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

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

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

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

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

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

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After the FDA published draft guidance on the use of NAC last week, people have wondered if Amazon will resume sales of the ingredient.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

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.

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

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