Since 1939, the U.S. Food & Drug Administration (FDA) has been helping consumers ensure the quality and authenticity of certain products through its Standards of Identity (SOI) for Food program.
Today, consumers can trust that everything from canned vegetables to jellies to fruit pies contains what the product says it presents thanks to SOIs – which are essentially an agreed-upon legal definition of what food actually is and was introduced as a means of consumer protection.
“SOIs were first established in 1939 to help address economic adulteration that was occurring in the marketplace,” says the FDA. “For example, there were products that were represented as jams containing fruit, but the products contained little fruit (e.g., the SOI for fruit preserves and jams requires that products represented as jam contain a minimum amount of fruit).”
SOIs often describe in detail what a food must contain and what is optional and sometimes describe the amount or proportion of ingredients or components. Many SOIs also prescribe a method of production or formulation.
The FDA has now established more than 250 SOIs for products including milk, milk chocolate, various breads, peanut butter, and ketchup.
SOIs Protect Consumers and Promote Honesty and Fair Dealing
SOIs were developed to help protect consumers and promote honesty and fair dealing. SOIs have been established to ensure that the characteristics, ingredients, and production processes of specific foods are consistent with what consumers expect.
“SOI is an important tool for defining product quality and can also be used to ensure authenticity. SOI describes what constituents must be present in a certain food, what should not be present, and what may be present,” said the authors of Food Fraud Mitigation: Strategic Approaches and Tools. “SOI often specifies product descriptions and labels that may be used in the marketplace. Food products labeled as standardized food that do not meet the requirement of the SOI may be considered mislabeled and potentially fraudulent.”
In 2016, for example, a woman and two western Pennsylvania cheese firms her family controls pleaded guilty to mislabeling grated parmesan and Romano cheese that contained only other cheeses and filler made from wood pulp.
"Consumers have a right to expect that products they purchase are what they purport to be," FDA spokeswoman Lauren Sucher said in a statement. "In this case, products that were labeled as containing 100 percent Parmesan or 100 percent Romano cheese contained no Parmesan or Romano cheese."
The authors of Food Fraud Mitigation point out that without the FDA SO for Parmesan and Romano cheeses, it may have been more difficult for prosecutors to demonstrate fraud.
FDA’s Work on SOIs is Ongoing
The FDA’s work to update SOIs falls into three categories:
- Establishing principles to communicate more transparently 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.
Recent actions taken by the FDA on SOIs include:
- Canned Tuna: The FDA issued a proposed rule to revise the standard of identity and the standard of filling containers for canned tuna.
- Pasteurized Orange Juice: The FDA issued a request for information in August 2023 on a citizen petition asking the FDA to amend the standard of identity for pasteurized orange juice by lowering the minimum soluble solids content, known as the Brix level.
- Salt Substitutes and Standards of Identity: The FDA issued a proposed rule in April 2023 to amend the standards of identity (SOIs) to permit the use of salt substitutes in foods for which salt is a required or optional ingredient. The proposed rule would provide manufacturers with flexibility and facilitate industry innovation to reduce sodium in standardized foods.
- French Dressing: The FDA issued a final rule in January 2022 revoking the SOI for French dressing because it is outdated. Based on information submitted to the FDA, consumers appear to expect French dressing to have certain characteristics not required by the standard, such as containing tomatoes or tomato-derived ingredients. Products tend to maintain these characteristics in the absence of requirements for them.
- Frozen Cherry Pie: The agency proposed in December 2020 to revoke the SOI and standard of quality for frozen cherry pie. The standards do not appear necessary to ensure that these products meet consumer expectations, and the FDA has tentatively concluded that they are no longer necessary to promote honesty and fair dealing in the interest of consumers and may limit flexibility for innovation.
- Cheeses and Ultrafiltered (UF) Milk: In April 2020, the FDA re-opened the comment period on a proposed rule to permit the use of fluid UF milk and fluid UF nonfat milk in the production of standardized cheeses and related cheese products. Reopening the comment period allows the FDA to solicit any new information, including current industry practices, regarding the use of fluid UF milk and fluid UF nonfat milk in cheesemaking and on labeling of fluid UF milk and fluid UF nonfat milk when used as ingredients.
Current FDA activities on SOIs include:
- General Principles: The FDA is collaborating with the U.S. Department of Agriculture (USDA) to establish a set of general principles to use when considering whether to revise, eliminate, or establish a food standard. This is being informed, in part, by comments received when the FDA reopened the comment period in February 2020 on a joint FDA-USDA rule proposed in 2005 to establish a set of general principles for food standards.
- Yogurt: The FDA reviewed objections submitted by the International Dairy Foods Association and Chobani in July 2021 to certain provisions in the final rule to amend the yogurt standard of identity. The FDA issued the final rule to amend the yogurt SOI in June 2021. On March 22, 2022, the FDA published a notice to clarify that the effective dates of certain provisions of the yogurt standard of identity final rule have been stayed. On December 14, 2022, the FDA responded to several objections and requests for a hearing on provisions in the yogurt standard of identity final rule. The FDA denied the requests for a hearing and modified certain provisions in the final rule. On April 14, 2023, the FDA issued a final order to modify the yogurt standard of identity final rule with respect to maximum pH. The compliance date is January 1, 2024. Additional details can be found in the Federal Register notice.
