Marc Ullman was cited in the NutraIngredients-USA article, “Confidence USA ordered to close after decade of inspection failures.”

A dietary supplement manufacturer has been ordered to close after a decade of alleged non-compliance with cGMP regulations.

Marc is critical of what he calls the FDA’s overly deliberate pace of enforcement.

Read the full article here.

Bob Iseman was quoted in the Part B News article, “Provider Relief Fund audits coming; pick your method and keep good records.” The story discusses what healthcare providers that received funds should expect with, and how they should prepare for, an upcoming audit.

To read the article, click here.

On Monday, January 25, 2021, the New York State Bar Association’s Food, Drug and Cosmetic Law Section will host a panel presentation as part of a larger program called Hot Topics in FDA Law during the COVID Pandemic.

The panel, entitled “Advertising During a Pandemic. How Are Regulators Handling the Marketing of Products with Immune

Marc Ullman, in the Nutraceuticals World article, “Dietary Supplement Leaders Lament Pitfalls of FDA’s Approach to NDIs,” expressed frustration that, despite several New Dietary Ingredient applications (NDIs) being rejected, a synthetic supplement with a history of adverse events in animal testing was allowed to reach the market. The article describes how the U.S. Food and Drug Administration’s

On December 2, 2020, Matthew Lampert, along with the Chair of the NCBA’s Plaintiff’s  Personal Injury Committee, will be jointly presenting a CLE Program entitled “Why Civility in the Practice of Law Matters.” It will be held over Zoom from 5:30 to 7:30 P.M.  This will be a free CLE program. The format for the

Geoffrey R. Kaiser was quoted in the Healthcare Risk Management article, “$50 Million Stark Settlement Shows Risk of Violation, Whistleblowers.”

A West Virginia hospital settled U.S. Department of Justice allegations that it violated the Stark Law and the Anti-Kickback Statute by excessively compensating referring physicians. Jeff noted, “…a hospital may not pay excessive compensation to its

Rivkin Radler LLP is pleased to announce that 23 attorneys were named to the 2020 New York Metro Super Lawyers List and 13 attorneys were named 2020 New York Metro Rising Stars. Following is a list of attorneys, the practice areas for which they were recognized, and the years they were included in Super Lawyers.

Marc Ullman was cited in the NutraIngredients-USA article, “FDA takes aim at claims for infant food allergy prevention.”

Two companies have received warning letters from the FDA for claiming that their products can prevent young children from developing certain food allergies.

Marc states that the companies can petition the FDA for a broadening of the

Marc Ullman spoke to Natural Products Insider for the story, “Execs of once-thriving supplements brand USPlabs sentenced to prison.”

USPlabs’ product, OxyElitePro, was implicated in dozens of cases of liver injuries. In 2015, the company and its contract manufacturer were indicted along with USPlabs’ executives who defended the charges for years.

Marc noted that FDA-regulated

On October 13, Jeff Kaiser will be speaking at the Life Sciences 2020: Navigating Legal Challenges in Drug and Device Industries.

Jeff will be speaking on the topic of, “Enforcement Trends impacting the Drug and Device Industries” focusing on the following areas:

• False Claims Act
• Anti-Kickback Statute
• Off-label promotion
• Individual liability

Click here