Generic pharmaceutical drugs are versions of brand-name counterparts with one major difference:  they typically cost a lot less. By FDA regulation, the two have the same active ingredients, dosage forms and strengths, and routes of administration.[1] And while federal law generally regulates pharmaceutical approval, states can regulate pharmaceutical distribution. Why is this significant? All states permit pharmacies to substitute generic drugs for the brand name equivalent, and some states require substitution in certain circumstances.…

Long-anticipated changes to California’s Proposition 65 warning requirements took effect on August 30, 2018, through amendments and new rules issued by the California Office of Environmental Health Hazard Assessment. Among other changes, the new rules now (1) require businesses to provide California consumers with product warnings at the time of purchase, including at the time of online purchases; and (2) change the text of the warnings that businesses may use to qualify for “safe harbor”…

Manufacturers start with good intentions. They endeavor to create and develop safe products, advertise them accurately, and equip consumers with sufficient warnings and instructions to enable safe and proper use of their products. But despite these efforts, consumers will occasionally find ways to misuse or abuse products in ways that the manufacturer neither intended nor, in some cases, even contemplated.…

“Smart luggage” is truly smart. Companies have created sleek, stylish bags that also contain practical, convenient accessories. Although smart luggage solves all sorts of problems, it has grabbed the attention of airlines and authorities due to the use of lithium batteries. When companies develop new products, they can often turn to existing regulations to inform the plan and design, ensuring that it complies with the regulations when it is released. But sometimes innovation can make…

If a company facing a recall has managed it effectively, the hardest part is probably over. After writing about how companies can prepare for and manage an effective recall, here are strategies companies can use to restore order and maintain brand loyalty following a product recall.…

You put countless dollars and hours into making the best possible product, and it becomes a hit. But something goes wrong, and consumers may be getting hurt. A recall becomes necessary. As part of our series on managing product recalls, this post focuses on important steps companies can take during a product recall. The first step, as we wrote last week, is to be prepared for a recall. We explained some strategies for how to…