On May 3, 2013, the U.S. Food and Drug Administration (FDA) announced that it is currently investigating the safety of added caffeine in foods, particularly in response to a recent trend of caffeinated products. The FDA is primarily concerned with …
FDA Issues Warning Letters to Online Cigarette Companies
In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the …
Company’s Operations Halted for Violating FDA Food Labeling Rules
On March 13, 2013, the U.S. Food and Drug Administration (“FDA”) announced that a federal judge has signed a consent decree of permanent injunction, enjoining a New Jersey-based food company’s operations. In particular, Butterfly Bakery Inc. (“the Company”) is prohibited from processing …
FDA Approves Orphan Drug to Treat Aplastic Anemia
On February 21, 2013, the U.S. Food and Drug Administration (“FDA”) granted orphan drug status to an aplastic anemia treatment. Aplastic anemia is a rare condition where bone marrow does not produce sufficient blood cells or platelets. The treatment, placental …
Food Seasonings Recalled Due to Undeclared Allergens
On February 15, 2013, the DeCoty Coffee Company of San Angelo, Texas announced that it was recalling its 1.25 pound and 5.75 pound DeCoty Taco Seasoning products. Prompting this recall are labeling concerns, specifically that the products contain an undeclared …
Marshals Seize Supplements with Undeclared Drug Ingredients
On February 14, 2013, U.S. Marshals, acting on behalf of the U.S. Food and Drug Administration (FDA), raided the headquarters of Globe All Wellness, LLC, a dietary supplement manufacturer based in Hollywood, Florida. Marshals seized what are alleged to be …
FDA/FTC Issue Joint Warning Letter to Company Marketing Flu Remedy
On January 24, 2013, the U.S. Food and Drug Administration (“FDA”) and the U.S. Federal Trade Commission (“FTC”) issued a joint warning letter to Flu & Cold Defense, LLC (“the Company”), a Florida company, for unlawfully marketing its “GermBullet” inhaler …
FDA Warns Online Cigarette Retailers for Marketing Violations
In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes, detailing certain marketing or product statements made that are in violation of federal laws that govern the practice. Several companies …
FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis
On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, …
Court Finds FDA’s Prohibition of Off-Label Promotion Unconstitutional
On December 3, 2012, the U.S. Court of Appeals for the Second Circuit reversed the conviction of a pharmaceutical sales representative, finding that promotion of FDA-approved drugs for unapproved uses, in and of itself, does not constitute a violation of …