The Foreign Supplier Verification Program

What is the Foreign Supplier Verification Program?

As the name suggests, US importers now have the legal and financial responsibility to approve and verify foreign suppliers, ensuring that the products they import and distribute in the US fully comply with the food safety standards and methods mandated by the Food Safety Modernization act of 2011. This requires three major new procedures:

  1. hiring or engaging a qualified individual with knowledge of Hazard Analysis and Risk-Based Preventive Control (HARPC) methods.
  2. creating a foreign supplier verification program (see below)
  3. providing the FSVP importer “unique facility identifier” (UFI) each time when filing an entry with the Customs and Border Protection (CBP)

Those US importers who are not able to show complete FSVP records upon request by the FDA within 24 hours will or may face fines. Moreover, many larger retailers demand to see proof that importers have and maintain FSVP records.

What Investments are Necessary to Create and Maintain a FSVP?

Importers and Foreign Suppliers are likely to be approached by many consultants and law firms trying to make a quick buck by stirring fear and alarm about the consequences of non-compliance with FSMA and FSVP. No panic, keep calm. The FDA does not have the resources to check all importers at once and is not interested in shutting businesses down. All importers can create and maintain a FSVP under $2,000 and a little dedicated time. They can hire PCQI consultants (Preventive Controls Qualified Individual) or any employee or owner can attend online or in-class training seminars to become qualified. Training is offered at the Food Safety Preventive Control Alliance (FSPCA)

10 Steps to Create a FSVP

  1. Appoint, hire or train a “preventive control qualified individual” who is familiar with matters food safety, hazard analysis, risk assessment and preventive control
  2. Conduct and document a hazard analysis based on the risk profile of your foreign suppliers’ food and beverage products
  3. Document your supplier’s preventive controls of the hazards you identified in the analysis
  4. Document how your supplier and you monitor the implementation of preventive controls in and outside the production facility
  5. Document how your suppliers adjust their controls over time and keeps records of all food safety related activities
  6. Create a recall plan for all food products you’re importing.
  7. If these activities and the resulting food safety plan are part of an audit under the Global Food Safety Initiative (GFSI) scheme, such as IFS, BRC, SQF or SSC 222000, make sure you get a copy of the audit summary and understand, how that audit covers the FSVP requirements.
  8. At least once every three years, visit the factory and become familiar with the systems and checks and balances your supplier have in place to control the safety of the food they produce.
  9. Keep records of all your FSVP activities in an easy to find folder or in computer files. These records have to be made available to the FDA upon request.
  10. Continually inform your employees and your suppliers of your FSVP related activities

What FSVP formats are required?

The FDA prescribes no specific format and it’s up to the importer to establish the most effective FSVP that fits his/her business needs. Of course, it is advisable to keep records in one place, ideally in electronic files and retrievable by any qualified individual in the company. It is also advisable to have a summary of the FSVP ready for retailers upon request.

What are the differences between FSVP Importers, Importers of Record, FDA US Agents and US Import Agents?

The Importer of Record and FSVP Importer are usually the same entity with direct financial interest in the imported food, i.e. those who are the new owner /consignee/purchaser of an import shipment. However, these can also be separate entities. For example, a retailer can be the Importer of Record, while another firm acts as the FSVP importer who creates maintains the FSVP for a given food item and the respective supplier. If no FSVP Importer has been designated by the exporter or customs broker at the point of entry in the US, the FDA will look for a designated US Import agent. This can be any qualified entity (consultant, customs broker, individual) who consented in writing to act as the FSVP Import Agent, without necessarily taking ownership of the food shipment. The FDA US Agent is a US resident who acts as liaison to the FDA in accordance with the Bioterrorism Law of 2001. The Bioterrorism FDA US Agent is not automatically the FSVP US Agent.

What Codes are required to identify FSVP importers and related food products?

FSVP importers are well advised to obtain a Universal Facility Identifier (UFI) Number, at no charge, from Dun & Bradstreet: the so-called DUNS number. When you export a food or beverage products that falls under the FSVP categories is exported, you need to file one of the following Affirmation of Compliance Codes in the CBP / ACE system:

  • FSV – for food products under FDA oversight subject to FSVP
  • FSX – for food exempt from FSVP or not yet subject to FSVP
  • RNE – for food subject to research and evaluation, i.e. samples, not to be sold

Additionally, you need to file the FSVP Importer’s Universal Facility Identifier (UFI), i.e. DUNS Number. If the DUNS Number is not known, the export or import broker can file the Code “UNK” (unkown) for a limited time.

Do Food Audit Standards under the Global Food Safety Initiative (GFSI) cover all FSVP requirements?

The four main GFSI food audit schemes – IFS, BRC, SQF and FSSC 22000 – cover “most all” of the US FSMA, FSVP and Preventive Control requirements. This is the conclusion of a Comparative Analysis between the IFS Standard and FSMA. US Importers are well advised to get a summary report of their suppliers’ most recent GFSI audit as well as the corresponding certificate for the records. In addition, US importers should check other mandatory measures, such as the prevention of intentional adulteration, audits of the external environment etc..

