FSMA: The Meaning of Adulterated Foods

Here is what the US Congress defined as “adulterated” food in the context of the Food Safety Modernization Act. US manufacturers or US importers of foreign manufactured foods can be criminally liable to knowingly introduce adulterated food into interstate commerce. This includes food and beverages that:

  1. …contain poisonous or insanitary ingredients or substance that lead to injurious health, including undeclared allergens, pesticides, bacteria, chemicals, additives, animal drugs, filthy, putrid or decomposed substances, meat from diseased animals, packed in containers that is made from poisonous or deleterious substances (for example Bisphenol A), or radiation
  2. … lack valuable constituents, includes substitutes of ingredients not labeled correctly, comes in damaged containers, is “bulked up” by added substances that would increase weight or reduces the food’s quality or nutrient content, or may it appear to be of better value than it is (for example counterfeited olive oils, truffles, or rare fish.)
  3. … contain unsafe color additives not permitted in the United States
  4. … are confectioneries containing alcohol in excess of ½ % of volume (only alcohol derived from flavor extracts). However, national law does not supersede state law. Many states allow the sales of alcohol-filled chocolates, and these laws count in the respective state
  5. … are confectioneries containing non-nutritive substances or have embedded an non-nutritive object (for example Kinder Surprise Eggs so popular in Europe and Canada).
  6. … are dietary supplements containing dangerous ingredients that are harmful to human health or that are manufactured without Good Manufacturing Practice Standards
  7. … have previously been denied admission into a country anywhere in the world
  8. are transported under unsanitary conditions

See FDA website with more information

More facts to know:

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

 

 

 

 

Food Safety Modernization Act – Update

fda_buildingIt took five years from the president’s signature to the publication of the final rule.

Now it’s here: as of September 2015, the first final rule of the Food Safety Modernization Act (FSMA) comes into force.

In the following, we’ve summarized the most significant aspects of the FSMA rules and how they may impact producers, exporters and the import community (click on links to read more):

Significance:

  • The Food Safety Modernization Act of 2011 ist the largest overhaul of the US food safety system and Food & Drug Administration’s mandate since the presidency of Franklin Delaneor Roosevelt (the 1930s)
  • Prior to FSMA, the FDA’s food safety policies were primarily geared towards preventing the spread of food poisoning outbreaks. FSMA gives FDA the authority to prevent food outbreaks before they happen and puts the responsibility to prevent food-borne illnesses and outbreaks squarely onto the shoulders of food manufacturers and suppliers.
  • This increases the liabilities to own, operate and manage a food business. Shipping mis-branded or adulterated foods can be very costly, even if no consumer is harmed. The risk for manufacturers and importers residing in the US is financial, reputational and personal: owners and managers may go to jail, if their products caused severe harm to the health of consumers due to negligence or bad intent.

Scope:

  • FSMA and related laws literally affect anyone in the food industry: Retailers, Manufacturers, Distributors, Warehouse Operators, Transport Agencies, Importers, Exporters, Consultants, Audit Firms (Certification Bodies), and even Foreign Governments.
  • FSMA rules affect all segments of the food and beverage industries, with the exception of seafood, produce, and fruit juices. These three categories are subject to very similar, but separate rules, established in previous decades.   A separate law also regulates low acid canned foods; however, only in regards to microbiological hazards. FSMA also aligns with US Department of Agriculture (USDA) safety protocols guiding the meat industry.

The Eight Segments of FSMA

FSMA rulemaking is structured and implemented in four phases (final rule dates)

  1. Preventive Controls for Human Food (September 2015)
  2. Preventive Controls for Animal Food (September 2015)
  3. Standards for Produce Safety (November 2015)
  4. Foreign Supplier Verification Programs (FSVP) for Importers (November 2015)
  5. Voluntary Qualified Importer Program (November 2015)
  6. Accreditation of Third Party Auditors/Certification Bodies (November 2015)
  7. Transportation of Human and Animal Foods (April 2016)
  8. Strategies to Protect Food Against Intentional Adulteration/Food Defense (June 2016)

Implementation Schedule

The rules for Preventive Controls for Human and Animal Foods are final and must be implemented as follows:

  • Manufacturer
    • Medium to Large Size Businesses by September 2016
    • Small Businesses with fewer than 500 employees by September 2017
    • Very Small Businesses with less that $1 million in sales and assets, with FDA approved records that support their status by September 2018
    • Dairy Businesses subject to the Pasteurized Milk Ordinance by September 2018
  • Distributor/Warehouses/Receiving Facilities:
    • Medium and Large Businesses by March 2017
    • Small Business with less than 500 employees by September 2017

The 5 steps for Preventive Controls:

FSMA Preventive Control rules are essentially about risk based Current Good Manufacturing Practices (CGMP) Most established and experienced food manufacturers around the world will already employ CGMP in some form or another, especially if they are certified by standards under the Global Food Safety Initiative. Risk-based preventive controls include:

  1. hazard analysis and risk assessment
  2. preventive controls
    1. the process
    2. food allergens
    3. sanitation
    4. supply-chain program
  3. verification of these controls and corrective actions as necessary
    1. monitoring
    2. corrective actions
    3. verification
  4. recall plan
  5. record keeping requirements (all of the above)

Hazards? What Hazards?

