Recent News - Marc S. Ullman


Ullman Cited in Article on FDA’s Takedown of NMN
November 15, 2022 | Compliance Investigations & White Collar | Health Services

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

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Ullman Quoted in NutraIngredientsUSA
November 1, 2022 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredientsUSA article, titled “DOJ prohibits Arizona company from distributing adulterated or misbranded supplements.”

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

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Ullman to moderate discussion at SupplySide West regulatory session
October 28, 2022 | Compliance Investigations & White Collar

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

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Ullman Quoted in Article on Warning Letters to Amazon
September 16, 2022 | Compliance Investigations & White Collar | Health Services

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

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Ullman Moderates Panel on Regulation and Litigation in US Supplement Market
August 24, 2022 | Compliance Investigations & White Collar

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
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Ullman Comments on “Compliance responsibilities when using a contract manufacturer”
August 8, 2022 | Compliance Investigations & White Collar

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

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Ullman Quoted in Nutra Ingredients Article
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 ability

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Ullman Reacts to FDA’s Amnesty for NDIN Non-Filers
June 10, 2022 | Compliance Investigations & White Collar

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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Ullman Cited in Missing NDI Filings Article
June 8, 2022 | Compliance Investigations & White Collar

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

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NDI warning letters fuel criticism of FDA enforcement approach—again
June 2, 2022 | Compliance Investigations & White Collar

Marc Ullman was cited in the Natural Products Insider article “NDI warning letters fuel criticism of FDA enforcement approach—again.”

In May, the FDA issued warnings to several companies who sell dietary supplements. The warning letters indicated that some of the supplements “could potentially harm consumers,” according to a constituent update. Targeting six supplements specifically, the

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Ullman Weighs In on FDA Warnings and the Delta-8 THC Market
May 16, 2022 | Cannabis

Ullman was cited in the Natural Products Insider article “Lawyers skeptical FDA warning letters will chill delta-8 THC market.”

The article discusses the effect of the recent rash of FDA warning letters on delta-8 THC products. The warning letters note that delta-8 THC is not an approved treatment for medical conditions.

Asked whether the warning

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Ullman Expresses Suspicion of FDA Warning Letters
May 10, 2022 | Compliance Investigations & White Collar

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

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Ullman Comments on Future Results of FDA Policy on NAC
April 29, 2022 | Compliance Investigations & White Collar

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

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Ullman Cited in Article on Amazon’s Sales of NAC
April 26, 2022 | Compliance Investigations & White Collar

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”

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Ullman Quoted in Article on FDA’s Enforcement Discretion for CBD
April 26, 2022 | Compliance Investigations & White Collar | Cannabis

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.

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Ullman Comments on FDA’s Guidance for NAC
April 21, 2022 | Compliance Investigations & White Collar | Health Services

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

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Ullman to Present at GMP Compliance Virtual Seminar
February 15, 2022 | Compliance Investigations & White Collar

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

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Ullman Comments on Legal Landscape of Weight Loss Supplements
February 9, 2022 | Compliance Investigations & White Collar

Marc Ullman was cited in the NutraIngredients-USA article, “Navigating the legal landscape of weight loss supplements.”

The article explains that since over 42% of adults in the United States are obese, the weight loss industry has an easier time marketing their products. However, this category of supplements has a checkered history and their claims are

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Ullman Quoted on FDA’s Rejection of NDIN for Kratom
February 2, 2022 | Compliance Investigations & White Collar

Marc Ullman talked with Nutraingredients-USA for the article, “Sixth time still not a charm: FDA again rejects NDIN for Kratom.”

Despite five prior attempts, FDA rejected the latest New Dietary Ingredient (NDI) notification for kratom. American Botanicals Corp. filed three of the six, and the most recent filing is the topic of this article.

Marc

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Ullman and NY Bar Association Panel Blast NDI Enforcement Efforts
February 2, 2022 | Compliance Investigations & White Collar

The Nutraingredients-USA article, “Bar association panel takes FDA to task over NDI enforcement,” details a January 29, 2022, New York Bar Association online panel discussion moderated by Marc Ullman. The program was intended to review the current status of the New Dietary Ingredient provision of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

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Ullman Featured in Whole Foods Magazine
January 31, 2022 | Compliance Investigations & White Collar

Marc Ullman was featured in the Whole Foods Magazine article, “Industry Members Call FDA Inaction “Disheartening.”

The article mentions the 2022 NYSBA Annual Meeting and explains how the panel discussion focused on intellectual property and FDA’s protection of it, or lack thereof. Ullman moderated the meeting and opened with a story about a dietary supplement

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Ullman to be Moderator at NYSBA Annual Meeting
January 18, 2022 | Compliance Investigations & White Collar | Health Services

Marc Ullman will be moderating the presentation, “FDA, New Dietary Ingredients, and Intellectual Property: Recent Developments in a Difficult Area” at the New York State Bar Association Annual Meeting of the Food, Drug and Cosmetic Law Section.

Friday, January 28, 2022 at 2:00 PM

The Dietary Supplement Industry has long struggled with issues surrounding its

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Ullman Cited in Article on Alleged Disease Claims
November 11, 2021 | Compliance Investigations & White Collar

Marc Ullman was cited in the NutraIngredientsUSA.com article, “FDA takes Quicksilver Scientific to task over alleged disease claims in blog post.”

The article examines how narrow the margin between acceptable language and an alleged disease claim can be. Dietary supplement manufacturer, Quicksilver Scientific, made a number of alleged disease claims in blog posts that earned

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Ullman Comments on Phenibut Usage Research Result
September 22, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredientsUSA.com article, “Cohen-led team concludes phenibut warnings had no deterrent effect.”

The article explains how Dr. Pieter Cohen’s team did research on dietary supplements that contained phenibut in 2017, and found that not only did the companies continue using the ingredient in 2019 after being issued warning letters from

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Ullman Opines on Characterization of Synthetic Glycans
September 9, 2021 | Compliance Investigations & White Collar

Marc Ullman was interviewed for the Nutraingredients-USA article, “Synthetic glycans developer issued warning over failure to file IND in COVID-19 trials.”

The Food & Drug Administration (FDA) issued a warning letter to Kaleido for the way they set up trials for its synthetic glycans product. The FDA’s position was that the trials were attempting to

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Ullman to Present at GMP Compliance Virtual Seminar
July 14, 2021 | Health Services

Marc Ullman will be presenting at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Virtual Seminar.

The event will be held on September 28 and 30, and October 5 & 7. Ullman will be presenting with EAS Consultants Tara Lin Couch and Robert Fish.

The GMPs dictated in 21 CFR 111 have been in place

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Ullman Quoted on Labeling Calories in Sports Nutrition Products
July 7, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredients-USA.com article, “Experts offer clarity on labeling calories for non-macronutrients.”

The article focuses on the citizen’s petition filed by the Natural Products Association regarding the labeling of calories from branched chain amino acids.

Ullman explained that there are some issues with the regulation. “There’s no way to put these

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Ullman Quoted on FTC’s “Made in the USA” Rule
July 6, 2021 | Compliance Investigations & White Collar

Marc Ullman commented in the NutraIngredients-USA.com article, “FTC finalizes ‘Made in the USA’ rule.”

According to the article, the Federal Trade Commission has issued its final ‘Made in the USA’ rule about how companies can make this claim on their packaging and in advertising.