Minimum FSVP documentation you should have on hand for all suppliers

At the very minimum, all importers should maintain an updated file containing the following information about each supplier:

  1. Supplier Contact Name, Title, Email Address, Phone number
  2. Does this company have over 500 employees? Yes No
  3. Factory Name Factory Address Factory Contact Person Contact Person Title Contact Email Address Contact Telephone, Factory Business License Number(s), if available
  4. Food and Drug Administration (FDA) Registration Number(s)
  5. How long has this facility shipped food for human consumption to the US?
  6. Has this facility previously produced any food product recalled by the US Food and Drug Administration (FDA)?
  7. If yes, what type of food was recalled and when?
  8. Has this facility ever been issued a warning letter of cited by local health inspection authorities or the US FDA?
  9. If yes, what was the violation and when was the warning letter issued?
  10. Has this facility been listed on a US FDA Import Alert?
  11. If yes, what was the import alert number?
  12. GFSI certified audit
  13. Which certification body performed the audit on the facility?
  14. What is the GFSI certified audit score?
  15. When is the audit expiration date?

Which products do not require a FSVP ?

Foreign suppliers do not have to identify a FSVP importer when filing a CBP entry or US importers do not have to create and maintain a FSVP for the following food and beverage products:

  • juice and seafood, as long as their suppliers comply with the respective HAACP procedures
  • small quantities of foods and beverages used for research and evaluation, are not intended for retail sales or distributed to the public
  • small quantities for personal consumption
  • low acid canned foods (importers do not have to identify risks of  microbiological hazards, as they are covered by the LACF permit)
  • certain alcoholic beverages
  • trans-shipped foods and beverages
  • meat, poultry and egg products regulated by the USDA

Please note: In 2017, first time exporters do not need a FSVP importer for sending samples to trade shows. After May 30, 2017, use the Acronym UNK as Code for the importer.

Please contact CMA Global Partners , if you have any further questions, are in need of an external FSVP Importer, PCQI or US FDA Agent.

Food Regulation USA Update 2021

food-industry-news-5A summary of regulatory changes and updates in 2021, as published by the FDA (US Food & Drug Administration), USDA (US Department of Agriculture) and TTB (Tobacco and Alcohol Tax and Tariff Bureau). We provide a brief synopsis and comment under each link.

The most important regulatory changes in
Food label changes, menu labeling initiative, FSMA, Prop 65 and more…
The Food Safety Modernization Act – explained in German
Food Safety Plan, Hazard Analysis, Preventive Controls and more…


January 2017

Listeria Control. The FDA published a guidance to industry on how to prevent contamination by one of the most pernicious bacteria:  Listeria monocytogenes. This bug are found primarily in ready-to-eat foods made at home or prepared in factories, restaurants and supermarkets, such as cheese, salads, sandwiches, prepared seafood, or freshly-cut vegetables. At best, L. monocytogenes causes mild stomach upsets, but increasingly it also kills people, especially those with weak immune system, pregnant women and their fetuses, or elderly people. This bug can occasionally survive freezing temperatures, grow slowly in the refrigerator and blossom at room temperature.




All About the FSMA Food Safety Plan – in German

fda_buildingIm Jahr 2011 verabschiedete der US Kongress und Präsident Obama den Food Safety Modernization Act (FSMA). Dieses bahnbrechende Gesetz gibt der US Food & Drug Administration (FDA) grundlegend neue Befugnisse zur Überwachung und Regulierung von Lebensmitteln, die in den USA hergestellt oder vertrieben werden. Die Behörde brauchte immerhin fünf Jahre, um das Gesetz in umzusetzen. Hier sind die drei wichtigsten Eckpunkte:

  • Die Verantwortung und Haftung bei Ausbrüchen von Lebensmittelvergiftungen liegt nun ausschliesslich bei Herstellern, Importeuren, Großhändlern und Transportunternehmen, nicht bei der FDA
  • Die FDA hat nun die uneingeschränkte Befugnis, Lebensmittelbetriebe oder Importfirmen in den USA zu schliessen, wenn diese den Vorsorge und Kontrollpflichten nicht nachkommen und eine Gefahr für die Allgmeinheit darstellen.
  • Eigentümer und Angestellte von Betrieben und Importeure, die nachweislich und vorsätzlich vergiftete Lebensmittel vertreiben, werden nun immer häufiger und rigoroser vor Gericht gestellt und, wenn schuldig befunden, zu langen Haftstrafen verurteilt.

Wir können nur mit Nachdruck allen deutschen und europäischen Herstellern von Lebensmitteln, die von der FDA überwacht werden,  empfehlen, die neuen Regeln des Food Safety Modernization Acts zu lesen, zu verstehen und umzusetzen. So kann vermieden werden, dass Lieferungen an der Grenze hängenbleiben, FDA Kontrollen nicht bestanden werden oder US Handelskunden Aufträge stornieren oder andere Lieferanten bevorzugen.

