Recent News - Compliance, Investigations & White Collar


Ullman Comments on “Compliance responsibilities when using a contract manufacturer”
August 8, 2022 | Compliance Investigations & White Collar

Marc Ullman spoke with Natural Products INSIDER for the article, “Compliance responsibilities when using a contract manufacturer.”

Some brands contract out their products to individual manufacturers. During this collaboration, many questions can arise regarding compliance responsibility and reporting regulations.

There are a multitude of manufacturing and reporting requirements, such as cGMPs (current good manufacturing practices), FSMA

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Ullman Quoted in Nutra Ingredients Article
July 27, 2022

Marc Ullman was quoted in a Nutra Ingredients article titled, “Study finds supplements with dodgy ingredients still for sale years after warning letters.” The article discusses a recent study that uncovered questionable supplement ingredients years after the FDA issues safety warning letters.

“The results of this survey are no surprise. FDA has eviscerated its own ability

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Lunch & Learn Series: New OMIG Compliance Regulations: What You Need to Know
July 12, 2022 | Compliance Investigations & White Collar | Health Services

On July 13, the Office of Medicaid Inspector General (OMIG) published proposed regulations implementing 2020 changes to law relating to provider compliance programs, Medicaid managed care fraud, waste and abuse prevention programs, and OMIG’s self-disclosure program. The proposed changes will significantly impact both payers and providers alike.

Hear from Robert Hussar, a compliance professional and

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Kaiser a PLI Panelist on Drug and Device Enforcement Trends
July 6, 2022 | Compliance Investigations & White Collar | Health Services

On September 28, 2022, Jeff Kaiser will be a panelist at the Practising Law Institute’s program, Life Sciences 2022: Navigating Legal Challenges in Drug and Device Industries. The program is designed for attorneys and allied professionals who counsel pharmaceutical and life sciences companies.

Entitled “Enforcement Trends Impacting the Drug and Device Industries,” Jeff’s panel will

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Ullman Reacts to FDA’s Amnesty for NDIN Non-Filers
June 10, 2022 | Compliance Investigations & White Collar

Marc Ullman spoke with Natural Products INSIDER for the article, “FDA hoping to shrink pool of noncompliant ingredient notifications.”

The story discusses the U.S. Food & Drug Administration’s recent guidance that it is providing a 180-day amnesty to manufacturers of nutritional products that failed to file a New Dietary Ingredient (NDI) notification.

Marc is not convinced

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Ullman Cited in Missing NDI Filings Article
June 8, 2022 | Compliance Investigations & White Collar

Marc Ullman was cited in the NutraIngredientsUSA article, “FDA announces enforcement discretion amnesty window on missing NDI filings.”

The article explains the FDA’s announcement that it will exercise enforcement discretion on missing New Dietary Ingredient Notifications.

Ullman stated that the announcement has less impact than it should.

“When that window closes, what are they going

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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
April 26, 2022 | 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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