Compliance Investigations & White Collar
May 10, 2022 |
Marc Ullman, quoted in the NutraIngredients-USA article, “FDA cites 10 firms for use of ingredients flagged as illegal,” expressed his suspicion of the recent warning letters that the FDA sent to 10 dietary supplement companies using ingredients that have been added to its Ingredients Advisory List.
The FDA has marked some of these potentially harmfulRead More
April 29, 2022 |
Marc Ullman commented on how the FDA’s recent enforcement discretion of NAC will bring some certainty to the market in NutraIngredientsUSA article, “Enforcement discretion gives some solace to NAC space, observers say.”
Ullman stated, “FDA enforcement discretion on matters like NAC should be fairly reliable in the absence of any data emerging indicating a potentialRead More
April 26, 2022 |
Marc Ullman was cited in the Natural Products Insider article, “Supplements sector eyes Amazon after release of FDA NAC guidance.”
After the FDA published draft guidance on the use of NAC last week, people have wondered if Amazon will resume sales of the ingredient.
Ullman stated that the draft guidance is “a win for industry”Read More
Marc Ullman was quoted in the Natural Products Insider article, “FDA written enforcement discretion on CBD unlikely.”
The article discusses how the FDA is unlikely to issue a formal policy of enforcement discretion for CBD-containing products marketed as dietary supplements.
Ullman doesn’t believe the agency would issue a CBD enforcement discretion policy similar to NAC.Read More
April 21, 2022 | |
Marc Ullman commented on the FDA’s recent announcement that it will exercise enforcement discretion on the use of NAC in the NutraIngredientsUSA article, “FDA formally announces NAC enforcement, but legal handover remains.”
The draft guidance came in response to two petitions, one referencing the DSHEA grandfather date of 1994. The FDA rejected the grandfather dateRead More
February 15, 2022 |
Marc Ullman will be presenting at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Virtual Seminar.
The event will be held on May 3, 5, 10, and 12, 2022. Ullman will be presenting with Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services, and Tamika Cathey, EAS Independent Consultant.
At the DietaryRead More
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 areRead More
February 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.
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 More
January 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 supplementRead More
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