Tag Archives: labeling

Paul Dewsbury, B.Sc.
In the Food Lab

Is that Pricey Wine the Real Deal? Using IRMS to Detect Fraud

By Paul Dewsbury
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Paul Dewsbury, B.Sc.

By Paul Dewsbury, B.Sc.

Upon conducting some online research to find a nice bottle of wine to bring to a party, I became distracted by a story about the world’s most expensive wine, priced at an eye-watering $195,000. With just a few clicks, I uncovered stories about auctioning a single bottle of wine for more than $300,000, and a case of 114 bottles selling for a record $1.6 million. Some of the reasons for the huge sums invested in pricey wines include rarity, social status of owner (aka famous), vintage, and perhaps most importantly, region and vineyard.

Ever the analytical chemist, I wondered, how do buyers identify whether that the extravagant bottle of wine they’re purchasing is the real thing? Perhaps the serious wine collectors out there could benefit from having an isotope ratio mass spectrometer (IRMS) in their cellar! But seriously, could IRMS play a role in authenticity testing?

Testing for Authenticity and Geographic Origin of Wine

Increasingly, fraud surrounding the provenance of wine has become a problem. Last year, a man was sentenced to 10 years in prison for selling millions of dollars of counterfeit wine. He not only created fake labels, but he also mixed and blended lower-priced wines to imitate the taste and character of rare and much more expensive wines.

An article published last year about the authenticity and geographic origin of wine discusses the results of investigating the stable isotope composition (C and O) of wine samples.1 The authors claim to have found significant isotope variations within samples from the same country as well as between samples from different countries.

¹³C and Simultaneous ¹⁸O and ²H Isotope Analysis in Ethanol with Thermo Scientific DELTA V Isotope Ratio Mass Spectrometers is also a useful resource, as it defines the configuration required for such testing. The method demonstrates excellent results and could be quite suitable for origin testing of wine. Isotopic analysis of wine has become a widespread tool to evaluate the quality, authenticity and origin of labeled products. This application note shows the ability and performance of the analysis of ethanol with combustion and with a high temperature carbon reduction technique in combination with a DELTA V IRMS. With this configuration, the ethanol can be analyzed for oxygen and carbon isotope composition. The analysis allows for the quantification of exogenous sugar added during the fermentation process, which is used to increase the alcohol content of the wine. This control is also needed for the detection of frauds, such as mislabeling regarding both ingredients and origin.

Most laboratories will seek alternative or complimentary techniques for authenticating wine. A few months ago, I blogged about using an ion chromatography method to verify the authenticity of your wine. I was also captivated by the poster, Related Seasonal and Geographical Differences in Wine from California’s Central Coast, which describes how a high performance liquid chromatography coupled to mass spectrometry (LC-MS) configuration was successfully implemented to analyze several wine varieties from different areas to show simultaneous detection and relative quantification of the wine’s components.

Wine authenticity is a fascinating subject, and I will leave you with this unbelievable but true story. In 1989, a bottle of 1787 Château Margaux from Thomas Jefferson’s wine collection was valued at more than $500,000 by its owner, William Sokolin, a New York wine merchant. At a dinner, it was accidentally knocked over and broke. What’s more,  the insurers paid $225,000 for the loss of the wine.

And to get back to where I started—I went to the supermarket and picked up a cheap bottle of wine. I don’t think anyone was the wiser, either.

References

1. Horacek, M., Papesch, W., Ogrinc, N., Magdas, A., Wunderlin, D., and
Misurovic, A. (2014). Control of Authenticity and Geographic Origin of Austrian, Slovenian,Romanian, Montenegrin and Argentinean wine, Geophysical Research Abstracts, 14. Retrieved from: http://www.josephinum.at/fileadmin/content/BLT/Puplikationen/1444-00_E.pdf.

Does Your Company Really Understand GMO Labeling?

By Maria Fontanazza
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Consumers want to know what’s in their food, from artificial sweeteners and high-fructose corn syrup to dyes and pesticides. The latest hot-button issue surrounds foods made from genetically modified organisms (GMO) and the demand for companies to indicate on labeling whether a product contains GMOs.

In a recent Q&A with Food Safety Tech, James Cook, Food Scientific and Regulatory Affairs Manager at SGS, briefly discusses the challenges and misconceptions surrounding GMOs and labeling.

Food Safety Tech: What are the biggest challenges food companies face in communicating that their products are GMO-free?

James Cook: The biggest challenge for a company is to determine what words or phrases can be used concerning the regulations and/or laws of country that the product will be received into. Companies want to use GMO free, a terminology recognized by consumers, which is actually prohibited in certain locations such as the European Union (EU), and discouraged by the FDA.

FST: How has public (consumer) awareness of this issue complicated matters?

Cook: There is a diverse difference in dealing with the consumers in the EU that have a clear knowledge and unfortunately outrage to GMOs, and the consumers from the United States, where some have no idea what GMOs are.