Die folgenden Fragen und Antworten fassen die wichtigsten Bestandteile und Auflagen der FSMA Vorschriften zusammen.

Was schreibt FSMA vor?

FSMA reguliert drei Hauptbestandteile bei der  Lebensmittelherstellung:

  1. Current Good Manufacturing Practices – CGMP (Gute Herstellungspraxis/ Qualitätsmanagementsysteme)
  2. Hazard Analyis (Gefahrenanalyse)
  3. Risk Based Preventive Controls for Human Foods (Auf Risiken basierende Vorbeugungsmaßnahmen für die Herstellung von Lebensmitteln)

Ab wann müssen die FSMA Verordnungen befolgt werden?

Seit September 2015 sind diese Verordnungen für alle gesetzlich verpfichtend.

  • Ab September 2016 müssen alle Hersteller mit mehr als 500 Mitarbeitern die Vorschriften erfüllen
  • Ab September 2017 müssen kleine Betriebe mit weniger als 500 Mitarbeitern und über $1 Millionen Umsatz die Vorschriften erfüllen
  • Ab September 2018 müssen alle Kleinstunternehmen mit Umsätzen unter $1 Millionen oder sogenannte “qualified facitities” (z.Bsp. Bauernhöfe mit Lebensmittelherstellung) die Vorschriften erfüllen

Proposed Rules MeetingWer muss die neuen FSMA Vorschriften befolgen?

  1. Alle Betriebe in den US, die Lebensmittel (siehe Punkt 4) herstellen, weiterverarbeiten, verpacken, lagern, und transportieren, also bei der FDA registriert sind
  2. Alle US Importeure von ausländischen Lebensmitteln, die nun verpflichtet sind, die Sicherheit der von ihnen eingeführten Produkte zu überprüfen und für deren Sicherheit haftbar gemacht werden.
  3. Alle ausländischen Hersteller, die bei der FDA registriert sind und Lebensmittel (siehe Punkt 4) in den USA vertreiben. Nach letzter Schätzung sind das rund 114,000 Betriebe in 200 Ländern. Über kurz oder lang müssen alle ausländischen Betriebe von der FDA inspiziert werden (oder im Auftrag der FDA von einheimischen Organisationen). Wenn Betriebe die Inspektion nicht bestehen, kann die FDA die Registrierung löschen – und damit dürfen diese Betriebe dann keine Lebensmittel mehr in die USA vertreiben oder verkaufen.

Welche Lebensmittelkategorien unterliegen den FSMA CGMP Vorschriften?

  1. Zutaten für Nahrungsergänzungsmittel
  2. Säuglingsnahrung
  3. Getränke
  4. Früchte und Gemüse
  5. Fisch und Meeresfrüchte
  6. Milchprodukte
  7. Backwaren
  8. Snacks
  9. Süsswaren
  10. Gesäuerte und schwachsaure Lebensmittel
  11. Wildfleisch

Wer muss die neuen FSMA Vorschriften nicht, oder nur zum Teil, befolgen?

  1. Sehr kleine Betriebe (mit Umsatz unter $1 Millionen) und sogenannte “qualified facilities” mit Umsatz unter $500,000 müssen den FSMA Food Safety Plan nur bedingt erfüllen
  2. Hersteller von Fleisch- und Eiprodukten, die vom US Department of Agriculture überwacht werden
  3. Hersteller/Exporteure von Fischen und Meeresfrüchten, die die sogenannten Seafood HAACP Verordnungen befolgen müssen
  4. Hersteller/Exporteure von Fruchtsäften, die die sogenannten Fruit HAACP Verordnungen befolgen müssen.
  5. Hersteller/Exporteure von schwachsauren Lebensmitteln, die für mikrobiologische Gefahren die Low Acid Canned Food Verordnungen erfüllen müssen (sie benötigen ein spezielles Zertifikat der FDA), für alle anderen Gefahren aber den FSMA Verordnungen unterliegen
  6. Hersteller/Exporteure von Nahrungsergänzungsmitteln (die unterliegen den Nutritional Supplement Good Manufacturing Practices)
  7. Hersteller/Exporteure von alkoholischen Getränken (die unterliegen den Vorschriften des Alcohol and Tobacco Tax and Trade Bureau – TTB)

Wie müssen die FSMA Vorschriften befolgt werden?

