FDA

Marc S. Ullman, of counsel to Rivkin Radler, wrote the March 28 article “FDA sends a message with two warning letters to Amazon” in Natural Products Insider.

In the article, Marc explains the importance of the FDA warning letters on homeopathic “supplements” and products that contain active pharmaceutical ingredients. Marc writes, “During the

A September 29 article in NutraIngredients-USA, “New Jersey Man Arrested for Selling Counterfeit Supplements on Amazon,” discussed the arrest of Brad Snyder of Marlton, NJ, for allegedly counterfeiting Pure Encapsulations and Nature M.D. branded products and selling them online. Rivkin Radler’s Steve Shapiro was quoted in the article.

Steve noted the seriousness

On September 14, Rivkin Radler’s Jeff Kaiser will participate on a panel at Practising Law Institute’s Life Sciences 2023: Navigating Legal Challenges in Drug and Device Industries program in New York City.

Held at PLI’s New York Conference Center at 1177 Sixth Avenue, the program will cover the explosive growth of digital health and the

On December 20, the Federal Trade Commission’s Bureau of Consumer Protection announced the issuance of Health Products Compliance Guidance. The revised Guidance updates the FTC’s 1998 guide, Dietary Supplements: An Advertising Guide For Industry, and is a must read for everyone involved in marketing, labeling, and creating and evaluating substantiation for dietary supplements and

Rivkin Radler partners Evan Krinick and Michael Sirignano authored an article, “Compounding the Fraud: Questionable Billing by Pharmacies,” in the July 6 issue of the New York Law Journal. The article discussed the U.S. Department of Justice’s continued concern over fraudulent claims for reimbursement to federal healthcare programs for compounded prescription drugs.

On May 19, the U.S. Food and Drug Administration (FDA) issued final guidance for assessing the safety and compatibility of medical devices within magnetic resonance imaging facilities. The guidance applies to implanted devices, external devices like insulin pumps and pulse oximeters, and any other devices that may be brought into MRI rooms, but not to

In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined not to impose sanctions under the federal Anti-Kickback Statute (AKS) on a drug manufacturer program that offers a free drug to certain eligible patients. The manufacturer uses personalized medicine technology to make the drug from

This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a  violation of the federal Food, Drug, and Cosmetic Act (FD&C Act).

In a news release issued on March 22, 2021 the FDA