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.
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.
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.
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 […]
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 […]
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 […]
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?
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 […]