Alle o.g. Betriebsstätten müssen eine sogenannten Food Safety Plan erstellen, der die folgenden Themen behandelt

  1. Hazard Analysis: Eine Analyse der Gefahren bei der Herstellung, Verabeitung, Lagerung, dem Einkauf von Zutaten und Transport, die zu Lebensmittelvergiftungen führen können
  2. Preventive Controls: Eine Liste und Zusammenfassung aller Präventivmassnahmen, um die analysierten Gefahren zu verhinden.
  3. Risk-based Supply Chain Program: Ein Plan zur Überwachung und Gefahrenvermeidung Ihrer Lieferkette – ein Schritt zurück, ein Schritt vorwärts
  4. Recall Plan: Ein Plan für den Fall einer Rückrufaktion. Die Anzahl von freiwilligen oder angeordneten Rückrufaktionen von Lebensmitteln hat sich seit FSMA mehr als verdreifacht.
  5. Monitoring the Implementation of Preventive Controls: Eine Beschreibung der Massnahmen zur Präventivkontrolle
  6. Verification of the effectiveness of preventive controls: Eine Beschreibung der Verfahrensweise zur Überwachung der Wriksamkeit von Präventivkontrollen und deren eventuellen Anpassungen

Je größer der Betrieb und je mehr Umsatz in den USA gemacht wird, desto eher wird empfohlen, diesen Food Safety Plan in englischer Sprache zu erstellen.

Wie unterscheidet sich der FSMA Food Safety Plan von Überprüfungen großer Handelsketten, also den Audit Standards der  Global Food Safety Initiative (GFSI), zum Beispiel IFS, BRC, FSSC 22000, oder SQF ?

Der FSMA Food Safety Plan muss von einem/r designierten Experten/in für Qualität und Lebensmittelsicherheit (qualified individual) erstellt werden. GFSI Standards, wie IFS, BRC, SQF, oder FSSC22000, decken fast alle FSMA Vorgaben ab (Exec summary IFS FSMA Comparative Analysis May 2016f).  Es ist aber ratsam, dass sich die Betriebsexperten mit den Prüfungsfirmen oder den MItarbeitern der GFSI Standards auseinandersetzen und herausfinden, welche FSMA Vorgaben sonst noch erfüllt werden müssen.

Food_Processing_iStock_000018272872smHazard Analysis: Welche Gefahrenquellen müssen identifiziert werden ?

  1. Biologische – speziell mikrobiologische Gefahren, wie Parasiten, Bakterien, Viren und andere Pathogene aus der Umwelt
  2. Chemische – Nukleare Verseuchung, Pestizide, Arzeneimittelrückstände, natürliche Giftstoffe (wie Mycotoxine), Verwesung, nicht genehmigte Farbstoffe oder Zusatzmittel, nicht deklarierte Allergene
  3. Physische – Steine, Glas, Metallfragmente

Hazard Analysis – Bei welchen Aktivitäten müssen Gefahrenquellen analysiert und bewertet  werden?

Hier sind ein paar Beispiele:

  1. Lebensmittelzutaten – Säure oder Zusatzstoffe, die den Wachstum von Mikroorganismen verhindert oder diese abtöten. Manche dieser Zutaten können Allergien erzeugen
  2. Zustand, Funktion und Design des Betriebs oder der Maschinen – Lose Teile, die schlecht gereinigt werden, können Pathogene beherbergen. Machinen mit Metallteilen können Metallsplitter erzeugen
  3. Reinigung, Hygiene – Chemikalien während der Reinigung können in Lebensmittel greaten. Ungewaschene Hände von ungeschulten Mitarbeitern können zu Vergiftungen führen
  4. Zutaten – kontaminierte Zutaten, die nicht gescheckt wurden, können das fertige Lebensmittel vergiften
  5. Transportwege – Ungenügende Temperaturkontrollen während des Transports von Lebensmitteln können diese vor derm Verkauf verderben oder schädliche Krankheitserreger hervorbringen.
  6. Herstellungsprozess – Ungenügende Kühlung, Erhitzung oder Lagerung kann Krankheitserreger oder Giftstoffe hervorbringen.
  7. Verpackung und Etikettierung – Glasverpackung kann splittern. Fehler bei der Gestaltung, dem Druck und dem Anbringen von Etiketten können dazu führen, das Allergeninformationen für Verbraucher nicht verfügbar oder lesbar sind
  8. Lagerung und Distribution – Ungenügende Kühlung bei heissen Temperaturen oder während des Transports
  9. Vorhersehbare Benutzung des Produkts – Manche Lebensmittel, die gekocht werden sollten, werden auch manchmal roh gegessen. Hinweise müssen auf den Verpackungen erscheinen, die vor einem vorhersehbaren, unsachgemässen Verzehr des Produkts warnen
  10. Umweltverschmutzung – in bestimmten klimatischen Zonen können Krankheitserreger aus der Luft bestimmte Lebensmittel, die gleich verzehrt werden, kontamiieren.

Tomato_Inspected_iStock_000006170909MediumPreventive Controls: Was muss im FSMA Food Safety Plan enthalten sein?

