On July 16, 2025, the U.S. Food and Drug Administration (FDA) announced that it was revoking and proposing to revoke 52 food standards. The FDA has regulatory “standards of identity” (SOI) for certain foods to ensure that the “characteristics, ingredients, and production processes of specific foods” meet consumer expectations. However, in alignment with the Trump Administration’s deregulatory initiatives directed through Executive Order 14192, “Unleashing Prosperity Through Deregulation,” FDA is revoking 52 SOIs that it believes are obsolete and unnecessary. This article is the latest in a series entitled “Food Foundations,” and will explain the basics of FDA and USDA SOIs and discuss FDA’s recent decision.
Legal Background of SOI
The Federal Food, Drug, and Cosmetic Act (FDCA) authorizes the FDA to create regulations for “a reasonable definition and standard of identity, a reasonable standard of quality, and reasonable standards of fill.” 21 USC § 341. The purpose of this language is to allow FDA to promote “honesty and fair dealing” and to specifically combat the economic adulteration of foods. Economically motivated adulteration is defined by the FDA as “intentionally leav[ing] out, tak[ing] out, or substitut[ing] a valuable ingredient or part of a food.”
When these regulatory standards were created, food companies would often substitute certain, expensive ingredients for an inexpensive alternative, yet market the food product as though it still contained the more valuable ingredient. For example, in the 1930s, it was common for a food company to sell a product that claimed to be “jam” and contain fruit but did not actually contain any fruit. To combat this, FDA created a SOI for jam that required for a product that represented itself as “jam” to contain a minimum amount of fruit. 21 CFR § 150.160.
The other federal agency that is primarily responsible for food safety in America is the U.S. Department of Agriculture (USDA). The USDA is authorized by the Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA) to also establish standards of identity or composition if it is deemed “necessary for the protection of the public.” 21 USC § 607(c); 21 UCS § 457(b). However, USDA’s standards must not be “inconsistent with any such standards established under the FDCA.” Additionally, to avoid inconsistency, the Secretary of Agriculture must consult with the Secretary of the Department of Health and Human Services to avoid such inconsistency. USDA has established approximately 80 standards for meat and poultry products.
FDA: What is a SOI?
There are currently over 250 SOIs published in the FDA regulations that can be found in 21 CFR § 130 – 169. They include information about mandatory ingredients, optional ingredients, manufacturing requirements and labeling requirements. Often the SOI will describe the proportions of ingredients a food must contain and articulate the method of production for the food. For example, 21 CFR § 163.130 requires that for a product to represent itself as “milk chocolate” it must contain “not less than 3.39 percent by weight of milkfat and not less than 12 percent by weight of total milk solids.” On the other hand, 21 CFR § 163.124 requires that white chocolate products must contain “not less than 3.5 percent by weight of milkfat and not less than 14 percent by weight of total milk solids.” Additionally, via their SOIs, milk and white chocolate have a similar formulation process and are created by “intimately mixing and grinding. . . dairy ingredients and… nutritive carbohydrate sweeteners.” However, the chocolates have different starting ingredients with milk chocolate being formulated from chocolate liquor and while chocolate being formulated from cacao fat.
FDA: How are SOIs used?
One justification the FDA is using to revoke these 52 SOI is that in the years since the inception of SOIs, the agency has created other regulatory requirements that address the threat of economic adulteration. Specifically, the FDA considers its requirements for ingredient labeling and nutrition labeling information and claims to be more proficient at protecting consumers.
One of FDA’s labeling requirements is that the packaging of food products contains a “statement of identity” on the package’s principal display panel. The regulatory term “statement of identity” means the name of the food as established by law or regulation. A food’s name as “established by law or regulation” is referring to foods that have a SOI. However, the FDA recognizes that not every food has a legal or regulatory name. When that is the case, the “common or usual name” of the food should be used, and if there is no common or usual name, then a non-misleading descriptive name should be used.
It is important to note that a brand name is not considered a statement of identity and is not enough to meet this requirement. For example, a common or usual name of a food would be “crackers.” Specifically, a Ritz crackers package will bear the brand name “Ritz” in a bold large type, but the front of the package will also include the statement “crackers.” When comparing Ritz’s packaging with Club, a competitor cracker brand owned by a different company, the Club packaging will also contain the statement “crackers.” The consistency between these two packaging statements appears because “crackers” is the common or usual name for this type of food and thus is required to meet the statement of identity labeling requirement.