  • Allergens: The failure or accidental mistake to declare all allergens present in a food is by far the Number One reason for recalls in the US
  • Microbiological contaminants: Interestingly, spices imported from around the world are most frequently identified as sources of contaminated food. Herbs, sprouts and produce follow suits as frequent carriers of dangerous bacteria, such as salmonella, listeria and E coli. FSMA mandates the verification of the entire supply chain!
  • Chemical contaminants, such as pesticide and herbicide residues or residues of chemical solvents or detergents, may be detected in food.
  • Physical hazards in food, such as glass, metal, plastic
  • Sanitation: The FDA has now the power to revoke the registration and order the shutdown of food facilities with unsanitary conditions or lack of proper cleaning procedures. This happens more frequently now.
  • Environmental contamination: This is especially important for processors of produce, but also applies to areas with a lot of wildlife, water pollution or animal diseases
  • Intentional contamination. Do you have procedures in place that prevent disgruntled employees or outsiders to enter your food production areas and contaminate your food intentionally?

Investment in People and Procedures (Preventive Controls)

  1. Employee Qualification: FSMA mandates that you have to employ a “qualified individual(s)” to conduct preventive controls and write a food safety plan. A random employee assigned to the task, including a senior manager, do not qualify, if he or she has not undergone extensive training. Similarly, all employees directly involved in “manufacturing, processing, packing or holding food” need to be qualified to perform their assigned duties.
  2. Education and Training: Qualified Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
  3. Product testing & Environmental Monitoring FSMA specifically mandates product testing and environmental monitoring for all manufacturers, on a risk based frequency. The results of the tests have to properly recorded and kept on file.

Written Food Safety Plans and Record Keeping

  • All steps of the hazard analysis and preventive controls, monitoring and verification, corrective action, and recall plans have to be documented and updated every three years.This is part of the FSMA’s record keeping mandate.
  • The Written Food Safety Plan must or should be shared with you importer of record. FSMA obliges importers to verify the safety of the products they bring into commerce in the US under the Foreign Supplier Verification Program
  • Also share the results of all food safety and quality audits with your importer. The audit schemes benchmarked under the Global Food Safety Initiative, such as IFS, BRC, SQF or FSSC 22000, are likely to be FSMA compliant (see below).

Foreign Supplier Verification and, if applicable, Voluntary Qualified Importer Program

Importers will be obliged to verify the food safety of their export partners on an annual basis and keep records of their verification. Specifically, importers have to

– Determine known or reasonably foreseeable hazards with each food

– Evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance

– Use that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities

– Conduct supplier verification activities

– Conduct corrective actions

More specifically:

  1. Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
  2. Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
  3. Importers will be obliged to inspect foreign manufacturers facilities at least once a year if the food they import is deemed to be high risk, i.e. could cause “serious adverse health consequences or death to humans or animals.”
  4. Like domestic and foreign manufacturers, importers will also be subject to controls by FDA inspectors.
  5. Importers or the designated manufacturer agent will be liable for all costs related to FDA mandated recalls and re-inspection of facilities, if these failed the first inspection.
  6. Importer investment into verification, record keeping and qualified food safety personnel will likely increase the costs of doing business for many small importers (and may limit the number of available importers for exporters in the long run)
  7. Manufacturers samples and food imported for research purposes is not subject to Foreign Supplier Verification, but need to be produced according to FSMA standards.
  8. FDA will more vigorously target and pursue smugglers of food who illegally introduce imported food into commerce that could have a potential public health risk.

Third Party Accreditation and the Global Food Safety Initiative

This (not yet final) rule is all about enlisting non-governmental organizations, foreign governments, accreditation agencies and audit/certification bodies to control food safety in lieu of the FDA. The agency already has to few inspectors and limited budgets. The question is: who will be an accredited third party and what will that cost the accredited organization.

For example, most consumer packaged food and beverage companies are subject to retailer audits according to four major standards or schemes:

The accreditation of the private standards holders and their audit/certification bodies may fulfill the FSMA requirements for the audited firm and importer, which will greatly lower the risk for the imported or distributed foods.