In regards to dietary supplements, “Made in the USA claims continue

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Ullman Comments on FDA’s Handling of New Dietary Ingredients
July 1, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredients-USA article, “FDA lists NDI update among priorities for coming year.”

The article discusses a list of priorities released yesterday by the US Food and Drug Administration (FDA), which included New Dietary Ingredients (NDI) Draft Guidance.

“FDA’s entire handling of NDIs has been absurd,” Ullman said. “It seems to

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Ullman Comments on FDA’s Failure to Regulate the CBD Market
June 16, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredients-USA article, “COVID-19 and legal chaos dent CBD market – but Congress and a stronger economy offer hope.”

The article discusses the state of the CBD market amid the COVID-19 pandemic and legal battles.

Ullman says the market is in disarray due to the FDA’s inaction.

Read the full

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Ullman Comments About Risk to NAC Retailers
May 17, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the Natural Products Insider article, “Stakeholders can’t sue FDA over NAC warning letters.”

A recent court decision prevents stakeholders from suing the FDA based merely on its positions asserted in warning letters. The article discusses how a lingering dispute between the agency and the dietary supplement industry regarding NAC (N-acetyl-L-cysteine)

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Ullman Remarks About Recent Supreme Court Ruling
April 23, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredients-USA article, “Supreme Court curbs FTC’s ability to levy fines.”

The article discusses a rare unanimous Supreme Court ruling that the Federal Trade Commission (FTC) can no longer levy fines against dietary supplement companies it brings to court.

Ullman views this decision as having the potential to weaken the

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Ullman Comments on the Wild West of the GRAS Process
April 9, 2021 | Health Services

Marc Ullman spoke on the issues of the GRAS process in the NutraIngredients-USA article, “As a result of GRAS process FDA has no idea of what’s on market, say paper’s authors.”

The article discusses how a paper found that the FDA does not know how many new ingredients have entered the market due to the

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Ullman Authors Article for Nutrition Industry Executive
April 7, 2021 | Health Services

In this month’s Nutrition Industry Executive, Marc Ullman authored the article, “It’s Not Just the Federal Government: State Issues of Concern for the Supplement Industry.”

Ullman collaborated with Kyle Turk, the Director of Government Affairs for the Natural Products Association on the article.

Read the full publication here.

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Ullman Quoted in Natural Products Insider Article
April 1, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the Natural Products Insider article, “Supplement manufacturer avoids recall.”

The article discusses a manufacturer that was recently ordered to shut down due to FDA violations, but avoided a recall of the product.

Ullman views the government’s request for a recall in this instance as an attempt to publicly shame the

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Ullman Cited in Natural Products Insider Article
March 23, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the Natural Products Insider article, “Extensive history of cGMP infractions preceded gov’t lawsuit against supplement maker.”

The article discusses a supplement manufacturer with an extensive history of violations that has somehow been largely left alone by the FDA. Like other experts cited in the article, Ullman finds the level of noncompliance

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Ullman Quoted in NutraIngredients-USA Article
March 17, 2021 | Compliance Investigations & White Collar

Marc Ullman was quoted in the NutraIngredients-USA article, “FDA seizes Chinese imports over NDI status.”

The article discusses how the FDA issued an import alert and seized two products from two companies that were offering New Dietary Ingredients that have not gone through the notification process.

Ullman remarked that the move is a welcome one,

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Ullman Cited in Inspection Failure Article
March 10, 2021 | Compliance Investigations & White Collar

Marc Ullman was cited in the NutraIngredients-USA article, “Confidence USA ordered to close after decade of inspection failures.”

A dietary supplement manufacturer has been ordered to close after a decade of alleged non-compliance with cGMP regulations.

Marc is critical of what he calls the FDA’s overly deliberate pace of enforcement.

Read the full article here.

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Ullman to Speak at Dietary Supplement (GMP) Compliance Virtual Seminar
March 9, 2021 | Health Services

Marc Ullman will be a speaker at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Virtual Seminar.

The event will be held on May 3, 5, 10 & 12, 2021.

In these unprecedented times, the dietary supplement industry is playing an essential role for the U.S. consumer. Never before have more questions been raised regarding

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Ullman to be Panelist at Dietary Supplement (GMP) Compliance Virtual Seminar
January 13, 2021 | Health Services

Marc Ullman will be a panelist at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Virtual Seminar.

The seminar will be held on February 2, 4, 9 and 11 from 11:00am to 4:00pm.

In these unprecedented times, the dietary supplement industry is playing an essential role for the U.S. consumer. Never before have more questions

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Panel: Advertising During a Pandemic for Products Making Immunity Claims
January 6, 2021 | Compliance Investigations & White Collar

On Monday, January 25, 2021, the New York State Bar Association’s Food, Drug and Cosmetic Law Section will host a panel presentation as part of a larger program called Hot Topics in FDA Law during the COVID Pandemic.

The panel, entitled “Advertising During a Pandemic. How Are Regulators Handling the Marketing of Products with Immune

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Ullman Reacts to Risks of Lax NDI Policy
December 8, 2020 | Compliance Investigations & White Collar

Marc Ullman, in the Nutraceuticals World article, “Dietary Supplement Leaders Lament Pitfalls of FDA’s Approach to NDIs,” expressed frustration that, despite several New Dietary Ingredient applications (NDIs) being rejected, a synthetic supplement with a history of adverse events in animal testing was allowed to reach the market. The article describes how the U.S. Food and Drug Administration’s

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Ullman Quoted on FDA Warning Letters
October 23, 2020 | Compliance Investigations & White Collar

Marc Ullman was cited in the NutraIngredients-USA article, “FDA takes aim at claims for infant food allergy prevention.”

Two companies have received warning letters from the FDA for claiming that their products can prevent young children from developing certain food allergies.

Marc states that the companies can petition the FDA for a broadening of the

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Ullman Quoted on Sentencing of Supplement-Maker Execs
October 23, 2020 | Compliance Investigations & White Collar

Marc Ullman spoke to Natural Products Insider for the story, “Execs of once-thriving supplements brand USPlabs sentenced to prison.”

USPlabs’ product, OxyElitePro, was implicated in dozens of cases of liver injuries. In 2015, the company and its contract manufacturer were indicted along with USPlabs’ executives who defended the charges for years.

Marc noted that FDA-regulated

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Ullman Speaks at Natural Products Insider Webinar
October 6, 2020 | Cannabis

On September 30, Marc Ullman spoke at the Natural Products Insider webinar “Hemp Evolution: Surviving the imminent regulatory shockwave.”

The presentation discussed mitigating legal risks and thriving in the multi-billion dollar hemp phytocannabinoid market.

The video is still available to view. Click here to register and watch.

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Ullman to Speak at American Association of Naturopathic Physicians Webinar
October 6, 2020

On October 7, 2020, Marc Ullman will be a panelist at the webinar “Your COVID Communications Could be Illegal: Here’s How to Avoid FDA & FTC Trouble.”

The event is hosted by the American Association of Naturopathic Physicians and is free to attend.

In this program, you’ll learn about:

  • The laws governing permissible language
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Ullman to Speak at SupplySide Education Series
September 15, 2020 | Health Services

On Friday, September 18 Marc Ullman is speaking at the SupplySide Education Series “Testing trials for contract lab partnerships” webinar.

