Foreign Supplier Verification Program – What Does It Mean For Your Business

If you export food, food ingredients, food packaging, dietary supplements or food additives to the United States, your U.S. Importer will soon require that you provide documentation verifying that your company is compliant with the Food Safety Modernization Act (FSMA) regulations from the U.S. Food and Drug Administration (FDA). This could include compliance with a range of new rules, including "Preventive Controls for Human Foods (PCHF)", "Preventive Controls for Animal Feeds (PCAF)", and Produce Safety regulations.

What does that mean for your business? What kinds of documents will your business be asked to provide?

Join EAS Consulting Group Independent Advisor for FSMA, Charles Breen and EAS Independent Consultant Dr. Susan Moyers in a webinar directed at foreign embassy staff, and foreign food, food ingredient and food additive firms who export to the United States.

Beginning May 26, 2017, FDA’s “Foreign Supplier Verification Program (FSVP)” goes into effect for large firms; smaller firms may have additional time to comply. The FSVP requires U.S. importers to verify that their foreign suppliers of food, food packaging, food ingredients, dietary supplements and/or food additives imported to the U.S. possess the same level of public health protection as is offered by domestic producers.

In a related FSMA regulation, the FDA is also offering an optional “fast-track” in 2018 for manufacturers who have a documented safety policy and a solid record of safety in their products.

In an exclusive webinar for EAS, Charles Breen and Dr. Susan Moyers will help foreign firms understand the requirements and documents that they will have to meet under FSMA and what U.S. importers will be expecting from them.

Process Labeling – Pathway to Transparency?

By Steve Armstrong, EAS Independent Advisor, Food Law & Regulation

A thirty-year old federal court opinion that is well known to students of food and drug law holds that in the absence of a detailed, Congressionally mandated definition, courts and regulators should follow the common understanding of “food” as an article that delivers “taste, aroma and nutrition.” In the 21st century, however, food not only nourishes and satisfies, it also frequently makes a statement — about how it was made, where it came from and how the earth and its inhabitants were treated along the way.

Foods with these sorts of claims – called “Process Labeling” — are everywhere. Even on a casual trip to the supermarket, it’s hard to miss the increasing use of labels claiming that a food is “certified organic,” “shade-grown,” “free-range,” or “rain forest certified,” to name but a few. Process labeling is oftentimes also about what was notdone to a food. For example, “Non-GMO” indicates that the food used no ingredients made from genetically modified organisms, or “GMOs,” shorthand for the agricultural bioengineering methods that have helped farmers grow corn, soybeans and other cash crops.

Consumer Appeal

Food marketers today, as one of them recently told me, need to appeal to consumers’ desire to know about the “genealogy” of a food. Of course, this interest is relatively new but growing exponentially and to a very real extent can be attributed to the fact that food in the United States is by and large safe, plentiful and relatively inexpensive. Two authors who have studied communication in modern agriculture explained the phenomenon this way:

As top concerns for consumers are already largely being met, there is a freedom that was not historically available to delve deeper into food issues, to ponder how food was grown and raised and to think about these matters while waiting to check out. Consumers are not wrong for doing this; it is a fundamental right of the consumer to question.

The Communication Scarcity in Agriculture, J. Eise, W. Hode (New York, N.Y. 2017) at p. 46.

Consumer concerns over the impact of modern food production on health and the environment have helped drive the popularity of Process Labeling. The Council for Agricultural Science and Technology, a nonprofit scientific organization, recently assembled a cross-functional panel of experts to assess the phenomenon and make policy recommendations. The panel concluded:

Under appropriate government oversight, these ‘process labels’ can effectively bridge the information gap between producers and consumers, satisfy consumer demand for broader and more stringent quality assurance and ultimately create value for both producers and consumers.

The mounting popularity of Process Labeling is readily apparent. In the U.S., consumer purchases of organic products have reached record levels, amounting to over $43 billion last year, and up 11% over the previous year. The demand for environmental or “eco” labeling is robust, with more than 460 different labels relating to 25 industry sectors now in use in nearly 200 countries. Food companies are embracing Process Labeling in the name of “transparency,” with many committing to provide more information – via labeling – about how food is produced.

Execution Challenges

While Process Labeling has great appeal and potential utility, execution can be difficult for three reasons.