FST: Are there misconceptions among consumers that present additional challenges to food companies?

Cook: The biggest misconceptions are: Everything created by humankind is evil, food crops have never changed, and the government and the industry are lying. Another misconception is that in the future, we will have enough food to feed the world population, without making significant changes in the way we produce food.   

FST: What are the most critical developments regarding state and federal labeling laws that we need to know about?

Cook: At this time, the Vermont law is the only breakthrough for the requirement [of] GMO labeling in the United States. If some non-government organization obtains passage of their bill through U.S Congress then this law will not come into effect. If this law becomes effective, we will have many states issuing and passing a similar law, as their consumers will want to know why this is required in Vermont but not in their states.

On April 16 Cook will be offering more insight on the topic during a GMO Labeling webinar. Register for the webinar now.

FST: Where do you see the GMO issue headed over the next year or so?

Cook: We will have some sort of GMO labeling law in the United States. Whether this law only affects one state or all of the U.S. is still unknown. Even if this is not solved, more locations in the United States will continue to ban the growing of GMO crops. Eventually these bans will make it into the courts, because you are dictating to a farmer what crops they can grow and sell.  

FST: What key questions will you address during the GMO Labeling webinar?

Cook: What does my company need to do in order to verify to a Non-GMO program?
Does one have to review the entire supply chain in order to prove the product is GMO free?
Why isn’t GMO product just labeled as such in the USA?
Why the vast difference of GMO policies between EU and USA?

 

Related Content: Expanding GMO Labeling Requirements in the U.S.


InstantLabs Launches DNA-based Atlantic and Coho Salmon SpeciesID Test Kits to Combat Seafood Mislabeling

The company has broadened species identification product line created in partnership with University of Guelph and plans to release additional test kits during the year.

InstantLabs announced today the expansion of its SpeciesID product line by offering DNA-based tests for Atlantic and Coho salmon. InstantLabs SpeciesID™ tests provide accurate DNA verification in under two hours.

The launch of the salmon test kits highlights InstantLabs’ efforts to meet market demand by expanding the affordable, simple-to-use InstantID™ product line. The company already offers kits to identify Atlantic Blue Crab, pork and horse meat. The InstantLabs’ system gives food wholesalers, processors and inspectors a fast and reliable option for product tests.

The two new products were created in partnership with the University of Guelph, an international leader in agricultural and food science. The InstantID test kits for Atlantic (Salmo salar) and Coho salmon (Oncorhynchus kisutch) are the first of four salmon assays planned for release during 2015. InstantLabs will launch InstantID™ for Chinook (Oncorhynchus tshawytscha) and Sockeye (Oncorhynchus nerka) salmon later this year.

Expanding its presence in the high-demand seafood market, the Baltimore-based manufacturer of the Hunter® system expects to also release InstantID™ kits for snapper, catfish, grouper, and tilapia.

“Producers, wholesalers and government entities needs robust tools to combat seafood fraud,” said Steven Guterman, chief executive officer of InstantLabs. “InstantLabs’ real-time PCR testing systems and reagent kits can become an integral part in a testing program to verify labeling accuracy.”

InstantLabs’ Hunter® Real-Time PCR instrument combines accuracy, speed, and ease-of-operation into a compact portable system. The Hunter system is designed for use at points-of-need to detect and analyze a wide variety of food samples by targeting DNA. Results delivered quickly allow seamless integration into food industry firms’ processes and facilities.

Dr. Robert Hanner, Ph. D., has directed the University of Guelph’s research in conjunction with InstantLabs. “This collaboration has been essential in commercializing DNA-based food authentication tests for the seafood industry,” said Dr. Hanner, associate professor at the Center of Biodiversity Genomics. “This technology will help safeguard against existing supply chain vulnerabilities, protecting both businesses and consumers from food fraud.”

InstantLabs identification tests are designed for use on the Hunter, a real-time PCR system developed by the company, and are also available for use with other PCR instruments.

Seafood industry reports continue to highlight concerns about fraud, species substitution and consumer preferences to use sustainable fish stocks. Approximately one-third of all fish sold in the U.S. was mislabeled, reported a recent survey from Oceana. The U.S. Food and Drug Administration identifies a range of lower valued fish regularly substituted for 20 higher-priced species. InstantLabs will provide critical tool sets needed by the industry to ensure the integrity of the supply chain.

