On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a ‘third country’ from the date of its withdrawal from the EU. This will impact a number of
Enforcement
FDA Issues Draft Guidance on Public Warning and Notification of Recalls and Announces Move to Expedite Release of Recall Information
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) has issued Draft Guidance on public warning and notification of recalls under 21 C.F.R. Part 7, and has announced steps to release recall information more quickly. The Draft Guidance provides recommendations to industry and FDA staff regarding the use, content, and circumstances for issuing public warnings and public…
FDA Issues FSMA Guidance Documents on Supplier Verification and Preventive Controls for Animal Food
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The U.S. Food and Drug Administration (FDA) has issued five FDA Food Safety Modernization Act (FSMA) final and draft guidance documents relating to supplier verification under both the Foreign Supplier Verification Program (FSVP) and the Preventive Controls for Human Food (PCHF) rules, as well as draft guidance regarding the Preventive Controls for Animal Food (PCAF)…
FDA Announces Enforcement Discretion for Certain FSMA Provisions
On January 4, 2018, the Food and Drug Administration (FDA) announced through Guidance that it does not intend to enforce particular provisions of the Preventive Controls for Human Food (PCHF), Preventive Controls for Animal Food (PCAF), Produce Safety, and Foreign Supplier Verification Programs (FSVP) regulations issued under the FDA Food Safety Modernization Act (FSMA). This …
FDA Issues Draft Guidance on Refusal of Inspection by Foreign Food Establishments
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government. Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all…
FSMA Implementation Update: Written Assurances, Food Defense, Human Food By-Products, and More
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
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…
Sunset of the Proposition 65 Interim BPA Warning Regulation
By Martin Hahn & Xin Tao on
The Proposition 65 Interim BPA warning regulation that allows companies to rely on a generic warning posted in California retail establishments will sunset on December 30, 2017. Food and beverage companies that have BPA containing packages in California and that have been relying on the interim BPA warning regulation for compliance should reassess their Proposition…
UK ‘Sugar Tax’ – Draft Regulations Published
By Richard Welfare & Jane Summerfield on
Posted in Enforcement
The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018.
The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5…
FDA Issues Guidance on Co-Manufacturer Supplier Verification Under FSMA
By Joe Levitt, Maile Hermida & Elizabeth Fawell on
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 Implementation Update: “Solely Engaged” Draft Guidance, Animal Food cGMP Guidance, Sanitary Food Transportation Training for Carriers, and Compliance Dates
By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham on
FDA is continuing to release resources intended to assist industry with implementation of the FDA Food Safety Modernization Act (FSMA). This post discusses four such documents that were released recently. First, FDA released Draft Guidance explaining the meaning of the phrase “solely engaged,” which is used in the regulations to establish several exemptions from the…