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FDA’s New FSMA Traceability Rule; What Food Companies Need to Know

Updated March 9, 2023

The U.S. Food and Drug Administration (FDA) recently finalized an eighth rule under the Food Safety Modernization Act (FSMA) known as Requirements for Additional Traceability Records for Certain Foods (Food Traceability Final Rule). The Rule is intended to fulfill recordkeeping requirements under FSMA that help FDA quickly identify recipients of adulterated food.

FDA Proposed Traceability Rule FSMA CTE KDE FTL
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Who Does This Affect?

This rule applies to persons who manufacture, process, pack, or hold human food on FDA’s Food Traceability List (FTL), including retailers and distributors. Unlike many of the other FSMA rules, the Food Traceability Proposed Rule is not limited to facilities registered with FDA.

The FTL defines products that FDA has determined are at higher risk of carrying foodborne illnesses and thus will be subject to these additional tracking requirements. The Agency makes the important distinction that the rule applies “not only to the foods specifically listed, but also to any foods that contain listed foods as ingredients.”

FDA may add products to the FTL if they deem other foods to be high risk and require additional tracking. FDA only requires traceability records for products on the list, but they encourage companies to apply the requirements of the rule to other products they handle.

FDA has established exemptions for small farms and other small originators; farms that sell directly to consumers; handlers of produce products that are processed commercially in a way that adequately reduces the number of harmful microorganisms; and handlers of certain foods that are rarely consumed raw.

What Does This Rule Require?

The Food Traceability Proposed Rule requires covered persons to keep records of Key Data Elements (KDEs) for certain Critical Tracking Events (CTEs). FDA considers growing, receiving, creating, transforming, and shipping to be Critical Tracking Events.

Each Critical Tracking Event has different applicable Key Data Elements. For example, growers are required to record the coordinates of their growing area as a Key Data Element. The receivers of the product must establish records of quantity and measurements of the products, location identifiers established by the originator of the food, and more.

The first person to receive the product must establish a traceability lot code if they receive the food from an originator who has not already established one. Each subsequent person must maintain similar records of the product’s quantity and its identifier code.

Each covered person in the supply chain is required to maintain records of the Key Data Elements up until the point of a “kill step.” A kill step is defined by the FDA as a process that significantly minimizes pathogens found in the food. This could include cooking, high pressure processing, pasteurizing, and other processing activities. The person who implements the kill step must keep record of the step, as well as the Key Data Elements of previous Critical Tracking Events they conduct, but subsequent owners do not need to continue to track Key Data Elements. The kill step marks the end of the Key Data Element recordkeeping requirements of the rule.

In addition to requiring records of Key Data Elements, the proposed rule requires covered persons to establish and maintain traceability program records. These records are intended to help the FDA quickly and easily understand an entity’s traceability program. The traceability program records are meant to contain a “description of the reference records on which the firm maintains the required Key Data Elements.” These records also contain a list of which foods on the FTL are shipped by the entity, how their traceability lot codes are assigned, and other information on how the records can be better understood by FDA regulators.

Where Can I Keep the Records?

The proposed rule allows persons to keep the records in either electronic or original form, so long as they are kept in a manner that will prevent deterioration and loss. Persons must also maintain an electronic sortable spreadsheet containing the traceability information. Records need to be provided to FDA within 24 hours of the Agency requesting them. FDA requires covered persons to keep most records for two years from the date they create them.

How Do I Comply?

FDA allows persons subject to the to designate a third-party to establish and maintain the required records on their behalf. Registrar Corp can establish and maintain your Key Data Element records. Simply contact us for assistance.

Alternatively, Registrar Corp’s Document Management System (DMS) (available as an add-on for the FDA Compliance Monitor) can simplify the process of developing and documenting your Key Data Elements.  Persons covered under the Food Traceability Proposed Rule will find Registrar Corp’s DMS to be the perfect solution for requesting and storing required documentation for each of the products they handle.

Talk to our Regulatory Specialists today to learn more about how Registrar Corp can help by calling +1-757-224-0177 or emailing us at [email protected].  You may also chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat

 

Registrar Corp launches new Document Management System for FDA-Regulated Goods

Introducing an all-in-one solution for supplier monitoring and document management.

