The alert follows a wave of warning letters the agency sent to Supergoop!, Vacation Inc. and three other popular brands, ...

Federal health officials are warning sunscreen companies for violating drug regulations by selling products in unapproved ...

A popular Aldi snack is facing a voluntary nationwide FDA recall. According to a recent FDA announcement, the Park Street ...

Popular sunscreen products that come in mousse form, such as Supergoop!'s body mousse, may not protect wearers from the sun's ...

The FDA is cracking down on foaming, mousse sunscreen products. This week the agency posted a handful of warning letters that ...

The format is not allowed under current US rules for sunscreens, prompting the regulator to take action against several brands ...

Whoop Inc., the maker of screen-less fitness bands, said it will not disable its blood-pressure tracking tool despite a request from the US Food and Drug Administration.

FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying ...

On July 14, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued a warning letter (the “Warning Letter”) to WHOOP, Inc.

The Boston wearables firm says the software tool doesn't meet the definition of a medical device and shouldn't be regulated ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...