Recent News - Compliance, Investigations & White Collar
August 8, 2022 |
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), FSMARead More
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 abilityRead More
July 12, 2022 | |
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 andRead More
July 6, 2022 | |
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 willRead More
June 10, 2022 |
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 convincedRead More
June 8, 2022 |
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 goingRead More
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
April 26, 2022 | |
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
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