Allergen Advisory Statements and Your Favorite Chocolates

Allergen Advisory Statements and Your Favorite Chocolates

Over the holidays we received emails from community members concerned about the gluten-free status of various candies, including those made by See’s Candies and Hammond’s Candies.

Focusing on See’s Candies (and long story short), this is what their website currently states about gluten:

Allergen Information

Valid January 1, 2019 – December 31, 2019

GLUTEN INFORMATION

Candies produced in See’s Candies facilities do not contain gluten, and these products are the vast majority of those we sell. We purchase a small amount of specialty candies made by third parties, and these also do not contain gluten with the sole exception of Candy Canes sold in our retail shops and online at Sees.com with wheat indicated on the Ingredient Statement of the Candy Canes.

Consumer concern was caused by a statement that was included on the See’s Candies website for a period of time that stated, “Because some of our sourced ingredients are produced in a facility that also processes wheat, See’s Candies are not gluten-free.”   

While it is understandable why the latter (and now removed) statement caused concern, please keep in mind that a product can be free of gluten-containing ingredients AND some of the ingredients may be sourced from suppliers that also process wheat in their facility. If both statements are true, does this mean that the product in question contains gluten? Maybe but maybe not.

  • In our published database review of 101 products NOT labeled gluten-free but appearing to be free of gluten-containing ingredients and tested through Gluten Free Watchdog:
    • Of the 87 products that did NOT include an advisory statement for wheat, 13 (15%) contained quantifiable gluten at or above 5 ppm, including 4 products that tested at or above 20 ppm of gluten.
    • Of the 14 products that DID include an advisory statement for wheat, only 1 (7%) contained quantifiable gluten at or above 5 ppm

How can the above data be accurate? Keep in mind that allergen advisory statements for wheat in the U.S.:

  1. Refer to manufacturer processing practices, such as the use of a shared facility, shared production line, or shared equipment.
  2. May appear on a label as “made in a facility that processes wheat” or “manufactured on equipment that also processes wheat”
  3. Are voluntary statements and not currently covered by any federal regulation.
  4. Must be truthful and not misleading, according to the FDA.
  5. Do NOT reflect the gluten content of foods appearing to be free of gluten-containing ingredients but not labeled gluten-free.
  6. Could result in a consumer choosing a product with a higher level of gluten if the consumer relies on the presence or absence of such a statement when choosing between products appearing to be free of gluten-containing ingredients but not labeled gluten-free
  7. Are NOT typically included on the labels of single ingredient “naturally gluten-free” grains—products with some of the highest risks for cross contact with wheat (and barley).

Note: As part of FDA’s Food Safety Modernization Act (FSMA), ‘FDA’s longstanding position that CGMPs address allergen cross contact is now explicit in the regulatory text’. Covered establishments must have a food safety plan in place that includes preventive controls for allergens. FSMA does not appear to directly address allergen advisory statements and it is unclear at this time how (if at all) they will be impacted.

Future needs: Allergen advisory statements must be helpful to consumers. Currently, in the opinion of GFWD they are not. The FDA should strongly consider regulating allergen advisory statements, especially in light of FSMA. Such statements must be standardized and related to consumer risk.

Next steps for Gluten Free Watchdog: We will be starting a campaign asking FDA to regulate allergen advisory statements.

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