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Food Labeling Claims

By on June 8, 2020

Federal Regulations

“Natural” “GMO” “Organic”

The primary authorities in the federal regulation of food labels are from the Federal, Food, Drug, and Cosmetic Act (FFDCA), the Nutrition Labeling and Education Act (NLEA), the FDA and the Federal Trade Commission (FTC).  In addition to regulatory issues surrounding the terms “natural,” “GMOs,” and “organic” that have been involved in the significant food-labeling cases to date.

Congress passed the FFDCA in 1938 to grant the FDA power to ensure that “foods are safe, wholesome, sanitary, and properly labeled.”  Two sections of the FFDCA that are often referenced in food-labeling lawsuits are sections 201(n) and 403(a).  Section 201(n) provides that a label is misleading if it fails to reveal facts that are material in light of representations made on the label, or in light of consequences that may result from the use of the food. Section 403 enables consumers to choose foods carefully by ensuring that the labels communicate accurate information. More specifically, section 403(a) states that a food is misbranded “[i]f. . . its labeling is false or misleading in any particular.”

In 1990, Congress amended the FFDCA to include the NLEA, which “sought ‘to clarify and strengthen the Food and Drug Administration’s legal authority to require nutrition labeling on foods, and to establish the circumstances under which claims may be made about nutrients in foods.’”  More specifically, the NLEA codified at 21 U.S.C. § 343 governs food nutritional labeling. It expressly preempts state-imposed nutrition labeling requirements and, as such, prohibits states from imposing labeling requirements that are not identical to federal standards. This section has been the subject of significant litigation. Plaintiffs try to avoid its scope by focusing their labeling claims on things that are not specifically addressed by the FDA, such as the term “natural.”

The FDA is responsible for protecting public health by ensuring the safety and proper labeling of all domestic and imported food, except meat, poultry, and processed eggs. Pursuant to its authority under the NLEA, the FDA has promulgated regulations permitting three types of nutrition claims on food packages: (1) health and qualified health claims; (2) nutrient content claims; and (3) structure/function claims.

The FTC has overlapping jurisdiction with the FDA regarding the regulation of advertising and labeling of food. These agencies coordinate their responsibilities through a Memorandum of Understanding that has been in place since 1971. Like the FDA, the FTC does not define “natural,” but rather decides such issues on a case-by-case basis. The FTC does require that companies have a reasonable basis for all express or implied claims made in food advertising. Some specific types of nutrition claims have received significant focus in litigation.

Natural

The FDA does not object to the use of the term on food labels if it is used in a manner that is truthful and not misleading and the product does not contain added color, artificial flavors, or synthetic substances. Use of the term “natural” is not permitted in the ingredient list, with the exception of the phrase “natural flavorings.” The FDA has long maintained this stance on the term “natural.”

In early 2014, three judges requested the FDA to provide a definition for “natural” as they believed that the issue was one for which the FDA had primary jurisdiction. For instance, in Cox v. Gruma Corp., United States District Court Judge Yvonne Gonzalez Rogers stayed the case for six months on primary jurisdiction grounds and referred the issue of GMOs and labeling of natural foods to the FDA for the first time. The court agreed with the defendants that the FDA, not the courts, should decide the issue and found that the FDA had primary jurisdiction over “the question of whether and under what circumstances food products containing ingredients produced using bioengineered seeds may or may not be labeled ‘Natural’ or ‘All Natural’ or ‘100% Natural.’”

The FDA declined the opportunity to address the issue and provided a number of reasons why it would not define the term “natural.” These reasons include that (1) amending its policy on the term would involve a public process; (2) it would require coordination and cooperation with the USDA and other federal agencies; (3) it would entail a consideration of a variety of things, such as scientific evidence, processing methods, consumer preferences and beliefs, food production, and First Amendment issues; (4) it lacks the resources to do so and has more urgent matters to look into; and (5) defining “natural” has implications well beyond the scope of the case immediately before the court. Thus, for these reasons, the term “natural” remains undefined by the FDA and continues to be a highly contentious issue in food-labeling litigation.[2]

GMO

GMO foods are those that have been genetically engineered, meaning that scientific methods were used to introduce new traits or characteristics to an organism. Such procedures can create a tolerance to herbicides, promote resistance to viruses, increase yields, and alter acidic content.  Ingredients derived from these GMO crops include amino acids, aspartame, ascorbic acid, vitamin C, citric acid, high fructose corn syrup, molasses, and xantham gum and are often found in foods as diverse as cereals, snack foods, and salad dressings. It has been estimated that GMOs end up in approximately 70% of all processed foods. Currently, states and legislature are sorting out whether GMOs should be labeled and whether they are good or bad for human consumption.