  • Kontrollen an kritischen Kontrollpunkten (CCP – Critical Control Points)
  • Kontrollen ausserhalb der CCPs, an Punkten, die eenfalls kritisch für die Lebensmittelsicherheit sein können

Darunter fallen:

  1. Parameter und Kontrollen bei Kochprozessen, wie zum Beispiel Erhitzung, Säurung, Radiologische Behandlung, Kühlung
  2. Allergenkontrolle, Vermeidung von Cross-Kontamination, Kontrolle der Etiketten
  3. Kontrolle der sanitären Massnahmen
  4. Kontrolle der Lieferkette (supply chain program)
    • Auswahl von Lieferanten, die den FSMA Verordungen entsprechen
    • Regelmässige/jährliche Kontrolle der Sicherheit von Lieferantenprodukten
    • Möglicherweise direkte Audits der Betriebe von Lieferanten
    • Labortests und Bemusterung
    • Überprüfung der Sicherjeitsprotokolle von Lieferanten
  5. Kontrolle bei Rückrufaktionen:
    • Benachrichtigung der direkten Kunden,
    • Benachrichtigung der Öffentlichkeit,
    • Kontrolle der Wirksamkeit des Rückrufs,
    • Kontrolle der Vernichtung der rückgerufenen Lebensmittel
  6. Kontrolle der Schulung und Training von qualifizierten Mitarbeitern
    • Laut FSMA dürfen nur Mitarbeiter, die in “risk-based preventive controls,” Lebensmittelsicherheit und –hygiene geschult wurden, einen FSMA Food Safety Plan erstellen und dokumentieren.
    • Das Management eines Betriebes muss sicherstellen, dass die qualifizierten MItarbeiter für die Erstellung eines FSMA Fod Safety Plans entsprechend geschult werden oder von ausgebildeten Vorgesetzten betreut werden

Preventive Controls – Protokollierung

Die Dokumentation der Kontrollen und Massnahmen im Präventivsystem ist eine der wichtigsten Komponenten der FSMA Verordnung. Bei FDA Audits müssen die entsprechenden Protokolle der folgenden Aktivitäten vorgezeigt werden:

  1. Überwachung (Monitoring) der Kontrollpunkte und der Kontrollen
  2. Massnahmen zur Vermeidung und Beseitigung von potentielle Gefahren
  3. Sicherstellung und Bestätigung dieser Massnahmen
  4. Labortests und Umweltüberwachung
  5. Protokollführung

Wenn ein Betrieb bestimmte Lebensmittel an Weiterverarbeiter zuliefert und diese Weiterverarbeiter die oben genannten Präventivkontrollen zur Lebensmittelsicherheit durchführt, dann braucht der Zulieferbetrieb diese Protokollierung nicht durchführen.

commercial container shipDie Kontrollpflicht der Importeure

Eine der Säulen des Food Safety Modernization Acts ist das sogenannte “Foreign Supplier Verification Program”. Damit werden alle Importeure verpflichtet, die Sicherheit von Lebensmitteln zu überprüfen.

Die deutschen/europäischen Lieferanten von Importeuren, Großhändlern und EInzelhändlern sollten eine Kurzversion des Food Safety Plans Ihren Kunden senden, damit diese ihren Pflichten des Foreign Supplier Verification Programs nachkommen.

Mehr Informationen (auf Englisch)

Food Industry Faces Paradigm Shift

Brief Introduction to German Fruit Preserve Regulations

Here is a brief introduction to the German fruit preserve law, the classifications and legally prescribed fruit content.

Pumpkin orange ad 2Classification

The official term for fruit preserves in German is Konfitüre (fruit spread).  Yet, in  German vernacular, you can find many other words:

Marmelade (engl: marmelade): Derived from the Portugese word “marmelo” (engl: quince).  Most Germans use the word as umbrella term for all fruit preserves and jams. Yet, European and German law mandates that only citrus-based preserves may officially be called Marmelade  

Konfitüre (engl: fruit preserve or jam): This words leans on the French la confiture and stands for jams with visible bits of fruits or berries. Today, it’s the common term for all jams

Gelee (engl: jelly): Fruit jellies can only be made from fruit juices.

Fruchtbutter or -mus (engl: fruit butter): Fruit butter, like Pflaumenmus, or Apfelbutter, is a thick spread made from lots more fruits in weight than what comes out as fruit spread.

Conventional and Organic German PreservesQuality differences

German and EU law mandates the amount of fresh fruits that processors have to be use in the commercial production of jams, jellies and fruit butters.

  • For most fruit jams, the minimum is 35% (350g in 1000g jam).
  • For some berries, that may be too sour or inedible in their natural state, the minimum share of fresh fruit is 25% (this includes black and red currant, rosehip, sea buckthorn, and quince).
  • For plum butter, the amount of fruit used is 140% of the final product, because plums are slowly cooked and thicken over time.

Most German, Austrian or Swiss quality brands use between 45% and 55% for all fruit jams. In contrast to many of the widely distributed US brands, German fruit preserves do not contain corn-derived sweeteners,  just GMO-free sugar beets, fruit pectin as gellant and lemon juice as preservative. That makes all the difference in taste and texture.