The session will explore:

  • How to choose the right lab and how often a lab should be audited
  • How to ensure tests are fit for purpose and what standards should be used,
  • COVID-19-related factors
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Ullman Featured in NutraIngredients-USA Podcast
September 8, 2020 | Health Services

Marc Ullman was featured in a NutraIngredients-USA podcast, “Are brands responsible for consumer reviews?”

Recently the National Advertising Decision (NAD) addressed when companies will be liable for consumer reviews. Marc discussed both when they will be responsible, if they should respond to the reviews and best practices overall.

Click here to listen to the podcast.

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Ullman Offers Insight in NutraIngredients-USA Article
September 2, 2020 | Health Services

Marc Ullman was quoted in NutraIngredients-USA, “Sabinsa ups ante in amla debate, demands AFS disclose alleged added Vitamin C.”

The article discusses how the Indian ingredient supplier Sabinsa Corp. has dialed up the pressure in its crusade about the chemical profile of amla with a legal action against a fellow supplier Applied Food Sciences.

Click

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Ullman Speaks with NutraIngredients-USA
August 26, 2020 | Health Services | Cannabis

Marc Ullman was quoted in a NutraIngredients-USA article, “AHPA event aims to guide CBD industry.”

The article discusses how products containing cannabidiol (CBD) represent a rapidly growing yet uncertain market segment, with those in the industry often finding themselves with more questions than answers.

Click here to read the full article.

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Ullman Quoted in NutraIngredients USA
August 21, 2020 | Health Services | Cannabis

Marc Ullman was quoted in a NutraIngredients USA article, “Upcoming event aims to help fill regulatory holes in hemp/CBD industry.”

The article discusses how CBD firms are often unprepared for the regulatory compliance side of operating a dietary supplement firm. The upcoming event that is being discussed in the article looks to assist with that.

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Ullman Quoted on FDA Import Alert Request
August 4, 2020 | Compliance Investigations & White Collar

Marc Ullman was interviewed for the Natural Products Insider article, “FDA, supplement manufacturer debate NDI import alert request.”

The article discusses why the FDA should issue an import alert on beta-alanine ingredients manufactured in China.

To read the full article, click here.

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Ullman to Present at Virtual Hemp-CBD Supplement Congress
July 20, 2020 | Compliance Investigations & White Collar | Health Services | Cannabis

On August 27, Marc Ullman will be presenting at the American Herbal Products Association (AHPA) Hemp-CBD Supplement Virtual Congress. The seminar will provide companies with an understanding of federal and state legal and regulatory obligations and current issues and opportunities in the hemp-CBD market.

Click here to register.

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Ullman Participates in Q&A on COVID-19 and the Natural Products Industry
July 2, 2020 | Compliance Investigations & White Collar

Marc Ullman spoke with Vitamin Retailer about the repercussions of the Coronavirus pandemic on the natural products industry. He was joined by 11 other panelists representing manufacturers, industry associations and consultants to the industry.

To read the Q&A click here.

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Ullman Cited in Article on CBD in Foods and Beverages
June 15, 2020 | Health Services | Cannabis

Marc Ullman was cited in Nutritional Outlook’s article, “High anxiety: Will CBD ever be legal in foods and beverages?”

The article discusses whether or not the FDA will ever approve the use of CBD in foods and beverages. Currently, it is not a lawful ingredient. Ullman provided advice on the procedures necessary to prove the

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Ullman Lends Perspective on FDA Warning Letter
June 4, 2020 | Compliance Investigations & White Collar | Cannabis

Marc Ullman was quoted in a Nutraingredients-USA.com article entitled “Warning letter cites CBD’s regulatory status as leading issue.”

The Food and Drug Administration sent a warning letter to a supplement manufacturer regarding various failures in good manufacturing practice (GMP). For the first time, however, the letter cited the health claims made about CBD as the first

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Ullman Lends Perspective on Import Alerts for Dietary Supplements
June 3, 2020 | Compliance Investigations & White Collar

Marc Ullman was quoted in the Nutraingredients-USA.com article, “NPA calls for FDA to issue import alerts on imported adulterated dietary supplement ingredients.”

The Natural Products Association is requesting that the Food and Drug Administration deal with the import of nutritional supplements that fail to comply with New Dietary Ingredient (NDI) regulations. Marc noted that FDA has

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Ullman Quoted in Nutraingredients-usa.com Article
May 14, 2020 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in the Nutraingredients-usa.com article, “CRN ends NAD funding, but value of claims evaluation program will go on.”

Click here to read the article.

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Ullman Interviewed about ABH Recall
April 7, 2020 | Compliance Investigations & White Collar

Marc Ullman spoke with NutraingredientsUSA.com about the impact of the ABH recall on the entire nutritional supplements industry, as thousands of products were recalled as part of a consent decree, which covered 859 businesses and brands. ABH is a contract manufacturer that was sanctioned by the FDA for repeatedly failing to comply with regulations.

Marc

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Ullman Quoted in NutraIngredients-USA
March 31, 2020 | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “NAD tells Church and Dwight to drop gummy absorption claim; appeal filed.”

Click here to read the article.

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Ullman to Present at Dietary Supplement GMP Compliance Seminar
February 21, 2020 | Health Services

THIS EVENT HAS BEEN POSTPONED OUT OF CONCERN FOR THE GUESTS’ HEALTH

Marc Ullman will be presenting at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar on April 16-17, 2020 at the Hilton Garden Inn Melville in Plainview, New York.

EAS Consulting Group will be conducting the seminar to help firms prepare for

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Ullman Quoted on ABH Manufacturing Recall
February 3, 2020 | Compliance Investigations & White Collar

Marc Ullman was interviewed for an article in Natural Products Insider entitled “Supplement contract manufacturing recall ‘unprecedented.'”

The article discusses how ABH, along with 859 of its nutritional products brands, was shut down by a U.S. Department of Justice consent decree.

To read the article, click here.

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Ullman’s Op-Ed on CBD Appears in Long Island Business News
January 29, 2020 | Compliance Investigations & White Collar | Cannabis

On January 29, 2020, Marc Ullman’s opinion piece, “FDA’s lack of CBD guidance is a disservice to Long Island firms,” appeared in Long Island Business News.

Marc notes that an exploding market for CBD products has created a conundrum for companies wishing to cash in. Either they obey FDA’s regulations and lose out, or they break

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Ullman Quoted on Contract Manufacturer Product Recall
January 22, 2020 | Compliance Investigations & White Collar

Marc Ullman spoke with Nutraingredients-USA about a recall of 1,200 products manufactured by Edgewood, NY-based ABH Nature’s Products, Inc. (also doing business as ABH Pharma, Inc. and Stocknutra.com, Inc.). The company issued a recall under a consent decree with the United States District Court for the Eastern District of New York.

The recall is intended to

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Ullman Quoted on Proposed CBD Legislation
January 21, 2020 | Compliance Investigations & White Collar | Cannabis

Marc Ullman spoke to Nutraingredients-USA about a new bill that would include CBD in the definition of dietary supplements in the federal Food, Drug and Cosmetic Act. The legislation is an attempt to cope with the raft of products now on the market that are technically illegal.

Marc said he thinks the bill will only

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Ullman Quoted on FDA’s Targeting of CBD
January 17, 2020 | Compliance Investigations & White Collar | Cannabis

Marc Ullman was quoted in a Nutraingredients-USA story entitled “Warning letter analysis shows FDA has target on CBD, not hemp.”

To read the article, click here.

