Compliance, Investigations & White Collar

FDA remains broken—and mandatory product listing will only make it worse
February 17, 2022 | Marc S. Ullman | Compliance, Investigations & White Collar

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

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Update on NYS Cannabinoid Licensing, Manufacturing and Labeling
January 3, 2022 | Steven Shapiro | Cannabis | Compliance, Investigations & White Collar

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

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Shapiro Authors Article on Mandatory Product Listing
December 3, 2021 | Compliance, Investigations & White Collar

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

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Acting Medicaid IG Frank Walsh Shares Agency’s Priorities
June 1, 2021 | Robert Hussar | Ashley (Osadon) Algazi | Health Services | Compliance, Investigations & White Collar

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

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FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 24, 2021 | Steven Shapiro | Marc S. Ullman | Cannabis | Compliance, Investigations & White Collar

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

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CBD Health Claims Raise FTC’s Hackles (and Prompt Class Action Suits)
March 11, 2021 | Marc S. Ullman | Compliance, Investigations & White Collar | Cannabis

Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could treat diseases and serious medical conditions such as cancer, diabetes, Alzheimer’s disease and more.           

At the same time, the FTC announced proposed settlements

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In NY, CBD Manufacturers and Distributors Now Must Be Licensed
February 26, 2021 | Benjamin P. Malerba | Joseph P. DiBella | Cannabis | Compliance, Investigations & White Collar

Governor Andrew Cuomo announced that the New York State Department of Health is now accepting applications from businesses seeking licensure to operate as cannabinoid hemp processors, retailers, or distributors. Cannabinoid hemp includes many CBD products currently available for purchase, including tinctures, vaporizations, oils, topicals, pills, capsules and food and beverages.

Pursuant to Article 33-B of

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The Biden Administration’s Expected Criminal Enforcement Stance on Marijuana
February 1, 2021 | Geoffrey R. Kaiser | Cannabis | Compliance, Investigations & White Collar

As a candidate running for the office he now holds, President Biden advocated decriminalizing the use of marijuana, automatically expunging all prior marijuana use convictions, legalizing marijuana for medical purposes and rescheduling marijuana from Schedule I to Schedule II in order to permit scientific research into its effects, while leaving decisions regarding legalization of marijuana for

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New AKS Safe Harbors Finalized
December 3, 2020 | Geoffrey R. Kaiser | Health Services | Compliance, Investigations & White Collar

The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective

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Cannabis Investments and Exit Strategies: A Case Study
August 3, 2020 | Marc S. Ullman | Steven Shapiro | Compliance, Investigations & White Collar | Cannabis | Corporate

It is relatively easy for investors to make investments in cannabis companies. Given the risks, however, they would be well-advised to have an exit plan in the event their investment does not live up to their expectations.

An investor decided to make an investment in a Colorado company that was seeking to create

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