Tag Archives: Labeling

California Voters Reject Prop 37 on GMO Labeling

Posted on November 7, 2012 | Leave a comment

California voters rejected Prop 37, the ballot initiative that would mandate the labeling of foods with any genetically-modified ingredients.  According to the San Francisco Chronicle, the proposed labeling law is headed for a clear defeat with 94% of all precincts reporting.

“We said from the beginning that the more voters learned about Prop. 37, the  less they would like it,” said Kathy  Fairbanks, a spokeswoman for the opposition. “We didn’t think they would  like the lawsuits, more bureaucracy, higher costs, loopholes and exemptions.  It looks like they don’t.”

The California Right to Know campaign issued a press release today which stated, in part, as follows:

Yesterday, we showed that there is a food movement in the United States, and it is strong, vibrant and too powerful to stop. We always knew we were the underdogs, and the underdogs nearly took the day. Dirty money and dirty tactics may have won this skirmish, but they will not win the war.

Today, we are more than 4 million votes closer to knowing what’s in our food than when we started. This is a victory and a giant step forward. We are proud of our broad coalition of moms and dads, farmers, nurses, environmentalists, faith and labor leaders who did so much with so few resources to bring us to this point, and we will carry forward.

Please see the entire article from the San Francisco Chronicle here.

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Posted in Genetically Modified Organisms, Labeling

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My Q&A with Silliker (Part 1 of 2)

Posted on October 29, 2012 | 1 Comment

It’s a privilege to present my Q&A with Silliker, a leading, worldwide provider of food quality, safety and nutritional consulting services.  Silliker is one of three subsidiaries of the Mérieux NutriSciences Corporation, along with Biofortis and Bioagri.  I was fortunate to tour Silliker’s new Solutions Center in Crete, Illinois at its grand opening this September.  It’s an amazing, 71,000 square-foot facility, and the largest laboratory in Silliker’s global network.   Special thanks to Patrick Kennedy of Silliker who helped facilitate this feature.  I’ll post Part 2 later in the week.

Food Identity Blog:  There has been a lot of publicity over California’s ballot proposal that would mandate labeling of food products that contain any GMO ingredients.  In this regard, the proposed law would exempt from the labeling requirements:

Food that an independent organization has determined has not been knowingly and intentionally produced from or commingled with genetically engineered seed or genetically engineered food, provided that such determination has been made pursuant to a sampling and testing procedure approved in regulations adopted by the [California Department of Food and Agriculture] ….

What issues and challenges exist for food companies that want to make the determinations set forth in this provision?   What challenges do you see for food companies with regard to testing and their internal processes if it wants to sell non-GMO food in light of the proposed law’s zero tolerance for co-mingling?

Silliker:  It has been estimated that up to 70 percent of food products sold in grocery stores might contain ingredients derived from genetically modified organisms (GMOs).  If Proposition 37, the Genetically Engineered Foods Right to Know Act, becomes law, it could have profound implications for the food industry related to labeling, marketing and new product formulation.

For years, the Food and Drug Administration and several highly-regarded public health institutions have maintained that products containing GMOs or genetically modified ingredients, are equivalent in terms of safety to the conventional counterparts.   In effect, Proposition 37 would not improve the safety of foods marketed in California, but consumers might perceive the mandatory labeling statement as a type of warning label.

Testing for genetically engineered ingredients and auditing manufacturing facilities are potential options for companies seeking to avoid a mandatory labeling statement.   Since GMO ingredients are not recognized as a food safety risk, mandatory pre-market testing of foods for GMOs seems unlikely to occur.  Currently, no federal regulations exist in the U.S. to mandate thresholds or testing requirements for genetically engineered material in food.

To control the comingling of GMO derived ingredients with food labeled as GMO-free, independent third-party auditors could inspect manufacturing facilities as is currently done in the case of allergens.   Food processors control allergens through programs that monitor production scheduling, sanitation effectiveness, control of rework, storage of allergenic ingredients and inspection of incoming ingredients.  An audit of an allergen control program can be conducted [by companies like Silliker] as a stand-alone audit or as an addendum to a more comprehensive audit of GMPs.   Testing for the presence of allergens in food products is typically conducted to validate and verify in-plant processes.