- Partially Hydrogenated Oils: To facilitate the production of healthier standardized foods, the FDA is amending all SOIs that allow the inclusion of partially hydrogenated oils (PHOs) to no longer list PHOs as optional ingredients. The FDA previously determined that PHOs, which are the primary dietary source of artificial trans fat in processed foods, are no longer generally recognized as safe.
- Substitute Ingredients: The FDA is exploring how it can facilitate the production of healthier standardized foods to allow for substitute ingredients through a horizontal approach. Under such an approach, all SOIs that permit or require a particular ingredient could be modified in one rulemaking to permit a substitute ingredient(s). This approach could be used as a substitute ingredient that could make foods healthier.
- Citizens Petitions: The FDA continues to review citizen petitions regarding SOIs, such as a request to establish an SOI for olive oil and olive pomace oil and a request to amend the SOI for maple syrup.
For Some Foods, There is No Standard of Identity
For some foods, there is no definition or standard of identity.
According to the FD&C act, no standard of identity or definition may be established for:
- Fruits (fresh and dried)
- Vegetables (fresh and dried)
- Avocados
- Cantaloupes
- Citrus fruits
- Melons
“This means there’s no specific definition for what is an apple, and it means there’s no regulation that the word “apple” must appear on an apple that is being sold,” says the FDA. “If you produce a product that falls into this category, then you don’t need to be particularly concerned about misbranding your product due to standards of identity/definitions.”
Non-Standardized Foods Subject to Specific Requirements
There are some foods that don’t have standards of identity per se, but they are subject to some requirements. You can quickly review this small list of foods in 21 CFR Part 102.
“If the food you produce falls into this category, then it’s important to understand these requirements, but otherwise your product is not a standardized food,” says the FDA.
Foods in this category include:
- Protein hydrolysates
- Peanut spreads
- Frozen “heat and serve” dinners
- Foods packaged for use in the preparation of “main dishes” or “dinners”
- Beverages that contain fruit or vegetable juice
- Mixtures of edible fat or oil and olive oil
- Onion rings made from diced onion
- Potato chips made from dried potatoes
- Fish sticks or portions made from minced fish
- Pacific whiting
- Bonito
- Fried clams made from minced clams
- Crabmeat
- Seafood cocktails
- Non-standardized breaded composite shrimp units
- Greenland turbot
Standardized Foods That Have an SOI
These are foods that the FDA has decided to define because there is a public expectation of what that food is.
Anyone who makes a” standardized” food must make sure it satisfies the standards outlined for that food. These requirements range from mandated ingredients to packaging standards, to banned ingredients.
The categories for all standardized foods can be found in CFR Parts 131-170 and include:
- Bakery Products
- Beverages
- Cacao Products
- Canned Fruit Juices
- Canned Fruits
- Canned Vegetables
- Cereal Flours and Related Products
- Cheese and Related Cheese Products
- Eggs and Egg Products
- Fish and Shellfish
- Food Additives
- Food Dressings and Flavorings
- Frozen Desserts
- Frozen Vegetables
- Fruit Butters, Jellies, Preserves, and Related Products
- Fruit Pies
- Macaroni and Noodle Products
- Margarine
- Milk and Cream
- Sweeteners and Table Sirups
- Tree Nut and Peanut Products
- Vegetable Juices
Examples of SOIs
Manufacturers must meet different SOIs for various food products including the following examples:
- Mayonnaise: Must contain a minimum of 65 percent vegetable oil by weight and no more than 2.5 percent egg yolk solids.
- Ketchup: Must contain a minimum of 33 percent tomato solids and not exceed 30 percent total soluble solids.
- Chocolate: Must contain cocoa solids and cocoa butter, with specific requirements for milk chocolate (must contain at least 10 percent milk fat and 3.5 percent milk solids) and dark chocolate.
- Honey: Must be made by bees and consist of at least 80 percent sugar, with no added substances
- Bread: Must contain flour, water, and other optional ingredients, with specific standards for enriched bread and whole wheat bread, with whole wheat bread being made from 100 percent whole wheat flour.
- Peanut Butter: Must contain at least 90 percent roasted peanuts, with specific requirements for the composition of optional ingredients.
- Cheddar Cheese: Must contain a minimum of 51 percent milk fat, be made from cow's milk, and age for a specific period to be labeled as "cheddar."
- Ice Cream: Must contain specific levels of milk fat, nonfat milk solids, sweeteners, and emulsifiers, depending on the type of ice cream (e.g., regular, reduced-fat, low-fat).
- Orange Juice: Must be made from oranges and meet specific standards for flavor and composition, such as minimum levels of natural orange juice content.
- Mustard: Must contain specific proportions of mustard seed, vinegar, and optional ingredients like spices and sweeteners.
- Cream Cheese: Products labeled “cream cheese: must be composed of a minimum of 33 percent milk fat and no more than 55 percent moisture.
- Yogurt: Must be made from milk and may contain live and active cultures of bacteria.