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Ullman Speaks to Natural Products Insider about Listing Supplements with the FDA
January 7, 2020 | Compliance Investigations & White Collar

Marc Ullman was quoted in a Natural Products Insider article entitled “Trade group plans to lobby Congress on listing dietary supplement products  with FDA.” The story reveals that the Council for Responsible Nutrition will look for sponsors of a bill to require nutritional supplements to be listed with the Food and Drug Administration.

Marc, who opposes

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Ullman Quoted in Nutraingredients-USA.com
January 6, 2020 | Compliance Investigations & White Collar

Marc Ullman was quoted in the Nutraingredients-USA.com article, “Inconsistencies between NDA, GRAS raised in a letter to FDA.”

To read the article, click here.

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Ullman Quoted in Natural Products Insider
January 3, 2020 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in the Natural Products Insider article, “Sweeping changes proposed to dietary supplement notification system.”

Click here to read the article.

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Ullman Responds to Sen. Schumer’s Call for Federal Proble of Supplements Makers
January 2, 2020 | Compliance Investigations & White Collar

Marc Ullman was interviewed for the January 2 Long Island Business News story, “Schumer: FDA must reform diet supplement industry.” The article discussed Sen. Charles Schumer’s press conference, where he called for the Department of Health and Human Services to investigate three supplement makers based on Long Island.

Marc said that new regulations aren’t necessary. The

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Shapiro Participates in Nutritional Products Industry Forecast
December 30, 2019 | Compliance Investigations & White Collar

Steven Shapiro offered his predictions for the vitamin/nutritional products industry in Vitamin Retailer’s “2020 Forecast.”

Along with other industry notables, Steve discussed a range of issues that will affect the industry in the New Year, including the Dietary Supplement Health and Education Act, subscription-based personalized nutrition services and the call for the federal government to

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Ullman Quoted in NutraIngredients-USA
December 18, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in the NutraIngredients-USA article, “Across the Nutra-verse: New York’s hemp regulations, Poland’s new vitamin level limits, and more.”

Click here to read the article.

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Ullman Quoted in Nutraingredients-USA
December 12, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a Nutraingredients-USA article, “New York law sets stage for strictly regulated market for cannabinoids.” New York state recently put into place regulations that govern hemp cultivation within its boarders.

Click here to read the article.

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Ullman Quoted in Natural Products Insider
December 5, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a Natural Products Insider article, “CBD industry hit with nearly half a dozen class action lawsuits.” The FDA’s batch of warning letters last month to CBD marketers spawned a growing number of proposed class action lawsuits.

Click here to read the article.

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Ullman quoted in Nutraingredients-USA article
December 4, 2019 | Compliance Investigations & White Collar | Cannabis

Marc Ullman was quoted in a Nutraingredients-USA article, “Appeals court decision, recent warning letters open door for more CBD suits.”

Click here to read article.

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Ullman Discusses FDA Revision of Consumer Info on CBD
November 27, 2019 | Health Services | Cannabis

Marc Ullman is quoted in a Nutraingredients-USA article, “FDA revises consumer info on CBD, says ingredient is not GRAS, sends 15 CBD warning letters.”

Click here to read the article.

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Ullman Quoted in Nutraingredients-USA
November 25, 2019 | Health Services

Marc Ullman was quoted in a Nutraingredients-USA article, “11th Circuit concludes ‘adulterated’ supplements are worthless and this economic loss is sufficient to sue.”

Click here to read the article.

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Ullman Speaker at Dietary Supplement Regulatory Strategy Conference
November 20, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

On December 4-5, Marc Ullman will be speaking at the 4th Annual Dietary Supplement Regulatory Strategy Conference at the Key Bridge Marriott in Arlington, VA.

Topics to be addressed include:

  • Ongoing Impact of CBD Use in the Dietary Supplement Industry
  • Regulatory Oversight of Social Media Influencers & Supplement Claims
  • Interpretation of USDA National Bioengineered
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Ullman Instructor at GMP Compliance Seminar
November 5, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman will be an instructor at the Dietary Supplement Good Manufacturing Practices (GMP)  Compliance Seminar being held in Irvine, CA on November 14-15.

Click here to register.

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Ullman Quoted in Nutra ingredients-usa.com Article
October 29, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a Nutra ingredients-usa.com article, “Mississippi adds to regulatory tangle with warning on CBD products.”

Click here to read article.

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Ullman Quoted in Natural Products Insider Article
October 25, 2019 | Complex Torts & Product Liability | Health Services

Marc Ullman was quoted in a Natural Products Insider article, “DSHEA’s 25th Anniversary: Industry vets, critics respond.”

Exactly 25 years ago, President Bill Clinton signed a bill that has enabled the dietary supplement industry to flourish over the last quarter century. In the spirit of giving due consideration to the law’s successes and shortcomings, Natural

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Ullman Speaker at SupplySide West and American Herbal Products Association
October 11, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman will be a speaker at SupplySide West summit, “CBD from Seed to Shelf: The Supply Side Story.” Ullman’s session will be “Legal Eagles: Risk Update, Plus Your Questions Answered.” The Session will take place on Oct. 16 at Mandalay Bay, Las Vegas, NV.

Program Description:

Cannabinoids are on everyone’s mind—consumers, industry, regulators and

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Rivkin Radler Supports Hurricane-Relief Efforts
October 2, 2019

On September 28, 2019, Rivkin Radler attorneys Nancy Del Pizzo, Shari Claire Lewis, Steven Shapiro and Marc Ullman presented a certificate commemorating Rivkin’s donation to the Bahamas Disaster Relief Fund in support of Hurricane Dorian recovery efforts.  The presentation was made to Her Excellency Ms. Sheila Carey, Ambassador and Permanent Representative of the Commonwealth of

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Shapiro and Ullman Speakers at NPA Conference
September 10, 2019 | Health Services

On September 11-12, Steve Shapiro and Marc Ullman will be speaking at The Big Natural Conference hosted by the Natural Products Association. It will be held at the MGM National Harbor Hotel and Casino in Oxon Hill, MD.

Click here to register.

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Ullman Quoted in NutraIngredients-USA
August 16, 2019 | Health Services | Cannabis

Marc Ullman was quoted in a NutraIngredients-usa.com article, “Patchwork quilt of regulations could further complicate CBD picture if FDA doesn’t act quickly.”

Click here to read the article.

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Ullman Quoted on Confusing Web of CBD Laws
August 13, 2019 | Complex Torts & Product Liability | Health Services | Cannabis

Marc Ullman was quoted in the Long Island Business News’ article, “Confusing Web of Laws Muddles CBD Industry.” The article discusses the confusing web of contradictory laws and inconsistent enforcement in products containing CBD.

The sudden swell in CBD products stems in large part from the passage of the 2018 Farm Bill. CBD is derived

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Ullman Authors Article in Vitamin Retailer
July 11, 2019 | Privacy, Data & Cyber Law

Marc Ullman authored an article in Vitamin Retailer, “Cyber Security Basics for Retailers.”

Click here to read the article.

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Ullman Featured in The Big Mouth Pharmacist Podcast
July 8, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was a guest on Neal Smoller’s The Big Mouth Pharmacist podcast, “Supplement Manufacturing: Compliance and Concerns.”

Click here to listen to the podcast.

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Shapiro and Ullman Quoted in WholeFoods Magazine
May 23, 2019 | Health Services

Steve Shapiro and Marc Ullman were quoted in a WholeFoods Magazine article, “Phytocannabinoids: 25 Things to Know Now.”