Food Identity Blog:  What changes have you seen over the past few years in the restaurant industry in light of the increased focus on restaurant menu labeling and the new federal regulations that will likely be finalized in 2013?  What are the biggest concerns you’re hearing from restaurants?

Silliker:  While some restaurant chains have been very proactive in preparing for the upcoming menu labeling requirements, other companies appear to have lagged behind due to the delayed publication of the final rules.

Earlier this year, the U.S. Supreme Court decision upheld the controversial health care law (Patient Protection and Affordable Care Act), which ensured the FDA would move forward with nutrition labeling regulations for “restaurants or similar retail food establishments” as mandated by the law.  To advance the regulations, the FDA must first resolve a few issues, including an industry challenge related to the scope of the rules.

The FDA issued proposed regulations for the disclosure of calorie information on restaurant menus (FDA-2011-F-0172) and vending machines (FDA-2011-F-0171) in April 2011.  Under the proposed regulations, “restaurants or similar retail food establishments” with 20 or more locations must post calorie information for standard menu items on printed menus, menu boards, and drive-through menus.   Upon request, restaurants must provide written nutrition information including: total calories, calories from fat, total fat, saturated fat, cholesterol, trans fat, sodium, total carbohydrates, sugars, dietary fiber, and protein.

Due to concerns about the scope of the regulations, the FDA proposed exemptions for certain establishments, including movie theaters and hotels, which only sell food in support of their primary business.  However, retail food trade associations and several members of the U.S. Congress urged the FDA to also provide exemptions for grocery stores.  Retailers have suggested the existing state and local laws for menu labeling do not apply to supermarkets.  The restaurant industry supports a consistent national approach to menu labeling.

Proactive restaurant companies have prepared for the upcoming regulations through database nutrient calculations and the analytical testing of menu items.  In general, the restaurants and other retail food establishments responding to the upcoming rules seem to be most concerned with efforts to reduce calories, fat and sodium in menu offerings.

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Posted in Labeling

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ConAgra Sued for False Advertising Over Parkay Spray butter substitute

Posted on August 17, 2012 | Leave a comment

A woman has filed a complaint against ConAgra Foods in U.S. District Court for the District of Nebraska and, as always, is seeking class action certification.  Plaintiff alleges that, although ConAgra’s Parkay Spray butter substitute is advertised as “fat free” and “calorie free,” it “contains 832 calories and 93 grams of fat per bottle.”  According to the Parkay website, the “Servings Per Container” on the bottle’s Nutrition Facts panel is “about 226 sprays” with a serving size being 5 sprays.  Plaintiff, however, alleges that these “product labels include artificially small ‘serving sizes’ that fail to account for the manner in which these products are customarily consumed.”  ConAgra’s advertisements are thus false because, according to the Complaint, the product “contains ingredients that are fats which, even in small quantities, add trivial amounts of fat per serving.”

Notably, plaintiff alleges that ConAgra’s labeling directly violates the FDA’s regulatory scheme by providing a smaller “serving size” than the amount of food “customarily consumed at one eating occasion” based on “consumption data under actual conditions of use” as required under C.F.R. §§101.9(b)(1).  Based on that contention, Plaintiff further alleges that ConAgra “made unlawful ‘fat free’ and ‘calorie free’ nutrient content claims” because a “product that uses unlawful serving sizes cannot claim to be ‘fat free’ or ‘calorie free.’  21 C.F.R. §101.62(a)(3); 21 C.F.R. §101.60)a)(3).”

Finally, Plaintiff alleges that Con Agra was aware that its Parkay Spray was mislabeled based on consumer complaints and an FDA guidance letter from March 2005 that “reminded” the food industry about the importance of accurately determining proper serving sizes for their products.  The Complaint includes eight different claims with the primary claims alleging violations of Nebraska’s Consumer Protection Act and Uniform Deceptive Trade Practices Act.  See the entire Complaint here.

This will be an interesting case to watch because Plaintiff cannot prevail  if ConAgra shows that it properly complied with FDA regulations on calculating serving size.