Leading U.S. Food and Drug Administration (FDA) compliance firm Registrar Corp is introducing a new Document Management System (DMS) add-on to the FDA Compliance Monitor, making the Monitor the only complete solution for supplier monitoring and document management.  Users can now request, approve, and manage needed documentation (food safety plans, product labels, certifications, etc.) while monitoring supplier compliance in a single, secure system.

“The FDA Compliance Monitor has facilitated our facility management, supplier review, and FSVP compliance management,” said Georgina Jaramillo Robles, Quality Assurance and Food Safety Manager at West Pak Avocado. “It has it all- the portal is easy to navigate, you can quickly add more facilities to your monitor plan, reports are easy to generate, training materials are available, and you can find all of this in a single portal. This is a great tool!”

Automate FSVP Compliance

Registrar Corp’s DMS addresses the requirements of FDA’s Foreign Supplier Verification Program (FSVP) rule, which requires US food importers to maintain written FSVPs that verify food imported from foreign suppliers meets FDA food safety standards. Importers must develop FSVPs for each individual food imported from each supplier.

Importers commonly choose to review their suppliers’ food safety plans in order to meet FSVP requirements, but may also collect other verification documents including sampling and testing reports, monitoring records, and third-party audits.  FDA requires FSVP documentation to be stored for at least two years.  The DMS makes it easy for importers to request, store, and quickly retrieve food safety plans and other documentation for each food they import.

“Based on feedback from our importer and retailer customers, we came up with a workflow automation system to efficiently manage all FSVP related compliance processes,” said Ankit Kumar, Vice President of Product Management at Registrar Corp. “You no longer have to review disparate and disconnected systems like Excel, Sharepoint, email, and calendars to see what documents are expiring or missing. It allows for a proactive approach to managing food safety documents and compliance events.”

DMS Key Features

 

Filters – Importers can easily filter by supplier, documentation type, and request status (valid, awaiting review, missing, etc.) to quickly access the information they need.

 

 

Templates – The DMS comes complete with a robust library of templated documents for importers to use. Users may also create their own document types with custom attachments.

 

 

Notifications – The FSVP rule requires importers to re-evaluate the risks posed by food they import at least every three years.  The DMS allows you to set validity dates for approved documentation.  The system will then notify you when a validity date is approaching, so you never miss a re-evaluation deadline.

 

 

Security – Data is stored in a secure SOC 2 compliant environment with end-to-end encryption, instant rollout of security packages, role-based access control, and backup systems.

 

 

FDA’s New FSMA Rule on Traceability 

In September 2020, FDA proposed a new rule under the Food Safety Modernization Act (FSMA) entitled “Requirements for Additional Traceability Records for Certain Foods” (also known as the “Food Traceability Proposed Rule”).  When finalized, this rule will require persons who manufacture, process, pack, or hold high-risk foods to maintain documentation of certain activities surrounding those foods (for example, bills of lading, records containing the location of the previous supplier, etc.).  In most cases, these records must be stored for two or more years.

Persons covered under the Food Traceability Proposed Rule will find Registrar Corp’s DMS to be the perfect solution for requesting and storing required documentation and Key Data Elements for each of the products they handle.

The FDA Compliance Monitor

The DMS is available as an add-on for Registrar Corp’s FDA Compliance Monitor, a tool that allows importers to monitor and document their suppliers’ FDA registration status and compliance history, including recalls, inspection results, and more. Users are notified anytime there is a change in a monitored supplier’s compliance.

The DMS follows the launch of RegiScore, which was added to the FDA Compliance Monitor in February 2020.  RegiScore provides risk scores for suppliers and their individual products based on data from over three hundred million shipments of FDA-regulated goods.  With both of these additions, importers can immediately gauge the risk of buying specific products from a supplier, monitor changes in their suppliers’ compliance, and manage their suppliers’ documentation all within one simple and secure system.

To learn more about the FDA Compliance Monitor and Document Management System, contact Registrar Corp by phone: (757) 224-0177, by email: [email protected], or schedule a free demo to see the software in action.

Frequently Asked Friday: Can I Choose Not to Act as FSVP Importer?

Before the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) was largely responsible for ensuring that companies exporting food to the United States were complying with U.S. food safety regulations.  For the most part, importers of these food products went unregulated in terms of food safety. FSMA introduced the Foreign Supplier Verification Program (FSVP) rule, which placed new responsibility on the person who owns the food upon entry to the United States.  Now U.S. food importers must develop FSVPs for each product that they own at the time of entry.