Click here to read the article.

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Ullman Quoted in Natural Products Insider
May 6, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a Natural Products Insider article, “Hi-Tech sues FDA over DMHA enforcement.” The article discusses how Hi-Tech complained that FDA’s “arbitrary and capricious” enforcement against the stimulant threatens its CEO Jared Wheat’s bond stipulations in a multi-count federal criminal indictment.

“A botanical might have been marketed as a dietary ingredient [before DSHEA],

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Chambers and Partners Recognizes Rivkin Radler
April 25, 2019 | Health Services | Insurance Coverage

Uniondale, New York – April 25, 2019 – The prestigious Chambers USA Directory has once again included Rivkin Radler LLP in its New York rankings.  The firm’s Insurance Coverage Practice Group is ranked in Band 3 in the Insurance: Dispute Resolution: Insurer category and its Health Services Practice Group ranked in Band 4 in the

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Ullman Quoted in Natural Products Insider
April 19, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a Natural Products Insider article, “The Vitamin Shoppe to carry CBD following FDA’s move to exercise ‘enforcement discretion.'” The article discusses the FDA’s announcement to exercise “enforcement discretion” related to foods and supplements containing CBD as a factor driving mass-market retailer activity in the category, including The Vitamin Shoppe’s recent move

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Ullman Gives Insight on FDA Warnings Letters
April 18, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “FDA sends warnings letters on illegal ingredients in sports, weight loss products.” The article discusses the 11 warning letters that were sent to companies that have non NDI ingredients in their products. Eight of the warning letters concerned DMHA and the other three concerned phenibut.

Ullman has

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Ullman Quoted in NutraIngredients-USA
April 17, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “FDA’s new advisory list receives mixed reactions from industry.” The article discusses how the FDA announced a new ‘rapid communication tool,’ called the Dietary Ingredient Advisory List. Trade groups and industry experts applauded the effort, but many opined that this step still has much left to be

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Ullman Reflects on Need for More FDA Enforcement
March 18, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “Indictment handed down in Florida over sale of SARMs, steroids.” Six people and two companies were charged by federal prosecutors for allegedly selling drugs unapproved by the FDA as supplements.

“Some of these people seem to think, ‘What’s the worst that can happen to me? A warning letter?

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Ullman to Participate in GMP Compliance Seminar
March 11, 2019 | Compliance Investigations & White Collar | Health Services

On April 2, Marc Ullman, along with the EAS Consulting Group, will conduct a Dietary Supplement GMP Seminar to help firms prepare for increased FDA enforcement. Given by former FDA compliance officials and industry experts, this intensive training program will provide all the information needed to comply with the rules, covering the responsibilities of domestic and

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Ullman and Shapiro Present at Supplyside East
March 8, 2019 | Compliance Investigations & White Collar | Cannabis

On April 10, 2019, Marc Ullman and Steven Shapiro will be featured speakers at Supplyside East, presenting on the topic, “What Is the Regulatory Current State of Play with CBD?”

The pair will discuss the latest insights around regulatory issues related to cannabidiol at the international, national and local levels.

Supplyside East, which bills itself

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Ullman Quoted on Future of CBD Regs upon Gottlieb’s Departure
March 6, 2019 | Compliance Investigations & White Collar | Cannabis

Dr. Scott Gottlieb, who announced his plan to resign as FDA commissioner on March 5, 2019, had in the previous week just announced plans to develop a regulatory framework for CBD.

Marc Ullman spoke with Nutraingredients-USA about what might happen with the CBD initiative for the article entitled “Advocates hopeful that Gottlieb’s departure won’t derail

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Ullman Quoted in NutraIngredients USA
February 28, 2019 | Health Services | Cannabis

Marc Ullman was quoted in a Nutraingredients-USA article, “Gottlieb: FDA plans meeting in April on new CBD regulations.” FDA Commissioner Scott Gottlieb said the agency is planning a public meeting in April to initiate a rule making procedure on CBD.

Click here to read the article.

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Ullman Quoted in NutraIngredients-USA
February 19, 2019 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “Stakeholders cautiously optimistic on Gottlieb’s proposal for info protection in NDI filings.” The comments made by the FDA Commissioner Scott Gottlieb, MD, on the NDI’s issue have made dietary supplement industry stakeholders sit up and take notice.

“I’m encouraged just in that it is good to hear

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Ullman Participates in 2018 Farm Bill Webinar
February 7, 2019 | Compliance Investigations & White Collar | Cannabis

On March 13, 2019, Marc Ullman will be a presenter in an EAS Consulting Group webinar entitled “What Does the 2018 Farm Bill Mean for the Cannabis Industry?” The webinar will offer an informative discussion on the FDA’s position on cannabis and how the patchwork of state regulations makes the topic confusing.

Accompanying Marc will

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Ullman Discusses CBD Use for Pets
February 4, 2019 | Compliance Investigations & White Collar | Cannabis

Marc Ullman was quoted in the Nutraingredients-USA article, “Hemp and CBD in pet supplements weaves same tangled web as in products meant for humans.” The focus of the article is the regulatory gray area for hemp and CBD in supplements intended for animals.

Ullman noted, “FDA has been very quiet in this area. CB in pet

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Ullman to Speak at the Committee on Cannabis Session
January 11, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

On January 15, Marc Ullman will be speaking at the New York State Bar Association’s “Hot Topics in Cannabis Law 2019: What Lawyers Need to Know.”

He will be speaking on the topic of “CBD: What is it and What it Can Be.”

1. 0 CLE credit in the Areas of Professional Practice being offered.

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Ullman Discusses CBD in Pharmaceuticals for Life Science Leader
January 3, 2019 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was interviewed for a January 2, 2019, article in Life Science Leader magazine entitled “The Unique Challenges Facing Cannabis-based Pharma.” The story covers the lengthy process to get Epidiolex, the first ever pharmaceutical derived from cannabis, approved for medical use.

Marc noted that GW Pharmaceuticals, which developed Epidiolex, was successful because it is

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Ullman, Trade Associations Score Big Win in Arizona
January 2, 2019 | Compliance Investigations & White Collar

On behalf of a client, Marc Ullman helped secure a decision by the Arizona State Board of Pharmacy to withdraw its attempt to regulate the dietary supplement industry at the state level.

The matter arose when the client, a dietary supplement distributor, received the Board’s demand that it register with the state as a Non-Resident

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Ullman Participating in Hemp CBD Roundtable
December 4, 2018 | Compliance Investigations & White Collar | Health Services | Cannabis

On December 14, Marc Ullman will be participating in the Hemp CBD Legal Roundtable at the Governor’s Office in NYC.

The roundtable will be facilitated by Axel Bernabe, Assistant Counsel to the Governor, Scott Wyner, General Counsel of the Department of Agriculture and Markets, and Brian Malkin, Co-Chair of the New York State Bar Association’s

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Rivkin Radler Launches Healthcare Electronic News Bulletin
November 1, 2018 | Health Services

Rivkin Radler has launched “Rivkin Rounds,” a new electronic news bulletin for businesses, professionals, investors and stakeholders in the healthcare industry. The bulletin will present brief articles with links to primary sources, covering such items as developments in regulations and laws affecting the healthcare industry and related health insurance market, and important cases and regulatory

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Ullman, in Yahoo Finance, Discusses Herbalife
October 31, 2018 | Compliance Investigations & White Collar

Marc Ullman was asked about Herbalife’s regulatory woes for a Yahoo Finance piece that talks about the multilevel marketer’s role as one of the hottest stocks on the market. To read the story, click here.

