Compliance Investigations & White Collar
June 16, 2021 |
Marc Ullman was quoted in the NutraIngredients-USA article, “COVID-19 and legal chaos dent CBD market – but Congress and a stronger economy offer hope.”
The article discusses the state of the CBD market amid the COVID-19 pandemic and legal battles.
Ullman says the market is in disarray due to the FDA’s inaction.
Read the full
Read MoreMay 21, 2021 | |
Please join us on June 10 from 12 to 1 p.m. as Rivkin Radler Partner Robert H. Iseman discusses False Claims Act (FCA) compliance.
The FCA applies to any person or entity doing business with the federal government. Every year the federal government collects billions of dollars from FCA defendants, and most of that
Read MoreMay 17, 2021 |
Marc Ullman was quoted in the Natural Products Insider article, “Stakeholders can’t sue FDA over NAC warning letters.”
A recent court decision prevents stakeholders from suing the FDA based merely on its positions asserted in warning letters. The article discusses how a lingering dispute between the agency and the dietary supplement industry regarding NAC (N-acetyl-L-cysteine)
Read MoreApril 28, 2021 | |
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
Read MoreApril 23, 2021 |
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
Read MoreApril 7, 2021 | |
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
Read MoreApril 1, 2021 |
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
Read MoreMarch 29, 2021 | |
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
Read MoreMarch 23, 2021 |
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
Read MoreMarch 17, 2021 |
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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