FSMA: Meaning of Misbranded Foods

Here is what the US Congress defined as “misbranded” food in the context of the Food Safety Modernization Act:

Should misbranded food knowingly introduce misbranded food into interstate commerce cause a danger to the health and lives of people, the responsible US manufacturer or US importer of foreign manufactured foods will be held financially or criminally liable.

In the vast majority of cases, misbranded food has to be pulled off the shelf which also can be costly, especially for small companies.

Increasingly, imported food that does not comply with US labeling laws, will be stopped at the border. As governmental oversight and enforcement becomes stricter and more costly, importers, wholesalers and retailers demand an Affidavit or Letter of Guarantee from foreign manufacturers.

This includes food and beverages that

  1. Is labeled or advertised in a false or misleading way and in a material respect. Examples include foods labeled “natural” that contain GMOs or non-natural substances, or the famous POM Wonderful vs. Coca Cola case.
  2. Offer for sale under a different name
  3. Contains imitations of a natural substance without declaring this (such as imitation vanilla)
  4. Is packaged in a misleading container (for example when the size of the container suggests more products inside that it actually contains)
  5. Comes in containers without proper labels, i.e. does not contain the name and place of the manufacturer, packer or distributor, does not contain an accurate net weight, measure or numerical count; or does not contain the mandatory nutrition panels and ingredient statements; does not prominently display information as mandated by law.
  6. Does not conform the legally prescribed standard of identity
  7. Does not conform to legally prescribed or labeled standards of quality and safety
  8. Does not contain food ingredients such as vegetables and food in leagally prescribed quantities (for example fruit juices)
  9. Falsely represents a specific dietary use (for example weight loss products)
  10. Contains pesticides, artificial coloring or chemical preservatives that are not properly labeled (see also California’s Prop 65 regulations)
  11. Contains non-approved color additives
  12. Does not provide mandatory label information, including
    • mandatory serving sizes in an amount customarily consumed (see also Reference Amount Customarily Consumed RACC)
    • number of servings
    • total number of calories derived from any sources and those derived from fat
    • nutritient information (fats, sodium, carbohydrates, protein, vitamins and minerals
    • presence or potential presence of allergens
    • substantiated and legally conforming health claims or nutrient levels

More facts to know:

FSMA: The Meaning of Adulterated Foods
California Proposition 65
Vermont Non-GMO law
FSMA: Letter of Guarantee