Compliance Investigations & White Collar


A Conversation with the New Acting Medicaid Inspector General
April 28, 2021 | Compliance Investigations & White Collar | Health Services
On Thursday, May 13 from 12 to 1 p.m, Frank T. Walsh, Jr., the new Acting Medicaid IG, will provide an overview of OMIG’s priorities and key initiatives. He will also address participants’ questions, which are to be submitted at registration. The program will be moderated by Robert Hussar, a partner in Rivkin Radler’s Compliance, …
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Ullman Remarks About Recent Supreme Court Ruling
April 23, 2021 | Compliance Investigations & White Collar
Marc Ullman was quoted in the NutraIngredients-USA article, “Supreme Court curbs FTC’s ability to levy fines.” The article discusses a rare unanimous Supreme Court ruling that the Federal Trade Commission (FTC) can no longer levy fines against dietary supplement companies it brings to court. Ullman views this decision as having the potential to weaken the …
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Malerba Shares HIPAA Updates with Coalition for Behavioral Health
April 7, 2021 | Compliance Investigations & White Collar | Health Services
On April 6, Benjamin Malerba gave a presentation to members of the Coalition for Behavioral Health. The presentation was entitled “HIPAA in an Evolving Health Care Environment: Proposed Changes for 2021 and Response to COVID-19.” The Coalition for Behavioral Health provides policy, advocacy, training and technical assistance to more than 100 community-based behavioral health providers …
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Ullman Quoted in Natural Products Insider Article
April 1, 2021 | Compliance Investigations & White Collar
Marc Ullman was quoted in the Natural Products Insider article, “Supplement manufacturer avoids recall.” The article discusses a manufacturer that was recently ordered to shut down due to FDA violations, but avoided a recall of the product. Ullman views the government’s request for a recall in this instance as an attempt to publicly shame the …
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Shapiro Quoted on CBD Warning Letters in Vitamin Retailer
March 29, 2021 | Compliance Investigations & White Collar | Cannabis
Steven Shapiro was quoted in the Vitamin Retailer article, “FDA Warns Selling of Topical CBD Products Violates FD&C Act.” The FDA has issued warning letters to two companies addressing the illegal marketing of unapproved drugs labeled as containing CBD. Shapiro questions the letters as neither discussed the potential to use CBD as an inactive ingredient …
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Ullman Cited in Natural Products Insider Article
March 23, 2021 | Compliance Investigations & White Collar
Marc Ullman was quoted in the Natural Products Insider article, “Extensive history of cGMP infractions preceded gov’t lawsuit against supplement maker.” The article discusses a supplement manufacturer with an extensive history of violations that has somehow been largely left alone by the FDA. Like other experts cited in the article, Ullman finds the level of noncompliance …
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Ullman Quoted in NutraIngredients-USA Article
March 17, 2021 | Compliance Investigations & White Collar
Marc Ullman was quoted in the NutraIngredients-USA article, “FDA seizes Chinese imports over NDI status.” The article discusses how the FDA issued an import alert and seized two products from two companies that were offering New Dietary Ingredients that have not gone through the notification process. Ullman remarked that the move is a welcome one, …
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Ullman Cited in Inspection Failure Article
March 10, 2021 | Compliance Investigations & White Collar
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. …
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Iseman Weighs in on PRF Audits for Part B News
February 22, 2021 | Compliance Investigations & White Collar | Health Services
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. …
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Panel: Advertising During a Pandemic for Products Making Immunity Claims
January 6, 2021 | Compliance Investigations & White Collar
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 …
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