Recent Publications - Marc S. Ullman


FDA’s Misguided NDI Amnesty Scheme – But Companies Should Still Comply with the Law
July 27, 2022 | Compliance, Investigations & White Collar

Marc Ullman authored the article, “FDA’s Misguided NDI Amnesty Scheme – But Companies Should Still Comply with the Law,” in the August issue of Nutrition Industry Executive.

Ullman discusses the FDA’s proposed guidance document on new dietary ingredients.

Read the full article here.

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FDA remains broken—and mandatory product listing will only make it worse
February 17, 2022 | Compliance, Investigations & White Collar

Nearly 8 years ago, I published an article reviewing FDA’s failure to enforce the Dietary Supplement Health and Education Act of 1994 (DSHEA), especially in connection with the requirement that new dietary ingredients (NDIs) provide evidence of a reasonable expectation of safety.

I expressed concerns about the potential public health risk posed by knockoffs of NDIs of

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FDA Warns that Topical Pain-Relief Products Containing CBD Violate FD&C Act
March 24, 2021 | Compliance, Investigations & White Collar | Cannabis

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 | Compliance, Investigations & White Collar | Cannabis

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

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Cuomo to Again Seek Legalization of Recreational Marijuana in NYS
October 21, 2020 | Cannabis

Earlier this week, Axel Bernabe, Assistant Counsel to NY State Governor Andrew Cuomo, indicated that he expected the state budget to once again include provisions legalizing the recreational use of marijuana and permitting the use of CBD (cannabidiol) in food and beverages. Bernabe disclosed the news during an interview with Canopy Growth Corp.’s David Culver

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Kern and Ullman Publish Article in Pratt’s Journal of Bankruptcy Law
September 17, 2020 | Cannabis

Bob Kern and Marc Ullman published the article, “Cannabis Investments and Exit Strategies: A Case Study” in Pratt’s Journal of Bankruptcy Law.

The article discusses the easiness with which investors can make investments in cannabis companies. However, due to the risks, they would be well-advised to have an exit plan in the event their investment

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Cannabis Investments and Exit Strategies: A Case Study
August 3, 2020 | Compliance, Investigations & White Collar | Corporate | Cannabis

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

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Ransomware Attacks Continue Unabated in the Era of COVID
June 10, 2020 | Privacy, Data & Cyber Law

On June 9, the Beazley Group, a specialty insurer affiliated with Lloyd’s Underwriters, issued a pointed reminder that, as we continue to fight the global pandemic of COVID-19, the cyber pandemic of ransomware continues.

According to Beazley’s Breach Response Services group, ransomware incidents in the first quarter of 2020 increased by 25% compared to Q4

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Blue Bell Creameries Pleads Guilty to 2015 Listeria Outbreak, Former CEO Charged
May 5, 2020 | Commercial Litigation | Compliance, Investigations & White Collar

The United States Department of Justice (DOJ) announced that it had reached an agreement with Blue Bell Creameries of Brenham, Texas, to permit the company to plead guilty to two misdemeanor counts of distributing adulterated ice cream in violation of the federal Food Drug and Cosmetic Act and pay a criminal fine and forfeiture amount

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Ullman Published in Nutrition Industry Executive
April 27, 2020 | Compliance, Investigations & White Collar | Health Services

Marc Ullman published an article in Nutrition Industry Executive entitled, “The ABH Nature’s Products Recall – Lessons for Own Label Distributors.”

Click here to read the article.

