Compliance Investigations & White Collar
November 15, 2022 | |
Marc Ullman was cited in the NutraIngredientsUSA article, “FDA’s takedown of NMN raises fairness transparency concerns.”
The FDA has disallowed the anti-aging ingredient, NMN, and this has raised questions of fairness and transparency.
Ullman said the current FDA interpretation sets up a situation in which a pharma company could file an IND, let the issue
Read MoreNovember 3, 2022 | | | | | |
Rivkin Radler is pleased to announce that the Firm has been named to the U.S. News – Best Lawyers “Best Law Firms” list for 2023. The Firm was ranked in the following regions and practice areas:
Metropolitan Tier 1
Albany: Commercial Litigation, Health Care Law
Long Island: Elder Law, Health Care Law, Insurance Law, Litigation-Health Care,
Read MoreNovember 1, 2022 |
Ullman discussed a federal court’s recent ban on Arizona based company, Global Vitality Inc. The company repeatedly violated the Federal Food, Drug and Cosmetics Act over the last decade, by selling “adulterated and misbranded dietary
Read MoreOctober 28, 2022 |
Marc Ullman spoke with Natural Products INSIDER for the article “Ullman to moderate discussion at SupplySide West regulatory session”
SupplySide West brings together more than 18,000 ingredient buyers and suppliers from the dietary supplement, beverage, functional food, personal care and sports nutrition industries. This year’s conference will be held at the Mandalay Bay Resort & Casino in
Read MoreSeptember 16, 2022 | |
Marc Ullman was quoted in the NutraIngredientsUSA article, “Amazon warning over skin tag products puts online giant on notice for assuring regulatory compliance.”
The article explains that the FDA issued a warning letter to Amazon for two marketers whose products are sold on Amazon’s site. These products claim to remove skin tags, but are not
Read MoreAugust 24, 2022 |
As part of SupplySide West 2022, Marc Ullman will moderate a panel entitled “State of dietary supplement regulations and litigation: 2022 update.”
The session, which takes place November 3, 2022, will cover:
- Mandatory product listing and broader reform of the Dietary Supplement Health and Education Act of 1994 (DSHEA)
- NAC, CBD and other ingredients
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), FSMA
Read MoreJuly 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 and
Read MoreJuly 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 will
Read MoreJune 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 convinced
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