FDA Issues First Warning Letter for FSVP Violations, Creates FSVP Import Alert
On August 13, the U.S. Food and Drug Administration (FDA) issued its first warning letter related to violations of the Foreign Supplier Verification Program regulation to an importer of Tahini. The warning letter follows and FDA inspection conducted in response to a Salmonella outbreak, which revealed the importer was not in compliance with FSVP. FDA stated that moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk.
FDA also announced in the warning letter press release that they have established a new import alert– Import Alert #99-41, Detention without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the FSVP Regulation. Being subject to this import alert means all of your shipments will be detained by FDA upon arrival into the U.S.
These actions mark a shift in FDA’s enforcement stance regarding FSVP. It is imperative that food retailers, wholesalers and manufacturers ensure they are in compliance with the FSVP regulation.
Please contact Erik Lieberman at firstname.lastname@example.org or 202-765-1800 for more information.
FDA Publishes Menu Labeling Fact Sheet
On August 13, FDA published a fact sheet on implementation of the Menu Labeling Regulations. The agency stated it will:
- Provide continued support for industry stakeholders.
- Assess implementation progress to inform further education and outreach.
- Engage with state, local, tribal, and territorial (SLTT) regulatory partners to ensure consistent implementation.
FSIS Releases Label Approval Advice
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has released advice on the label approval process in its latest constituent update.
When FSIS stamps a label application “APPROVED AS MODIFIED,” establishments must modify labels as instructed prior to use. Establishments are not required to resubmit the label to FSIS once they make the noted modifications.
CBP Publishes Notice of Proposed Rulemaking Requiring Customs Brokers to Obtain Credit Reports of Clients; DUNS Numbers (or Similar Identification #s) Before Filing Entries for Them
CBP is proposing to require brokers to collect:
1) The client’s name;
(2) For a client who is an individual, the client’s date of birth;
(3) For a client that is a partnership, corporation, or association, the grantor’s date of birth;Start Printed Page 40317
(4) For a client that is a partnership, corporation, or association, the client’s trade or fictitious names;
(5) The address of the client’s physical location (for a client that is a partnership, corporation, or association, the physical location would be the client’s headquarters) and telephone number;
(6) The client’s email address and business website;
(7) A copy of the grantor’s unexpired government-issued photo identification;
(8) The client’s Internal Revenue Service (IRS) number, employer identification number (EIN), or importer of record (IOR) number;
(9) The client’s publicly available business identification number;
(10) A recent credit report;
(11) A copy of the client’s business registration and license with state authorities; and
(12) The grantor’s authorization to execute power of attorney on behalf of client.
The information must be reverified annually.
EU Publishes Deforestation-Free Supply Chain Communication
On July 23, 2019, the European Commission released a Communication detailing actions the EU could take to combat deforestation in the world. The EU wants European citizens to be able to consume products coming from “deforestation-free supply chains”. The next Commission led by President-elect Ursula von der Leyen is expected to propose regulatory and/or non-regulatory measures to that effect. More information may be found here.
EU Authorizes Ten GMOs
The Commission authorized ten Genetically Modified Organisms (GMOs): seven for food and feed uses (cotton GHB614xLLCotton25xMON1598, maize 5307, maize MON 87403, maize 4114, maize MON87411, maize Bt11xMIR162x1507xGA21, soybean MON87751), two renewed authorizations also for food and feed (oilseed rape Ms8xRf3 and maize 1507xNK603) and one carnation as ornamental cut flower. For more information on GMOs in the EU see here. (For more information: Anna-Kaisa Itkonen – Tel.: +32 2 29 56186; Aikaterini Apostola – Tel.: +32 2 29 87624)
FSIS Publishes Final Rule Increasing Flexibility for Production of Uninspected Product in Establishments
The rule makes it easier for inspected establishments to produce pet food and allows them to produce uninspected product at times in which an FSIS inspector is not present. Previously uninspected product could only be produced during the regular hours of inspection. The rule is available here.
APHIS Seeks Comments on Authorization of Importation (i.e. Draft Pest Risk Assessments) on Avocados from Brazil, Passionfruit from Ecuador and Kiwis from Argentina
The Animal and Plant Health Inspection Service is seeking comments on authorization of importation (draft pest risk assessments) on:
Kellogg Company Submits Food Additive Petition for Vitamin D3 in Cereal and Granola Bars
The Kellogg Company has submitted a petition with FDA on the safe use of vitamin D3 as a nutrient supplement in breakfast cereals and in grain-based nutrition bars (e.g., granola bars).
FSIS Updates List of Plants from Brazil Eligible to Export to U.S.
APHIS Adds Cambodia and Vietnam to List of Countries Affected by African Swine Fever
Importers can be Sued by Competitors, Interest Groups, Consumers for Improper Classification of Products, Manipulating Shipments under the False Claims Act
Latest FDA Warning Letters
Below are the latest FDA warning letters relating to food and supplements:
Please contact Erik Lieberman at email@example.com or 2027651800 if you have any questions.