The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP).
FDA Launches Revised Food Defense Plan Builder
The U.S. Food and Drug Administration (FDA) has launched an updated version of the Food Defense Plan Builder to help companies meet the requirements of the Mitigation Strategies to Protect Food Against Intentional Adulteration regulations at 21 C.F.R. part 121, also known as the Intentional Adulteration (IA) rule.
FDA Announced Public Meeting on New Era of Food Safety
The U.S. Food and Drug Administration (FDA) recently announced it will hold a public meeting on October 21, 2019 to discuss the “New Era of Food Safety.” FDA is exploring new and emerging technology to assess risks and prioritize resources, while creating a digital, traceable, and safer system. The agency’s initial focus areas are traceability, smarter tools and approaches for prevention, the challenges of new business models and retail food safety, and support for the development of food safety cultures.
FDA Announces Meeting on Modernizing Standards of Identity
The U.S. Food and Drug Administration (FDA) announced it will host a public meeting on September 27, 2019 to discuss FDA’s efforts to modernize standards of identity and provide information about changes the FDA could make to existing standards of identity.
This public meeting is part of FDA’s Nutrition Innovation Strategy, which seeks to improve…
New Statutory Requirements for Texas Wind Farm Leases
The Texas legislature recently passed House Bill 2845 (“HB 2845”) imposing specific requirements on wind energy leases and wind developers’ decommissioning obligations for wind energy projects. While wind leases typically impose obligations on project companies relating to the removal of wind projects, HB 2845 mandates that wind leases must include specific provisions describing such obligations.
FDA Releases Guidance on Convert Units of Measure for Certain Nutrients on Nutrition and Supplement Facts Labels
The U.S. Food and Drug Administration (FDA) recently released guidance to assist food and dietary supplement companies on how to convert the previous units of measure for folate, niacin, vitamin A, vitamin D, and vitamin E to the new units required on the updated Nutrition Facts and Supplement Facts labels. The guidance includes step by step instructions, conversion factors for each nutrient, and sample calculations for converting to the new units of measure.
FDA Proposes New Health Warning for Cigarette Packages and Advertisements
Today, the U.S. Food and Drug Administration (FDA) issued a proposed rule that would require health warnings on cigarette packages and advertising. The warnings include color images depicting some of the lesser-known health risks of cigarette smoking. This is FDA’s second attempt to require graphic warnings for cigarette packages and advertisements.
FDA Issues First Warning Letter under FSVP Regulations
On July 30, 2019, the U.S. Food and Drug Administration (FDA) issued its first Warning Letter to an importer for violations of the Foreign Supplier Verification Program (FSVP) requirements at 21 C.F.R. Part 1, Subpart L (21 C.F.R. §§ 1.500 through 1.514). The Warning Letter was issued to a U.S. importer related to imported tahini implicated in a multi-state Salmonella Concord outbreak in spring 2019.
Updates on CERCLA Financial Assurance Requirements for Industry Sectors
D.C. Circuit Upholds USEPA Decision to Not Require Financial Assurance Under CERCLA for Hardrock Mining
We have previously blogged (in June 2019 and 2017) on a proposed rule released during the final days of the Obama Administration which required hardrock mines to provide financial assurance demonstrating they are able to fund the costs associated with the future cleanup of the mines under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), the federal statute designed to address releases of hazardous substances and the cleanup of hazardous waste sites nationwide. In December 2017, the USEPA stated its intention not to issue the final rule, finding that there was no need for any CERCLA financial assurance mechanism for operating hardrock mines based on existing federal and state programs as well as modern mining practices. Several environmental organizations filed suit in the U.S. Court of Appeals for the D.C. Circuit, challenging the USEPA’s decision not to issue the rule.
Is Your Animal Food Safety Plan up to Snuff?
We are approximately nine months into FDA’s animal feed and pet food facility inspections for compliance with the Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food (PC) rule. With PC inspections starting for small businesses this Fall, there are a few lessons we have learned from the inspections that have occurred to date.