However, the current draft rules suggest that a third party may have to pay in $16,000 per year for the accreditation and have to submit the audits to the FDA based on request. Many foreign governments and private organizations view these requirements as potential trade barriers and sticking points for compliance – issues that will likely be resolved before the final rules come out.

 

Die Kosten des Markteintritts

Dollar EuroIdealerweise würde der Export in die USA so beginnen:

Sie buchen für Ende Juni einen Flug und Hotel in New York , besuchen die Summer Fancy Food Show, treffen dort eine Auswahl von Importeuren für Lebensmittel, die sich für Ihre Produkte interessieren.

Sie wählen dann den richtigen Partner aus, der auch Deutsch spricht, senden Produktinformationen und Preise, der Importeur bestellt dann ein paar Paletten oder vielleicht sogar einen Container und lagert diesen auf eigene Kosten ein und übernimmt den Vertrieb an Groß-und Einzelhändler.

Bei den ersten Bestellungen senden Sie Ihre Exportware mit “internationalen” Etiketten, die sich in vielen Ländern verkaufen. Oder sogar deutsche Ware, die der Importeur dann auf eigene Kosten mit US Labels überklebt.

Es kommen dann bald Neubestellungen in so großem Umfang, das sich die Investition einer US exklusiven Verpackung lohnt und mindestens ein Produktiondurchlauf für US Ware eingeplant werden kann. So kostet der Export in die USA wenig und ist von Anfang an gewinnbringend.

Tja, so war das vielleicht mal vor fünfzig Jahren, als die Heimweh von Millionen deutscher Auswanderer die Nachfrage nach deutschen Lebensmitteln steuerte.

Investment Needed

Heutzutage ist der Markteintritt mit einem erheblichen Investment seitens des Exporteurs verbunden. daß laut unserer Erfahrung bei € 30,000 pro Jahr anfängt und bis zu € 300,000 Euro  in den ersten drei vier Jahren kosten kann. Je mehr investiert wird, desto höher sind die Umsatzchancen, oder aber auch mögliche Verluste.

Dollars Euro bills_140 copyWas sind die Kostenfaktoren:

  1. Reisekosten in die USA – für die Suche nach potentiellen Handelspartnern oder Broker-Repräsentanten
  2. Einstellung einer Exportfachkraft für die Exportabwicklung
  3. Anstellung eines US Repräsentanten
  4. Beauftragung eines FDA US Agenten
  5. Design und Produktion von US Verpackung
  6. Design und Produktion von Verkaufspräsentationen
  7. Versand von Produktmustern
  8. Freie Ware für Erstlistungen
  9. Ausstellung bei Fachmessen
  10. Listungsgebühren oder Marketingunterstützung für Großhändler
  11. Listungsgebühren oder  Promotionunterstützung für den Einzelhandel
  12. Manufacturer Charge Back (MCB), mit oder ohne Genehmigung  seitens Großhändler oder Einzelhändler
  13. Verbraucherkommunikation / Schaffung von Nachfrage
  14. Vernichtung oder Schleuderverkauf von unverkäuflichem Inventar (kurz vor Ablauf oder nach Ablauf des MHD)
  15. Währungskursverluste

Return on Investment

Erfahrungsgemäß erreichen Hersteller zwei Jahre nach dem Markteintritt den Break Even Point und nach drei Jahren den ersten Gewinn, je nachdem sich die Produkte im Wettbewerb behaupten.  Nach fünf  Jahren ist die Geschäftsentwicklung dann entweder so stabil, dass die Umsätze langfristig und gewinnbringend wachsen können. Oder es ist Zeit, sich vom Markt zu verabschieden und die Verluste als “Lehrstück” abzuschreiben.

The Importance of the Marketing Mix Dollar Euro Chessboard_140

Interessanterweise gelingt es auch kleinen und mittelständischen Exporteuren immer wieder,  die finanziellen Mittel aufzubringen und einen US Markteintritt profitabel zu gestalten. Die Erfolgsfaktoren sind kein Geheimnis: es kommt immer auf die richtigen Partner und den Marketing Mix (product, packaging, price, promotion, channel, costs, competition, consumers) an.

Wir helfen unseren Kunden mit umfassender Marketing und Handelsexpertise, strategischer und taktischer Planung, einem weiten Kontaktnetzwerk, effektiver Kommunikation und gut kontrolliertem Finanzmanagement das Risiko eines Markteintritts und der Einführung neuer Produkte so gering wie möglich zu halten.

