. The focus of the FSMA is on preventing...


HTMLCourt Rules that FTC’s Substantiation Requirements Are Applicable to Claims for Medical Foods
Riëtte van Laack; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 17, 2014, previously published on March 12, 2014
Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products - Diabetic Pack and Insulin Resistance - as medical foods. In 2005 and 2006, FDA issued two Warning letters to them, claiming the products were marketed as unapproved drugs. In 2007, the FTC...


HTMLIs That “Hummus” Really Hummus?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 12, 2014, previously published on March 11, 2014
Sabra Dipping Co., LLC ("Sabra") submitted a citizen petition (Dokcket No. FDA-2014-P-0259) asking FDA to establish a standard of identity ("SOI") for hummus. The proposed SOI would define hummus as “the semisolid food prepared from mixing cooked, dehydrated, or dried...


HTMLAmicus Filings in POM Wonderful’s Lanham Act Case Reflect Myriad of Views on Proper Interaction Between the FDC Act and Lanham Act
James P. Ellison; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
March 12, 2014, previously published on March 10, 2014
We previously posted about the Supreme Court case that will be argued next month in which the parties are debating the proper interplay between the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Lanham Act. Briefly, the issue in the case is whether POM’s Lanham Act...


HTMLOntario Introduces Legislation Requiring Food Service Chains to Post Caloric Information
Derek Ronde, Larry M. Weinberg; Cassels Brock & Blackwell LLP;
Legal Alert/Article
March 6, 2014, previously published on March 3, 2014
If it becomes law, the Making Healthier Choices Act will impose new responsibilities on restaurant chains in the province of Ontario. On February 24, 2014, the Ontario government introduced legislation which, if passed, would require food service chains with 20 or more premises in Ontario to...


HTMLWhat's in the Box? FDA Proposes Revisions to Nutrition Facts Panels
Venable LLP;
Legal Alert/Article
March 3, 2014, previously published on February 27, 2014
Today, February 27, 2014, the U.S. Food and Drug Administration proposed three rules that would make landmark revisions to the iconic black and white Nutrition Facts panel if finalized. The proposed changes affect all packaged foods, including dietary supplements where applicable, except certain...


HTMLMajor Medical, Scientific, and Food Associations Object to FDA IND Guidance
A. Wes Siegner; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
February 27, 2014, previously published on February 26, 2014
The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA has now done:


HTMLNew Schedule Set for Issuance of FSMA Rules
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
February 24, 2014, previously published on February 21, 2014
FDA entered into a consent decree with the Center for Food Safety that specifies new deadlines for the agency’s submission of final rules implementing FSMA to the Federal Register for publication. The consent decree marks the latest chapter in a case that started in August 2012 and wound its...


HTMLHealth Canada's Modernization Makeover: New Food Inspection and Safety Regulations on the Way
Sara Zborovski; Davis LLP;
Legal Alert/Article
February 21, 2014, previously published on February 19, 2014
Health Canada is in the midst of a “modernization makeover,” with some changes already in force and many more to come. Advances in science and technology, globalization of the food industry, and changing consumer demands have rendered the current Canadian regulatory environment for food...


HTMLInfant Formulas Required to Comply with New FDA Rules
James P. Nevin; Brayton Purcell, LLP;
Legal Alert/Article
February 19, 2014, previously published on February 13, 2014
New Food and Drug Administration (FDA) rules will require companies producing infant formula to strengthen "their quality control procedures and reporting requirements." Although many firms already meet those requirements, the rule "will give the agency more control over enforcing...


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