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Posted in False Advertising

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FDA’s Public Comment Period Ends for Study on Nutrition Facts Footnotes and “Added Sugar” Labeling

Posted on August 12, 2012 | Leave a comment

On May 31, 2012, the FDA announced that it was seeking public comment on a potential “Experimental Study on Consumer Responses to Nutrition Facts Labels With Various Footnote Formats and Declaration of Amount of Added Sugars.”  The “footnote formats” generally relates to exploring “consumer responses to various food label formats for the footnote area of the Nutrition Facts label, including those that exhibit information such as various definitions for percent Daily Value, a succinct statement about daily caloric intake, and general guidelines for high and low nutrient levels.”

Groups supporting the study include the American Heart Association, the Center for Science in the Public Interest (“CSPI”), and the Rudd Center for Food Policy & Obesity at Yale University.  Their comments included the following:

  • American Heart Association:  “While ‘sugars’ is listed, the Nutrition Facts label does not distinguish between naturally occurring sugars such as those found in fruit or milk, which are associated with other important components inherent to foods such as vitamins and minerals, and added sugars, which are not.”
  • Rudd Center:  “The Rudd Center suggests testing more succinct statements for recommended caloric intake, including statements of calorie ranges and alternative types of statements indicating that calorie requirements change with age, height, and activity level, and statements suggesting consumers check their own caloric needs on a government run website.”  Further, “including added sugar and naturally occurring sugar on the Nutrition Facts Panel under total sugar would increase consumer understanding of products’ nutritional attributes and healthfulness. Consumers are used to seeing subcategories under total fat (i.e., saturated fat, trans fat), so this would be in line with current understanding and increase comprehension of the additional information.”
  • CSPI:  Besides supporting the proposed study, “CSPI urges FDA also to evaluate the effects of labels that show only added sugars and juice sugars.  While CSPI … supports the idea of a Nutrition Facts label that lists added sugars (and juice sugars) instead of total sugars and urges FDA to test such labels, at a minimum Nutrition Facts labels should distinguish between added sugars that consumers should limit (caloric sweeteners and juice sugars) and sugars that occur naturally in milk, fruit, or vegetables.”  Even if some sugars are chemically identical, “fruits, vegetables, and low-fat dairy foods may help prevent heart disease, stroke, osteoporosis, and other diseases.  In contrast, soft drinks, fruit drinks, bakes sweet, candy, and other sources of added sugars … may increase the risk of disease, either by adding sugars to the diet or by displacing more nutritious foods from the diet.”  CSPI’s preferred Nutrition Facts label is set forth below.

Groups  opposing the study include the American Bakers Association, the Independent Bakers Association, the American Beverage Association, the International Dairy Foods Association, the National Dairy Council, the National Milk Producers Federation, the National Confectioners Association, Ocean Spray Cranberries and the Sugar Association.   Reasons provided  in opposition to the study included the following:

  • Ocean Spray Cranberries, Inc.:  “Ocean Spray’s opposition is threefold: (1) we believe that the focus on added sugars, as opposed to total sugars, is misplaced, (2) the focus on added sugar disproportionally impacts cranberry products, which require sweetening to be palatable, and (3) the FDA lacks authority to require the declaration of added sugars as the FDA has no means of testing for enforcement of an added sugar declaration without requiring access to proprietary formulas.”
  • National Dairy Council:  “[C]urrent food labels provide information about the amount of total sugars on the Nutrition Facts label and the names of added sugars on the Ingredients Panel. Nutrient content claims, such as reduced sugar, sugar free or no added sugar, may also be present.  Consumer research to date indicates that consumer judgments about the nutritional attributes and overall healthfulness of foods and beverages can be impacted by information currently on foods labels. A review of the current research indicates potential for consumer confusion and unintended consequences from declaration of added sugars on the Nutrition Facts label.”
  • American Beverage Association:  “Although ABA supports FDA efforts to research the ways in which consumers use and understand the Nutrition Facts label, ABA continues to believe that the proposed study’s review of an added sugars declaration is wholly unnecessary and lacks practical utility for a variety of reasons.  First, FDA itself has repeatedly taken the science-based position that there is no need for a mandatory disclosure of added sugars since the body does not distinguish between added sugars and those naturally occurring in food.  FDA has also expressly acknowledged that an added sugars declaration would be ‘unenforceable’ since the agency would be unable to determine, for many products, the accuracy of any such label declarations. ….  Moreover, … it is well-established that added sugars are not uniquely linked to the problem of obesity [and a] misplaced focus on added sugars would only detract from the importance of total calories as the crucial piece of information necessary to inform consumers of the relationship between food intake and weight management.   Finally, … the proposed study contains a number of methodological and other flaws and may not produce reliable information on added sugars labeling.”