Get Help With FSVP Requirements

Registrar Corp’s Qualified Individuals can develop and implement your FSVPs

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Under the FSVP rule, Customs Brokers now must identify an “FSVP importer” for covered shipments when filing entries. This listed FSVP importer is the entity responsible for FSVP compliance and whom FDA will inspect in the case of a routine FSVP inspection or when a food safety concern arises.

Many importers have asked Registrar Corp if they can require their foreign suppliers to designate and list a different FSVP importer, as FSVP compliance can be complicated and time consuming. FDA defines the FSVP importer as “the U.S. owner or consignee of an article of food that is being offered for import into the United States.” Furthermore, FDA defines the U.S. owner or consignee as “the person in the United States who, at the time of entry of an article of food into the United States, either owns the food, has purchased the food, or has agreed in writing to purchase the food” (21 CFR1.500).  The exporting facility may not designate a different FSVP importer, nor may the importer refuse to be listed as the FSVP importer if they meet FDA’s definition.

Exceptions

According to FDA, “if there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the FSVP importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under the FSVP regulation.” When this is the case, the exporter must designate an FSVP importer, also referred to by some as an FSVP Agent. There are also cases where multiple entities meet the definition of FSVP importer for the same food and supplier; when this happens, one of the entities can act as FSVP importer on behalf of the others if they’ve agreed to do so as confirmed in a signed statement of consent.

Additionally, some imported products are exempt from the FSVP rule. For example, products not intended for sale or distribution in the United States are not usually subject to the FSVP regulation. These include products intended for personal consumption, research or evaluation, and food for processing and export. Alcohol, seafood, juice, meat, poultry, and egg products subject to USDA are also exempt and do not require an FSVP importer.

Nevertheless, most food products entering the U.S. do require an FSVP importer, and those who meet the definition should make sure to familiarize themselves with the relevant regulatory requirements.

What is Required of an FSVP Importer?

An FSVP importer is responsible for developing FSVPs in which they evaluate and regularly verify their foreign supplier’s compliance with the applicable FDA food safety regulations. They must have an FSVP for each product they import per foreign supplier. FSVPs serve to provide assurances that the food imported was produced in compliance with FDA food safety standards and that it will not present a risk to the health of citizens in the U.S.

The importer is responsible for determining foreseeable hazards associated with the type of food, evaluating the risk it poses, verifying that the foreign supplier’s processes and practices meet  FDA standards, evaluating the foreign supplier’s compliance history with FDA, ensuring product labels properly list the major allergens, as applicable, and conducting corrective actions when problems are found.

Importers that are not developing and implementing FSVPs for their products are subject to repercussions that can have a lasting impact on their brand and finances but most importantly their consumers’ health. FDA issues Warning Letters, Import Alerts, and other regulatory action against U.S. Importers that fail to comply with FSVP. This action may also extend against the foreign supplier if the U.S. importer’s FDA inspection reveals they are not producing food in accordance with the applicable FDA standards.

Develop Your FSVPs Today

Don’t want to navigate FDA compliance on your own?  Registrar Corp provides assistance in developing FSVPs. Our trained professionals can also act as the Qualified Individual for U.S. importers and, when there is no U.S. owner or consignee at entry, we may act as FSVP Agent (subject to approval).

Get Help with FSVP

To learn more, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

Food Facilities Must Renew Their FDA Registrations Between Oct. 1 and Dec. 31, 2020

The U.S. Food and Drug Administration (FDA) requires all facilities that manufacture, process, pack, or store food for U.S. consumption to renew their facility registrations between October 1st and December 31st, 2020.  This includes facilities that registered this year. Even if a facility registers as late as September 30th, 2020, they will still be required to renew that registration.

It is important to note that facilities located outside of the U.S. must also designate a U.S. Agent to communicate with the FDA on their behalf. FDA will not finalize a facility’s renewal until the U.S. Agent accepts the designation.

New this year, both U.S. and non-U.S. facilities will need to submit  Unique Facility Identifiers (UFIs) as part of their renewal. If your facility does not already have a UFI, it is prudent to request one immediately. It is possible that this new requirement will cause a backlog of UFI requests. A delay in receiving your UFI puts you at risk of not being able to renew your facility in time.