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DOJ Charges California Physician with COVID-19 Fraud
April 20, 2020 | Health Services

On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in connection with his offer to sell “COVID-19 treatment packs” to patients and the general public. Emails sent by

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FTC and FCC Take Joint Action to Stop COVID-19 Scam Robocalls
April 8, 2020 | Compliance, Investigations & White Collar

On April 3, 2020 the Federal Trade Commission (FTC) and the Federal Communication Commission (FCC) announced that they had issued Warning Letters to VoIP providers: SIPJoin, Connexum and VoIP Terminator d/b/a BLMarketing. According to the letters, investigations have revealed that the companies transmitted calls offering fraudulent COVID-19 home testing kits or claiming that HVAC cleaning

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DHS-CISA Updates Guidance on Essential Industries
March 31, 2020 | Health Services

On March 28, 2020, the U.S. Department of Homeland Security’s Cybersecurity and Infrastructure Security Agency issued a much-needed update clarifying what constitutes “essential industry” during the national COVID-19 response.  This updated Guidance is especially important as many of the individual state declarations of emergency refer to “essential industry” without any enumeration, or specifically reference DHS-CISA

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DOJ Takes First Action against COVID-19 Fraud
March 24, 2020 | Privacy, Data & Cyber Law

On March 22, 2020, the U.S. Department of Justice (DOJ) issued a press release announcing its first action against COVID-19 fraudsters: a civil complaint seeking an injunction ordering the website coronavirusmedicalkit.com to shut down while an investigation into the site’s operators continues.

According to the complaint, filed in the Western District of Texas, “Information published

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Cannabis: A Business Opportunity for Those with an Appetite for Risk
September 26, 2019 | Compliance, Investigations & White Collar | Corporate | Health Services | Cannabis

In the past 10 years, the legalization of marijuana and other cannabis-related products have expanded tremendously throughout the United States. Currently, medical marijuana is legal in 33 states and the District of Columbia, while 11 states and the District of Columbia have legalized recreational marijuana use for adults 21 and over.

Additionally, cannabidiol (CBD) got

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Lessons from the FTC Settlements with Facebook and Equifax
July 30, 2019 | Privacy, Data & Cyber Law

Recent settlements of Federal Trade Commission (FTC) actions against Facebook and Equifax received significant publicity for the deals’ large payments to consumers and the Commission. Facebook’s deal calls for a $5 billion penalty for misuse of user’s private data. The Equifax deal requires the company to pay up to $575 million to consumers whose personal

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Ransomware Goes Public: Cities Pay Over $1 Million to Get Their Data Back
July 16, 2019 | Privacy, Data & Cyber Law

In the second and third week of June, the municipalities of Lake City, and Riviera Beach, Fla., agreed to pay a combined total of over $1 million to cyber criminals claiming responsibility for shutting down municipal computer systems necessary to the operation of crucial municipal functions.

The Riviera Beach attack was traced to an email

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Ullman’s Article on CBD in Supplements Appears in USLAW Magazine
March 28, 2019 | Compliance, Investigations & White Collar | Cannabis

Marc Ullman wrote “Regulations Remain Hazy around CBD Use in Supplements” for the Spring/Summer 2019 issue of USLAW Magazine.

The article reveals the regulatory confusion shrouding products made from Cannabis Sativa plants and their byproducts, with a special focus on cannabidiol as a supplement ingredient.

To read the article, click here.

 

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FTC Issues Privacy and Data Security Update
March 28, 2019 | Privacy, Data & Cyber Law | Compliance, Investigations & White Collar

On March 15, 2019, the Federal Trade Commission (FTC) issued its 2018 Privacy and Data Security Update, which reported on the agency’s enforcement activities for that calendar year.

As the United States’ primary consumer protection agency, the FTC has authority to enforce a variety laws directly related to privacy and data security, including the Truth in

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‘Made in the USA’ Claims: Handle With Care
May 15, 2018 | Compliance, Investigations & White Collar

Marc Ullman published an article in Natural Products Insider entitled, “‘Made in the USA’ Claims: Handle With Care.” The article focuses on how the Federal Trade Commission has increased its enforcement of its “Made in the USA” standards, which states “all or virtually all” of a product must be made/produced in the United States.

Click

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Shapiro and Ullman Author Article in Vitamin Retailer
May 1, 2018 | Health Services

Steven Shapiro and Marc Ullman co-wrote an article published in the May 2018 issue of Vitamin Retailer, the dietary supplement industry’s leading magazine.