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Ullman Quoted in Natural Products Insider
August 22, 2018 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a Natural Products Insider article, “FDA warns drug manufacturer marketing CBD products.”

According to FDA, all CBD products sold as supplements are noncompliant, said Ullman.

“But they [FDA officials] are using their discretion for now and acting only against the products making illegal drug claims,” Ullman informed. “The thing about enforcement discretion

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Ullman a Speaker at Good Manufacturing Practices Seminar
August 2, 2018 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman  will be a speaker at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar, with a special section on applying GMP concepts to the cannabis industry. The program will take place at Hotel Indigo in Dallas, Texas in September 2018.

At the Dietary Supplement GMP Seminar, You Will:

  • Receive detailed practical guidance
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Ullman Warns Sports Nutrition Companies of False Advertising
July 9, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “NAD ruling reaffirms that science on ingredients shouldn’t be extrapolated to cover finished formulation.”

The National Advertising Division has recommended that a sports nutrition marketer called VH Nutrition discontinue claims made on their supplement “TriDrive” in which they indicate boosts oxygen update capacity and speed recovery.

Ullman said, “you

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Ullman Gives His Input on NDI Filings
July 6, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article, “NDI filings coming in at expected rate, FDA says, but questions on GRAS process remain.” The article focuses on the FDA’s belief that there will not be a significant change in how many companies are choosing to go through the process to file NDIs.

“I have been

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Ullman Quoted in NutraIngredients-USA
June 28, 2018 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a NutraIngredients-USA article, “FDA says Gottlieb statement does not signal CBD enforcement shift, but some questions unanswered, observers say.”

A statement by FDA Commissioner Dr. Scott Gottlieb noted that the US Food and Drug Administration has approved the first CBD drug, which was developed by English company GW Pharmaceuticals. The

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Ullman a Speaker at Vitafoods Asia at the Sands Expo & Convention Centre
June 25, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman will be a speaker at the Vitafoods Asia at the Sands Expo & Convention Centre at Marina Bay Sands, Singapore in September 2018. Marc’s topic is “Bringing Your New Dietary Ingredient to the US Market May Be Easier Than You Think (But Maybe Not).”

Program Descriptive;

  • Understanding whether you have a new
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Ullman Quoted in NutrIngredients-USA
May 18, 2018 | Health Services

Marc Ullman was quoted in a NutrIngredients-USA article, “Some Shady Ingredients Find Home in Nootropics Category.” The article focuses on the fairly new dietary supplement topic, “nootropics” otherwise characterized as “smart drugs.”

Ullman says, “I think there is a stigma associated with nootropics. A lot of these ingredients are really old drugs that have been

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Ullman on Class Action Panel at Dietary Supplements Forum
May 17, 2018 | Compliance Investigations & White Collar

On Wednesday, June 20, 2018, Marc Ullman will speak on a panel at the American Conference Institute’s 6th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements.

Entitled, “Coattail Claims: The Latest Influx of Class Action Litigation Impacting Dietary Supplements,” the discussion will cover:

  • Recent class action filings against dietary supplement manufacturers
  • Strategies to
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Ullman Quoted in Natural Products Insider Article
May 15, 2018 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a Natural Products Insider article entitled, “CO Hemp Food Bill Passed by Legislature Seeks to Pre-Empt Pharma Lawsuits.” The article addresses a proposed bill in Colorado that will codify into law an existing policy to regulate hemp as a food ingredient.

Click here to read the article.

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Ullman Quoted in Natural Products Insider Article
April 24, 2018 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a Natural Products Insider article entitled, “FDA Triggered Industry Shift from ‘CBD’ to ‘Hemp Extracts’ in Dietary Supplements.” The article addresses the point that amid the escalating demands for CBD in the United States, many companies are selling “hemp extracts,” a strategy based on regulatory and scientific considerations.”

“If you’re

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Ullman Gives His Perspective on ‘Memory Improvement’ Product
April 19, 2018 | Compliance Investigations & White Collar

Marc Ullman was interviewed for a Nutraingredients-USA article entitled, “FTC Begins Refunding Consumers in False Memory Claims Case.” The article discusses a product named CogniPrin, promoted via radio segments that were created to sound like radio talk shows.

Marc noted that using radio ads to promote nutritional products can create compliance issues. “There is a

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Ullman Quoted in NutraIngredients-USA
April 3, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article entitled, “CRN says more enforcement should go with FDA’s plan to step up package screenings.” The article discusses the FDA’s challenges in monitoring the large influx of packages being brought into the country.

Marc notes another recurring issue that FDA needs to address, “Along with the increased

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Ullman Quoted on DOJ’s Request to Turn Down Amarin Appeal
March 29, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NutraIngredients-USA article entitled, “Department of Justice joins chorus asking court to turn down Amarin appeal.” The article discusses the Department of Justice’s request for the federal appeals court not to rule in favor of the drug maker’s attempt to force the International Trade Commission (ITC) to hear its plea that

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Ullman an Instructor at Dietary Supplement GMP Compliance Seminar
March 28, 2018 | Compliance Investigations & White Collar

Marc Ullman will be an instructor at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar, which takes place on April 4-5, 2018 in Denver, Co.

At this seminar you will learn the requirements of the final rule and understand how they differ from the proposed rule that was published in March 2003.  You will

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Ullman Speaks on Broken NDI Process
March 13, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman, a regular presenter at SupplySide East, the East Coast’s large ingredients trade show, will again weigh in at this year’s show. On Tuesday, April 10, in New York City, he will  present on the topic, “25 Years after DSHEA & the NDI Process Still Broken.”

Marc will discuss how, 25 years and two

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Ullman Quoted in Article on Pre-Market NDIs
February 23, 2018 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a Natural Products Insider article entitled, “Basic Omissions Doom Many Dietary Supplement Ingredient Notices to FDA.” The article discusses why the FDA objected to the majority of pre-market notifications for new dietary ingredients (NDIs) in 2017.

Marc notes, “It isn’t a surprise when you submit an incomplete form to anyone that

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Ullman Presents at EAS Dietary Supplement GMP Compliance Seminar
January 16, 2018 | Marc S. Ullman | Compliance Investigations & White Collar

Marc Ullman will be a presenter at the Dietary Supplement Good Manufacturing Practices (GMP) Compliance Seminar, to be held April 4-5 in Denver, CO.

The GMPs dictated in 21 CFR 111 have been in place for over a decade, but the FDA continues to issue numerous Warning Letters to the industry for a failure to

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Ullman Quoted in MedPage Today
January 5, 2018 | Health Services

Marc Ullman was interviewed for an article in MedPage Today entitled, “How Will the Supplement Industry Fare without Hatch?” The article focuses on the recent retirement announcement of Senator Orrin Hatch and highlights his victories for the supplement industry during his time in office. It was noted that Senator Hatch’s departure from office will not adversely

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U.N.-Affiliated Initiative Gets an Assist from Rivkin Radler
December 12, 2017 | Shari Claire Lewis | Marc S. Ullman | Steven Shapiro | Nancy A. Del Pizzo | Compliance Investigations & White Collar | Health Services | Intellectual Property

The Island Women Open Network (IWON), created by the Sustainable Energy and Climate Resilience Initiative in partnership with the United Nations Industrial Development Organization (UNIDO), signed an agreement engaging Rivkin Radler LLP for legal assistance.