FDA: SOI Enforcement
The FDA can enforce SOI through various tools including warning letters, voluntary recalls, and mandatory recalls. Typically, when the FDA is aware that a manufacturer has violated FDA regulations, the FDA will first notify the manufacturer through a warning letter. After the manufacturer is notified, it must be provided with the opportunity to conduct a voluntary recall. If the manufacturer does not comply with the voluntary recall and stops distributing the problematic food, then the FDA may order it to stop and notify other distributors to stop distributing the food. Following the order, the FDA must offer the manufacturer a hearing to learn why the order was made and offer its defenses against the mandatory recall. After the hearing, the FDA will determine whether the mandatory recall is needed. To learn more about food recalls, click here to read NALC article “Food Foundations: What are Food Recalls and How do They Work?”
In some instances, there are foods that have a SOI established, but the FDA chooses to avoid enforcement in certain cases where it is violated. For example, there is an established SOI for milk which can be found at 21 CFR § 131.110. However, over the past decade, there has been a large increase in consumer demand for plant-based alternative milk products, such as soy milk, almond milk, cashew milk, and more. Though these products do not meet the milk SOI requirement that it is “obtained by the complete milking of one or more healthy cows,” they are still permitted by FDA to use the term “milk.” Specifically, the FDA states in a 2023 draft guidance that some plant-based milk alternatives, like soy milk and almond milk, are now so widely used that common or usual names have been established for them. For other plant-based milk alternatives, a non-misleading descriptive name should be used. For example, a plant-based milk alternative that is made from cashews should be labeled as “Cashew Milk.” To learn more about SOI and plant-based foods, click here to read Congression Research Service Report “Standards of Identity for Foods and Plant-Based Food Products.”
FDA’s work to update SOI
A justification that the FDA is using to revoke the 52 SOIs discussed above is that the agency has created other regulatory requirements that address the threat of economic adulteration. Specifically, the FDA considers its requirements for ingredient labeling and nutrition labeling information and claims to be sufficient for protecting consumers. For example, FDA currently requires that all ingredients present in food be listed in an ingredients list on its packaging. 21 CFR § 101.4. If a food is found to contain a food ingredient that is not listed correctly in its labeling, then it is considered misbranded and could be subject to FDA enforcement. Thus, this requirement is a deterrent to the economic adulteration problem that was prevalent in the 1930s.
Because of the modern guardrails, such as ingredient lists, FDA has in place to combat economic adulteration, the agency has undertaken the goal of updating SOIs. Specifically, the agency categorizes its work into three groups:
- Establishing principles to more transparently communicate what the agency will consider when determining whether to revise, eliminate, or establish a food standard.
- Updating individual SOIs to allow for continued innovation in the marketplace, including updating SOIs to reflect modern technologies and processing methods.
- Updating SOIs to ensure they are supporting the production and innovation of healthier food.
As part of this work to update SOIs, the FDA issued final rules revoking the SOIs on Frozen Cherry Pie in 2024 and French Dressing in 2022. The FDA has also proposed rules revising the SOI for Canned Tuna and Salt Substitutes; issued a request for information on the SOIs for Pasteurized Orange Juice and Yogurt to change certain processes and ingredient requirements; and re-opened the comment period on a proposed rule that would permit the use of fluid ultrafiltered milk and fluid ultrafiltered nonfat milk the production of certain cheeses. Additionally, the FDA recently proposed to revoke and revoked 52 SOIs.
Revocation of 52 SOI
Canned Fruits and Vegetables
The first of the 52 SOI that FDA is revoking are standards for 11 types of canned fruits and vegetables that the agency claims are no longer sold in U.S. grocery stores. Included in this list are seven standards for fruits artificially sweetened with saccharin or sodium saccharin. This direct final rule had a comment period that was open until August 18, 2025, and if no significant adverse comment was received by the end of the period, then it would become effective on September 22, 2025. As a precautionary move, the FDA also published a companion proposed rule that would create a procedural framework for the rule’s finalization if the direct final rule needed to be withdrawn. At the time of this article’s publication, FDA has not announced a significant adverse comment that will force its withdrawal.
Dairy Products
The next category of the 52 SOIs that is being revoked includes 18 SOI for dairy products. Thirteen of these products are being proposed for revocation because the FDA has determined that these standards “cover few marketed products.” Five of these products are being proposed for revocation because the foods “could easily be marketed as a non-standardized food using the name of a standardized food in the non-standardized food’s full name.” For example, “cream cheese with other foods” is one of the SOIs being revoked. “Cream cheese” has its own SOI, so the FDA is revoking the SOI “cream cheese with other foods” because it believes it is redundant and unnecessary to protect consumers. This proposed rule is now in a public comment period that is open until September 15, 2025. Comments can be submitted here.
