The other option for allergen labeling is through the use of a “Contains” statement. This type of statement lists allergens in the product immediately after the ingredients statement. In the example listed above, the manufacturer could list whey protein in the ingredients statement and follow that with “Contains milk.” Note that the “Contains” statement must immediately follow the ingredients statement as a separate line and must use the same font size and style as the ingredients statement. The “C” in “Contains” also must be capitalized. If a manufacturer chooses to use a “Contains” statement, it must list all allergens present in the product, even if they also are identified in the ingredients statement.
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The FDA prefers manufacturers to either identify all allergens in the ingredients statement, using parenthetical identifications as necessary, or to use a “Contains” statement. Some manufacturers use both, and while this is not a violation, it is discouraged.
Finally, many manufacturers choose to use additional allergen warning statements such as, “This product was manufactured in a facility that also manufactures products containing peanuts.” The FDA does not recognize these statements, but does not prohibit them. The agency has indicated such statements cannot take the place of a proper allergen control program. In addition, such statements may be considered disallowed intervening material depending on where they are placed on the label.
Additional Labeling Requirements
Food manufacturers should also be aware that there is a long list of labeling regulations related to permitted health and nutrient content claims. The regulations are very specific in terms of what kind of claims can be made and how they can be made. Food manufacturers wishing to make such label claims should carefully review the applicable regulations before finalizing their label design.
Imported foods must comply with all U.S. labeling requirements. In addition, processed foods not originally manufactured or processed in the U.S. must declare that product’s country of origin on the label. The only exception to this requirement is if the product is “substantially transformed” by further processing in the U.S.
Finally, there are some label elements that are commonly seen on food products that are surprisingly not required by regulation. One example is UPC coding. This may be required by various wholesalers and/or retailers to facilitate inventory control, pricing, and collection of sales data, but they are completely optional as far as the government is concerned.
For more information on labeling:
- Electronic Code of Federal Regulations, Title 21, part 101 – Food Labeling
- FDA Guidance for Industry: A Food Labeling Guide
- FDA Guidance for Industry: Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance
McGlynn is a horticultural food scientist at Oklahoma State University’s Robert M. Kerr Food & Agricultural Products Center, which strives to discover, develop, and deliver information that will stimulate and support the growth of value-added food and agricultural products and processing in Oklahoma. Reach him at email@example.com.