Marc Ullman was published in Natural Products Insider. His article, “Analysis: CBD food industry unlikely to placate FDA,” discusses the potentially negative impact on the FDA’s interpretation of the exclusionary clause in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Ullman fears the current interpretation of the act will have a long lasting

On September 15, Deputy Attorney General (“DAG”) Lisa Monaco delivered remarks announcing updated guidance on how the Department of Justice will be prioritizing and prosecuting corporate crime.  Her remarks were accompanied by a formal memo, titled “Further Revisions to Corporate Criminal Enforcement Policies Following Discussions with Corporate Crime Advisory Group” (https://www.justice.gov/opa/speech/file/1535301/download).  However inelegant the title,

In an effort to help prevent and combat money laundering, terrorist financing, corruption, tax fraud, and other illicit activity, the United States Department of the Treasury just issued a final rule [RIN: 1506-AB49]. The rule requires certain businesses to file reports with FinCEN (Financial Crimes Enforcement Network) that identify two categories of individuals: the beneficial

Healthcare fraud related to durable medical equipment (DME) is extremely costly to insurers yet often continues without criminal or civil consequences.

Fraudulent schemes by DME supply companies vary in complexity but usually prove extremely costly to insurers. Likely victims of DME fraud include Medicaid, Medicare, automobile insurers, workers’ compensation insurers, and other private health insurers.

Marc Ullman authored the article, “FDA’s Misguided NDI Amnesty Scheme – But Companies Should Still Comply with the Law,” in the August issue of Nutrition Industry Executive.

Ullman discusses the FDA’s proposed guidance document on new dietary ingredients.

Read the full article here.

Nearly 8 years ago, I published an article reviewing FDA’s failure to enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA), especially in connection with the requirement that new dietary ingredients (NDIs) provide evidence of a reasonable expectation of safety.

I expressed concerns about the potential public health risk posed by knockoffs of NDIs of

The New York State Office of Cannabis Management (OCM) has announced regulations concerning the manufacturing and labeling of cannabinoid hemp products, and the availability of an online portal to facilitate required state licensure. Cannabinoid hemp products sold in the state must comply with the regulations by April 25, 2022. The OCM will be reaching out

Steven Shapiro authored the article, “Should the Dietary Supplement Industry Support FDA’s Push for Mandatory Product Listing?” for Nutrition Industry Executive.

The article discusses talk of creating “DSHEA 2.0” which would a require a “mandatory product listing” of all dietary supplement products to be submitted to the FDA. There seems to be a split in

On May 13, 2021, Rivkin Radler Partner, and former OMIG First Deputy, Robert Hussar kicked off Rivkin Radler’s new Healthcare Compliance Lunch and Learn Series. He interviewed Frank T. Walsh, Jr., who offered his first public comments since assuming his role as Acting NYS Medicaid Inspector General (pending State Senate confirmation).

Mr. Walsh provided health

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