New York Paralegal Blog

The U.S. Food and Drug Administration issued four warning letters to companies that manufacture and market over-the-counter (OTC) drug products, including hand sanitizers, that claim to prevent infection from methicillin-resistant Staphylococcus aureus bacteria (MRSA). Labeling and marketing materials for the affected products also claim that they can prevent infection from other disease-causing agents. In addition, the labeling of some of the firms’ hand sanitizing drug products make claims related to preventing infection from E.coli and/or H1N1 flu virus. The FDA does not have sufficient evidence demonstrating that these products are safe and effective for these purposes. The FDA warning letters were sent to the following firms: Tec Laboratories for Staphaseptic First Aid Antiseptic/Pain Relieving Gel; JD Nelson and Associates for Safe4Hours Hand Sanitizing Lotion and Safe4Hours First Aid Antiseptic Skin Protectant; Dr. G.H. Tichenor Antiseptic Co. for Dr. Tichenor’s An...

(openPR) - The Law Offices of James Sokolove (LOJS), dedicated to providing equal access to the civil justice system, sees the stricter medication guides now required by the Food & Drug Administration (FDA) on certain arthritis drugs as consumer critical. The FDA took action following the more than 200 reports that associated higher incidences of fungal infections, and even deaths, with the use of four tumor necrosis factor alpha blockers (TNF-alpha blockers) arthritis drugs. “For the over 1 million Americans suffering from rheumatoid arthritis and facing chronic and debilitating pain, drugs, such as these, can help create normalcy in their daily lives,” says Attorney Jim Sokolove, founder of the LOJS. “While the FDA has responded here, consumers must remain highly vigilant themselves, so they can weigh the relief versus the risks imposed in using any drug.” More...