- On August 13, FDA announced the issuance of the first warning letter to a U.S. food importer under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP). As our readers may know, FSVP generally requires importers to conduct a range of activities to ensure that food from foreign suppliers is produced in compliance with applicable food safety provisions, including, but not limited to, HARPC requirements or produce safety standards. The first FSVP compliance date began May 30, 2017, however there are a range of compliance dates according to a number of considerations.
- The warning letter, dated July 30, was issued to Brodt Zenatti Holdings LLC in Jupiter, Florida who imported tahini from the Israel-based manufacturer, Karawan Tahini and Halva. In May, the tahini was implicated in a Salmonella outbreak and was voluntarily recalled. In response to the Salmonella outbreak, FDA conducted an FSVP facility inspection, and found that the importer was in significant violation of the FSVP rule. As discussed in the warning letter, the importer did not develop an FSVP for the tahini as required by section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1 subpart L. Within 15 working days, FDA has requested a response to the warning letter that demonstrates plans to correct or evidence that they have corrected the violations. Should the importer fail to correct the violations, they may be placed on the newly established Import Alert #99-41.
- Since 2017, FDA has been conducting FSVP inspections in order to help importers understand the requirements and how to take corrective actions if deficiencies are observed. FDA will continue to take 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. Additionally, as outlined in FDA’s Strategy for the Safety of Imported Food, FDA is committed to working with importers to come into compliance with all applicable FSMA regulations, including FSVP. FDA’s Strategy is guided by four goals:
- (1) Food offered for import meets US food safety requirements
- (2) FDA border surveillance prevents entry of unsafe foods
- (3) Rapid and effective response to unsafe imported food
- (4) Effective and efficient food import program.
An overview of the Strategy can be found here.
Keller and Heckman attorneys are available to assist interested parties in preparing the necessary documentation for and navigating compliance under the FSVP rule. For assistance, please email: firstname.lastname@example.org.
1st Circuit Gives Coffee Buyers 2nd Shot at False Ad Suit (subscription to Law360 required)
- On August 8, 2019, the U.S. Court of Appeals for the First Circuit reversed a district court’s dismissal of a lawsuit charging that the label on New England Coffee’s Hazelnut Crème coffee violates Massachusetts’ consumer protection laws because the product does not contain hazelnuts. Kathy Dumont originally brought a putative class action against New England Coffee Company and Reily Foods Company (New England Coffee Company is a subsidiary of Reily Foods Company) in May 2018 in the U.S. District Court for the District of Massachusetts. U.S. District Judge Rya W. Zobel dismissed that case in September 2018.
- In reversing the district court’s decision, Circuit Judge William J. Kayatta Jr., writing for the majority, stated that even though the ingredient list stated, “100% Arabica Coffee Naturally and Artificially Flavored,” the name of the product could be taken to imply the presence of hazelnuts. He also suggested that while a reasonable consumer who cared whether the coffee contained real hazelnuts would check the list of ingredients, “perhaps a reasonable consumer would find in the product name sufficient assurance so as to see no need to search the fine print on the back of the package, much like one might easily buy a hazelnut cake without studying the ingredients list to confirm that the cake actually contains some hazelnut.” (See Dumont v. Reily Foods and New England Coffee Company, U.S. Court of Appeals for the First Circuit, No. 18-2055.)
- The Court of Appeals also found that Dumont’s claim under Massachusetts General Laws chapter 93A (concerning unfair and deceptive practice), was not impliedly preempted by federal law but did point out that the Federal Food, Drug, and Cosmetic Act will limit the scope of Dumont’s argument.
- Judge Sandra Lynch wrote a dissenting opinion, stating, “…a reasonable consumer plainly could not view the phrase ‘Hazelnut Crème’ as announcing the presence of actual hazelnut in a bag of coffee which also proclaims it is ‘100% Arabica Coffee’.”
- With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation. The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported. Each food item being imported must have its own FSVP review.
- An Import Alert is guidance within the Food and Drug Administration (FDA) that certain shipments into the United States should be held until the importer proactively demonstrates compliance with the law. Additionally, Import Alerts generally explain the problem and provide guidance to FDA field staff on how to uniformly describe the problem in paperwork. The Import Alert will often have a green list (as an exception to a general rule to prevent products from coming in), a yellow list (to identify entities that are known to be working towards compliance but whose products are still to be detained), or a red list (the specific entities whose products will be detained) of entities. For example, IA 45-02, for detention of foods containing illegal and undeclared colors has both a green and red list and IA 22-01 for detention of cantaloupes from Mexico has both a green and yellow list.
- The import alert for FSVP violations directs field staff to consult the red list but, thus far, the red list is empty. This implies that FDA expects to use the import alert process as a means of targeting importers who do not comply with their regulatory obligations for FSVP.
- Of interest, the beginning of produce safety inspections, addressed in yesterday’s Daily Intake Blog post, is important not just for produce operations – FDA has previously indicated that it will begin FSVP inspections of importers of produce from large farms “in Fall 2019” which would allow for these inspections to begin “approximately six months after FDA begins routine inspections of those large farms under the Produce Safety rule.” It may be that the FSVP inspections of imports of produce from large farms will result in the first additions to the red list for IA 99-41. Given FDA’s policy of using initial FSVP inspections to educate, we might expect the first entrants on the red list to be importers who have already undergone FSVP inspections.
Please feel free to contact Keller and Heckman at email@example.com with any questions about compliance with FSVP, responding to FDA correspondence regarding an FSVP inspection, or about clearing products listed on an import alert so as to allow imports into the country to proceed.