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 a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” FDA Commissioner Scott Gottlieb reflected on the 25th anniversary of the Dietary Supplement Health and Education Act, and stated his

Hogan Lovells will offer a free seminar on new U.S. food manufacturing, labeling, and inspection requirements that apply to any Mexican company exporting food to the U.S. These requirements cover both finished goods and ingredients.

Hogan Lovells U.S. partners Maile Hermida and Elizabeth Fawell will be visiting from Washington, D.C. to discuss these latest U.S. food law developments and how they affect all foreign companies that sell food to the U.S.

Who should attend?
Regulatory, quality control, and legal personnel from Mexican companies that export or intend to export food to the U.S.

Why attend?
Mexican companies that export food to the U.S. are required to follow U.S. requirements for manufacturing and labeling. They also are subject to inspection by the U.S. Food and Drug Administration.  Further, new U.S. requirements for U.S. food importers mean that Mexican food exporters will be subject to greater scrutiny by and questions from their customers. Failure to meet new U.S. food requirements can result in food being held up at the U.S. border and refused admission.


Continue Reading

The Office of Management and Budget (OMB) recently released the Fall 2018 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

The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food

The Food and Drug Administration (FDA) has released an Excel file that lists all general inspection citations included on every FDA Form 483 (Inspectional Observations) issued for almost the past ten years, from October 2008 through February 2018. The information is specific to each establishment that has been inspected by FDA across all areas of

On January 11, 2018, the Food and Drug Administration issued its 2018 Strategic Policy Roadmap (the Roadmap) in an effort to provide transparency about the FDA’s policy undertakings. The Roadmap outlines key priorities that the Agency will pursue in 2018 to advance its public health mission. The Roadmap covers all FDA-regulated product areas and includes

The U.S. Food and Drug Administration (FDA) has issued Draft Guidance on public warning and notification of recalls under 21 C.F.R. Part 7, and has announced steps to release recall information more quickly. The Draft Guidance provides recommendations to industry and FDA staff regarding the use, content, and circumstances for issuing public warnings and public

The U.S. Food and Drug Administration (FDA) has issued five FDA Food Safety Modernization Act (FSMA) final and draft guidance documents relating to supplier verification under both the Foreign Supplier Verification Program (FSVP) and the Preventive Controls for Human Food (PCHF) rules, as well as draft guidance regarding the Preventive Controls for Animal Food (PCAF)