ABOUT INSTANTLABS:

InstantLabs, a molecular diagnostic device company, developed and markets the Hunter® Accelerated-PCR system, a fully-integrated, easy-to-use, portable and affordable real-time polymerase chain reaction (RT-PCR) platform for rapid, accurate pathogen detection. InstantLabs Medical Diagnostics Corp., the legal entity, offers the Hunter® system for use with several food-borne pathogen test kits for the global food industry. The Hunter® system is especially well suited for use at points-of-care and points-of-need to detect and analyze a wide variety of common and problematic pathogens. InstantLabs’ growing worldwide customer base includes some of the world’s leading food companies. InstantLabs is also developing products for additional markets, including medical diagnostics where gold-standard accuracy, combined with Ease-of-use and rapid results, are critical. Founded in 2008, InstantLabs is located in Baltimore, MD. For more information please visit www.instantlabs.com.

ABOUT THE UNIVERSITY OF GUELPH:

Acknowledged as one of the leading public research universities, the University has 39 Canada Research chairs in natural sciences, energy, health services and social sciences. With a commitment to student learning and innovative research, University leaders are dedicated to cultivating the essentials for our quality of life – water, food, environment, animal and human health, community, commerce, culture and learning. The University community also shares a profound sense of social responsibility, an obligation to address global issues and a concern for international development. Learn more at www.uoguelph.ca.

Additional resources on seafood fraud:

Horsemeat Scandal: Defendants Receive Prison Sentence, Fines

By Food Safety Tech Staff
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A slaughterhouse owner has been fined around $12,000, and a manager given a four-month suspended sentence, in the first prosecution for criminal charges relating to the 2013 horsemeat scandal.

The first prosecutions in England regarding the 2013 horse meat scandal in Europe has resulted in a one defendant being fined and another getting a prison sentence. More developments are expected from a Dutch trial currently underway.

Slaughterhouse owner Peter Boddy, who admitted to not following the traceability regulations enforced by the European Union and “field to fork” traceability standards was fined about $12,000. Boddy has admitted to selling 55 horses from his abattoir, in Todmorden, West Yorkshire, and accepting 17 animals without keeping proper records.

David Moss, the slaughterhouse manager, received a four-month prison sentence that would be suspended for two years after confessing he falsified an invoice for the number of horses sold in a deal on February 12, 2013.

Speaking about the importance of traceability of food products in relation to public health, the Judge presiding over the case, Alistair McCreath said: “If meat causes ill health, then it is important that those responsible for investigating the cause of it should quickly be able to discover where the meat came from and trace it backwards … to find where the problem lies and prevent the problem escalating.”

Trial is also underway for Dutch meat trader Willy Selten in Den Bosch, who has denied substituting horse meat for beef consignments, claiming that a storage mistake led to a mix-up that eventually led to a 50,000-ton recall of European meat in 2013. Selten is thought to be at the center of a scheme that saw 300 tons of horse meat from Ireland, England, and the Netherlands processed and sold as pure beef.

The horsemeat scandal shocked retail consumers two years ago when authorities discovered horse meat being passed off as beef in numerous products sold at retail in major grocery stores chains and under brands associated with beef products.

UK’s Food Standards Agency (FSA) has expressed being pleased with the results of the prosecution. Jason Feeney, FSA’s chief operating officer said, “The rules on food traceability are there to protect consumers and legitimate businesses. Criminal activity like this across Europe contributed to the horse meat incident. Consumers need to know that their food is what it says it is on the label. FSA continues to support the ongoing investigations into the incident.”

FSA and other government departments have also been implementing the recommendations from the Elliott Review to bolster the integrity of the UK food chain, which includes the establishment of the Food Crime Unit, to focus more on enforcement against food fraud.

Expanding GMO Labeling Requirements in the U.S.

By James Cook
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In November 2014, the people of Oregon and Colorado voted for mandatory labeling of foods produced from genetically modified organisms (GMO). These initiatives from Maine, Connecticut, Vermont, and subsequently Oregon and Colorado speak of the public’s desire to know what they are eating, a mistrust of the industry, and a lack of action from the Federal government.

Currently in the U.S.. there is no Federal law that requires the labeling of GMO derived products, providing the product is not significantly different to the non-GMO product, or different in use, nutrition, or includes an unexpected allergen. However, FDA has produced voluntary labeling guidance on GMO and non-GMO. While many companies have option to label their products as non-GMO, there hasn’t been the same desire by the industry to label their products as GMO.

Unwanted events have caused the public to believe that the industry cannot be trusted and that the government is not doing everything it can to protect the public. One case involved a strain of GMO corn (Starlink) that was only approved for animal feed and fuel, because it cause a reaction in people. Unfortunately, this strain of corn did end up in the human food supply chain, causing the U.S. price of corn to plummet on the world market, and dozens of products to be recalled.

Another case involved the development of GMO wheat. T his was a product that foreign markets had no desire for. There, after field trials from 2000 to 2003, the company that created the GMO wheat dropped the project despite FDA completing its food safety consultation on it in 2004.

In 2013, this strain of GMO wheat was found growing in a field in Oregon. After extensive review, the USDA completed an investigation and published its findings on September 26, 2014, concluding that it was the same GMO variety created by the aforementioned company. The report added that the wheat had not come from local field trials, and that they were “unable to determine exactly how the GMO wheat was found growing in Montana. That investigation is still ongoing.

