Nutrition Facts FAQs

FDA Nutrition Facts label changes FAQ

Susan Gosnell Food and beverage Leave a Comment

The US Food and Drug Administration (FDA) introduced the Nutrition Facts label in 1993 with the goal to provide valuable nutritional information for consumers. After more than two decades, the design of the label is undergoing significant design and content changes. This list of frequently asked questions gives an insight into the most vital information about these changes. Why is …

Serving size changes

How will the change in serving and package sizes affect your nutrition labels?

Susan Gosnell Food and beverage Leave a Comment

Since the FDA announced the changes in nutrition label design in May 2016, one of the most discussed topics has been the adjustment of serving and package sizes. These will impact both nutrition label information and design, especially with packages larger than one serving that can be consumed in one or multiple sittings. Learn about the new FDA regulations so …

FDA Nutrition Facts label

What are the main changes to the FDA Nutrition Facts label?

Susan Gosnell Food and beverage Leave a Comment

In May 2016, the FDA announced changes to the Nutrition Facts label for packaged foods. The well-recognized food label design will keep most of its characteristics, but some declarations will no longer be required and new declarations will be added. All nutrition label changes can be grouped into three categories: design changes, declaration changes based on scientific findings, and changes …

Medical Device labeling

A recap of the Medical Device Packaging & Labeling Summit

Susan Gosnell Medical Devices Leave a Comment

Last week, medical device manufacturers from across the U.S. came together to discuss the constantly changing world of labeling at Q1 Productions’ 6th Semi-Annual Medical Device Packaging and Labeling Summit. While abiding by FDA labeling requirements presents ongoing challenges for these companies, topics like localization and translation also dominated much of the agenda. This group is always candid and open …

UDI compliance date extension

What you need to know about the UDI compliance date extension

Susan Gosnell Pharmaceutical 2 Comments

On September 6, 2016, the U.S. Food and Drug Administration (FDA) issued an extension letter to device labelers, extending the UDI compliance date to September 24, 2018 for certain Class II devices. The devices impacted by the UDI compliance date extension are classified as: Convenience kits Repackaged single-use devices The letter also clarified that the compliance date for biologic and …

Helpful resource in planning for September UDI deadline for Class II device compliance

Susan Gosnell Medical Devices Leave a Comment

Manufacturers of Class II medical devices must comply with the FDA’s Unique Device Identifier (UDI) regulations by September 2016, the latest in a series of deadlines for varying devices. Are you ready? The FDA manages a Global Unique Device Identifier Database (GUDID), to which manufacturers must submit their device details, via one of three accredited agencies. There is a fair …

Common UDI label mistake: The barcode prints over the edge of the label

UDI labeling: common mistakes and best practices

Marko Vrbnjak Medical Devices Leave a Comment

There’s no doubt that UDI is a hot topic among medical device manufacturers. They are currently under pressure to comply with the FDA’s UDI requirements. Europe plans to introduce similar rules that companies will need to adhere to in the next three to four years. Other countries like Brazil, Turkey and China are introducing their own rules. It’s clear that …