Continue reading “Die Kosten des Markteintritts”

U.S. Import Regulations (in German)

Nachstehend führen wir die wichtigsten Schritte für die Einfuhr von Lebensmittel in die USA auf:

Für alle Produkte:commercial container ship

  1. Registrierung bei der FDA zur Erfüllung des Bioterror-Gesetzes, Bestimmung eines FDA US Agenten
  2. Etikettierungsvorschriften der Food & Drug Administration (FDA) erfüllen. Die FDA genehmigt keine Etiketten. Die Behörde setzt voraus, das Exporteure die Vorschriften für Nährwerttabellen und Allergiewarnungen etc. einhalten.
    • Fehler bei der Etikettierung können teuer werden. Container werden immer häufiger an der Grenze festgehalten und erst nach Wochen oder Monaten freigegeben. Die FDA kann Rückrufaktionen oder sogar betriebsschliessungen im Inland anordnen.
  3. Zolltarif feststellen
  4. Einen US erfahrenen Spediteur finden, der die US Vorschriften zur Zollabfertigung entsprechend vornehmen kann
  5. Voranmeldung (Prior Notice): Wichtig ist daß man die Termine einhält, die Prior Notice wirklich vor Ankunft der Sendung in USA gemacht ist. Zeitverschiebungen entschuldigt der Zoll / FDA nicht, auch nicht, wenn die Sendung ohne Wissen des Versender früher als gebucht eintrifft.
  6. Die FDA- Reg. No sollte immer auf dem Frachtbrief / Rechnung in direkter Verbindung mit der Absenderanschrift mit angebeben werden.

Für Exporteure von Käse:Weiss Wein und Kaese_sq

  • Die FDA hat Standards (Normen) fuer spezifische Käsesorten. Diese Normen müssen erfüllt werden, um bestimmte Namen für Käsesorten (zum Besipiel Gouda) zu verwenden.
  • Ein Importeur mit zutreffenden Einfuhrlizenzen für Käse muss gefunden werden
  • Es gibt  Importeure mit “Historical” und “Nonhistorical” Käselizenzen
  • Die USDA vergibt jährlich Lizenzen an Antragsteller gemäß deren Erfahrungen und  Volumenumsatzes
  • Ein US Importeur muss mindestens 85% seiner Lizenz im Jahr aufbrauchen sonst verliert er 50 – 100% seines Kontingents
  • Käselizenzen werden nach Land und Käsesorte klassifiziert (z.B. Emmentaler aus der EU; Blauschimmelkaese aus Argentinien, etc)
  • Aufgrund der WTO Verhandlungen sind Quantitäten pro Land und Sorte festgelegt
    US Customs Reference for Importing Cheese
    Dairy Import Licensing Program
    Guidelines from the American Cheese Society

Für Exporteure von alkoholischen Getränken:

Für Exporteure von Lebensmittel mit Zutaten aus frischen Eiern oder Geflügel:

Fuer Mustersendungen / Teilnahmen an Messen (ohne ein Importeur)Sample Mailer

  • es darf keine handelbare Menge versandt werden.
    (nicht über 100 Produkte pro Sorte)
  • auch für Mustersendungen müssen sich der Versender und Hersteller bei derFDA registrieren (hier gibt man “Muster- oder Regelversand” an). Es bedarf einer Bestätigung der sicheren Lagerung /Transport.
  • Bei der Voranmeldung müssen die Produkte innerhalb der “FDA Product Codes”  klassifiziert werden
  • die beteiligten Spediteure müssen bei der FDA registriert sein
  • für die Prior Notice muß der Versender / dessen Spediteur angeben zu welchem Zweck versand wird ( Mustersendung).Der Versender muß den Hersteller angeben, 24 h ctc und Tel des Herstellers / Versenders mit angeben Beim Empfänger muß die genaue Anschrift angegeben werden mit Tel. etc.
  • die Prior Notice drucken und dem Empfänger / dessen Broker / Spediteur vor Ankunft der Sendung zusenden. Der muß dann das Avis der Sendung / und zuletzt den korrekten Eingang der Sendung in USA beim FDA bestätigen. Bei Kleinmengen gibt es normalerweise keine Schwierigkeiten – wenn alle o.g. Punkte beachtet sind.
  • Für Exporteure von Käse oder anderer Frischware: Es wird empfohlen,  die Ware per Luftfracht zu schicken (bis 20 kg Gesamtgwicht). Achten Sie darauf, das das Transportunternehmen garantiert, das die korrekte Lagertemperatur eingehalten wird.
  • Beipacken von Trockeneis ( da Gefahrgut ) ist nicht erlaubt.
  • Achtung: bei den Product-Codes muss aufgepasst werden, dass sie der Art und Herkunft der Milch oder anderer Rohstoffe und der Art der Verpackung entsprechen
  • Zollseitig sollten sie wahrscheinlich mit One-time permits arbeiten – und die Zölle und Steuern bezahlen.

