Publications

publication October 7, 2026

Extended Producer Responsibility — The State of the States by Evan Phelps

For dietary supplement companies, state packaging EPR laws are an increasingly important compliance issue, but states take different approaches. In his update published by SupplySide Journal, Evan Phelps highlights California, Oregon and Colorado.

publication March 11, 2026

Extended Producer Responsibility (EPR) for Packaging: New Regulatory Burden for CPG by Evan Phelps

Brand owners face new financial obligations as states shift packaging waste costs from municipalities to producers. Evan Phelps outlines who is affected, what is required, and how to prepare for compliance in SupplySide Supplement Journal.

publication December 10, 2025

State of the Supplement Industry by Ivan Wasserman

In a year-end “State of the Supplement Industry” review published in Nutraceuticals World, Ivan Wasserman highlights anticipated new federal rules on GRAS notifications, increased state activity, and a potential resurgence in enforcement from the FTC and state attorneys general.

publication November 5, 2025

“Trends and Developments in Dietary Supplement Class Action Lawsuits in the US” by Rend Al-Mondhiry and Jennifer Adams

The US dietary supplement industry faces an increasing risk of class action lawsuits driven by claims related to labeling, testing, and compliance. In an article just published by RAPS.org, Rend Al-Mondhiry and Jennifer Adams examine current trends in class action cases, including challenges to FDA disclaimers for structure/function claims, inaccurate protein %DV declarations, and discrepancies […]

publication November 5, 2025

“Medical Device Warning Letters Under the First Nine Months of the Trump Administration” by Evan Phelps

Savvy medical device manufacturers understand that reviewing FDA Warning Letters offers strategic, operational, and compliance benefits. For example, such information can reveal patterns regarding FDA’s evolving priorities and enforcement focus areas, which, in turn, can enable device firms to create focused, data-driven risk mitigation plans. Publicly available records indicate that at least 34 medical device-related […]

publication October 21, 2025

“How to Navigate GLP-1 Supplement Claims and Compliance” by Rend Al-Mondhiry

Interest in GLP-1 products has grown exponentially over the past year. With this growth has come questions and scrutiny around the types of claims that can be made for dietary supplements intended for GLP-1 support — and rightly so, as there are boundaries regarding what can be said about the benefits of these products, and […]

publication October 6, 2025

“Preparing for the Transition to the Quality Management System Regulation: Are You Ready?” by Neil O’Flaherty

U.S. Good Manufacturing Practices (GMPs) for medical devices are poised to change. It’s been a minute: The last time they changed was in 1996 — almost three decades ago. How Are Device GMPs Changing — and When?

publication September 23, 2025

“What Information Does the FDA Expect in Your IFU?” by Neil O’Flaherty

When entering the U.S. market, a medical device’s Instructions for Use (IFU) are not just a technical document—they are a legal requirement. As a core part of labeling regulated by the FDA, the IFU must demonstrate your product’s intended use, safety, and compliance. A well-prepared IFU can support a successful FDA product marketing submission, while […]

What's Now

California Restricts Sales of Weight-Loss and Muscle-Building Products to Minors

A new California law (AB 2030) prohibits the sale of over-the-counter diet pills and dietary supplements marketed for weight loss or muscle building to consumers under 18. Each violation is punishable by a civil penalty MORE >

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