Oregon mandatory labeling

One of the counties of Oregon, Jackson County, has banned GMO crops. Oregon was one of the states involved in the unwanted GMO wheat event, and has voted no to changing its existing law to require the labeling of raw and packaged foods produced entirely, or partially by genetic engineering. This law would have required retailers to properly label raw product as “genetically engineered.”

Manufacturers of pre-packaged foods would have to place labels clearly and conspicuously stating “produced with genetic engineering” or “partially produced with genetic engineering” on the front or back of the package. These phrases did not have to be part of the product name, nor did the manufacturer have to identify which ingredient or ingredients are derived from genetic engineering. No company would have been subject to injunction or fines, if the pre-packaged foods have less than 0.9 percent genetic engineered materials by the total weight of the package or were unknowingly, or unintentionally, contaminated with genetically engineered material. For pre-packaged products, retails would have been only responsible for their own labeled products. This would not apply to animal feed or food served in restaurants.

Colorado Right to Know Act

A law proposed in Colorado but also not passed, dealt with labeling requirements for products derived for genetic modification. Had it been passed, it would have been effective from July 1, 2016. Its main aim was that packaged and raw agriculture products derived from GM would have to have been labelled as “produced with genetic engineering.” The exemptions from the labeling requirements were:

  • Animal food or drink,
  • Chewing gum,
  • Alcoholic beverages,
  • Food containing one or more processing aids,
  • Enzymes produced or derived from genetic engineering,
  • Food in restaurants and food produced for immediate consumption not packaged for resale,
  • Food for animals not derived from genetic engineering but fed feed or injected with a drug derived from genetic engineering, and
  • Medically prescribed food. 

Food would not have been considered misbranded if it had been produced by someone unaware that the seed or food was derived from genetic engineering, or that it was either unknowingly or unintentionally co-mingled with genetically engineering seed or food.

The Grocery Manufacturers’ Association (GMA), a major U.S. industry association that is against the individual state laws regarding GMO labeling, supports the HR 4432 Safe and Accurate Food Labeling Act introduced by the House of Representatives’ Mike Pompeo and G. K. Butterfield. This proposed law would not require products with GMO ingredients to be labelled as such, unless there are safety issues or substantial differences between them and the non-GMO ingredient, but it will set specific requirements for GMO free claims and require FDA to develop requirements for Natural claims. While this law was introduced into Congress in April 2014, it hasn’t progressed to the point that anyone believes that it will signed into law anytime soon. Vermont is still the only state to have passed an unencumbered GMO law. Currently, laws in Maine and Connecticut with there requirements still not met, will not be enacted, at least, at this time. The state of Vermont is being sued with the GMO labeling debate in the U.S. still continuing even though the European Union has required labeling of GMOs since 1997. To date, there are more than 60 countries, as well as the EU, requiring labeling of GMOs.

This article originally appeared in SGS Hot Source Food Newsletter 6. For further information, please visit www.FoodSafety.SGS.com.

Want to learn more about GMO Labeling? Register for this complimentary webinar, on April 16, 2015, which will discuss

  • Next steps for state and federal labeling laws,
  • An update on the status of the non-GMO supply chain and certification programs,
  • Where organic fits in the non-GMO discussion, and
  • What are the marketplace challenges of going non-GMO?

Dietary Supplements: Verifying Label Claims “By Input” Unacceptable

By Tara Lin Couch, Ph.D.
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FDA issued more than 400 Warning Letter citations for inappropriate specifications in dietary supplement during 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications, but recent citations have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The FDA regulations dictated in 21 CFR 111, Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, require that each batch of a finished dietary supplement product must meet quality requirements for identity, purity, strength, composition, and limits of potential contaminants.

Criteria used to establish that these requirements are met are supposed to be provided in a Finished Product Specification developed by the dietary supplement company. FDA issued more than 400 Warning Letter citations for inappropriate specifications in 2013 and 2014. Many of these violations were due to a failure to have Finished Product Specifications at all, but recent Warning Letters have also noted that using solely the input of a dietary ingredient for verifying the strength “By Input” is unacceptable.

The input of a dietary supplement alone is not a scientifically valid analytical test method for determining the strength of a dietary ingredient in a finished product. Chemical testing of the ingredient should be accomplished whenever possible. If that is not possible due to the unavailability of a scientifically valid test method, the testing may be exempted provided dietary ingredient raw material testing, in-process testing, other finished product testing, process controls, and additional information can support that the strength of the dietary ingredient can be verified without testing, as allowed in 21 CFR 111.75(d)(1).

