Florida health care attorney, Medicare compliance & suspension, AHCA licensing, Florida Board of Medicine, and Florida Medicaid overpayments. FDA attorney attorney for drug, cosmetics and medical devices including software as a Medical Device (SaMD), and digital therapeutics.

Phone: 786.440.8115

Representing clients in matters of Florida and federal laws and regulations. Licensed to practice law in Florida, only.

Category Archives: unapproved new drug

21 Jan

FDA issues warning letter to dietary supplement for illegal drug claims and unapproved dietary ingredients

On 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

09 Jan

FDA warns that over the counter HCG products marketed for weight loss are illegal

The 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