IWON’s main objective is to empower women and children at the grassroots level to transform the sustainable-energy sector of Small

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Ullman Quoted in Natural Products Insider
November 7, 2017 | Health Services | Cannabis

Marc Ullman was interviewed for an article in Natural Products Insider entitled, “Hemp Lawyer: FDA CBD Warning Letters Shouldn’t Alarm Industry.” The article centers on the FDA’s intolerance of claims that CBD-containing foods and dietary supplements treat diseases such as cancer. The FDA advised that  CBD (cannabidiol) cannot be sold in dietary supplements, or added to

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Shapiro and Ullman Quoted in Natural Products Insider
October 17, 2017 | Compliance Investigations & White Collar

Steven Shapiro and Marc Ullman were interviewed for a story in Natural Products Insider entitled, “FDA’s Efforts to Develop Pre-DSHEA List Face Mounting Skepticism.” The article discusses how sources in the dietary supplements industry doubt whether the FDA’s plan to build a list of “old” dietary ingredients is feasible.

To read the article, click here.

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Rivkin Radler Team Presents at SIDS DOCK
September 29, 2017 | Privacy, Data & Cyber Law

On September 22, Nancy Del Pizzo, Steve Shapiro and Marc Ullman made a presentation to the Small Island Developing States (SIDS DOCK) Island Women Open Network (IWON) at the Commonwealth Joint Offices in New York City. The presentation, which took place at the first meeting of the SIDS DOCK IWON Committee, described the legal services

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Ullman Quoted in NutraIngredients-USA
September 21, 2017 | Compliance Investigations & White Collar

Marc Ullman weighed in on a story in NutraIngredients-USA.com entitled, “Amarin’s ITC case against omega-3s players decried as attempt to corner EPA market.”

The article discusses how, as the concentration levels of omega-3 dietary supplement products have steadily risen, pharmaceutical manufacturer Amarin has moved to protect its competitive turf by filing a trade complaint against

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Ullman Quoted in Nutraingredients-USA
September 6, 2017 | Compliance Investigations & White Collar

Marc Ullman was interviewed for an article entitled, “ChromaDex-Elysium fight highlights glitches in NDI and GRAS processes.” The article discusses the tussle between ChromaDex and Elysium Health, which highlights the curious dance between a New Dietary Ingredient Notification and a GRAS affirmation as a way to bring ingredients to market.

To read the article, click

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Ullman to Speak at SupplySide West Workshop
August 30, 2017 | Compliance Investigations & White Collar | Health Services

Marc Ullman will participate on a panel for a workshop entitled, “FDA Lawsuits and Class Action Litigation in the Dietary Supplement Industry,” to be held at the SupplySide West annual conference.

The September 26 workshop, which will take place at the Mandalay Bay Expo Hall in Las Vegas, will examine the FDA’s years-long court battle

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Ullman Weighs in on DMAA Ruling
July 28, 2017 | Compliance Investigations & White Collar

Marc Ullman was quoted in Natural Products Insider’s article: “Hi-Tech Files Appeal in DMAA Fight with FDA,” which discusses Hi-Tech Pharmaceuticals Inc.’s quarrel with the federal government regarding the legality of the supplement DMAA, or 1,3-dimethylamylamine.

To read the article, click here.

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Ullman Quoted in Natural Products Insider
July 20, 2017 | Compliance Investigations & White Collar

Marc Ullman was quoted in a July 20, 2017 article entitled, “Executive Sold DMAA Supplements, Sentenced to Prison.” The story centers on the president of a dietary supplement company who was sentenced to an 18-month prison term for failing to disclose the presence the amphetamine derivative DMAA on the product labeling for his company’s supplements.

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Ullman quoted in Nutritional Outlook
April 24, 2017 | Compliance Investigations & White Collar

Marc Ullman was quoted in an article entitled, “How Will Donald Trump Affect Global Ingredient Sourcing?,” which was published in the April 2017 issue of Nutritional Outlook.

Click here to read the article.

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Ullman quoted in NUTRA ingredients-usa.com
April 11, 2017 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in an article entitled, “FDA Prevails Over Hi-Tech On DMAA, But Ruling Could Open Door On Synthetic Botanicals,” which was published in the April 2017 issue of NUTRA ingredients-usa.com.

Click here to read the article.

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Ullman Participates in Webinar for the American Herbal Products Association
March 28, 2017 | Compliance Investigations & White Collar

Marc Ullman and a panel of industry lawyers will present a webinar entitled, “Ensuring Your Dietary Supplement Claims are Truthful, Substantiated and Will Help Sell Your Product.”

The Federal Trade Commission (FTC) enforces against false, misleading and deceptive advertising. Claims can be misleading if they are not substantiated. Testimonials and social media can trip you

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Ullman Participates in American Herbal Products Association Webinar
February 14, 2017 | Compliance Investigations & White Collar | Health Services

On March 28, Marc Ullman will be participating in a webinar sponsored by the American Herbal Products Association entitled, “Claims Substantiation – Ensuring Your Dietary Supplement Claims are Truthful, Substantiated and Will Help Sell Your Product.”  The webinar will address legal standards, today’s regulatory environment and the lawsuit risks and liabilities marketers face if claims

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Ullman quoted in NUTRAingredients-usa.com
February 2, 2017 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a NUTRAingredients-usa.com article entitled, “Trump’s Executive Order Could Upend Current Regulatory Structure, Experts Say.”

Pres. Trump’s executive order requiring new regulations to be offset by the elimination of existing ones could wreak havoc with the pending roll-out of long awaited rules, such as the NDI draft guidance, observers say.

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Ullman quoted in Nutritional Outlook magazine
January 13, 2017 | Complex Torts & Product Liability | Health Services

Marc Ullman was quoted in an article entitled, “Dietary Supplement Contract Manufacturing in a Time of Trump,” which was published in the January 2017 issue of Nutritional Outlook.

Click here to read the article.

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Ullman & Shapiro Participate on NYSBA Panel
January 5, 2017 | Health Services

Marc Ullman will be speaking, and Steven Shapiro will be moderating, a panel for the Food, Drug & Cosmetic Law Section of the New York State Bar Association at its 140th Annual Meeting. The panel, “Hot Topics in Food/Dietary Supplements,” will examine how a new ingredient intended for use in dietary supplements can be brought

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Ullman Quoted in Nutritional Outlook
December 23, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in a Nutritional Outlook Magazine article entitled, “GNC’s Department of Justice Deal is a ‘Fair Deal,’ One Expert Says.” The titular expert, Ullman shared his view on GNC’s non-prosecution agreement with the DOJ:

“I think GNC was lucky they weren’t prosecuted,” adding, “When you read between the lines, there was the

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Ullman Named to the Board of Directors of Natural Products Association Eastern Region
December 21, 2016 | Complex Torts & Product Liability | Health Services

Marc Ullman has been named to the Board of Directors of the National Products Association Eastern Region.

The Eastern Region of the National Products Association is active in promoting the natural products trade in  Maine, Vermont, New Hampshire, Rhode Island, Massachusetts, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, Virginia, and Washington, DC.  It’s work

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Ullman Quoted in NUTRAingredients-usa.com
November 15, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman was recently quoted in the NUTRAingredients-usa.com article entitled, “Linnea May Quit the US Entirely if FDA Takes Action Against Vinpocetine.”

