Sep 30, 2021 | Cannabis, Cosmetics, Dietary Supplements, Drugs, Foods, Issue of the Month, Medical Devices, Tobacco, Veterinary
By Susan Crane, Independent Advisor, OTC Drugs and Labeling Historically, it has been straightforward for the FDA to review and monitor labeling and advertising for products under their jurisdiction, particularly drugs and medical devices. However, the widespread use...
Sep 1, 2021 | Foods, Issue of the Month
By Richard D’Alosio, EAS Independent Consultant I have always described working in regulatory as an iceberg, with the obvious black and white answers to inquiries akin to the visible iceberg floating in the water. However, underneath the water is the unknown or...
Jul 27, 2021 | Foods, Issue of the Month
By Ronald J. Levine Food labels are under attack. Every day new lawsuits are filed, often as class actions, as well as through regulatory actions. Legal actions concerning words such as “natural,” or “healthy” are all too common. THE FIVE STAGES OF GRIEF While some of...
Jun 28, 2021 | Foods, Issue of the Month
By James Goldman CPP, EAS Independent Consultant “It’s the packaging supplier’s fault!” Package quality disputes between suppliers and customers often start with someone in the filling plant stating “these packages aren’t as good as the ones we ran last week” without...
Jun 15, 2021 | Drugs, Issue of the Month
By EAS Senior Advisor for OTC Drugs and Labeling Susan Crane The Food and Drug Administration monitors the safety of drug products marketed in the United and requires the pharmaceutical industry to document and, as applicable, report adverse events experienced by...
Jun 1, 2021 | Foods, Issue of the Month
By Charles Breen, EAS Independent Advisor for Food Safety The popularity of new breweries, wineries and craft distilleries has created a community of devoted followers. Many producers do not realize one crucial thing—in addition to the Treasury Department’s Alcohol...
