Thought Leadership

While U.S. product recalls were relatively flat from the second to third quarter, expect an upsurge in the weeks and months to come as regulators – under growing pressure from Congress and consumer groups – turn their attention to currently unregulated categories.  Part of that pressure on regulators is a result of past handling of […]

If there was any doubt whether the entire active pharmaceutical ingredient (API) industry is a target for continued FDA scrutiny, it should be gone. Donald Ashley, director of FDA’s Office of Compliance, talked about major concerns the agency has with the API industry at the Association for Accessible Medicines’ conference. As reported in an article […]

For parents, especially first-time moms and dads, learning the do’s and don’ts of raising a child is like drinking from a firehose. But parents aren’t the only ones facing information overload when it comes to all the products on the market and the growing body of research related to infant and child safety. Regulators feel […]

The product recall by Denver-based marijuana cultivator Bonsai Cultivation reminds us all of the unique regulatory dynamic facing the cannabis industry. In this case, the cultivator – working with state officials – pulled marijuana products off the market because they may contain elevated yeast and mold counts. The recall followed a Denver Department of Public […]

FDA started issuing draft industry guidance related to Hazard Analysis and Risk-Based Preventive Controls for Human Food (PCHF) in January 2018, but the 16 chapters are still a work in progress. Most recently, the FDA alerted the industry in the federal register that Chapter 14: Recall Plan is now available. The PCHF guidance specifies that […]