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 MoreSince 2015, an increasing number of cosmetic companies have come under the harsh scrutiny of the US Food and Drug Administration (FDA) for reasons ranging from “misbranding” due to drug like claims to “adulteration” by contamination. The FDA’s increased focus on cosmetic companies and cosmetic products is seen in the recent uptick in warning letters,
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 MoreOn December 31, 2013 the U.S. Food and Drug Administration (FDA) issued a warning letter to Star Scientific, Inc. covering two dietary supplement products bearing illegal drug claims and unapproved new dietary ingredients — Antabloc and CigRx The U.S. Food and Drug Administration (FDA) has warned Star Scientific that the therapeutic claims made in association
Read MoreThe U.S. Food and Drug Administration (FDA) issued a warning letter to Jin Han International, Inc., d/b/a Pacific Foods Co., after a facility inspection revealed “serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123)”. According to the letter, the
Read MoreThe U.S. Food and Drug Administration (FDA) announced today that it “is taking action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.” The FDA’s announcement comes just days after the agency issued Warning Letters to 15 foreign and
Read MoreOn 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 MoreThe U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued Warning Letters in December 2011 to seven companies marketing over-the counter (OTC) HCG products that are labeled as “homeopathic” for weight loss. The letters warn the companies that they are violating federal law by selling unapproved new drugs, and by making
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