The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary

What are the 3 letters that should strike fear into the heart of every food executive?  No, the 3 letters are not F-D-A.  Although the Food and Drug Administration is quite powerful, the agency can only wield that power against a particular food company ­­­­when it has the evidence to do so.

The 3 letters

As previously reported, the Food and Drug Administration (FDA) and the U.S Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) are operating under significantly reduced functions since funding for the agency lapsed on December 22, 2018. Recently, there have been a number of media reports with updated information from FDA Commissioner Gottlieb regarding

On December 22, 2018, funding expired for certain agencies within the federal government, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture’s (USDA’s) Food Safety Inspection Service (FSIS), and the Consumer Product Safety Commission (CPSC). These agencies will be operating under significantly reduced functions until the shutdown ends, i.e., until Congress passes

The Food and Drug Administration (FDA) recently issued technical amendments to the final rule revising the nutrition labeling requirements. These technical amendments restore provisions that were inadvertently omitted when the new regulations were published, correct errors in FDA’s sample Nutrition Facts Panel (NFP) and Supplement Facts Panel (SFP) formats, and update cross references that were

The California legislature has passed a law amending the state’s slack-fill statute for food containers subject to the Federal Food, Drug and Cosmetic Act (FFDCA). Assembly Bill 2632 (AB 2632), which Governor Jerry Brown signed into effect on September 19, 2018, revises the slack-fill statute by creating four new so-called “safe harbor” provisions, under which

The U.S. Food and Drug Administration (FDA) last month announced it would exercise enforcement discretion over two qualified health claims characterizing the relationship between the reduced risk of coronary heart disease (CHD) and the consumption of oleic acid in edible oils (containing at least 70 percent of oleic acid per serving) when consumed in place

This week, the Food Safety Preventative Controls Alliance (FSPCA) released the online course “Conducting Vulnerability Assessments Using Key Activity Types” (KAT Course). This course satisfies the training requirement in the Mitigation Strategies to Protect Food Against Intentional Adulteration final rule (IA rule) to conduct a vulnerability assessment if using the Key Activity Types method. Below,

The U.S. Food and Drug Administration (FDA) recently released its Plant and Animal Biotechnology Innovation Action Plan (“Action Plan”). The Action Plan provides an overview of the key priorities FDA expects to pursue through 2020 to support innovation in plant and animal biotechnology. As highlighted in FDA Commissioner Gottlieb’s statement, the agency is committed to