A Guide to US Market Entry – in German

 

CMA German Foods Services

 

Die zehn wichtigsten Schritte zur Vorbereitung auf den Markteintritt


 

 

 

 

Finding the Right Importer

What Do Importers Want? Here’s a list This is an important question Here you find a guide to what Your importer or distributor in North America expects to make a profit and get your support to build and grow your business. Here are the 10 most common  demands and worries of your trade partners:

  1. A Right to Make a Reasonable Profit
    • How much profit and profit opportunity does a supplier provide, how much work is associated with building a suppliers business, how much value do you expect an importer to provide in relation to the contribution margin?
  2. Investment to build the business and brand
    • Necessary investments below the line: Slotting, Free Fill, Market Research, Brand USP,
    • Necessary investments above the line: advertising and communication in TV, print, radio, social media, sampling (demos)
    • More marketing dollars are proportional to importer profits
    • In the early stage, suppliers cannot expect importers to foot the marketing bill
    • Accept and appreciate ideas to build the business locally (city by city, retailer by retailer) and don’t delay the request for funds or support.
  3. Appreciation
    • Invitation to visit headquarters, joint store checks, quota incentives for sales staff, lunch for support staff, letter of thanks or awards (distributor of the year)
  4. Unrealistic Expectations
    • Category growth is 1-2%, how can you expect to grow 10% year on year, unless you spend an extraordinary amount of money, which is risky. Normal business growth reflects market conditions
  5. Direct Sales and Contact with Retailers
    • The biggest asset of Distributors, Brokers and Importers is their contact and relationship to retail buyers and they guard these assets well. It is a natural inclination and too often standard practice among suppliers and retailers to “cut out the middle man” when sales and profits don’t meet their expectations. Retailers often try to persuade suppliers to provide more marketing dollars or buy directly from suppliers. Suppliers need to politely refer inquiries to the import partner or schedule a joint meeting.
  6. Last minute changes or last minute requests
    • Package or graphic redesigns, price increases marketing budgets, trade spend, or sales incentives are often changed at the last minute, without prior notice or in violation of the carefully crafted joint business plan.
    • The effect on importers, they have to cut their margins until price increases are accepted at their retail customers. Price increases have to be communicated at least a year in advance and very carefully so not to loose distribution.
    • Frequent last minute reports, frequent or unannounced last minute market visits,
  7. Short Shipments
    • Importers can be assessed penalties, store level space may be lost or need to be recaptures. Keep pipeline filled and treat foreign markets like your best customers t home
  8.  Faulty Shipments and Border Detentions
    • Increasingly, containers are being detained because the FDA or Customs inspectors find a faulting in labeling or in the documentation. The detention can last weeks or even months, because the FDA or CBP don’t have enough staff to resolve shipment disputes quickly. The re-inspection is expensive and at worst, the container content has to be destroyed. Reliability of labeling food correctly is the exporters first duty.
  9. Margin reduction
    • Importers take a gross margin of about 30%, but they have to pay for warehouseing, shipments to retailers or wholesalers, payments for brokers (5-10%), payments for office space and support staff, marketing, trade fair booth and travel costs. The net profit margin is in the less than 3%.
    • In order to stay in business and make a decent living, importers either need a lot of suppliers and thus have little time for each suppler, or have only a few suppliers, with more time dedicated to each supplier.
  10. Customer and Consumer Service

Adapted in part from Greg Seminara, Export Solutions

A Guide to US Market Entry (German Version)

Virginia Beach Harbor_rect

Der US Lebensmittelmarkt bietet enorme Absatzchancen für Hersteller aus der ganzen Welt. Die Handelsschranken und Zölle sind allgemein relativ gering und die Handelsstruktur relativ transparent.

So werden in diesem Markt derzeit über 700,000 Lebensmittel angeboten und es herrscht ein enormer Verdrängungswettbewerb um die Aufmerksamkeit und Kaufentscheidungen von Einkäufern und Endkunden. Von rund 40,000 Produkten in Lebensmittelgeschäften werden im Durchschnitt rund 3,000 neue Produkte in die Regale gebracht und 3,000 Produkte ausgelistet.

Entsprechend dem Wettbewerb innerhalb einer bestimmten Kategorie erfordert ein Markteintritt daher ein relativ hohes Investment an Zeit und Geld – zwischen €20,000 und € 100,000 Euro über 2 Jahre – die der Hersteller tragen muß. Die Chancen, das sich dieses Investment nach drei Jahren wieder einspielt und ein langfristiger Wachstum möglich ist, sind gut, wenn das Marketing Konzept stimmt und die Handelspartner gefunden werden.