First, such labels require a “process” clearly defined by a standard fixed either by the government or a well-established, independent agency. The standards for organic farming set by the National Organic Program are the leading example of such a third-party standard.[1] USDA’s systems of grading meat, poultry, butter and eggs, and requiring Country of Origin Labeling (“COOL”) are other examples of clearly defined process standards. Sellers, buyers, trade groups and industry associations have also established quality standards and guidelines against which Process Labeling claims can be assessed.[2] However, it is hard, if not impossible, to find widely accepted, well-established definitions for some of the most popular process claims such as “cage-free,” “grass-fed,” “free range,” “naturally raised,” and many others.

Second, even with a defined standard, substantiating Process Labeling claims can be challenging, especially for large-scale operations with far-flung suppliers. Adequate substantiation requires supply chains operating under strict control, with rigorous oversight and continuous monitoring. The food producer must maintain strong and transparent supplier relationships and check in frequently to assure that the operation is running as agreed and without errors or gaps. Independent verification is helpful, and producers can obtain that kind of help from the USDA’s Agricultural Marketing Service, which provides a wide variety of independent verification services through its Process Verified Program (“PVP”), a voluntary, user-fee-funded program. The PVP uses highly trained auditors to conduct inspections, review processes and documentation and thereby assure that a producer is adhering to the standards supporting the process claim.

Third, Process Labeling can send inferential messages about health or well being that can be highly misleading without prominent disclaimers or other disclosures. The Federal Food, Drug, and Cosmetic Act (“FFDCA”) provides that a food is misbranded if its labeling is “false or misleading in any particular.” The FFDCA has long been interpreted as holding a producer strictly accountable for the claims made in labeling. This includes accountability for omissions, as the FFDCA empowers FDA to find a label misleading if it fails to reveal facts that are “material” in light of the representations that are made for the product.

GMOs are a case in point. A recent consumer survey concluded that an overwhelming majority of consumers worldwide think non-GMO foods are healthier than foods made with GMOs. However, FDA has found no scientific basis to require labeling because GMO foods are safe and not materially different from non-GMO foods. Now consider whether the following claims should appear right alongside each other on a food’s principal display panel:

Healthy / Non-GMO

Is this lawful? Or does the implication that non-GMO foods are healthier violate the FFDCA by failing to disclose the scientific consensus that GMOs are safe and that avoiding them does not brings a health benefit? Information necessary to avoid misleading consumers should be provided at the point where the claim is made. In this case, the label should have noted the FDA’s position on the same panel, or at least on an adjoining one.


Process Labeling can inform consumers about the origins of their food and the methods by which it was produced, and in doing so promote a sense of interconnectedness and a better understanding of agriculture. However, such labeling requires clearly defined standards and significant investments in supply chain oversight and monitoring. Process Labeling claims can mislead consumers about benefits where none exist.

The CAST panel, while seeing the upside of Process Labeling, recommended strict regulation. Labelers should explain the scientific significance of the process (“GMO corn for reduced pesticide use”) and disclose when there is no benefit (“rBST-free / No significance difference has been shown in milk from non-rBST cows”). Such standards of care can certainly help unlock the potential of Process Labeling to educate consumers and help them feel just a bit closer to their world and the ways in which their food is made.

First FSVP Compliance Deadline Arrives

In a significant FSMA milestone, May 30, 2017 was the initial deadline for U.S. food importers to implement a foreign supplier verification program (FSVP).

Beginning May 30, the U.S. Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system is requiring filers to enter at least one additional code for their food shipments, noted Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine, in an interview posted on the agency’s website just days ahead of the deadline.

Importers covered by the deadline should enter the code “FSV” to indicate that the entry is subject to the FSVP regulation. When it sees that code, ACE will ask for the importer’s name, email address, and unique facility identifier (UFI) – and FDA has formally recognized the Data Universal Numbering System (DUNS) for this purpose.

If a food is exempt or not yet subject to the FSVP, the filer should enter “FSX,” to indicate that the food is exempt from FSVP or that compliance with FSVP is not yet required — or “RNE,” to indicate that the food is exempt because it will be used for research or evaluation.

For a limited time, Mayl said, importers can enter “UNK” – indicating unknown — for the DUNS number if they don’t have one. But this option is temporary and they will need to get a DUNS number to come into full compliance. Importers without DUNS numbers should use this link to obtain a free DUNS number:

FSVP verification by importers should be based on an evaluation of the risk of the food and the supplier’s performance, so verification could include a review of the supplier’s food safety records, sampling and testing, as well as onsite auditing.

FSVP compliance dates are based on the size of the foreign supplier and the regulations that apply to the supplier. Importers generally must comply six months after their foreign supplier must be in compliance with the FSMA preventive controls or produce safety rules.

For companies unsure of whether they are covered by the FSVP, the agency has created a useful chart titled Am I Subject to FSVP?