23 Other SOI
The last group of SOIs that the FDA is proposing to revoke includes 23 types of food products. Among this list of 23 foods is bakery products, macaroni and noodle products, canned fruit juices, fish and shellfish, and food dressings and flavors. Twenty of the SOIs are being revoked because they have “little to no market in the U.S.” One is being revoked because it includes another standardized food in its name, and similar to the category of dairy products revoked for this reason above, the FDA believes it is redundant and unnecessary. Two SOIs are being revoked because they could be covered by a broader standard. For example, the standard for “Olympia oysters” is being revoked because the FDA believes that these types of products are sufficiently covered under the broader SOI for “oysters.” The FDA clarifies though that for “Olympia oysters” the use of the term “Olympia” might still be necessary to describe the geographic origin of the product. However, FDA believes that having an SOI for “Olympia oysters” is unnecessary because its use would be permitted under the “common or usual name” rules. This proposed rule is in a comment period until September 15, 2025, and comments can be made here.
USDA Standards of Identity
The FDA is not the only federal agency with SOI rules for food. Specifically, USDA, which has jurisdiction over all meat, poultry, catfish, and unshelled egg products, has similar SOI regulations. The USDA is authorized by both the FMIA and the PPIA to create SOIs for meat and poultry products. 21 USC § 607(c); 21 UCS § 457(b). Regulations for USDA established SOIs can be found at 9 CFR Part 319 for meat, and 9 C.F.R. § 381 Subpart P for poultry. For example, 9 CFR 319.80 lists the SOI for “barbecued meats,” and requires that products bearing this SOI be “cooked by the direct action of dry heat resulting from the burning of hard wood or the hot coals therefrom for a sufficient period to assume the usual characteristics of a barbecued article.” Other requirements in the barbecued meats SOI include allowances that the product can be “basted with a sauce,” and that “the weight of barbecued meat shall not exceed 70 percent of the weight of the fresh uncooked meat.”
In addition to the SOIs established in the regulations, USDA’s Food Safety and Inspection Service (FSIS), the agency that operates USDA’s food safety arm, has established informal policy standards through both Policy Memorandums and its Food Standards and Labeling Policy Book (the policy book). The Policy book is a document that serves as a guidance to “help manufacturers. . . prepare product labels that are truthful and not misleading,” and basically functions as a dictionary for labeling claims. For example, the Policy book requires that for a food product to declare itself as “beef a la mode,” it must be sliced, cooked beef marinated in wine, cognac, or vegetable stock with carrots, onions, and other ingredients covered with wine sauce and containing at least 50 percent cooked beef.
Similar to the FDA labeling rules, USDA regulated products are required to bear a statement of identity. 21 USC § 601; 21 USC § 453. Thus, products regulated by the USDA, like those regulated by the FDA, must include either the legal/regulatory name, the common/usual name, or a non-misleading descriptive name. Also like the FDA, a brand name will not be the same as a statement of identity.
USDA operates differently from the FDA in that it requires pre-market approval for food labels. This means that FSIS must approve the label of a food product under its jurisdiction before that product may be marketed in interstate commerce. Thus, the manufacturer of a meat, poultry, catfish, or unshelled egg product must submit many types of labels to FSIS before it can be used and the conformance with regulations will be confirmed.
However, USDA has created a process for a “generically approved label” that permits a manufacturer to use a label without submitting it for FSIS approval if the label includes only certain components. One of those generically approved components is its “product name,” or statement of identity. This and other generically approved components are identified in the Policy book.
For those labels that contain non-generically-approvable components, USDA must give specific approval before they are used. This is noteworthy because it will ensure that the product name or statement of identity used on the food’s label is accurate. In contrast, since the FDA does not require pre-market approval, there is no oversight determining that the label is using an accurate statement of identity.
FDA & USDA
In 2005, FDA and USDA originally proposed a joint rule to establish a set of general principles for the agencies to use when considering whether to establish, revise, or eliminate a food standard of identity. The joint rule was never finalized, but the FDA reopened comments on its specific aspects of the proposed rule in 2020. However, following the re-opened comment period, FDA announced in February 2023 that it was withdrawing the proposed rule. Though no further updates have been announced about the joint work between the two agencies, FDA’s standards of identity page on the website states that they are still collaborating with the USDA to “establish a set of general principles.”
Conclusion
SOIs were created to combat the economic adulteration of foods by identifying ingredients and production practices, and have since been adopted by both FDA and USDA. However, as times change, so do standards, and both agencies are considering what the role of those standards will be in the future. To that end, the FDA is revoking and proposing to revoke 52 SOIs. In the meantime, however, SOIs play an important role in ensuring integrity in food labeling and consumer protection.