Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
On March 5, 2012, The U.S. Food and Drug Administration (FDA) issued a warning letter to Breathable Foods Inc., makers of AeroShot1, for false or misleading statements in the labeling of their product, and told the company that the Agency has questions about the safety of the “caffeine inhaler.” The FDA also expressed concern about the
Read MoreThe U.S. Food and Drug Administration (FDA) has asked a federal court to prevent Mexicali Cheese, a New York cheese manufacturer, from continuing to operate because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria. According to a complaint for permanent injunction filed by the U.S. Department
Read MoreFor the purposes of HIPAA, any person or business providing particular services to a covered entity involving “protected health information” (PHI) is known as a “business associate”; in fact anyone who would have occasion to encounter PHI in the course of their work for a HIPAA-covered entity—is a “business associate” and is not only under the same duty as the covered entity to comport itself by the dictates of HIPAA, but must also have a Business Associate Agreement (BAA). At Gaitan Morales, we regularly counsel health care entities and their subcontractors on such regulatory issues as HIPAA, the HITECH rule, the Red Flag rules and numerous other laws and regulations that govern the health care industry. To protect your medical practice or associated health care business from a regulatory mishap, call Rafael A. Gaitan, Esq. today at 305.329.1462, to schedule a free initial consultation and learn more about how the law firm of Gaitan Morales can help you.
Read MoreToday, the Federal Trade Commission (FTC) and Attorney’s General (AG) from 39 states announced a settlement with The Dannon Company over deceptive advertising practices, based on marketing campaigns heralding the health benefits of its Activia brand yogurts and DanActive brand dairy drinks.
Read MoreJust six days before trick-or-treaters head out to collect candy, the Food and Drug Administration (FDA) announced the recall of two popular Halloween treats – Mega Pops lollipops and RAISINETS® Fun Size. Mega Pops brand lollipops – Colombina S.A. has issued a voluntarily recall of specific lots of Mega Pops in 14-ounce and 28-ounce cellophane
Read MoreThrough an Oct. 1 letter to State Medicaid Directors, Peter Budetti, Deputy Administrator for the Center for Medicare and Medicaid Services (CMS), provided initial guidance on the implementation of the Recovery Audit Contractor (RAC) programs by State Medicaid agencies. Section 6411 of the Affordable Care Act, calls for the expansion of the RAC Program by
Read MoreAt the request of the U.S. Food and Drug Administration (FDA), the U.S. Department of Justice (DOJ) today filed a complaint for permanent injunction against Brooklyn-based juice company, Juices Incorporated (also known as Juices International and Juices Enterprises), to prevent it from processing and distributing juice products.
Read MoreTelledant LLC, a Miami based online distributor of dietary supplements, was issued a joint Warning Letter on September 28, 2010 by the U.S. Federal Trade Commission (FTC) and Food and Drug Administration (FDA). In the Warning Letter, the FTC and FDA warn Telledant, LLC that its marketing and claims for a variety of products are in violation of federal laws and regulations.
Read MoreOn October 1, 2010, The Food and Drug Administration (FDA) reported that a product marketed as Miracle Mineral Solution, Miracle Mineral Supplement, and MMS, “becomes a potent chemical that’s used as a bleach when mixed according to package directions.”
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