Compliance Investigations & White Collar


Ullman Expresses Suspicion of FDA Warning Letters
May 10, 2022 | Compliance Investigations & White Collar

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 harmful

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Ullman Comments on Future Results of FDA Policy on NAC
April 29, 2022 | Compliance Investigations & White Collar

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 potential

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Ullman Cited in Article on Amazon’s Sales of NAC
April 26, 2022 | Compliance Investigations & White Collar

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After the FDA published draft guidance on the use of NAC last week, people have wondered if Amazon will resume sales of the ingredient.

Ullman stated that the draft guidance is “a win for industry”

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Ullman Quoted in Article on FDA’s Enforcement Discretion for CBD
| Compliance Investigations & White Collar | Cannabis

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.

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Ullman Comments on FDA’s Guidance for NAC
April 21, 2022 | Compliance Investigations & White Collar | Health Services

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The draft guidance came in response to two petitions, one referencing the DSHEA grandfather date of 1994.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 date

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Ullman to Present at GMP Compliance Virtual Seminar
February 15, 2022 | Compliance Investigations & White Collar

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 Dietary

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Ullman Comments on Legal Landscape of Weight Loss Supplements
February 9, 2022 | Compliance Investigations & White Collar

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

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Ullman Quoted on FDA’s Rejection of NDIN for Kratom
February 2, 2022 | Compliance Investigations & White Collar

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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Ullman and NY Bar Association Panel Blast NDI Enforcement Efforts
| Compliance Investigations & White Collar

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).

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Ullman Featured in Whole Foods Magazine
January 31, 2022 | Compliance Investigations & White Collar

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

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