Consequences of Missed Renewal

Failure to renew a facility registration during the biennial renewal period could result in the cancellation of the registration. As a result of facilities failing to renew in 2018, FDA removed 20% of food  facilities from their registered database in early 2019.

Exporting food to the U.S. that was manufactured or processed by a facility that does not renew its registration may result in detention or refusal of the goods. Facilities within the United States that continue to produce food for U.S. consumption without a valid registration may be subject to civil or criminal penalties.

Renew with Registrar Corp

Registrar Corp, a consulting firm specializing in FDA regulatory compliance, can help food facilities properly renew their FDA registrations. Our trained Regulatory Specialists take the stress out of the renewal process. We aid facilities in obtaining their UFIs and act as the U.S. Agent for facilities outside of the United States. As part of our registration renewal service, companies receive year-round regulatory support, including free prior notice filings, FDA compliance monitoring of their facility, detention assistance, and more.

For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

FDA Actively Enforcing FSVP Regulations during Inspections; Issues Warning Letters to 31 Firms

The U.S. Food and Drug Administration (FDA) often inspects food importers for compliance with the Foreign Supplier Verification Program (FSVP) rule. During these inspections, FDA may ensure that importers have established an FSVP. So far this year, 7% (31 letters) of Warning Letters that FDA has issued were related to FSVP violations. This represents an increased focus on FSVP enforcement compared to 2019, in which only five facilities received Warning Letters for FSVP violations.

Even during the COVID-19 pandemic, FDA has continued remote FSVP inspections and is actively issuing Warning Letters for violations. FDA may also choose to add offending importers to Import Alert 99-41, which specifically targets importers that are not in compliance with FSVP.  FDA has added importers to this alert as recently as July 2017.

FDA requires most US facilities that import food products from outside of the United States to develop FSVPs. Importers must have FSVPs for each product they import from each supplier that verify the products follow applicable FDA regulations, such as Preventive Control requirements. Under FSVP, importers must also consider their suppliers’ compliance history, including whether the products are under Import Alert and whether the facility has been issued a Warning Letter. Importers must reevaluate their suppliers at least once every three years.

If an importer fails to develop an FSVP, has an incomplete FSVP, or does not reevaluate their suppliers as required, FDA may take enforcement action.

Violations for Not Developing an FSVP

In June 2020, FDA issued a Warning Letter to Martinez Mexican Produce LLC after an inspection revealed the facility did not have FSVPs for their imported mayonnaise and shredded coconut products.  FDA explained that it “may place all foods from your foreign suppliers on detention without physical examination (DWPE) when you import the products” if FSVPs are not developed. Products subject to DWPE will be stopped each time they arrive at the US border, resulting in continuous costly delays for affected importers.

Other examples of importers cited for not having FSVPs in 2020 include:

Violations for Incomplete FSVPs

FDA may also issue Warning Letters for not properly verifying supplier compliance. Kradjian Importing Company, Inc. was cited for not conducting proper hazard analysis on one of their suppliers. FDA stated that Kradjian “did not meet [their] requirements to conduct a hazard analysis…because [they] did not evaluate [their] foreign supplier’s performance in accordance with 21 CFR 1.505, nor did [they] perform foreign supplier verification.” The facility also provided HACCP plans for imported products as an FSVP.  HACCP plans do not satisfy the requirements of an FSVP, and FDA concluded Kradjian’s HACCP plans were deficient and did not provide the necessary information for FDA compliance.

Kaymile Trading, Inc. was issued a Warning Letter because, in addition to missing FSVPs for several of their products, they did not properly “approve [their] foreign suppliers on the basis of an evaluation of the foreign supplier’s performance and the risk posed by the food.” It is important for facilities to not only develop their FSVPs but to properly verify and evaluate foreign suppliers’ compliance with FDA food safety requirements. Under FSVP, it is the importer’s responsibility to verify that their suppliers are meeting FDA food safety standards.

Reduce Your Risk – Get Assistance with FSVP

Registrar Corp assists with FSVP compliance. Our online FSVP training will help your team understand what FSVP is, who is responsible for compliance, and how to meet requirements. If you don’t want to navigate these requirements on your own, Registrar Corp’s Qualified Individuals can develop, review and implement your FSVP for you. If you already have developed FSVPs, Registrar Corp offers a Mock FSVP Inspection service during which a Food Safety Specialist examines your FSVP documentation to identify any areas of concern.