Das Investment ist eine relative große Hürde für kleine und mittelständische Betriebe mit hochwertigen Lebensmittelspezialitäten und die Kosten sind natürlcih abhängig von der jeweiligen Lebensmittelsparte, den Absatzerwartungen und Produktionsmöglichkeiten des Herstellers, den tatsächlichen Wettbewerbschancen, der Qualität des oder der US Handelspartner und einer effizienten Logistikkette.

Als Minimum müssen Sie die folgende Kosten berücksichtigen:

  1. Die Einstellung einer Fachkraft für den Export, entweder in Deutschland oder einAgent in den USA, die den Markteintritt organisiert
  2. Eine marktgerechte Verpackung und Etikettierung
    • US Etikett mit Nährwerttabelle, Zutatenliste, Allergiewarnungen, Gewichtsangabe etc.
    • Nährwertanalyse, falls erforderlich, durch ein externen Labor
    • Empfehlung: Überprüfung des Etiketts durch einen sachverständigen Berater
  3. Die Beauftragung eines US FDA Agenten
    • Importeure mit exlusiven Vertriebsrechten übernehmen die Rolle des FDA US Agenten
  4. Eine Markt- und Konkurrenzanalyse zur Preisfindung und Positionierung Ihrer Produkte innerhalb des Wettberwerbs
  5. Die Suche nach und Beauftragung von Importeuren oder anderen Handelspartnern.
  6. Der Versand von Mustern und der Aufbau eines Grundinventars in den USA
  7. Listungsgebühren (normalerweise kostenfreie Ware)
  8. Marketingunterstützung während der ersten drei Jahre

Ob Sie Endprodukte für den Verbraucher herstellen oder teilweise gefertigte Produkte zur Weiterverarbeitung – das Investment in den Geschäftsaufbau ist für alle Sparten ziemlich gleich.

Continue reading “A Guide to US Market Entry (German Version)”

As NON-GMO Label Thrives, Calls for Mandatory Labeling Get Louder

Tomato_Inspected_iStock_000006170909MediumAs sales of non-GMO labeled products eclipsed $10 billion in 2014 and continues to pace at double digit growth, consumer and food industry advocates pressure the FDA and USDA to provide a clear guidance to what and what not constitutes foods free of genetically modified organisms. Current definitions and mandatory labeling laws vary from state to state, potentially leading to regulatory challenges for suppliers whose products are sold in multiple states, and confusion among consumers, who are paying more attention to such labels.

A Nielsen consumer survey found that 80 percent of respondents would pay a premium for non-GMO foods, though most say they don’t trust food labels. The independent Non-GMO Project, so far the most successful non-profit agency that has iussued guidelines for GMO-free foods, lists more than 24,500 products to date bearing the NON-GMO seal. Some of the Global Food Safety Initiative standards, such as IFS Food, the leading European standard, also audits Non-GMO records of food companies in Europe and the US.

Meanwhile, the Food and Drug Administration (FDA) has published a guidance of voluntary labeling of GMOs nationwide, but food industry critics demand mandatory labeling laws.

As the Food Safety News reported in February 2015:

Sens. Barbara Boxer (D-CA) and Richard Blumenthal (D-CT) and Rep. Peter DeFazio (D-OR) reintroduced legislation February 12 to label genetically engineered (GE) food.

The Genetically Engineered Food Right-to-Know Act would require the U.S. Food and Drug Administration to label GE food and foods containing GE ingredients.

“Consumers have a right to know what is in the foods they eat and parents have a right to know what they are feeding their families,” Boxer said.

“We cannot continue to keep Americans in the dark about the food they eat,” DeFazio said. “More than sixty other countries make it easy for consumers to choose. Why should the U.S. be any different?”

In 1992, FDA stated that it had no basis for concluding that bioengineered foods differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by the new techniques present any different or greater safety concern than foods developed by traditional plant breeding.

FDA currently supports voluntary labeling in which food manufacturers indicate whether their products have or have not been developed through genetic engineering, “provided such labeling is truthful and not misleading.”

“The public wants more information about the food they are buying and how it’s grown,” said chef Tom Colicchio, who joined the lawmakers and advocates from Just Label It, Food Policy Action, Environmental Working Group and Center for Food Safety at a press conference announcing the bill. “I applaud Sens. Boxer and Blumenthal and Rep. DeFazio for their leadership and urge their colleagues to join them in standing up for the 93 percent of Americans who want to know whether their food has been genetically modified.”

To date, the Just Label It campaign has collected 1.4 million signatures on its petition to FDA seeking mandatory labeling of GE foods.

