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Consumer Product Matters A product safety and consumer related regulation and litigation blog

Tag Archives: FDA Regulations

OTC Drug Manufacturers: Keep Your Eyes and Ears on Congress

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), U.S. Congress

As we previously blogged about in mid-2016, Food and Drug Administration officials have been exploring and pushing for the creation of a new user fee program to support its regulatory activities related to over-the-counter (OTC, also known as nonprescription) drug products. In June of 2016, the Agency held a public meeting to solicit stakeholder feedback on… Continue Reading

The Last Set of Major FSMA Regulations Are Done!

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Supply Chain Risk Management

The last of FDA’s seven “foundational” rules mandated under the Food Safety Modernization Act of 2011 (FSMA) was published at the end of last month, just a few days before the May 31, 2016 deadline agreed to by the Agency when it settled a lawsuit related to its implementation of FSMA (our posts on the… Continue Reading

A Decade Later, Rules for the Sanitary Transportation of Food Finally Finalized by FDA

Posted in Distributors, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Retailer Product Safety, Supply Chain Risk Management

Last week, FDA finalized new food safety regulations seeking to ensure the sanitary transport of human and animal food, as required under the Food Safety Modernization Act (FSMA). The final Sanitary Transportation of Human and Animal Food Rule will affect shippers, loaders, carriers, and receivers of food transported by rail or motor vehicle in the… Continue Reading

FDA Announces More Changes to FSMA Implementation Rules

Posted in Food & Drug Administration (FDA), Food and Beverage, Importer Safety, Supply Chain Risk Management

On September 19, 2014, FDA announced potential changes to four rules that the agency proposed in 2013 to implement the Food Safety and Modernization Act (“FSMA”). FSMA was signed into law in January 2011 in response to many reported incidents of food-borne illness during the 2000s. FSMA’s goal is to ensure that food in the… Continue Reading