Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
The risk of a product recall has increased in recent years due to changing global regulatory standards. Contributing factors include geographically widespread supply chains and different manufacturing protocols among nations...more
Increasing globalization of product markets brings tremendous opportunities for product manufacturers. New technologies enable companies to reach consumers in markets all around the world, and rapid geographical expansion is...more
Believe it or not, there are just six more weeks until spring. As the weather warms up and humidity rises, homeowners will start to use their portable dehumidifiers. The use of portable dehumidifiers poses a significant fire...more
The Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”) was signed into law alongside other reforms to the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) on December 29, 2022, as part of a broader consolidated...more
Already in 2011, the EU Commission stated its intention to revise the Directive 2001/95/EC on general product safety ("GPSD") "to improve the safety of products circulating in the EU through better coherence and enforcement...more
The United Arab Emirates ("UAE") has recently released a draft of its highly anticipated product safety law (the "Law"), set to come into force in July 2019. This is the first time the UAE has enacted bespoke legislation...more
Recent FDA Recall Highlights & Developments - • The agency finalized Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C; Guidance for Industry and FDA Staff, providing recommendations regarding the...more
The U.S. Consumer Product Safety Commission (CPSC or the Commission) is the regulatory agency responsible for protecting the public from unreasonable risks of injury and death associated with consumer products. Pursuant to...more
Recently, Health Canada released guidance to help companies understand their reporting obligations under section 14 of the Canada Consumer Product Safety Act, which requires that sellers, distributors, importers, and...more
So what is the CPSC’s “fast track recall” program and what is the benefit of participating in it? What is a “stop sale notice” and why does the CPSC generally request it for fast track recalls? What else is required by the...more