Recent Publications - Compliance, Investigations & White Collar
March 17, 2023 |
The FDA is facing possible legal action after three citizen petitions were rejected by the administration. All petitions were requesting that the FDA allow for the inclusion of CBD in dietary supplements, through some trade groups.
February 22, 2023 |
Jeff Kaiser’s article, “DOJ Issues New Guidance on Criminal Enforcement,” appeared in the winter 2023 issue of USLAW Magazine.
Click here to read the article.Read More
February 1, 2023 |
OMIG UPDATE: COMPLIANCE, SELF-DISCLOSURE, AND MANAGED CARE FRAUD, WASTE, AND ABUSE GUIDANCE POSTED
On the heels of publishing their final regulations, on January 31st, the Office of the Medicaid Inspector General (OMIG) released a variety of guidance documents addressing compliance programs; self-disclosure; and Medicaid managed care fraud, waste and abuse prevention programs. The guidance documentsRead More
January 6, 2023 | |
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 lastingRead More
October 10, 2022 | |
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,Read More
August 10, 2022 | |
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.Read More
July 27, 2022 |
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.Read More
February 17, 2022 |
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 ofRead More
January 3, 2022 | |
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 outRead More
December 3, 2021 |
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 inRead More
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