FDA
WARNING: FSVP Importers, Time is Running Out
Beginning July 24, 2022, consistent with 21 CFR 1.509(a), food importers will be required to ensure that their valid, 9-digit DUNS number is provided in the Entity Number field. As an Importer, what does this mean for you and your operation? Simply put, without having a valid DUNS number entered at the time of entry, YOUR ENTRIES WILL BE REJECTED!
For each entry line of food subject to the Foreign Supplier Verification Program (FSVP), offered for importation into the United States, you must ensure that your name, electronic mail address, and Unique Firm Identifier (UFI) are all recognized as acceptable by the Food and Drug Administration (FDA) and are provided electronically when filing entry with Customs and Border Protection (CBP). With the rollout of the regulation, FDA issued guidance recognizing the DUNS number as the acceptable UFI for the FSVP regulation. The DUNS number, a nine-digit unique number, is assigned and managed by Dun and Bradstreet (D&B) and is location-specific.
Since the implementation of FSVP 5 years ago, FDA has utilized its Enforcement Discretion regarding the use of the UFI for fear of interfering with stopping trade. Working with CBP, an entity identification code “UNK” was developed and accepted as an “Entity Number Field” which could be used in place of a DUNS number.
Additionally, the DUNS number, which is location-specific, must correspond to your U.S. location. If you have multiple U.S. locations and, thus, multiple DUNS numbers, you may choose to provide the DUNS number that applies to the location at which you maintain your FSVP records. FDA investigators may conduct FSVP records reviews at the location associated with the DUNS number you provide to CBP at entry. For example, if you maintain your FSVP records at your corporate headquarters, you may choose to provide the DUNS number of your headquarters when you identify yourself at entry as the FSVP importer. However, because the FSVP regulation allows importers to store records offsite if they can be retrieved and provided within 24 hours of request (see 21 CFR 1.510(b)(2)), you may instead provide the DUNS number for another of your locations. Once chosen, the same DUNS number should be used for all the importer’s FSVP entries, to the extent the DUNS number is applicable to an entry line.
The DUNS number is available free of charge to all importers and can be obtained by contacting D&B by phone at 866-705-5711, via email at govt@dnb.com, or by visiting D&B’s Websites at http://www.dnb.com/duns-number.html or https://fdadunslookup.com. Although a DUN’S number may be obtained within a few business days, in some circumstances it could take longer.
Consequences of non-compliance are easily avoidable. The regulatory specialists and attorneys at FDAImports and Benjamin L. England & Associates, LLC have the substantive expertise needed to develop compliant FSVP procedures for your operation. Please feel free to contact us or call us at 410.220.2800.
Additional Information may be found:
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
Consequences of FSVP Non-Compliance…
Did you know that your imported entry of food can be refused admission into the United States if it appears that you failed to comply with the requirements of the Foreign Supplier Verification Program (FSVP)?
Over the course of the last five years, FDA’s mantra has been “educating while regulating” while using its discretionary enforcement authority. However, we have recently observed that the educational tone has taken a marked shift towards one of an enforcement-guided nature. During an FDA FSVP inspection, the investigator obtains evidence documented with the issuance of an FDA Form 483a entitled “FSVP Observations.”
Just as with other types of FDA inspections, there is an enforcement progression with all FDA FSVP inspections starting with the inspection classifications as noted in FDA’s Field Management Directive (FMD) # 86:[1] No Action indicated (NAI)-If the supervisory investigator concludes that no objectionable conditions or practices were found during the inspection, or the objectionable conditions found do not justify further action, an Inspection Conclusion of No Action Indicated (NAI) should be entered; Voluntary Action Indicated (VAI)-If significant objectionable conditions and practices were observed, but the District is not prepared to take or recommend any regulatory action, the supervisory investigator should then assign the District Decision of Voluntary Action Indicated (VAI); and Official Action Indicated (OAI)-If the significant, objectionable conditions or practices warrant a Warning Letter or other regulatory actions listed below in the Regulatory Actions (Advisory, Administrative, or Judicial) section, the Supervisory Investigator will enter the District Decision, Official Action Indicated (OAI).
With the Food Safety Modernization Act (FSMA) signed into law, Congress’s intent was made quite clear. Specifically, FSMA requires each importer of food to perform certain risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements regarding hazard analysis and risk-based preventive controls of human and animal foods and standards for produce safety; and that the food is not adulterated or allergen misbranded. Complying with the request of Congress, the FDA added that refusal of admission can be a consequence if an importer fails to comply with FSVP requirements. In addition, FSMA further amended the Federal Food, Drug & Cosmetic Act to include Section 301(zz), which, in pertinent part, states that, “…importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act, is a prohibited act under the law.
