Tag Archives: FDA

Considerations for Companies Interested in Manufacturing Hand Sanitizer to Fight Against COVID-19

As the COVID-19 pandemic continues, many businesses are manufacturing essential public health and/or medical supplies that are now in high demand.  Companies around the world—from global luxury brands like Dior and Givenchy to local distilleries throughout the United States—have been switching their alcohol-based product lines from the manufacturing of products such as perfume and spirits … Continue Reading

FDA Guidance on Voluntary Recalls and Smarter Food Safety

Voluntary recalls are a key tool that the Food and Drug Administration (“FDA”), and FDA-regulated companies, use to protect public health.  Voluntary recalls are also a corporate nightmare, and can be extremely taxing on supply chain relationships.  For industries and products where recalls are common – such as food and drugs – supply chain partners … Continue Reading

Food Safety Modernization Act’s First Major Compliance Date – What Food Importers Need to Know

Previously, we discussed the Food and Drug Administration’s (“FDA”) seven major food safety rules mandated by the Food Safety Modernization Act (“FSMA”).  (See previous posts here, here, and here.)  Of the seven, the rule for Foreign Supplier Verification Programs (“FSVP”) for Importers of Food for Humans and Animals will have the biggest impact on importers … Continue Reading

Vermont Leads Nation in Requiring GMO Labeling; How Has Industry Responded?

In July 2016, Vermont’s Act 120 will take effect, requiring food manufacturers that sell into the state to indicate on food labels whether their products are made using genetic engineering.  The new law, which was enacted in May 2014, was precipitated by a growing GMO labeling movement that now has gained traction in at least … Continue Reading

Pending FDA Rule Governing Transportation of Human and Animal Food (Or, Keep it Cold) (Or, Greater Regulation of the Cold Chain Anticipated)

This week’s Global Squire Patton Boggs Global Supply Chain Law Blog will once again focus on emerging regulations that impact food and beverage supply chains.  One regulation, which is fairly sweeping, is the proposed rule governing Sanitary Transportation of Human and Animal Food.  Found at Federal Register Vol. 79, No. 24, the new rule is … Continue Reading

FDA Implements Three New Rules That Impact Food Supply Chains

On Friday, November 13, the Food and Drug Administration (FDA) finalized three new rules designed to increase food safety and prevent foodborne illnesses that will impact food supply chains. The first rule, called the Produce Safety Rule, establishes “science-based” minimum standards for safe growing, harvesting, packing, and handling of fruits and vegetables grown for human … Continue Reading

The Future of Pharmaceutical Supply Chains (Or, Unpacking the Drug Quality and Security Act)

On November 27, 2013, President Obama signed into law the Drug Quality and Security Act (DQSA), HR 3204, legislation that will have broad-reaching effects on pharmaceutical supply chains.  The DQSA was enacted to help protect consumers from contaminated, counterfeit, and stolen pharmaceutical products, and was enacted as a response to a meningitis outbreak in 2012, … Continue Reading
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