Is It Necessary for Congress to Amend the FD&C Act for FDA to Have the Authority to Prohibit Tianeptine’s Sale?

If the answer to this question is “no,” why are bills being introduced into Congress to give the U.S. Food and Drug Administration (FDA) expanded authority to regulate dietary supplements?

“Gas station heroin” is a

Steven Shapiro and Marc Ullman wrote the article, “What Dietary Supplement Companies Can Do to Address Potential Counterfeiting of Their Products,” for the August 2023 issue of Nutrition Industry Executive.

The article explains how counterfeit products are going mainstream by moving to legitimate websites. It details how two dietary supplement companies determined that a fraudsters were

Under the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 321(i), “cosmetics” are defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness or altering the appearance

The New York State Office of Cannabis Management (OCM) has announced regulations concerning the manufacturing and labeling of cannabinoid hemp products, and the availability of an online portal to facilitate required state licensure. Cannabinoid hemp products sold in the state must comply with the regulations by April 25, 2022. The OCM will be reaching out

Steven Shapiro authored the article, “Should the Dietary Supplement Industry Support FDA’s Push for Mandatory Product Listing?” for Nutrition Industry Executive.

The article discusses talk of creating “DSHEA 2.0” which would a require a “mandatory product listing” of all dietary supplement products to be submitted to the FDA. There seems to be a split in

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

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

Steven Shapiro wrote an article for Vitamin Retailer entitled, “Operating a Health Food Retail Establishment in the Age of Coronavirus.”

The article covers the measures retailers have taken to respond to the pandemic, including selling hand sanitizers and gloves, as well as the dangers of making claims about products purported to cure COVID-19. It also

Steven Shapiro published an article in Nutrition Industry Executive, “What is Slack-fill & Why You Need to Know.”

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Steven Shapiro authored an article “Making and Using Endorsements” that was published in Natural Products Insider. The article discusses the need for brands working with celebrity or influencer endorsements to share all pertinent information with its consumers.

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Steven Shapiro wrote an article published in the September 2018 issue of Vitamin Retailer entitled, “What is the story with CBD dietary supplements? Are they legal for sale in my store?”

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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.

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Steven Shapiro has published an article in Natural Products Insider entitled, “A Legal Look at the Definition of ‘Clean Label’.”

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Steven Shapiro weighed in on the FDA’s warning letter to JÙS By Julie over health claims. The company markets a variety of blended ready-to-drink blended smoothies and shots as well as soups and salads.

Steve compared JÙS By Julie’s situation to similar letters issued to 14 U.S. companies that were fraudulently promoting their products as treatments for cancer.

Steven Shapiro was quoted in a Natural Products Insider article entitled, “Dietary Supplement Industry Blasts N.Y. Labeling Legislation.”

In the article, Steven and other industry professionals weigh in on Assembly Bill 7607 which would require a dietary supplement in package form to bear a label containing the name and address of the manufacturer, distributor and

Caffeine seems to have been around forever. I do not remember my first cup of coffee or my first can of cola, but I do remember the over-the-counter (OTC) stimulant drug products containing 200 mg of caffeine that were an absolute necessity for most of my classmates to survive freshman year of college and first

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

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

In a highly followed litigation (CRN and NPA filed a number of amicus briefs), United States v. Bayer Corp. (US District Court for New Jersey) the Department of Justice and the Federal Trade Commission sought an Order holding Bayer in contempt of Court alleging that Bayer had violated the terms of a consent decree that