Exporters: How To Calculate Your Retail Price

Exporting food and beverages to the United States requires significant initial investments in money and time. Your product must be unique, of special quality, attractive, easy to understand, nutritionally sound, and – most importantly – competitive in the respective price segment. Below is a comprehensive list of all the costs underlying the sale of a food or beverage product to consumers in the US or Canada. Who in the end will pay for these costs? That depends on your negotiation skills, the attractiveness of your product, your product’s sales potential and, of course, the competition. Contact us for customized assistance to determine a sound pricing strategy.

Target Everyday Shelf Price (1)

Retail Margin

Retailer Fees (2)

Promotion Deductions (3)

Delivered Price to Retailer

Distributor Margin

Inland freight

Distributor Fees (4)

Delivered Price to Distributor

Importer Margin

Inland freight

Broker (External Sales Force) Fee

Trade Show Allowance

FSMA Foreign Supplier Verification


Delivered Price to Importer

Inbound Freight Harbor to Importer

Customs Fees / Tariff

Ocean Transport

FOB Harbor Cost

Transport Factory to Harbor

SOLAS Weight Verification

Ex Factory Cost

Above the Line Marketing Allowance

Market Research



Net/Net Cost

(1) In the US, sales tax varies by state and is calculated at checkout. You don’t have to include taxes in your calculation

(2) May includes Free Goods, or Fees for Merchandising, Listing, Central Distribution, Unsaleables (MCB) etc.

(3) May includes Shelf Price Discounts, Scan Downs, Feature Ads, Displays, Rebates, Coupons etc.

(4) May Include Fees/Deductions for New Product Listing, Marketing, Trade Show Allowance, Merchandising

Food Industry Faces Regulatory Paradigm Shift

The year 2016 will be remembered as a watershed for food producers, importers and retailers in the United States. A wave of new federal and state rules published over the past months will impact food companies, huge and very small, for years to come. The changes are so large they amount to a regulatory paradigm shift.

Of course, the goal to increase the food safety, improve the health of millions,  and provide transparency to consumers of what’s sold at retail stores and restaurants.

Yet, the legislation may increase the cost of doing business in this industry. Small, artisan producers may not be able to compete with well-financed rivals.

This is why we summarized the most important national and state laws and  Food & Drug Administration’s final rules published over the past twelve month in as simple a language as we were able to write.

Click on each headline to delver further into the topics or get to relevant original sources.

Calories and Sugar – Nutrition Facts

New Packaged Food Nutrition Label

It’s all about sugar awareness. Until July 2018, manufacturers of most packaged foods and beverages will have to make the significant changes to nutrition and ingredient panel: highlight calories, relate calories to package and portion size, list added sugars and others.

Restaurant Menu Nutrition Labels in [Fast Food] Restaurants and Food Service Establishments

All chain restaurants with more than 20 outlets have to list calories on the menu. Although not mandatory before 2017, many chains have already implemented that rule. This means, food service suppliers to restaurants better put caloric information on their packages.

Guidance on Evaporated Cane Juice

Some manufacturers thought they could avoid listing “sugar” in the ingredient list of their products and call it instead “evaporated cane juice.” No longer.

Local Taxes on Sweets and Soda

Some major states and metropolitan areas charge a local tax on sweets and soda, as do some European countries. The jury is still out whether this effort will reduce consumption of these foods and, by extension, the obesity epidemic.

Food Safety Modernization Act Final Rules

This is the largest food law overhauls since the inception of the Food and Drug Administration in 1916. The law that became final rule in 2015 and 2016 puts the responsibility of ensuring food safety squarely on the shoulders of food manufacturers. This may significantly increase costs and liabilities for those manufacturers who don’t pay attention to hazard prevention and control, labeling, sanitation and the safe transportation of food.

Food facility registrationAll facilities that “manufacture, process, pack or hold food for human or animal consumption” in the US and those that export to the US have to register with the FDA database. What’s new:  register with a valid e-mail and the type of activity conducted at the facility for each food product category.

Preventive Controls for Human and Animal Food

Produce Safety Rule

Both of these rules prescribe the type of “preventive control” approach that all domestic and foreign food manufacturers have to follow, if they want to sell in the US.

Foreign Suppler Verification Program

Now, all importers in the US are held responsible for the safety of the  foods they bring into the country.  15% of the food supply in the US is imported, from seafood, fruits and vegetables to all the foreign specialties you can buy in the supermarket.  The FDA records about 12 million line entries per year for the import of food and registered over 114,000 food facilities in 200 countries around the world.

Sanitary Transportation

Accredited Third Party Certification

Food Defense (Strategies against Intentional Adulteration)

National GMO Labeling Law

Now it’s official. In July 2016, President Obama signed the first national GMO Labeling Law, called the National Bioengineered Food Disclosure Standard. Pursued for years by advocates of natural and organic foods and fought bitterly by the conventional, mass market food industry, US Congress passed  a new law, mandating the labeling of genetically modified organisms in foods and beverages. The US Department of Agriculture has now 2 years to issue final regulations..

