Compliance, Investigations & White Collar


FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 24, 2021 | Steven Shapiro | Marc S. Ullman | Cannabis | Compliance, Investigations & White Collar
This week, the U.S. Food and Drug Administration (FDA) issued Warning Letters that effectively declare that the presence of cannabidiol (CBD) as an inactive ingredient in topical over-the-counter (OTC) drug products is a  violation of the federal Food, Drug, and Cosmetic Act (FD&C Act). In a news release issued on March 22, 2021 the FDA …
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CBD Health Claims Raise FTC’s Hackles (and Prompt Class Action Suits)
March 11, 2021 | Marc S. Ullman | Cannabis | Compliance, Investigations & White Collar
Near the end of 2020, in mid-December, the Federal Trade Commission (FTC) launched what it referred to as “Operation CBDeceit,” a law enforcement sweep challenging allegedly unproven representations that CBD products could treat diseases and serious medical conditions such as cancer, diabetes, Alzheimer’s disease and more.            At the same time, the FTC announced proposed settlements with …
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In NY, CBD Manufacturers and Distributors Now Must Be Licensed
February 26, 2021 | Robert C. Kern, Jr. | Benjamin P. Malerba | Cannabis | Compliance, Investigations & White Collar
Governor Andrew Cuomo announced that the New York State Department of Health is now accepting applications from businesses seeking licensure to operate as cannabinoid hemp processors, retailers, or distributors. Cannabinoid hemp includes many CBD products currently available for purchase, including tinctures, vaporizations, oils, topicals, pills, capsules and food and beverages. Pursuant to Article 33-B of …
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The Biden Administration’s Expected Criminal Enforcement Stance on Marijuana
February 1, 2021 | Geoffrey R. Kaiser | Cannabis | Compliance, Investigations & White Collar
As a candidate running for the office he now holds, President Biden advocated decriminalizing the use of marijuana, automatically expunging all prior marijuana use convictions, legalizing marijuana for medical purposes and rescheduling marijuana from Schedule I to Schedule II in order to permit scientific research into its effects, while leaving decisions regarding legalization of marijuana for …
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New AKS Safe Harbors Finalized
December 3, 2020 | Geoffrey R. Kaiser | Health Services | Compliance, Investigations & White Collar
The Office of Inspector General, Department of Health and Human Services (OIG) has finalized new safe harbors and modifications of existing safe harbors under the federal Anti-Kickback Statute (AKS) to reflect a policy priority favoring a value-based health care system that “pays for health and outcomes” and that will “remove potential barriers to more effective …
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Cannabis Investments and Exit Strategies: A Case Study
August 3, 2020 | Marc S. Ullman | Steven Shapiro | Cannabis | Corporate | Compliance, Investigations & White Collar
It is relatively easy for investors to make investments in cannabis companies. Given the risks, however, they would be well-advised to have an exit plan in the event their investment does not live up to their expectations. An investor decided to make an investment in a Colorado company that was seeking to create a particular …
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Shapiro Offers Guidance to Health Food Retailers amid COVID
July 2, 2020 | Steven Shapiro | Compliance, Investigations & White Collar
Steven Shapiro wrote an article for Vitamin Retailer entitled, “Operating a Health Food Retail Establishment in the Age of Coronavirus.” The article covers the measures retailers have taken to respond to the pandemic, including selling hand sanitizers and gloves, as well as the dangers of making claims about products purported to cure COVID-19. It also …
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New Executive Orders Aid OPWDD Facilities amid COVID-19
May 18, 2020 | John F. Queenan | Cassandra Rivais DiNova | Health Services | Compliance, Investigations & White Collar
In our prior bulletin, we discussed the likely lack of civil immunity from Justice Center enforcement actions conferred in other contexts by Executive Order 202.10. However, other Executive Orders provided some relief in the form of certain suspended or waived requirements applicable to facilities licensed by the Office of People with Development Disabilities (OPWDD). By …
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Whether Buying or Selling PPE, Protect Yourself
May 15, 2020 | Michael Vanunu | Compliance, Investigations & White Collar
There is no question that the COVID-19 pandemic has caused a shortage of personal protective equipment (PPE) and certain cleaning supplies. Although it may be tempting for manufacturers, suppliers and others with access to inventory or production of those products to use the supply shortage as a business opportunity, business owners should proceed with caution …
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Supreme Court Reverses ‘Bridgegate’ Convictions
| Michael Vanunu | Compliance, Investigations & White Collar
Last week, the Supreme Court of the United States issued a decision in Kelly v. United States[1] that limits federal prosecutors’ ability to seek criminal charges for public corruption. The Kelly case concerns the 2013 “Bridgegate” scandal that resulted in the prosecutions of Bridget Kelly, Deputy Chief of Staff to former New Jersey Governor Chris …
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