The incoming dietary ingredient raw material must be verified to meet quality requirements for identity, purity, strength, and the lack of potential contaminants. Warehouse controls must then ensure that the material is held in a condition in which its quality is not altered. The material must be formulated at an appropriate amount, with sufficient overage, to meet the label claim while taking into account manufacturing variability. This is dictated in an approved Master Manufacturing Record (MMR). Once executed, the Batch Production Record (BPR) must document that the correct amount of the dietary ingredient was actually dispensed into the product during manufacture. Established in-process examinations and tests are then used to verify that the batch is uniformly mixed and meets the unit dosage weight and weight variation requirements. Variations on weight cannot exceed the overage amount to ensure that even the smallest dosage unit still complies with the label. In-process chemical tests can also be employed to verify the amount of a dietary ingredient. This can be particularly beneficial if the reason a dietary ingredient is exempted from testing is because of matrix interferences or instrumental quantitation limits.

Other finished product testing can also be used to support that an exempted ingredient is present in the product at the correct, labeled amount. Test results from chemically similar ingredients that are determined to be as expected suggest that the exempted ingredient is also present at expected levels because these ingredients will tend to react the same way during manufacture, especially if both ingredients are introduced and processed in the same step. Results obtained from finished product testing of other ingredients whose concentrations are associated with the exempted ingredient may also support that the exempted ingredient is present as expected.

Finally, the number of other finished product ingredient tests that are performed is important. If all other test results are determined to be within specification, it indicates that the product was manufactured according to the MMR and there is no reason to expect anything different from an exempted dietary ingredient.

Dietary supplement companies that are compliant with all parts of 21 CFR 111 will already be performing these activities. A procedure that summarizes the overall process of verifying the addition of a dietary ingredient can then be created and used as the test method reference on the Finished Product Specification. A separate document that describes the details of test exemptions per product should also be generated. The actual result obtained should be acquired from the completed batch production record.

The “By Input” approach is no longer relevant.

This article originally appeared in EAS-e-News February 2015 issue.

Retail Food Safety Forum

All About Food Policy: Interview with Baylen Linnekin

By Chelsey Davis
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GMOs, FSMA and menu labeling are all hot topics right now in the world of food policy and regulation. To further discuss the latest updates,TraceGains’ Chelsey Davis sat down with Baylen J. Linnekin, Executive Director for Keep Food Legal, Adjunct Professor at George Mason School of Law, and Columnist at Reason, to explore his take on a few of these key issues.

GMOs, FSMA and menu labeling are all hot topics right now in the world of food policy and regulation. To further discuss the latest updates,TraceGains‘ Chelsey Davis sat down with Baylen J. Linnekin, Executive Director for Keep Food Legal, Adjunct Professor at George Mason School of Law, and Columnist at Reason, to explore his take on a few of these key issues.

Linnekin is a licensed attorney and is the founder and executive director of Keep Food Legal Foundation, a Washington, DC-based 501(c)(3) nonprofit that promotes food freedom of choice—the right of every American to grow, raise, produce, buy, sell, share, cook, eat, and drink the foods of their own choosing. He serves as an adjunct professor at George Mason University Law School and an adjunct faculty member at American University, where his teaching focuses largely on contemporary food-policy issues. Along with faculty from Harvard Law School and UCLA Law School, Linnekin is one of six founding board members of the new Academy of Food Law & Policy. He is currently writing his first book, which focuses on the ways that government policies often thwart sustainable food practices, for Island Press. He is also serving as an expert witness in an ongoing First Amendment food-labeling lawsuit.

What are your thoughts on the final rules for menu and vending labeling that are set to be enforced by December 2015 (2016 for vending)? Do you think it will help fight obesity?

Linnekin: From both a theoretical and practical standpoint, mandatory menu- and vending-labeling is a lousy idea. Looking forward—from a theoretical perspective—even the chief architect of the country’s first menu-labeling law, former New York City health department head Thomas Farley, admits menu labeling “won’t stop the obesity epidemic[.]” Practically, we know Farley is right, as study after study has found that mandatory menu labeling doesn’t lead consumers to choose lower-calorie options, and may even cause them to choose options with more calories.

What is your take on “natural” labeling and advertising claims? Do you think things like this should be regulated, or better yet, more specific in regulation?

Linnekin: This is properly a matter for the courts. If someone believes they’ve been harmed by an “all natural” label—e.g., they were tricked into buying something by what they believe is a misleading label—then they should sue. The FDA should stay out of it. Instead, the FDA should permit any food label so long as it contains the required information—including an accurate list of ingredients—and doesn’t contain statements that are demonstrably false (fraudulent).

You talk about GMO labeling in a few of your recently published articles. If Congress were to pass a mandatory GMO-labeling law, what do you think would be the immediate ramifications to food manufacturers?

Linnekin: Mandatory GMO-labeling laws are bad for food manufacturers and consumers. Costs would rise for both thanks to new regulatory requirements and, for the former, threats of lawsuits. Thankfully, there doesn’t seem to be any stomach in Congress for passing a mandatory GMO-labeling law.