Vermont GMO Labeling Law

A whopper of a legislation that forced all food and beverage manufacturers selling their products in Vermont to indicate on packages if their products contain more than 0.9% genetically modified organisms  Many retailers and distributors already required manufacturers to sign a  Letter of Guarantee, Affidavit.

This law is now superseded by the National GMO Labeling Law.

Poison in Packaging? California’s Prop 65

When it comes to environmental protection, Californians (like Germans) are somewhere “out there.” The California Proposition 65 (also called the Safe Drinking Water and Toxic Enforcement Act, passed in the 1980s) requires the labels on any household materials, food and non-food, that contains toxic levels beyond those determined by the California regulators. Got some pesticide residues in the grains or herbs ingredients of your snack bar? Using a cancer-causing chemical in your cleaner? You better indicate that on the product. Otherwise, any Californian with a test lab can check your product and notify the authorities. If the toxins exceed the official level … you pay the fine. Click the link above to a summary page.

Guidance on Medical Foods

What’s that?  These are food products “with distinct nutritional benefits usually delivered in liquid form by catheter to hospital patients, who require dietary management, have special therapeutic or chronic medical needs,  limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or have other medically determined nutrient requirements.” Phew. If you’re producing these kinds of foods, there are new FDA guidelines you need to consider.

No Poisonous Packaging: California’s Prop 65

In 1986, California voters approved an initiative to address their growing concerns about exposure to toxic chemicals. That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65.

Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm and requires all businesses to notify Californians if chemicals in the products they sell exceed the threshold levels determined by the authorities. For example, food manufacturer will have to place warnings on the label if the product contains more pesticides or Bisphenol A residues than allowed under the law.

The Office of Environmental Health Hazard Assessment (OEHHA) administers the Proposition 65 program. OEHHA, which is part of the California Environmental Protection Agency (Cal/EPA), also evaluates all currently available scientific information on substances considered for placement on the Proposition 65 list.

All larger businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to a listed chemical exceeding the limits published here.

Small businesses with less than 10 employees and government agencies are exempt.

A business has “safe harbor” from Proposition 65 warning requirements or discharge prohibitions if exposure to a chemical occurs at or below these levels.

Any district attorney or city attorney (for cities whose population exceeds 750,000) may enforce Proposition 65. In addition, any individual acting in the public interest may enforce Proposition 65 by filing a lawsuit against a business alleged to be in violation of this law. The number of lawsuits the have been filed by the Attorney General’s Office, district attorneys, consumer advocacy groups, and private citizens and law firms have increased dramatically over the past years.

Penalties for violating Proposition 65 by failing to provide notices can be as high as $2,500 per violation per day. This has come at a cost for companies doing business in the state. All foreign suppliers are well advised to check the list of substances listed under Prop 65 and make sure their products are well inside the “safe harbor” zone.

Bisphenol A (BPA)

One of the recent chemicals added to the Prop A list is a chemical compound found in all kinds of plastics that apparently is a risk to reproductive health.

The problem: BPA is one of the “ingredients” of food packaging, albeit in very small proportions. The safe harbor level for BPA is 290 micrograms per day of exposure.

More facts to know:

FSMA: The Meaning of Misbranded Foods
FSMA: The Meaning of Adulterated Foods
Vermont Non-GMO law
FSMA: Letter of Guarantee

The Right to Know GMO: Vermont Law C.P. 121

As the Vermont law Consumer Protection Rule # 121 comes into effect July 1, 2016, all food products containing genetically modified organisms (GMO) must be labeled accordingly or face a hefty fine. Food items containing less than 0.9% of GMO ingredients do not have to be labeled.

This is true both for all foods grown in Vermont and foods shipped into Vermont. Thus, the burden of checking and labeling rests with distributors and retailers.

The food industry has a grace period of 6 months. After January 1, 2017, non compliance can be costly. Accordingly,  many US importers and their distribution customers are asking their foreign suppliers to send a Letter of Guarantee or Affidavit.

More facts to know:

FSMA: The Meaning of Misbranded Foods
FSMA: The Meaning of Adulterated

California Proposition 65

FSMA: Letter of Guarantee

FSMA: Letter of Guarantee, Affidavit

As governmental oversight and enforcement in the US becomes stricter and potentially more costly for US importers, wholesalers and retailers, foreign manufacturers will be asked to vouch for the safety and label compliance of their exported products.

That’s why more and more industrial and retail customers in the US request a legally binding Letter of Guarantee or and Affidavit from their foreign suppliers that they do not ship adulterated or misbranded food – as defined by the Food & Drug Administration.

Similarly, the increasing wave of lawsuits in California due to non-compliance with Prop 65, or the potential wave of lawsuits in Vermont, due to non-compliance with the Non-GMO law C.P. 121

Here’s the text for the Letter of Guarantee recommended by the authorities:

Letter of Guarantee: Safety

(1) Limited form for use on invoice or bill of sale (i.e. limited to a specific shipment of an article, in which case it may be a part of or attached to the invoice or bill of sale covering such shipment)

(Name of person giving the guaranty or undertaking) hereby guarantees that no article listed herein is adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty or undertaking.)

