Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.
The U.S. Food and Drug Administration (FDA) on January 2, 2020, issued a policy prioritizing enforcement against flavored e-cigarette products that are manufactured and marketed in a manner that appeal to minors because the are flavored or marketed to taste or look like popular cereals, juices, or candies. Since implementation of the FDA’s premarket authorization
Read MoreU.S. Food and Drug Administration (FDA) issued a Warning Letter to U.S. food importer, B&I Overseas Trading Inc., for failing to implement supplier verification protocols, as required under the “Foreign Supplier Verification Program” (FSVP), to assure that fish imported by the company into the U.S. was produced in accordance with U.S. food safety regulations. In the FDA
Read MoreIn light of the recently finalized Deeming Rule, the FDA has been conducting periodic compliance check inspections to determine tobacco retail establishment’s compliance with the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and found several violations of the federal tobacco laws and regulations while conducting inspections. As a result, the FDA has
Read MoreRetailers, manufactures and retailer/manufacturers of tobacco products should take note that compliance with the U.S. Food and Drug Administration (FDA) new tobacco rules is rapidly approaching. Certain provisions of the final rule become effective Monday, August 8, 2016. On May 10, 2016, the FDA issued its final rule expanding the FDA’s definition of “tobacco
Read MoreOn May 12, 2016 the U.S. Food and Drug Administration (FDA) published a draft guidance titled “Use of Electronic Health Record Data in Clinical Investigation,” which is intended to guide clinical trial sponsors, investigators, contract research organizations (CRO), and institutional review boards (IRB) on the use of electronic health record (EHR) data in FDA-regulated clinical
Read MoreOn May 10, the U.S. Food and Drug Administration (FDA) issued draft guidance titled “Technical Considerations for Additive Manufactured Devices” providing its initial thoughts on regulatory requirements for additive manufactured (AM) devices (aka 3D printed medical devices), the category of manufacturing that includes 3-dimensional (3D) printing. The FDA described this as a “leapfrog” guidance through
Read MoreThe Food and Drug Administration (FDA) today announced long-awaited final rules expanding the FDA’s authority over e-cigarettes and other tobacco products. The rule broadens the definition of tobacco products to include e-cigarettes, hookahs, pipe tobacco, premium cigars, little cigars and other products. Acting under its authority as established through the Tobacco Control Act of 2009, the FDA has
Read MoreOn April 23, 2015 the U.S. Food and Drug Administration (FDA) issued warning letters to several dietary supplement companies distributing dietary supplements containing beta-methylphenethylamine (BMPEA), an ingredient widely used in weight loss, energy, and exercise endurance supplements. Studies show that BMPEA can cause an accelerated and irregular heartbeat. These warning letters come over one year
Read MoreToday, the U.S. Department of Agriculture (USDA) Animal Plant Health Inspection Services (APHIS) announced the potential expansion of fresh produce imports from Peru including papayas, oversized mangoes, peppers, and citrus, stating in its press release: [t]he U.S. Department of Agriculture (USDA)and the Peruvian Ministry of Agriculture (MOA) met in Washington, D.C., to recognize recent market
Read MoreToday the FDA posted draft guidance on the Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (OUS). When finalized, this guidance will provide information on: FDA’s policy of accepting scientifically valid clinical data from foreign clinical studies in support of premarket submissions for medical devices The special considerations that apply
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