Can you elaborate on what you mean when you say things like, our “food freedom is under attack”?

Linnekin: I define food freedom as an individual’s right to grow, raise, produce, buy, sell, share, cook, eat, and drink the foods of his or her own choosing. Federal, state, and local government officials—both elected and working in regulatory agencies—are threatening this individual right. Many cities restrict a person’s right to plant a garden in their own yard, or to share food with the homeless and less fortunate. States have banned foods and food ingredients—from foie gras to Four Loko to raw milk. The federal government subsidizes farmers who grow some crops (i.e., corn and soy) and bans farmers from growing others (e.g., hemp). And it’s cracking down on foods that contain salt, caffeine, trans fats, and other ingredients. The list goes on. If the government were to restrict our speech—what comes out of our mouths—in the same way it does what we put into our mouths, we wouldn’t hesitate to say that free speech is under attack. That’s why I say food freedom is under attack.

With so many food recalls that occurred during 2014 and in previous years, how would you suggest food manufacturers prevent these issues while also not requiring additional regulation?

Linnekin: The U.S. food supply is remarkably safe. That’s thanks in very large part to the nation’s farmers and food manufacturers. The threat of harming consumers and consumer confidence—not to mention the lawsuits and calls for increased regulations that arise when such harm occurs—should be incentive enough for food companies to seek to prevent these issues from arising. But not all food regulations—even newer ones—are bad. I support the FDA’s mandatory recall authority under FSMA for many reasons, including because I think it makes lots of sense given the FDA’s original mission to protect food safety.

What’s Changing with Nutritional Labeling and Serving Sizes?

By Michael Biros
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Bailey Pudenz, Nutritional Coordinator at Eurofins Nutrition Analysis Center, explains what the proposed changes are, and how the labeling would need to change under the new requirements.

FDA has proposed changes to the current nutritional labeling. Currently both the proposed nutritional labeling and serving size rules are in comment period which will close June 2, 2014. Once the final rule is published, it will become law 60 days after the publication date. Industry will then have two years to achieve compliance.

Calories

Calories, calories from saturated fat, the 2000 calorie reference, and percent daily value for calories will remain the same. However, calories from fat will be removed completely. FDA wants consumers to be more aware of the amount and type of fat they eat rather than the calories the fat contributes.

Fat

Total fat, saturated fat, trans fat, poly and monounsaturated fat, and cholesterol will remain the same. FDA considered changing the cutoff value for declaration of zero trans fat, but they have chosen not to change this either. Currently this value is 0.5g per serving. Anything less than this can be declared as zero. FDA is not allowing mandatory or voluntary declaration of the omega-3 fatty acids, EPA and DHA.

Carbohydrates

There are no proposed changes to mandatory declaration or daily reference value for total carbohydrates. However, FDA has proposed changing the name to total carbs. Other carbohydrates, such as starches, are no longer allowed to be voluntarily declared on the label.

FDA is also proposing to change the calories from carbohydrates calculation. The calories from carbohydrates would then be used to calculate the total calorie content in the product. This proposal would exclude soluble and insoluble non-digestible carbohydrates from the calculation. Calories from carbohydrates would then be calculated using 4kcal/g less the amount of non-digestible carbohydrates. Soluble carbohydrates will then be added at a value of 2 kcal/g.

Sugars

There are no proposed changes to mandatory declaration or daily reference value for sugars. However, the name will be changed to total sugars and and a new category of added sugars will be mandatory to declare. FDA has developed an extensive list of what is considered an added sugar: brown sugar, corn sweetener, corn syrup, dextrose, fructose, fruit juice concentrate, glucose, high fructose corn syrup, honey, lactose, maltose, malt sugar, molasses, raw sugar, turbinado, sugar, and sucrose. FDA acknowledges that there is no analytical method available to determine added sugars and will rely on ingredient records to determine the amount and type of added sugars. There are no proposed changes to sugar alcohols.

Dietary fiber

Dietary fiber will still be mandatory to declare, however FDA is proposing to increase the daily reference value to 28g per day. They will adopt the Institute of Medicine’s definition of total fiber which focuses on fiber that is beneficial to human health. There are no proposed changes to soluble or insoluble dietary fiber. 

Protein and Sodium

There are no proposed changes to protein. Sodium is still mandatory to list and FDA is considering lowering the daily reference value from 2400mg to 2300mg.

Essential Vitamins

Vitamins A and C will no longer be mandatory to declare on the label, but can still be voluntarily listed. Vitamin D will be mandatory to declare. FDA has proposed changing the units for vitamin A from IU to µg RAE (Retinol Activity Equivalents) and for vitamin D from IU to µg.