False Claims

These cases are broad and range from products that claim to be “natural” yet contain preservatives or high fructose corn syrup, falsely labeled that the product has “no refined sugars” when it actually does, and differences in terms such as “evaporated cane juice” which is the same as “sugar”.  The court has held for plaintiff in cases where the general consumer could be reasonable “duped” into thinking that a product is healthy and all natural, and the ingredient list is styled and written in a way to mislead, e.g., “evaporated cane juice” v. “sugar”.

“Paleo” diet foods excludes processed foods and those that include preservatives, sweeteners, or artificial coloring.  There have not been any cases yet, but with “claims” on packages and the possibility of processed foods in packaged items, these products are ripe for litigation.

Organic

Pursuant to federal law, a party cannot sell or label food as being “organic” unless it is produced and handled in accordance with the Organic Food Productions Act. For a product to be marketed or labeled as “organic” it must meet certain criteria. Specifically, the food must “(1) have been produced or handled without the use of synthetic chemicals. . . ; (2) . . .not be produced on land to which any prohibited substances, including synthetic chemicals, have been applied during the 3 years immediately preceding the harvest of the agricultural products; and (3) be produced and handled in compliance with an organic plan agreed to by the producer and handler of such product and the certifying agent.”

Regulations as to the labeling and marketing of products labeled as “100% Organic”

  1. For the packaging to use the term “100% Organic” to describe the product, the product must be made with all organic ingredients
  2. In the ingredient statement, each ingredient must have “Organic” written next to it
  3. Only water and salt may be included and not described as “Organic”
  4. The package must have the “USDA Organic” seal, and/or the seal of the agency which certified the product
  5. If third party seal is placed on package, it must not be larger than the USDA logo

Regulations as to the labeling and marketing of products as “Organic”

  1. For the packaging to use the term “Organic” to describe the product, the product must be made of 95% organic ingredients
  2. The label may identify the percentage of organic ingredients in the product
  3. The organic ingredients are to be identified in the same font and style as the rest of the package, no larger than one half-size the largest font on the package, and with the same type size, style, and color of font, without highlighting
  4. The product cannot contain organic and non-organic versions of the same ingredient
  5. In the ingredient statement, each organic ingredient must have “Organic” written next to it
  6. Only water and salt may be included in the ingredients and not described as Organic
  7. The package must have the “USDA Organic” seal, and/or the seal of the agency which certified the product
  8. If third party seal is placed on package, it must not be larger than the USDA logo

Regulations as to the labeling and marketing as “Made With Organic”

  1. For the packaging to use the term “Made With Organic” to describe the product, the product must be made of not less than 70 % organic ingredients
  2. The packaging, other than the ingredient list, must not identify more than three ingredients as organic
  3. The organic ingredients are to be identified the same font and style as the rest of the package, no larger than one half-size the largest font on the package, and with the same type size, style, and color of font, without highlighting
  4. The product cannot contain organic and non-organic versions of the same ingredient
  5. In the ingredient statement, each organic ingredient must have “Organic” written next to it
  6. Only water and salt may be included in the ingredients and not described as Organic
  7. The package must NOT INCLUDE the “USDA Organic” seal
  8. The package must include the identity of the agency which certified the product
  9. If third party seal is placed on package, it must not be larger than the USDA logo

Regulations as to the labeling and marketing of products made with less than 70% organically-produced ingredients

  1. Only the ingredient list may identify which ingredients are organic
  2. Only the ingredient list may identify what percentage of the product is made up of the organic ingredients
  3. The product cannot contain organic and non-organic versions of the same ingredient
  4. Water and salt may be included in the ingredients list but may not be described as “Organic”
  5. The package must NOT INCLUDE the “USDA Organic” seal
  6. The package must NOT INCLUDE the identity of any certifying agency

Regulations as to the labeling and marketing of organic textile products

  1. If USDA seal is displayed, the Organic textile product as a whole must not be made up of less than 95% Organic ingredients
  2. For the packaging to use the term “Made With Organic” to describe the product, the product must be made of not less than 70% organic ingredients
  3. The packaging must not identify more than three ingredients as “Organic”
  4. The organic ingredients are to be identified the same font and style as the rest of the package, no larger than one half-size the largest font on the package, and with the same type size, style, and color of font, without highlighting
  5. The product cannot contain organic and non-organic versions of the same ingredient

Regulations as to the labeling and marketing of organic cosmetic products

  1. Cannot display USDA organic seal
  2. Must not contain less than 70% organic ingredients
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