Additionally, Registrar Corp’s FDA Compliance Monitor helps you comply with FSVP supplier evaluation requirements by continuously monitoring your suppliers for Warning Letters, Import Alerts and more. The Monitor allows you to track which suppliers you have approved and provides information from five FDA databases in one convenient dashboard.  Receive email alerts when new information is published about your suppliers so you can make informed purchasing decisions and take necessary corrective actions.

For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.

Frequently Asked Friday: Does FDA consider my product a cosmetic or drug?

The U.S. Food and Drug Administration (FDA) regulates certain products that are commonly considered cosmetics as drugs. FDA regulations for drug products are strict and more comprehensive than regulations for traditional cosmetics, which can often cause confusion for manufacturers.

The distinction between a drug and cosmetic product is based upon the product’s ingredients as well as its intended use. Marketing a cosmetic product that may be subject to FDA drug regulations can result in the product being considered an unapproved drug.  Marketing unapproved drugs is violation of the Food, Drug, and Cosmetic (FD&C) Act and can result in criminal and civil penalties, warning letters, and other FDA enforcement action.

Drug vs Cosmetic Regulations

The difference in FDA regulations between cosmetics and drugs is significant. Cosmetic products may generally be marketed without FDA approval if they do not contain prohibited ingredients and appropriate claims are made. Cosmetic manufacturers are not required to register their facilities with FDA (although they may voluntarily), nor do they need to list their products.

On the other hand, drug facilities and products have stricter requirements. Drug facilities must register with FDA and list the drugs handled at the facility. It is important to note that registering with FDA does not mean you have obtained FDA approval.  Drug products must either conform to an over-the-counter (OTC) monograph or undergo the FDA approval process through a new drug application (NDA) to be marketed in the United States.

However, these differences may change in the near future. In September 2019, a bill called the Safe Cosmetics and Personal Care Products Act of 2019 was re-introduced to the U.S. House of Representatives. If passed, this bill would enact stricter regulation of cosmetics companies, including mandatory registration, standard good manufacturing practices, and ingredient statements.

Active Drug Ingredients in Cosmetics

FDA regulates cosmetic products as drugs when they contain active drug ingredients. For example, anti-perspirant deodorants contain Aluminum Zirconium Tetrachlorohydrex, an ingredient intended to prevent sweating (a function of the body). Other examples include anti-dandruff shampoos and acne-fighting cosmetics (Salicylic Acid), sunscreen and SPF face creams (octyl salicylate), and anti-cavity toothpastes (fluoride).

If an unapproved product containing active drug ingredients is marketed in the United States, the facility may face FDA enforcement action including detentions, import refusals, and Warning Letters. In the past year alone, FDA has refused nearly 3,000 drugs for lack of necessary approval, many of which are bath soaps, detergents, botox products, cleansers, deodorants and other “cosmetic” products.

Drug Product Claims on Cosmetics

Another common reason cosmetic products are regulated as drugs is because they make claims that they “diagnose, mitigate, treat, or prevent disease, or affect the structure or function of the body.” For example, some anti-aging creams claim to slow the process of aging by increasing the user’s production of collagen (a function of the body). Other examples include products that claim to repair skin or diminish irritation.

FDA has published a list of warning letters addressing products marketed as cosmetics that make drug claims.  In this warning letter issued to Health Habits, LLC, FDA states the following product description is evidence that the facility’s product is intended for use as a drug: “DermaTox® is an all-purpose skin wellness formula. Our customers tell us that they use DermaTox® daily to nourish their skin, speed healing, soothe the pain of a burn or bed sores, diminish irritation associated with eczema, psoriasis, rashes, cuts, bites, scrapes, spray on liver spots, moles, etc…”

Warning Letters are available to the public and thus can hurt your brand and reputation.  Typically, FDA gives facilities 15 working days to respond to a warning letter explaining how and when they will correct the noted issues.  Failure to respond to a Warning Letter within the allotted time can result in seizure of products.

Stay Compliant

Registrar Corp can help determine if your cosmetic products are regulated as drugs and help you to bring your products into compliance. Our Regulatory Specialists can assist you with FDA registration, labeling and ingredient reviews, and more.  For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.