Section 102.5 - General principles

7 Analyses of this regulation by attorneys

  1. FDA Declares Label “Evaporated Cane Juice” False and Misleading in New Guidance

    Kramer Levin Naftalis & Frankel LLPAugust 8, 2016

    Thus, the term “evaporated cane juice” is false or misleading because it suggests that the sweetener is “juice” or is made from “juice” and does not reveal that its basic nature and characterizing properties are those of a sugar.As provided in 21 CFR 101.4(a)(1), “Ingredients required to be declared on the label or labeling of a food . . . shall be listed by common or usual name . . . .” The common or usual name for an ingredient is the name established by common usage or by regulation (21 CFR 102.5(d)). Each class or subclass of food is to be given a common or usual name that states, in clear terms, what it is in a way that distinguishes it from different foods.

  2. The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

    Morrison & Foerster LLP - Class DismissedLuis Gabriel HoyosJune 14, 2017

    It remains to be seen, however, whether courts will dismiss these claims at the pleadings or summary judgment stage.Background on FDA’s ECJ Guidance. In 2009, FDA issued draft guidance stating that the term ECJ is false and misleading under Section 403(a)(1) of the FDCA because ECJ “does not accurately describe the basic nature of the food and its characterizing properties (i.e., that the ingredients are sugars or syrups, as required by 21 CFR 102.5.).” In other words, FDA suggested that ECJ could mislead consumers into believing that a product did not include sugar.

  3. What Do We Know About Plant-Based Products & Dairy Foods – FDA Wants to Know

    Goldberg SegallaDavid RutkowskiOctober 5, 2018

    This is the name by which it is known by the American public and generally established by its common usage. See 21 CFR 102.5(d).For “Standardized Foods”, the common or usual name must be declared on the principal display panel of the label when the food is in package form. Examples include milk, cultured milk, yogurt, and cheese.

  4. How to Name that Food: The Good Food Institute Petitions FDA for Clarity

    Hyman, Phelps & McNamara, P.C.Riëtte van LaackMarch 8, 2017

    Unlike the Petition by the soy industry in 1997, GFI’s Petition is not limited to “milk” alternatives and does not provide a definition or standard for certain terms. Instead, GFI requests that FDA amend 21 C.F.R. § 102.5, the regulation describing the principles for the common or usual name for nonstandardized foods, to include a provision that addresses the naming of a food by referencing the name of another food. GFI further asks that, in the interim, FDA issue guidance clarifying that foods may be named by referencing names of other foods consistent with the proposed amendment to the regulation. Similar to the 1997 Petition regarding soymilk, the GFI Petition provides a large number of examples of other foods in which FDA has allowed the use of a name that is defined by a standard of identity modified by another term, e.g., bread (defined as made from wheat) vs. rye bread, butter (defined as made from cream/milk) vs. peanut butter and apple butter, and noodles (defined as ribbon shaped products made from wheat flour that must contain egg products) vs. rice noodles.

  5. Trader Joe’s Targeted in Class Action Suit

    Michelman & Robinson, LLPMelanie Natasha HowardDecember 3, 2015

    That name must also not be “confusingly similar to the name of any other food that is not reasonably encompassed within the same name.” 21 C.F.R. 102.5(a). Food labeling is a significant area of concern at the FDA, and during 2015, the federal agency issued a number of policy guidance documents on a wide range of labeling issues, from “FDA’s Policy on Declaring Small Amounts of Nutrients and Dietary Ingredients on Nutrition Labels” (July 2015), to “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” (November 2015).

  6. Sweet(ener) Confusion: Court Divide Over Role of Primary Jurisdiction Doctrine in “Evaporated Cane Juice” Cases Grows

    Sheppard, Mullin, Richter & Hampton LLPRobin AchenApril 16, 2014

    Plaintiffs alleged that Santa Cruz Natural used the term “evaporated cane juice,” rather than sugar, in order to make its sodas, juices, and other beverages appear healthier. Plaintiffs invoked the FDA regulations that require food labels to reflect the common or usual name of an ingredient, (21 CFR § 101.4(a)(1)and 21 C.F.R. § 102.5(d)) and argued that Santa Cruz Natural’s use of “evaporated cane juice” violated those regulations. Plaintiffs then alleged violations of the UCL, FAL, and CLRA, as well as various common law causes of action.

  7. FDA Confirms that the Term “Dietary Supplement” Is a Legal Statement of Identity for Dietary Supplement Products and that FDA Guidance to the Contrary is in Error; State Regulators may Remain Confused and Have Taken Enforcement Action

    Hyman, Phelps & McNamara, P.C.Wes SiegnerMarch 4, 2009

    FDA's longstanding regulations lead directly to this result. Section 102.5 (21 CFR 102.5) sets out how the common or usual name of a nonstandardized food is to be derived. Under this provision, the common or usual name must accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food.