Compliance Investigations & White Collar
February 9, 2022 |
Marc Ullman was cited in the NutraIngredients-USA article, “Navigating the legal landscape of weight loss supplements.”
The article explains that since over 42% of adults in the United States are obese, the weight loss industry has an easier time marketing their products. However, this category of supplements has a checkered history and their claims are
Read MoreFebruary 2, 2022 |
Marc Ullman talked with Nutraingredients-USA for the article, “Sixth time still not a charm: FDA again rejects NDIN for Kratom.”
Despite five prior attempts, FDA rejected the latest New Dietary Ingredient (NDI) notification for kratom. American Botanicals Corp. filed three of the six, and the most recent filing is the topic of this article.
Marc
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The Nutraingredients-USA article, “Bar association panel takes FDA to task over NDI enforcement,” details a January 29, 2022, New York Bar Association online panel discussion moderated by Marc Ullman. The program was intended to review the current status of the New Dietary Ingredient provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Read MoreJanuary 31, 2022 |
Marc Ullman was featured in the Whole Foods Magazine article, “Industry Members Call FDA Inaction “Disheartening.”
The article mentions the 2022 NYSBA Annual Meeting and explains how the panel discussion focused on intellectual property and FDA’s protection of it, or lack thereof. Ullman moderated the meeting and opened with a story about a dietary supplement
Read MoreJanuary 18, 2022 | |
Marc Ullman will be moderating the presentation, “FDA, New Dietary Ingredients, and Intellectual Property: Recent Developments in a Difficult Area” at the New York State Bar Association Annual Meeting of the Food, Drug and Cosmetic Law Section.
Friday, January 28, 2022 at 2:00 PM
The Dietary Supplement Industry has long struggled with issues surrounding its
Read MoreDecember 1, 2021 | |
Eric Fader was quoted in Relias Media’s HIPAA Regulatory Alert. In an article entitled “HIPAA Changes Coming in 2022 Might Require Policy Revisions,” Eric notes that the proposed changes will necessitate more training for businesses and organizations to whom HIPAA applies. The changes may also place a greater burden on providers to offer access to patient
Read MoreNovember 11, 2021 |
Marc Ullman was cited in the NutraIngredientsUSA.com article, “FDA takes Quicksilver Scientific to task over alleged disease claims in blog post.”
The article examines how narrow the margin between acceptable language and an alleged disease claim can be. Dietary supplement manufacturer, Quicksilver Scientific, made a number of alleged disease claims in blog posts that earned
Read MoreNovember 10, 2021 |
Steven Shapiro was interviewed by HBW Insight for the article, “P&G Wraps Launch Of Super C Supplement Brand In Co-Packaging With DayQuil And NyQuil OTCs.”
The story describes how Procter & Gamble may have exploited an ambiguity in the Food & Drug Administration’s policy when packaging its Super C supplement brand with DayQuil and Nyquil. The
Read MoreOctober 1, 2021 |
On October 5, Geoffrey R. Kaiser will be part of PLI’s Life Sciences 2021: Navigating Legal Challenges in Drug and Device Industries.
Jeff will be a panelist on the program, Enforcement Trends impacting the Drug and Device Industries, which will cover the following topics:
- False Claims Act
- Anti-Kickback Statute
- Off-Label Promotion
- Individual Liability
For
Read MoreSeptember 22, 2021 |
Marc Ullman was quoted in the NutraIngredientsUSA.com article, “Cohen-led team concludes phenibut warnings had no deterrent effect.”
The article explains how Dr. Pieter Cohen’s team did research on dietary supplements that contained phenibut in 2017, and found that not only did the companies continue using the ingredient in 2019 after being issued warning letters from
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