To read the full article, Click Here.

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Ullman to Present at Dietary Supplement GMP Compliance Training Seminar
October 19, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman will be an instructor at the upcoming Dietary Supplement GMP Compliance Training Seminar in Salt Lake City, UT, October 25-26, 2016, presented by EAS.

At the GMP seminar you will:

  • Learn the requirements of the final Rule and understand how they differ from the proposed rule that was published in March 2003.
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Ullman Quoted in Article for Nutritional Outlook
October 19, 2016 | Compliance Investigations & White Collar | Health Services | Cannabis

Marc Ullman was quoted in a recent Nutritional Outlook article entitled, “Will Hemp CBD’s Regulatory Controversy Help or Hurt Its Future as a Supplement Ingredient?”

To read the full article, Click Here.

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Lewis, Balboni, Ullman & Shapiro to Speak at SupplySide West Expo
October 4, 2016 | Privacy, Data & Cyber Law | Compliance Investigations & White Collar

Shari Claire Lewis, Michael A.L. Balboni, Marc S. Ullman and Steven Shapiro will speak at the SupplySide West Expo being held in Las Vegas from October 4-8, 2016. SupplySide West is the world’s leading ingredient and solutions trade show where science and strategy intersect. Over a thousand exhibitors and 120 hours of educational programming attract

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Ullman Quoted in Natural Products Insider
September 1, 2016 | Compliance Investigations & White Collar

Marc Ullman was quoted in a recent Natural Products Insider article entitled, “DEA Likely Decimates Kratom’s Chances at Becoming Lawful Dietary Supplement.”

To read the full article, Click Here.

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Ullman quoted in NUTRA ingredients-usa.com
August 15, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman has been quoted in the Aug. 12 issue of NUTRA ingredients-usa.com, in an article entitled, “GRAS route will still be popular with hard line taken in NDI draft on synthetic botanicals.”

Click here to read the article.

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Ullman quoted in Nutra Ingredients-USA.com
July 19, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman has been quoted in a Nutra ingredients-usa.com article entitled, “AMA Warns Members About Rise of Nootropics.”

Click here to read the article.

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Health Services Practice Group Selected for Inclusion in The Legal 500
June 23, 2016 | Health Services

The prestigious Legal 500 has included Rivkin Radler LLP in its U.S. rankings.  The firm’s Health Services Practice Group is listed in the Healthcare: Service Providers category.

“Our Health Services group has made incredible strides this year,” said Managing Partner Evan H. Krinick. “The team deserves kudos for their client service, which was also recognized

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Ullman quoted in Natural Products Insider
June 13, 2016 | Complex Torts & Product Liability | Health Services

Marc Ullman was quoted in the June 9, 2016 issue of the Natural Products Insider in an article entitled, “Herb Kratom Faces Hurdles to Become Legal Dietary Supplement.”

Click here to read article.

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Ullman and Shapiro Issue USU Law Monthly Update
June 3, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman and Stephen Shapiro have issued their USU Law Monthly Update for June 2016.

June 2016 USU Law Update

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Ullman speaker at the Council for Responsible Nutrition Regulatory Summit
May 5, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman will be a speaker at the Council for Responsible Nutrition (CRN) Regulatory Summit.  Marc’s topic is entitled, “Industry perspective on ingredient status.”

CRN’s Regulatory Summit is a one-day conference in Washington, D.C.  It is focused on exploring FDA and industry perspectives on regulatory implementation and compliance regarding dietary supplement GMPs and other provisions

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Ullman quoted in Nutritional Outlook
March 4, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in the Nutritional Outlook article entitled, “Bearing Any Burden – Industry scrutiny and the economics of contract manufacturing.”

Click here to read entire article.

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Ullman quoted in Nutritional Outlook
February 24, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in the Nutritional Outlook article entitled, “The Price of Dietary Supplement Contract Manufacturing.”

Click here to read entire article.

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Ullman quoted in National Outlook magazine
January 13, 2016 | Compliance Investigations & White Collar | Health Services

Marc Ullman was quoted in the National Outlook article entitled, “Holding the Line.

Click here to read entire article: http://dc.cn.ubm-us.com/i/614811-nutritional-outlook-december-2015/15

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Mulè and Ullman Quoted in Natural Products Insider
November 13, 2015 | Appeals | Health Services

Michael Mulè and Marc Ullman were recently quoted in an article for Natural Products Insider entitled, “NBTY, Retailers Named in Amended Herbal Supplement Class-Action Lawsuit.”

To read the complete article, Click Here

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Ullman Quoted in NutraIngredient Articles
November 3, 2015 | Health Services

Marc Ullman has recently been quoted in a number of articles for nutraingredients-usa.com. Please click on the titles below to read the full article.

GNC Shares Drop 15% After Oregon AG Alleges use of “Illegal” Ingredients in Products

Sharfstein Floats New Regulatory Framework Dialing in on Safety and Backing Off on Claims

Supplement Firm Still in Operation Despite

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Ullman Quoted in Whole Foods Magazine
October 31, 2015 | Health Services

Marc Ullman was quoted in a recent Whole Foods Magazine article entitled, “Industry Leaders Discuss Future of Dietary Supplements.” Please click the link below to read the complete article.

Whole Foods Magazine

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Ullman Quoted in Nutritional Outlook Magazine
October 27, 2015 | Health Services

Marc Ullman was quoted in a recent article for Nutritional Outlook Magazine entitled, “The Dietary Supplements Industry Won the Bayer Case, but Still Needs to Watch the FTC, Leaders Warn.” To read the full article, Click Here

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Ullman on panel for webinar
October 21, 2015 | Health Services

Rivkin Radler partner, Marc Ullman, will be on the panel for a webinar entitled, “Choosing the Right Test for Your Dietary Supplement.”

Description of webinar:

There isn’t an identity test available that is a one-for-all.  While the FDA holds the manufacturer responsible for the identity, purity, strength and composition of the product. Not all manufacturers

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Ullman on Panel at SupplySide West Conference
October 7, 2015 | Health Services

Marc Ullman will be a panelist at the SupplySide West conference on October 7, in Las Vegas, NV.  The program is entitled, “Facing the Future of Dietary Supplements in the United States.” 

Program description:

“Last year was the 20th anniversary of the passage of the Dietary Supplement Health & Education Act (DSHEA), which forms the

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Ullman Instructor at EAS Consulting Group Seminar
September 29, 2015 | Health Services

Marc Ullman will be an instructor at EAS Consulting Group’s seminar entitled, “Dietary Supplement GMP Compliance Training Seminar,” to be held on September 29-30, 2015.

Program description:

In light of the pressure being placed on the FDA to increase enforcement of the dietary supplement regulations, a thorough review of good manufacturing practices (GMPs) is warranted. This

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Ullman & Shapiro & Ullman join Rivkin Radler as Of Counsel
August 31, 2015 | Health Services

Evan H. Krinick, Managing Partner of Rivkin Radler LLP, announced that Marc Ullman, Steven Shapiro and their firm, Ullman, Shapiro & Ullman have joined Rivkin Radler as Of Counsel. The new alliance brings together Ullman, Shapiro & Ullman, LLP (USU), one of the natural products/dietary supplements industry’s leading regulatory law firms with Rivkin Radler LLP,

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