To assist in the uniform enforcement of these requirements, FDA drafted and implemented Import Alert 99-41, “Detention Without Physical Examination of Human and Animal Food Imported from a Foreign Supplier by an Importer who is not in compliance with the requirements of the Foreign Supplier Verification Program (FSVP) Regulations.” Specific food or foods from a specific foreign supplier may be included on a red list to identify the food or foods subject to the Import Alert when imported or offered for import by the identified importer. Often added to these alerts are those importers who are “blatantly disregarding” the regulatory requirements, something which FDA investigators are well-trained to identify.
These consequences are easily avoided by implementing a written Foreign Supplier Verification Program. Are you in compliance? The regulatory specialists and attorneys at FDAImports and Benjamin L. England & Associates, LLC have the substantive expertise needed to develop compliant FSVP procedures for your operation. Please feel free to contact us or call us at 410.220.2800.
[1] FMD 86: Establishment Inspection Report Conclusions and Decisions https://www.fda.gov/media/87643/download
FSVP – Five Years After Roll Out, Importers Receive A Failing Grade
It has been nearly five years since FDA began inspections under the Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) regulations. Based on inspectional data from FDA’s Data/Compliance Dashboard for the last three years (2019-2022 YTD) FDA has conducted 1,645 FSVP inspections, of which only 17 inspections were found to comply with FSVP regulations – equaling a compliance rate of 1%… Giving the importing community a failing grade for their compliance with FSVP!
As a result of the enactment of FSMA in 2011, Congress mandated that FDA create regulations for a food safety system focusing on prevention rather than reacting to problems after they occur. Among other things, FSMA outlines rules for Hazard Analysis Critical Control Points (HACCP), which are risk-based preventive controls for food facilities that manufacture/process, pack, and hold human and animal foods. These rules apply to domestic food producers and those in other countries who export to the United States.
Over the last several years, the FSVP regulation has negatively impacted most food importers. FSVP requires importers to be responsible for approving their own suppliers by verifying that they meet certain food safety standards. Other than a few exceptions, the FSVP importer (i.e., the owner of the food at the time of importation) is required to develop, maintain, and follow a compliant FSVP for each food imported. FSVP compliance aims to ensure that food is produced in a manner that provides a specific level of public health protection, including preventive controls, safety regulations, and that helps to ensure that the food is not adulterated or misbranded concerning allergen labeling.
Leading up to FSVP’s implementation in May 2017, FDA was diligent in educating the industry on FSMA and the rules of importing affecting the importer community. The phrase “Educating while Regulating” was FDA’s strategy during the first couple of years of FSVP roll-out, with the Agency using enforcement discretion alongside its industry education efforts. Now, however, FDA has ramped up its enforcement of these regulations, placing many importers on Import Alert. And such administrative actions can be catastrophic to businesses; once on an import alert, FDA will continue to detain the affected products until the manufacturer, shipper, grower, or importer proves to the satisfaction of FDA that the violation has been corrected.
Importer’s FSVPs need to be in place and available for review upon request from FDA. During the last few years, we have seen changes in the Agency’s enforcement strategy with the issuance of Warning Letters. In October 2019, the first firm was placed on Import Alert 99-41, “Detention without Physical Examination of Human and Animal Food Imported from an FSVP Importer Who is Not in Compliance with the Requirements of the Foreign Supplier Verification Program Regulation.” Since that time many more have been issues and now there are currently 27 importers on this particular import alert alone.
Brian Ravitch, a Senior Regulatory Advisor with FDAImports, was instrumental in developing and implementing FSVP for the FDA. Mr. Ravitch has achieved a Level ll certification in Seafood HACCP and is a Qualified Individual in Preventive Controls. Currently, he primarily concentrates on Import Compliance, Foreign Supplier Verification Program (FSVP), Seafood HACCP, and Hazard Analysis Risk-based Preventive Controls.
Brian and the staff at FDAImports have the knowledge and experience to help you meet FSVP requirements with the ultimate goal of compliance; if you have legal questions relating to FSVP, please contact us or call at 410.220.2800.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
Now is the Time to Reevaluate Your Foreign Supplier Verification Program
As an importer, once you have completed Foreign Supplier Verification Programs (FSVP) for each of your food items from your foreign suppliers, you can file away your documents until a time when the Food and Drug Administration (FDA) requests to conduct an inspection of your written program(s), right? …. Not so fast!
There are three regulatory requirements for when you should revisit your programs: review and documentation of your verification activities, reevaluation at a minimum of every three years, and when an event triggers a corrective action.
The following will walk you through FDA’s requirements.
