The U.S. Food and Drug Administration (FDA) has released the first of three installments of its long awaited Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule.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
FDA. Food Safety
FDA Commissioner Gottlieb Announces New Nutrition Innovation Strategy
On March 29, 2018, Food and Drug Administration (FDA or the agency) Commissioner Scott Gottlieb, M.D., delivered a nutrition-related policy address. The Commissioner emphasized FDA’s role in helping Americans improve their nutrition as a step towards reducing chronic disease, with a particular focus on sodium reduction. The Commissioner’s address provides important insight into the shape…
FSMA Implementation Update (March 2018)
There have been several recent developments regarding implementation of the FDA Food Safety Modernization Act (FSMA). The below post summarizes the following topics:
- Guidance on application of the Foreign Supplier Verification Programs (FSVP) regulation to the importation of certain live animals;
- Draft Guidance on the definition of “small business” for purposes of the Preventive Controls
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FSMA Implementation Update: Written Assurances, Food Defense, Human Food By-Products, and More
FDA recently shared information regarding a number of ongoing FDA Food Safety Modernization Act (FSMA) implementation issues. This post summarizes updates and developments regarding the following matters:
1. The written assurance requirements under several FSMA regulations;
2. Industry concerns regarding the Intentional Adulteration regulation;
3. Regulation of human food by-products for use as animal food…
FDA Issues Guidance on Co-Manufacturer Supplier Verification Under FSMA
The U.S. Food and Drug Administration (“FDA”) recently issued a guidance document entitled “Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for
Human Food and Animal Food: Guidance for Industry.” This guidance is directed toward participants in “co-manufacturing” agreements in which a brand owner arranges for a second party
(the “co-manufacturer”) to manufacture food…
FSMA Preventive Controls for Human Food Training Course in Beijing, China
October 25 – 27
Hogan Lovells Office, Beijing, China
The new Preventive Controls for Human Food regulation issued by the U.S. Food and Drug Administration (FDA) under the FDA Food Safety Modernization Act (FSMA) is the most significant change to food regulation since the 1930s. FDA has started conducting inspections for compliance with the rule,…
FDA Proposes to Extend Compliance Date for Nutrition Labeling Final Rules
The Food and Drug Administration (FDA) has issued a proposed rule to extend the compliance date for the final rules revising the requirements for the Nutrition and Supplement Facts Labels and the declared serving sizes and reference amounts customarily consumed (RACCs). Under the proposed rule, the compliance date would be extended by about 18 months…
FSMA Implementation Update – Produce Safety and Preventive Controls Developments
There have been several notable recent developments involving FSMA implementation. Most significantly, FDA proposed to extend the compliance dates for the agricultural water provisions of the Produce Safety rule and announced it will delay the start of Produce Safety rule inspections until spring 2019. Additionally, FDA has issued another chapter of its Preventive Controls for…
FDA Seeks Comments to Identify Regulations for Modification, Repeal, or Replacement
The U.S. Food and Drug Administration (FDA) has issued a broad request for comment to assist the agency in identifying regulations and related paperwork requirements that it could modify, repeal, or replace to reduce the regulatory burden on the public. The request is specific to products within the jurisdiction of the Center for Food Safety…
FSMA Update: FDA Begins FSVP Inspections
FDA has started conducting inspections to assess compliance with its Foreign Supplier Verification Programs (FSVP) regulation. The initial FSVP compliance date was May 30, 2017, though FSVP importers may have later compliance dates for their various suppliers that are smaller sized businesses. Inspections started earlier this summer. In this post we provide a brief overview…