(2) General and continuing form (considered to have been given at the date such article was shipped or delivered by the person who gives the guaranty)

The article comprising each shipment or other delivery hereafter made by (name of person giving the guaranty or undertaking) to, or in the order of (name and post-office address of person to whom the guaranty or undertaking is given) is hereby guaranteed, as of the date of such shipment or delivery, to be, on such date, not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act, and not an article which may not, under the provisions of section 404, 505, or 512 of the act, be introduced into interstate commerce.

(Signature and post-office address of person giving the guaranty of undertaking.)

Letter of Guarantee: color additives for foreign manufacturers:

(Name of manufacturer and agent) hereby severally guarantee that all color additives listed herein were manufactured by (name of manufacturer), and (where color additive regulations require certification) are from batches certified in accordance with the applicable regulations promulgated under the Federal Food, Drug, and Cosmetic Act.

(Signature and post-office address of manufacturer.)

(Signature and post-office address of agent.)

Letter of Guarantee; GMO

As the Vermont law Consumer Protection Rule # 121 comes into effect July 1, 2016, US importers and their foreign suppliers may have to send to their customers the following sample Letter of Guarantee or Affidavit

I, ________________________, as the authorized agent of the manufacturer/producer listed above, hereby depose and state as follows:

The above named product(s) contains NO ingredients, additives or processing aides derived from commodities or seeds that have commercially grown genetically engineered varieties in the supply chain (i.e. contains no soybean, corn, cotton, canola, beet sugar, squash or papaya) or have not been knowingly or intentionally produced with genetic engineering and has been segregated from and has not been knowingly or intentionally commingled with food that may have been produced with genetic engineering.

I declare or affirm, under penalty of perjury, that the above statement is true and correct to the best of my knowledge.


The above named product(s) contain ingredients, additives or processing aides derived from commodities that have commercially grown genetically engineered varieties in the supply chain, BUT do not contain material derived from genetically modified plants because they have been sourced from traditional crops under an identity preserved program that is documented by the supplier.

It may help foreign manufacturers to obtain a Non-GMO certification, if this will help to sell and market their products in the US. The most widely recognized NON-GMO seal on food products comes from the Non-GMO Project.

More facts to know:

FSMA: The Meaning of Misbranded Foods
California Proposition 65
Vermont Non-GMO law
FSMA: The Meaning of Adulterated Foods

FSMA: Meaning of Misbranded Foods

Here is what the US Congress defined as “misbranded” food in the context of the Food Safety Modernization Act:

Should misbranded food knowingly introduce misbranded food into interstate commerce cause a danger to the health and lives of people, the responsible US manufacturer or US importer of foreign manufactured foods will be held financially or criminally liable.

In the vast majority of cases, misbranded food has to be pulled off the shelf which also can be costly, especially for small companies.

Increasingly, imported food that does not comply with US labeling laws, will be stopped at the border. As governmental oversight and enforcement becomes stricter and more costly, importers, wholesalers and retailers demand an Affidavit or Letter of Guarantee from foreign manufacturers.

This includes food and beverages that

  1. Is labeled or advertised in a false or misleading way and in a material respect. Examples include foods labeled “natural” that contain GMOs or non-natural substances, or the famous POM Wonderful vs. Coca Cola case.
  2. Offer for sale under a different name
  3. Contains imitations of a natural substance without declaring this (such as imitation vanilla)
  4. Is packaged in a misleading container (for example when the size of the container suggests more products inside that it actually contains)
  5. Comes in containers without proper labels, i.e. does not contain the name and place of the manufacturer, packer or distributor, does not contain an accurate net weight, measure or numerical count; or does not contain the mandatory nutrition panels and ingredient statements; does not prominently display information as mandated by law.
  6. Does not conform the legally prescribed standard of identity
  7. Does not conform to legally prescribed or labeled standards of quality and safety
  8. Does not contain food ingredients such as vegetables and food in leagally prescribed quantities (for example fruit juices)
  9. Falsely represents a specific dietary use (for example weight loss products)
  10. Contains pesticides, artificial coloring or chemical preservatives that are not properly labeled (see also California’s Prop 65 regulations)
  11. Contains non-approved color additives
  12. Does not provide mandatory label information, including
    • mandatory serving sizes in an amount customarily consumed (see also Reference Amount Customarily Consumed RACC)
    • number of servings
    • total number of calories derived from any sources and those derived from fat
    • nutritient information (fats, sodium, carbohydrates, protein, vitamins and minerals
    • presence or potential presence of allergens
    • substantiated and legally conforming health claims or nutrient levels

More facts to know:

FSMA: The Meaning of Adulterated Foods
California Proposition 65
Vermont Non-GMO law
FSMA: Letter of Guarantee