When labeling for the allergen wheat collides with a gluten-free claim

In honor of Celiac Disease Awareness Month 2018,

A series of bites, barks, tail wags, face licks, and pant tugs from Gluten Free Watchdog

May 8, 2018

Gluten Free Watchdog Pant Tug, Post # 8

The basic facts to keep in mind about FDA labeling:

• Gluten-free claim: Product as packaged must contain less than 20 ppm of gluten.
  • Includes cross contact with gluten.
• FALCPA statement for wheat: If an ingredient in a food is or Contains wheat protein, wheat must be named in the ingredients list or Contains statement
  • Does not include cross contact with wheat.
• Allergen advisory statement for wheat: Voluntary statement pertaining to manufacturing practices that may cause cross contact with wheat.

A gluten-free claim may co-exist on a product label with either a FALCPA statement for wheat or an allergen advisory statement for wheat.

More detailed information:

• Gluten-free claim: If a product is labeled gluten-free it must contain less than 20 parts per million of gluten, including from cross contact with wheat, barley, and rye.
  • The FDA’s gluten-free labeling rule is regulated.
• FALCPA statement for wheat: Under the Food Allergen Labeling and Consumer Protein Act (FALCPA), if an ingredient in food is or contains any of the top 8 allergens (including wheat), then the allergen must be named in either the ingredients list or a Contains statement.
  • Exception: If a Contains statement is included on product packaging, then any of the top 8 allergens included as ingredients in the product must be named in the Contains statement even when they are listed in the ingredients list.
  • FALCPA applies to ingredients only.
  • FALCPA does not apply to allergens that may be in a food product unintentionally due to cross contact.
  • FALCPA is a law.
• Allergen advisory statement for wheat: Allergen advisory statements/precautionary allergen labeling/may contain statements are voluntary statements pertaining to manufacturing practices that may cause cross contact with allergens, including wheat.
  • These statements are not currently defined by any federal regulation.
• Under certain circumstances, foods labeled gluten-free may include a Contains statement for wheat and/or an ingredient that identifies wheat in the ingredients list (e.g., glucose syrup [wheat]).
  • The ingredients wheat starch, wheat starch hydrolysates (e.g., glucose syrup [wheat], caramel color [wheat], maltodextrin [wheat], dextrin [wheat]), and sugar alcohols derived from wheat may be included in foods labeled gluten-free.
  • Wheat is being named in the ingredients list or Contains statement as a result of FALCPA not the gluten-free labeling rule.
  • If a food is labeled gluten-free and also includes the word “wheat” in the ingredients list or Contains statement due to the use of ingredients such as “wheat starch” the word “wheat” must be followed by an asterisk leading to another asterisk and the statement, “The wheat has been processed to allow this food to meet the Food and Drug Administration requirements for gluten-free foods.”

Questions? Please let me know!