Based on the outcome of your hazard analysis and the evaluation of the identified hazards, you will be required to select appropriate verification activities and a frequency for which the activities are obtained. These activities include:
- Onsite audits as specified in paragraph (e)(1)(i) of 21 CFR § 1.506 – “What foreign supplier verification and related activities must I conduct?”;
- Sampling and testing of a food as specified in paragraph (e)(1)(ii) of this section;
- Review of the foreign supplier’s relevant food safety records as specified in paragraph (e)(1)(iii) of this section; and
- Other appropriate supplier verification activities as specified in paragraph (e)(1)(iv) of this section.
It is your responsibility upon receipt to assess the activities and document in writing the outcome. The written documentation will be a record maintained within your program.
Reevaluation of a foreign supplier’s performance and the risk posed by a food.
As indicated in 1.505(c)(1), you must promptly reevaluate your Foreign Supplier Verification Program when you become aware of new information about factors that may change the foreign supplier’s performance or the risk posed by the hazards of the food.
At a minimum, you must reevaluate your programs at least every three years.
Factors that may trigger a reevaluation include:
1) Changes in the hazard analysis of the food, including the nature of the hazard requiring a control. As stated in 1.504(c)(3), this may include:
- The formulation of the food;
- The condition, function, and design of the establishment and equipment of a typical entity that manufactures/processes, grows, harvests, or raises this type of food;
- Raw materials and other ingredients;
- Transportation practices;
- Harvesting, raising, manufacturing, processing, and packing procedures;
- Packaging and labeling activities;
- Storage and distribution;
- Intended or reasonably foreseeable use;
- Sanitation, including employee hygiene; and
- Any other relevant factors, such as the temporal (e.g., weather-related) nature of some hazards (e.g., levels of natural toxins).
2) Any changes within the supply chain that significantly minimize or prevent the hazards requiring a control or verifying that such hazards have been substantially minimized or prevented. This may be the foreign supplier, the foreign supplier’s raw material or other ingredient supplier, or another entity in your supply chain.
3) Foreign supplier performance, including:
- The foreign supplier’s procedures, processes, and practices related to the safety of the food;
- Applicable FDA food safety regulations and information relevant to the foreign supplier’s compliance, including FDA warning letter, import alert, or other FDA compliance action related to food safety;
- Noncompliance with the relevant laws and regulations of a country whose food safety system FDA has officially recognized as comparable or determined to be equivalent to that of the United States; and
- The foreign supplier’s food safety history, including violative food testing results, non-conformities based on audit results relating to the safety of the food, and responsiveness of the foreign supplier in correcting problems.
4) Any other factors as appropriate and necessary, such as storage and transportation practices, which would affect the safety of the imported food.
What corrective actions must I take under my FSVP?
You must take prompt appropriate corrective actions if you determine that a foreign supplier of the food you import:
- Does not produce the food in compliance with processes and procedures that provide at least the same level of public health protection as those required under Hazard Analysis and Risk-Based Preventive Controls or Produce Safety, or
- Produces food that is adulterated or misbranding due to failure to provide labeling for the presence of major food allergens (this does not apply to animal food).
Your determination that you need to take corrective actions could be based on:
- The foreign supplier verification activities;
- A reevaluation of the foreign supplier’s performance and the risks posed by the food that you conduct;
- Reviewing consumer, customer, or other complaints related to food safety;
- Monitoring FDA compliance action information (e.g., import alerts, warning letters); or
- Any other relevant information you obtain, such as recalls or product withdrawals.
Examples of appropriate corrective actions will depend on the circumstances but could include:
- Notifying the foreign supplier of the problem and requesting documentation of corrective actions taken by the foreign supplier.
- Assisting the foreign supplier’s efforts to correct and prevent recurrence of the problem.
- Revising your FSVP.
- Discontinuing use of the foreign supplier until the cause or causes of noncompliance, adulteration, or misbranding are adequately addressed.
Regardless of the outcome, you must document any reevaluations, investigations, corrective actions, and changes to your FSVP.
During the roll-out of FSVP, FDA initiated guidance to the Field Investigators to “educate the importers” as they conduct the inspections. After a couple of years, the FDA continued to see large numbers of noncompliance. Most importers were written up for not having any program in place.
Due to excessively high numbers of noncompliance, FDA elevated their enforcement activities. This includes conducting second inspections of non-compliant importers, issuance of warning letters, and placing importers on Import Alerts. What does this mean for you? Under FDA’s authority, your non-compliant food can be refused from entering the United States.
Below are important questions to consider if you are an importer of food.
Question: How can I avoid disruptions to my importations?
- Answer: Develop a Foreign Supplier Verification Program through the assistance of an outside Qualified Individual.
Question: What do I do when I have received notification of an inspection?
- Answer: We can conduct a mock inspection and assess your program to ensure compliance. This can also include representation as your Qualified Individual during your inspection.
Question: What do I do when I have received a Form FDA 483a, FSVP Observations, or FDA Warning Letter?