The article focuses on the popular new dietary supplement, Kratom, its potentially hazardous effects and how the FDA is actively monitoring it.

Click here to read the article.

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FTC Continues to Focus on Data Protection
March 21, 2017 | Privacy, Data & Cyber Law

During 2016 the United States Federal Trade Commission (FTC) announced six formal enforcement actions. All involved corporate failures to protect sensitive personal information (health, financial or other) belonging to customers, other consumers or employees. These included proceedings against the owners of AshleyMadison.com (failure to protect the information of 36 million dating site users) and ASUS TeK

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Ransomware: A Threat to Any Business, Large or Small
September 20, 2016 | Compliance, Investigations & White Collar | Health Services

Marc Ullman’s article entitled, “Ransomware: A Threat to Any Business, Large or Small,” was recently published by Natural Products Insider.

According to a recent report by Malwarebytes, an anti-malware software company, a whopping 39 percent of the 540 companies from the United States, Canada, Germany and the United Kingdom surveyed in June 2016 suffered some form

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The Emerging Threat of Ransomware
April 12, 2016 | Privacy, Data & Cyber Law | Compliance, Investigations & White Collar | Health Services

Ottawa Hospital in southeast Ontario, Canada; Hollywood Presbyterian Medical Center in Los Angeles; Lukas Hospital in the German city of Neuss; the California law firm Ziprick and Cramer LLP; solo law practitioner Paul Goodson; and the town of Plainfield, New Jersey all have something in common:  they learned about the cyber threat posed by ransomware

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Wyndham Worldwide Corp. Settlement with the Federal Trade Commission: Consumer Data Protection Isn’t Only About HIPAA
January 1, 2016 | Compliance, Investigations & White Collar | Health Services

On December 9, 2015, the Federal Trade Commission (“FTC”) announced a settlement ending its two-and-a-half year-long litigation with Wyndham Worldwide Corp., the parent of Wyndham Hotels Group (“Wyndham”).  The case arose from three breaches of Wyndham’s computer systems by hackers in 2008 and 2009 during which personal financial information of thousands of consumers was stolen. 

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Federal Court Rebuffs FTC Effort to Apply Pharmaceutical Standards to Dietary Supplement Substantiation
November 3, 2015

In a case closely followed by all advertisers in general and the dietary supplement/natural products industry in particular, United States v. Bayer Corp., the United States District Court for New Jersey rebuffed an attempt by the Federal Trade Commission (FTC) to greatly increase the level of proof required for an advertiser to substantiate health related

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The New York Attorney General and Dietary Supplements: Six Months Later
August 31, 2015

With his February 3, 2015, announcement that four national retail chains were selling herbal supplements without any herbs in them, New York Attorney General Eric Schneiderman opened the door on an unprecedented wave of negative publicity for the dietary supplement industry. In the days following the disclosure of the AG’s investigation into this alleged fraud,

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FDA Looks to Undermine DSHEA – Again
August 31, 2015

Signed into law by President Clinton on October 25, 1994 after being adopted by unanimous consent by a Congress that received in excess of 2.5 million letters urging its passage, the Dietary Supplement Health and Education Act of 1994 (DSHEA) expressly provides that dietary supplements and the ingredients therein that were on the market as

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The New York Attorney General’s Dietary Supplement Investigation: Where We Stand Today
March 23, 2015 | Health Services

Marc Ullman’s article entitled, “The New York Attorney Geneal’s Dietary Supplement Investigation:  Where We Stand Today,” was published by Natural Products Insider.

Click here to read.

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FDA is Broken
May 16, 2014 | Health Services

The Mission Statement posted on FDA’s Office of Regulatory Affairs webpage by Associate Commissioner Melinda Plaisier on Jan. 21, 2014, stated we can expect the agency to be “Protecting consumers and enhancing public health by maximizing compliance of FDA-regulated products and minimizing risk associated with those products.” The problem, however, is that when it comes

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