See all the comments here. 

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UPDATE: Some Claims Dismissed, But General Mills Must Defend “Made With Real Fruit” Statement

Posted on May 20, 2012 | 2 Comments

A recent post discussed the pending class action suit over General Mills’ Fruit Snacks.  A District Court judge in the Northern District of California has now ruled on General Mills’ Motion to Dismiss that lawsuit and dismissed with prejudice plaintiff’s claims to the extent they are based on statements that Fruit Snacks are “fruit flavored,” “naturally flavored,” and “gluten free.”  The Court let the lawsuit proceed, however, with regard to the statement “Made with Real Fruit.”  See complete Opinion here.

Specifically, the Court agreed with General Mills that any claim based on ”fruit flavored” and “naturally flavored” is preempted by the Nutrition Labeling and Education Act (“NLEA”) and, more specifically, the FDA labeling requirements promulgated under 21 U.S.C. § 343(k).  In discussing the relevant labeling requirements - 21 C.F.R § 101.22(i) – the Court stated:

[T]he regulation allows a producer to label a product as”natural strawberry flavored,” even if that product contains no strawberries.  While the regulation’s logic is troubling, the Court is bound to apply it.

Turning to the “gluten free” claim:

 [T]he Court [found] that the statement “gluten free” cannot support Plaintiff’s claims under [California's unfair business practices and false advertising laws].  The statement is objectively true and communicates nothing more than the absence of gluten in the product — a message used to convey the suitability of the Fruit Snacks to consumers with celiac disease and others who may wish to avoid gluten.  A reasonable consumer is unlikely to interpret the statement  ”gluten free” to mean that the Fruit Snacks contain no partially hydrogenated oils, low amounts of sugar or corn-syrup, or that the Fruit Snacks are otherwise healthful.

The Court had a different view, however, of the “made with real fruit” claim.  Plaintiff  alleged that the statement “made with real fruit” incorrectly describes the ingredients, which include partially hydrogenated oil, sugars in quantities amounting to approximately half of each serving and “pears from concentrate” rather than the fruit indicated by the name of the product.  For example, strawberry-flavored Fruit Roll-Ups contain no strawberries.

A reasonable consumer might make certain assumptions about the type and quantity of fruit in the Fruit Snacks based on the statement “made with real fruit,” along with other statements prominently featured on the products’ packaging.  For example, the statement “made with real fruit” appears in large and colorful letters on the side panel of the packaging of strawberry Fruit Roll-Ups.  Additionally, the word “strawberry” appears in large letters on the front, back, top, and bottom panels.  Taken together, these statements might lead a reasonable consumer to believe that product is made with real strawberries, not pears from concentrate.  The names “Fruit Roll-Ups” and “Fruit by the Foot,” along with the fanciful depiction of the products, which resemble fruit leather, may lead to further confusion about the Fruit Snacks’ ingredients.  After seeing these prominent aspects of the packaging, a reasonable consumer might be surprised to learn that a substantial portion of each serving of the Fruit Snacks consists of partially hydrogenated oil and sugars.

On the one hand, the rejection of certain statements by the Court  takes away some of plaintiff’s “ammunition” for arguing that the overall product labeling was deceptive to reasonable consumers.   On the other hand, the Court views the “Made with Real Fruit” statement, in combination with other aspects of the packaging, as more than sufficient for the jury to consider at trial.  It will be interesting to see how this case proceeds and how this ruling might impact any potential settlement discussions.

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Posted in Front-of-Package Claims, Front-of-Package Litigation

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