Vitamin K, vitamin B6, vitamin B12, thiamin, riboflavin, biotin, and pantothenic acid will still be voluntary to declare. FDA is proposing the voluntary labeling of choline. The units for vitamin E will be changed from IU to mg. Folate/folic acid will still be voluntary, but they will no longer be interchangeable and the units will be changed from µg to µg DFE (Dietary Folate Equivalents). Niacin is still voluntary to declare, but the units will be changed from mg to mg NE (Niacin Equivalents).

Vitamins
Current RDIs
Proposed RDIs
Biotin
300 µg
30 µg
Choline
550 µg
550 µg
Folate 
400 µg
400 µg DFE
Niacin 
20 mg  
16 mg NE
Pantothenic Acid 
10 mg  
5 mg 
Riboflavin 
1.7 mg 
1.3 mg 
Thiamin 
1.5 mg 
1.2 mg
Vitamin A 
5000 IU 
900 µg RAE
Vitamin B6 
2.0 mg 
1.7 mg
Vitamin B12 
6 µg 
2.4 µg
Vitamin C 
60 mg 
90 mg
Vitamin D 
400 IU 
20 µg
Vitamin E 
30 IU 
15 mg
Vitamin K 
80 µg 
120 µg

Essential minerals

Calcium and iron will both remain mandatory to declare. It will be required to declare potassium. 

Phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, and chloride will still be voluntary to declare. Fluoride will be voluntary to declare and FDA is not defining a daily reference value. 

Minerals
Current RDIs
Proposed RDIs
Calcium
1000 mg
1300 mg
Chloride
3400 mg
2300 mg
Chromium
120 µg
35 µg
Copper
2.0 mg
0.9 mg
Iodine
150 µg
150 µg
Iron
18 mg
18 mg
Magnesium
400 mg
420 mg
Manganese
2.0 mg
2.3 mg
Molybendum
75 µg
45 µg
Phosphorus
1000 mg
1250 mg
Potassium
3500 mg
4700 mg
Selenium
70 µg
55 µg
Zinc
15 mg
11 mg

Serving sizes

Changes to RACCs (Reference Amount Customarily Consumed) were proposed if consumption data increased or decreased by 25 percent or more. Based on this, about 17 percent of the RACCs will change. FDA will also be adding 25 new RACC categories. Changes in the RACC can potentially change claims such as “low fat” or “a good source of calcium.”

FDA has proposed specifications for how to determine servings per container. Products containing 200 percent or less than the RACC are considered a single serving. Products containing 200-400 percent of the RACC can be labeled with dual columns (single serving and per container). Products with more than 400 percent of the RACC are multi-serving.

  

Nutrition Labels – Old and New
Nutrition-Label-Old-May-2014 Nutrition-Label-New-May-2014

Formatting

Calories and servings per container will be increased in size. The location of servings per container and serving size will be switched. Serving size will be right justified. The phrasing of amount per serving will be changed to include the serving size. Calories from fat will be removed. Percent daily value will be located on the left side of the label. Added sugars will be included below sugars. Mandatory vitamins and minerals will have quantitative amounts in addition to percent daily value. FDA is requesting comments on how the footnotes should be adjusted.

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

Food Safety Labeling – Putting Rare Steak On The Chopping Block

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

Like most people, I enjoy a good steak.  

I have also found that, in recent years, my options for good, quality steaks have increased significantly, as food processors and restaurant chains look for ways to distinguish themselves and their products. Industry has moved toward more value-added products, such as mechanically tenderized steaks, using needles to soften the meat and even to inject marinade. Indeed, I think it would be safe to say that the vast majority of steaks now consumed in restaurants are mechanically tenderized.

The use of such technologies, however, creates additional food safety challenges not present in non-tenderized products. This is because, to the extent there is any possible pathogenic contamination present on the exterior of a steak, the process of mechanical tenderization can push that contamination deep into the product, where it becomes more difficult to destroy through cooking.

With that backdrop, the U.S. Department of Agriculture is now becoming more involved in helping educate end-users on the risks associated with mechanically tenderized products. In particular, USDA has published new proposed rules requiring meat processors to properly label any mechanically tenderized meat products they sell. These new rules will likely have two effects: (1) they may make mechanically-tenderized rare or medium rare steaks nearly impossible to sell; and (2) they may drive the vast majority of these products out of the food service market.  

Here’s why. In addition to requiring processors to label these products as “mechanically tenderized,” USDA will also require processors to include validated cooking instructions which, if followed, will ensure that any harmful pathogens in these products are destroyed. The question, then, for industry will be whether cooking mechanically tenderized steaks to the higher temperatures needed to kill foodborne pathogens will prevent them in most cases from being served “rare” or even “medium rare.”  