- Answer: Please do not delay. It is not too late to respond and move forward with compliance.
If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys.
** This blog was written by Brian Ravitch, an affiliated consultant with FDAImports.com. He has had a 39-year career in the Federal Government, during which he served as a Subject Matter Expert instrumental in the development and implementation of FSVP.
FDA Issues First Warning Letter for Failure to Comply with FSVP
FDA issued their first Warning Letter to an importer for not complying with the Foreign
Supplier Verification Program (FSVP) that was introduced 8 years ago with the
Food Safety Modernization Act (FSMA).
For this first Warning Letter, FDA selected a food importer that was associated
with an outbreak of foodborne illness. In May of this year (2019), a Salmonella outbreak
was identified as originating from tahini products imported by Brodt Zenatti
Holding. Following current practices, FDA, Center for
Disease Control (CDC), and state health officials worked together to identify the
outbreak’s source and remove the product from the market. This led to Brodt Zenatti (the importer) issuing a recall and voluntarily
ceasing to import the product.
Beyond the recall, FDA conducted an FSVP inspection of the importer only to
identify that they needed to “develop an FSVP for sesame paste tahini
manufactured by Karawan Tahini and Halva in the West Bank.” When FDA completed
the inspection, they issued a Form 483 observing this violation of the Food,
Drug, and Cosmetic Act. The importer never responded and thus FDA issued a
public Warning Letter.
Noticeably, the importer failed to respond to FDA’s Warning Letter and
voluntarily resolve the issue. FDA has threatened to place the importer on
a new import alert, which lists companies that fail to comply with FSVP. Once an
importer is placed on this list, FDA will not allow it to import the covered
food product until the importer has resolved the violation (which we discussed more here).
With this first Warning Letter, FDA is seeking to connect failing to comply
with FSVP and the risk of violative products entering the food supply, which
could cause illnesses and injury. Attorney John Johnson
explains, “this Warning Letter is also a cautionary tale for importers, if
their products are associated with a recall, especially one involving illnesses
or injuries, FDA will conduct an inspection of the FSVP program to ensure its
existence and implementation.”
This represents the beginning shift away from “educate while you regulate” to traditional regulation and enforcement.
If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys.
Coming Soon: FSVP Enforcement?
Last week the Food and Drug Administration (FDA) took a critical step towards enforcement of FSVP by creating 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 Foreign Supplier Verification Program (FSVP) Regulation.” To date, FDA has not taken any enforcement action against an importer for not complying with the regulations, which first went into effect May of 2017. However, that may change soon.
Under the law, food imported by an importer who does not comply with FSVP may be refused admission into the United States. An import alert is an administrative enforcement tool that FDA uses to issue an import refusal. It is an internal directive that the local FDA office should detain (stop) an imported product because it appears to violate an FDA requirement and, after a hearing, issue an import refusal unless the importer overcomes the appearance of a violation. In this case, it means that an importer may not be able to successfully import food until the alert is lifted.
It remains unforeseen when FDA will place the first importer on Import Alert 99-41, thereby taking the first enforcement action. However, now with the import alert created, it is only a matter of time.
If you need help understanding your FSVP obligations or with any of your importing needs, please contact us and get professional advice from our consultants and affiliated attorneys.
So it Begins: FSVP Inspections
FDA has begun inspecting U.S. food importers for their compliance with the Foreign Supplier Verification Program (FSVP). The FSVP regulation has a staggered compliance date between May 30, 2017 through July 27, 2020 (depending on the food type and the foreign supplier’s size). Those subject to that first compliance date may soon be inspected by FDA, if not already.
It is our understanding that these first inspections are part of an “educate while regulate” paradigm discussed by Sharon Mayl and others, during which FDA has their regulatory “hammer put away. Thus FDA is pre-announcing the inspections and spending additional time explaining the rules and the Agency’s expectations. While the hammer is away, importers must take these inspections seriously as first impressions are long lasting in that they set the tone with FDA.
We have been working closely with our clients to understand the regulation, establish a robust FSVP protocol, and counsel them on how to make a good lasting first impression. FDAImports.com is pleased to report that the FSVP plans we have helped clients put into place are receiving very favorable comments from FDA’s inspectors with only minor suggestions for improvements. When asked about this outcome John F. Johnson III, our lead FSVP authority replied, “one of many important keys to getting control of the inevitable FDA inspection is to not copy and paste the foreign food supplier’s hazard analysis and substantive preventative controls into the FSVP protocol. You must make the hazard analysis your own, and understand the preventive controls. This is to seek to prevent the inspection from turning into a proxy inspection of the foreign supplier and their technical application of HARPC (Preventive Control Rule), and not about your FSVP operations.”
For help setting up your FSVP and staying compliant with the FDA contact us today!
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