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Accuracy in labeling a product is one of the most important elements a company must incorporate into its product labeling. Claims and warnings for potential allergens (such as announcing the product was made in a facility that also processes peanuts, or it may contain soy). The Consumer Protection Act of 2004 states that companies must notify consumers of potential food allergens. During FDA registration, companies should be diligent in providing this warning in their labeling to avoid a recall. 

The FDA estimates that nearly 90% of food allergies are caused by dairy products, eggs, fish, shellfish, nuts, and soy. If your products contain these ingredients or ingredients that may be a derivative of them, you must state them clearly on the ingredient list. All products that contain an undeclared allergen may be susceptible to a recall, and products that are mislabeled may be removed from the market by the FDA. 

The FDA has mandated nutrient content claims (NCC), and companies are not allowed to use nutrient claims that are not currently in the database. Common claims to used are:

  • Good sources of (ingredient)
  • High in (ingredient)
  • Free of (ingredient)
  • Low in (ingredient)

Terms such as “healthy” may be used in product artwork, but to use these terms, the food itself must have a smaller limit of nutrients such as fat, saturated, cholesterol, sodium, and less than 10% of certain nutrients. No false claims may be made, or again, companies risk their products being removed from the market. 

If “fresh” is used, the food must be unprocessed, in its raw state, not frozen, or have gone through thermal processing or preservation efforts. Wax coatings, post-harvest approved pesticides, mild chlorine/acid washes on produce, and treatment with ionizing radiation less than 1 kg may be labeled fresh. 

For more information on FDA food requirements, registration requirements, and FDA device registration, please visit our resources online. 

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