2015 Trend: New Era for International Trade

Cargo Ship3A nation’s economic prosperity depends on open and free trade with other nations and the international community is trying hard for the past 60 years to lower trade barriers, alas, with mixed success. The latest attempt to establish global free trade, administered by the Word Trade Organization, dubbed the Doha Round, went nowhere. So, the main economic centers are now working on bilateral deals, called the Trans Pacific Partnership (TPP = US and various Asian countries), and Transatlantic Trade and Investment Partnership (TTIP = US and the European Union). Despite ferocious opposition by vocal consumer and special interest groups, it is widely believed, that these trade deals are inevitable and will be signed in the next two years.

Here we’d like to focus on the the US-Europe free trade negotiations (TTIP) and highlight the opportunities and challenges for a final deal especially for the food and agricultural sectors.

The goal of TTIP:

– enable stronger economic activity and GDP growth,
– expand markets especially for small and mid-size producers,
– increase consumption and consumer choices
– provide long-term financial stability on both sides of the Atlantic.

How can that be done? First: reduce or remove all tariffs and customs duties. Second: harmonize as many import and regulatory rules in as many industries and as fast as possible.

The main sticking points:

a) although industry standards and regulatory frameworks are similar in many respects, especially in the US and European Union, it is very hard to harmonize or change them overnight. Governmental procedures, oversight authority and rule making differ substantially, often for historic and cultural reasons.

b) some regions and industry segments still need protection from open competition, especially in rural areas, or those vulnerable to unemployment.

c) Different world views about privacy, consumer vs.investor protection,  financial market regulation and de-regulation, business owners vs. employee rights and food production and safety practices  persist. These differences are based, again, on historical and cultural traditions, and are therefore highly emotionally charged. Even scientists cannot agree.

TTIP for the food and agricultural industries:

A transatlantic trade agreement would have to overcome a range of technical and perceptual hurdles, both of which are highly emotionally charged:

From the European side:

– widespread use of genetic modification, hormones and antibiotics in animal and crop farming
– food safety measures such as the chlorination of chicken
– disregard for the Protection of Geographic Indication for some foods, like Parmesan Cheese
– the domination of multinational corporations in the consumer foods industries and a penchant for mass produced, fast food in the USA

From the American side:

– High tariffs and protective measures
– Preference for imports from former colonial regions
– A disregard for science in regards to biotech and use of steroids and pharmacological products in agriculture
– A certain European arrogance in regards to the quality, taste and traditions of foods produced and consumed in the US

More to follow…

2015 Trend: Transparency and the Right to Know

Eating food is easy, but the path from seed to stomach has become ever more complex and complicated. As consumers demand ever more quality, safety, flavors and package sizes at ever-lower prices, food producers, retail stores, and restaurants owners (have to) use ever-new processes, food science, and biotech ingredients to fill demand. What fell by the wayside is a solid understanding of what’s in a food product and how it affects health and well-being.

This is about to change.

European and US regulators have enacted new labeling and food safety laws that come in effect in 2015 and 2016, all designed to provide more transparency around ingredients, origins and caloric values. As food establishments have an obligation to make expensive label changes, consumers will be asked to take the time, get informed and make the right nutritional choices for themselves.

New EU Labeling RegulationsEU Label Law

As of 2015, EU food producers, retailers and restaurants have to design product labels with new specifications:mandatory nutritional information have to be easily read (larger typefont); ingredients that can cause allergies have to be highlighted;

  1. restaurants and food service operators also have to flag allergens for all applicable menu items
  2. vegetable oils and fats have to identified by plant used in the process;
  3. Added proteins or nano-particles have to be identified
  4. Added water (in certain meats) have to be identified
  5. The origins of meat from pigs, sheep, goat and poultry has to be identified;
  6. Frozen foods need to indicate date of first freezing
  7. Online wholesalers and retailers have to post all mandatory nutritional information posted on product labels in brick & mortar stores.

New FDA Labeling Regulationsfda_building

As mandated by the Affordable Care Act, certain FDA label requirements for packaged food products have now mandatory for restaurants, retail food establishments and vending machines.

  1. Food service and vending machine operators have to post the caloric content of main menu items on menus and menu boards.
  2. Other nutritional information, such as total calories, calories from fat, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrates, fiber, sugars, and protein—will have to be made available in writing on request.
  3. Included are meals and snacks, such as take out food, delicatessen sandwiches, muffins at bakeries, popcorn at movie theaters, hot dogs sold at convenience and warehouse stores, and even certain alcoholic beverages
  4. New FDA proposals even envision a new label for packaged foods with clearer definitions of portions sizes and caloric content of the whole pack.

