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The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act (FSMA) regulations. Under the FSVP rule, importers must take steps to verify that their foreign suppliers produce food that satisfies U.S. food…

The Food and Drug Administration (FDA) recently announced its Fiscal Year (FY) 2020 fee rates, which in particular cover the fees for facility reinspections and participation in the Voluntary Qualified Importer Program (VQIP).  These fees were authorized by the FDA Food Safety Modernization Act (FSMA) and were first implemented in October 2011 (for FY 2012).…

Oatly, Inc. has chosen to discontinue its “no added sugars” advertising claims after the Campbell Soup Company brought a challenge before the National Advertising Division (NAD). Campbell argued that various claims found on Oatly oatmilk products, including “0 g added sugars” and “no added sugars,” were misleading because the products contain maltose, a sugar by-product…

The U.S. Food and Drug Administration (FDA) recently finalized its  “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive Controls Regulations for Human and Animal Food).” The Guidance is intended to help facilities determine whether they qualify as a “small business”…

FDA recently released a Draft Guidance for Industry entitled, “Reducing Microbial Food Safety Hazards in the Production of Seed for Sprouting” (“Draft Guidance”). The Draft Guidance addresses the growing, harvesting, conditioning, and holding of seed for sprouting.

The Draft Guidance notes that the FDA has reported 50 outbreaks of foodborne illness associated with sprouts in…

The Office of Management and Budget (OMB) recently released the Spring 2019 Unified Agenda of Regulatory Actions, which outlines the rulemaking actions currently under development in each federal agency. This memorandum summarizes the major actions that may be of particular interest to the food industry that are being planned by the U.S. Food and Drug…

On June 18, the Food and Drug Administration (FDA) issued its final guidance document on added sugars labeling for (1) honey, maple syrup, and other single-ingredient sugars and syrups; and (2) certain cranberry products. In this blog post, we summarize the FDA’s guidance on the added sugars declaration for each type of product. Notably, for…

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). The consent order, which was approved by the district court judge on June 11, 2019, establishes…

Today the Food and Drug Administration (FDA) issued draft guidance announcing that the agency intends to exercise enforcement discretion to allow the use of “potassium chloride salt” as an alternative common or usual name for “potassium chloride.” Potassium chloride is often used as a partial substitute for sodium chloride (i.e., salt) to facilitate sodium reduction…