To justify its new rules, USDA has cited a number of recent outbreaks caused by mechanically tenderized steaks. According to USDA, since the year 2000, there have been a total of six E. coli O157:H7 foodborne illness outbreaks attributable to mechanically tenderized steaks served in restaurants and consumer homes. These six outbreaks, spanning 13 years, have included a total of 176 confirmed E. coli O157:H7 cases that resulted in 32 hospitalizations and 4 cases of HUS (acute renal failure).  

While you can decide for yourself whether such a substantial change in the labeling of steak products is warranted by the fewer than 15 cases reported annually since 2000, what we do know is that the labeling rules are changing fast, and serving mechanically-tenderized medium rare steaks in restaurants may no longer be a legal option. Time (and temperature), of course, will tell. Ultimately, this is because whether the term “medium rare” survives will depend upon the validation studies governing any new labeling. USDA’s rules will require validated instructions to include, at a minimum: (1) the method of cooking; (2) a minimum internal temperature validated to ensure that potential pathogens are destroyed throughout the product; (3) whether the product needs to be held for a specified time at that temperature before consumption; and (4) an instruction that the internal temperature should be measured by the use of a thermometer. 

In turn, processors will need to demonstrate to USDA that the instructions are also “scientifically supported,” meaning they must demonstrate that: (a) the cooking instructions can repeatedly achieve the desired minimum internal temperature and, if applicable, rest time; and (b) the minimum internal time and, if applicable, rest time achieved by the instructions will ensure that the product is fully cooked to a level designed to destroy any potential pathogens throughout the product. On the other side of the coin, even if processors could properly validate their cooking instructions, it may be that we see some major restaurant chains shift away from using these products altogether.

Indeed, once the new labeling requirements go into effect, then restaurants will have a difficult decision to make: comply with the labeling instructions, or ignore them?Responsible restaurant chains will, of course, determine that they need to comply with the instructional labels. This is because the instructions, themselves, anticipate (or, at least warn) that the product at issue could possibly contain pathogens and thus must be cooked to a predetermined temperature in order to render that product safe for consumption. If those instructions are ignored, however, and a customer becomes sick (or, even dies, as a result), that company could be exposed to significant punitive damages for disregarding a known risk. Thus, the only responsible course will be to either:  (1) refine internal policy to ensure that all such products are cooked to the recommended temperatures; or (2) to purchase steaks that are not mechanically or needle tenderized. There really will be no other options.

So, the most likely longer term result, in my opinion, may be that the restaurant industry will begin to move away from needle or mechanically-tenderized products, unless and until those products can be subjected to processing interventions (like irradiation) that will allow the end users to prepare and then serve them somewhere south of well-done.  

So, if you like selling or serving (or, I suppose, eating) steaks that can be cooked medium rare, you may want to watch these new rules closely. In in the end, “medium rare” may become much more rare you think.

FST Soapbox

The Private Food Label Dilemma

By Barbara Levin
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Prevention-based food safety and quality assurance technologies have a good return on investment, and may be critical to the ongoing financial health of the food private label industry.

Tuesday morning I had my typical breakfast while running out the door – Trader Joe’s almond butter on a toasted whole grain waffle. Good, and good for you, as my mom likes to say. Then of course I got to my desk, looked through my daily FSQA news feeds, and saw that the peanut butter recall was expanded to almond butter – and to other brands besides Trader Joe’s from the supplier, Sunland!

Well so far so good – I’m healthy and not in a high risk group, but it did make me think once again about the problem for food retailers that – in the need to remain competitive for shelf space in their own stores – have turned to private labeling for more and more products store-wide.

I’m a big fan of Trader Joe’s.  I buy a lot of their private label brands – everything from almond butter, to tomato sauce to olive oil. And they did a good job of aggressively getting the tainted nut butters off of their shelves.

But it does make one think of the added challenge for those manufacturing and selling private label goods – where a manufacturer problem can create a huge negative impact on your private label brand. Obviously in cases such as the Sunland nut butters, the ability to trace where the product had gone was key for recalling it. And while that ability is critical – the initial damage to the private label brands is done. Now, it’s just a matter of how extensive the damage is and how much it will cost to repair: loss of inventory, loss of sales, loss of consumer confidence and of course the cost of illness and related lawsuits which have already begun to follow.

And this doesn’t count the non-direct costs – such as advertising to eventually get those customers back – those who may now be “private label shy” and go back to the brand names under the perception that they may be safer.

We challenge the industry to look not just at reactive measures – but proactive, preventative measures as well. How are you leveraging food safety and quality technology? Are you using technology only to trace back once a problem has already occurred? Or are you also using technology to help prevent contaminated ingredients from going into production – and non-compliant finished goods from being labeled and shipped – in the first place. Are you as retailers putting this extra pressure on your manufacturers to take not just the reactive steps but the proactive ones as well?  

Prevention-based food safety and quality assurance technologies have a good return on investment, and may be critical to the ongoing financial health of the food private label industry. Have a thought on this topic? Join the conversation by posting a comment below.