The Dispute about Genetically Modified Organisms (GMO) in the USAGrains 03_00414_2200x1600

The labeling of genetically modified ingredient is mandatory in the state of Vermont since 2014 and supposedly will have to be adhered to as of July 2016. The “Right to Know” Movement is growing stronger, even in face of well-financed opposition by food agricultural industry associations. Mandatory GMO labeling was – almost- approved in the states of Oregon, Washington and California. A federal bill  – The “Safe and Accurate Food Labeling Act of 2014” – is pending in the House of Representatives, which advocates the voluntary GMO labeling.

What makes labeling of GMO’s in consumer foods sold in the US so difficult: very few, if any, foods actually contain GMOs.

  1. Many food producers, like General Mills with their flagship brand Cheerios, now only use non-GMO ingredients for their products. The “Non GMO Project” has already certified over 16,000 everyday consumer food products in recent years
  2. According to Gregory Jaffe, Director at the Center for Science in the Public Interest (a non-profit agency and outspoken critic of the US mainstream agricultural and food industry), only 8 crops in the US use GMO seeds: alfalfa, sugar beet, corn, soybean, canola, cotton, papaya, squash. And those crops are used primarily in animal feed, biofuels, clothes, and processed foods. However, the GMO proteins break down during processing, so processed foods actually do not contain GMO ingredients anymore.

All NaturalCourt Battles over “False Advertising” Will Continue

Many well-known, large food retailers and food processors faced legal battles over certain claims on their food products in recent years, among them

  1. Whole Foods – understating the amount of sugar in some Private Label yogurts,
  2. General Mills – over the claim All Natural on Nature Valley Granola Bars (while high fructose corn syrup was present in the the products. General Mills settled out of court and withdrew the claim
  3. Trader Joe’s – over the claims “All Natural” on several products that contained processed ingredients, and on claims “no added sugar” on products that contained evaporated cane juice, deemed as sugar nontheless
  4. Hain Celestial – over the claim “Unpasteurized and 100% Raw”  on their BluePrint Juices, which were treated with High Pressure Processing to kill harmful bacteria

While some law suits were dismissed as frivolous, most food companies and retailers settled out of court to avoid lengthy legal battles and a damage to the brand reputation. It is likely that food companies will be  more cautious using “health” claims in coming years and resort to other ways to compete and differentiate new products in the crowded  marketplace.

 Product Sales with “Better for You Labels” are on the decline

The Specialty Food Association News (February 2, 2015) reports that consumers are purchasing fewer products that feature one or more of the predominant 12 “better-for-you-food” BFY labels, including low-sugar, caffeine-free, low-carb, and reduced sodium. Since 2008, products sales declined 27 percent since 2008 in the US, according to the research fim NPD Group in its 29th annual “Eating Patterns in America” report. Last year saw the lowest support for BFY products among consumers since 2004.

Analyst Harry Balzer is quoted that “consumers have gone through a few phases of food consumption, and today the focus is on foods that are unaltered or minimally processed. “Have we altered the food supply so much to make it better for us, that there is now a backlash against those products?” he suggests. “I think we’re looking for foods and beverages to be as they were meant to be.”

Shoppers are shifting their attention towards local, GMO-free, raw, fresh and “few ingredient” products.

FDA Proposal for Revamped Nutrition Label

New FDA LabelThe US Food & Drug Administration (FDA) unveiled in August 2014 a proposal to fundamentally change the nutrition label on the back of any packaged food product currently sold in the USA. In particular, the FDA calls for

More Nutrition Information

  • Require information about “added sugars.”
  • Update daily values for nutrients like sodium, dietary fiber
    and Vitamin D.
  • Declare the amount of potassium and Vitamin D
  • Remove “Calories from Fat”  (because research shows the type of fat is more important than the amount).

Updated Serving Size Requirements

  • Change the serving size and corresponding nutrition information to reflect how people eat and drink today
  • Require that packaged foods, including drinks, that are typically eaten in one sitting be labeled as a single serving and that calorie and nutrient information be declared for the entire package.
  • Provide “dual column” labels to indicate both “per serving” and “per package” calories and nutrient information for packages that are larger and could be consumed in one sitting or multiple sittings

Refreshed Design

  • Make calories and serving sizes more prominent
  • Shift the Percent Daily Value to the left of the label, so it would come first
  • Change the footnote to more clearly explain the meaning of the Percent Daily Value.

Here are examples of labels that the FDA would like to mandate within the next two to three years:

Proposed Label – Whats the Difference

Reality Check on Serving Size

The FDA is currently asking for comments from the public and the food industry. As can be expected, many food industry associations have pushed back due on the proposal, citing high costs and added complexity.

If and when the label changes will become law is yet to be determined. However, food companies are well advised to plan for label changes and proactively integrate some of the ideas into labels of new products or re-launches.