10 replies to this topic

[bkrjones]

Hi, all!

LTL here (Long time lurker)

We are a copacker for another company. Their packaging has an ingredients list and a contains statement. There is an allergen listed in the ingredients that isn't listed in the contains statement. Product in this packaging has been sent to distribution centers. 

Based on my research, it looks like a recall needs to be initiated. Would you all agree?

If so, who is responsible for initiating the recall? 

Any insight is appreciated. 

We are in the US. 

[Tony-C]

Hi bkrjones,

 

You should check with the company you are packing for before doing anything.

 

From Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5): Guidance for Industry

 

Figure 2. Example of snack bags declaring the major food allergen “wheat” in the ingredient list or in the “Contains” statement. In this situation, wheat flour is used as an anticaking agent in the “spices” ingredient, and it is an incidental additive in the finished chips products. In the image to the left, wheat is declared in the ingredients. In the image to the right, because wheat is not declared in the ingredient list, it must be declared in a “Contains” statement (section 403(w)(4) of the FD&C Act).

 

 Labeling Requirements of the Federal Food, Drug, and Cosmetic Act P8.png   833.23KB   0 downloads

 

Kind regards,

 

Tony

 

2025

[Setanta]

I agree with TonyC. Contact the company, let them know what you found and ask for their feedback/advice.  Are you an FDA facility or a USDA facility? If you have USDA, your inspector might be of help--after you reach to the company you co-pack for.

[bkrjones]

We are an FDA facility. 

The product contains almond flour and almond meal, which are listed in the ingredients. The contains statement does not mention tree nuts or almonds. It's extra annoying because this is an updated version of the packaging, and the original version did state Contains: ..., tree nuts (almonds). Gah!

We have contacted the company.

[bkrjones]

I see that Gerber did a recall in 2017 for the problem I am describing:

 

https://www.fda.gov/...pasta-pick-upsr

 

As well as Hostess in 2018:

 

https://www.fda.gov/...-creme-brownies

[kconf]

You never mentioned what the product is! Could it be obvious that it contains almond flour? What does the label/name say? 

[jfrey123]

Time to update your SOP's to include label review of the labels provided by your client.

 

Still, kudos for catching it, and you should start a full product trace now while contacting the client.  The primary responsibility for manufacture and marketing of the product lies with the client, as does the choice to initiate a voluntary recall (unless in your copacker agreement the companies have agreed you have the authority to initiate on your own).  If this hasn't left any of the distributors with no risk to the consumer population, it might qualify as merely a market withdrawal.

[GMO]

Slight off topic... but good luck for hopefully minimising risk to consumers and the business.

 

And this is why the EU updated their legislation with the food information regulation (FIR) to make the only place allergens were listed as IN the ingredients list but picked out in a different way (often in bold).

 

So, say something I've just copied off a retailer website, the change in legislation changed something like this:

 

Wheat Flour, Raspberries (18%), Sugar, Vegetable Margarine (Palm Fat, Rapeseed Oil, Water, Emulsifier (Mono- and Diglycerides of Fatty Acids), Acidity Regulator (Citric Acid)), Egg, Rapeseed Oil, Marzipan (Almonds, Sugar, Water, Invert Sugar), Wheat Starch, Almonds, Modified Potato Starch, Dextrose, Flavouring, Glucose-Fructose Syrup, Invert Sugar Syrup, Whey Powder (Milk), Raising Agents (Sodium Carbonates, Calcium Phosphates, Diphosphates), Fructose, Emulsifier (Mono- and Diglycerides of Fatty Acids), Salt, Apricot Kernels, Lactose (Milk), Acidity Regulators (Citric Acid, Sodium Citrates, Calcium Phosphates, Diphosphates), Thickeners (Xanthan Gum, Sodium Alginate, Calcium Alginate), Gelling Agent (Pectins), Ethanol, Potato Starch

 

Contains:  Wheat, Almonds, Egg, Milk

 

 

To this:

 

Wheat Flour, Raspberries (18%), Sugar, Vegetable Margarine (Palm Fat, Rapeseed Oil, Water, Emulsifier (Mono- and Diglycerides of Fatty Acids), Acidity Regulator (Citric Acid)), Egg, Rapeseed Oil, Marzipan (Almonds, Sugar, Water, Invert Sugar), Wheat Starch, Almonds, Modified Potato Starch, Dextrose, Flavouring, Glucose-Fructose Syrup, Invert Sugar Syrup, Whey Powder (Milk), Raising Agents (Sodium Carbonates, Calcium Phosphates, Diphosphates), Fructose, Emulsifier (Mono- and Diglycerides of Fatty Acids), Salt, Apricot Kernels, Lactose (Milk), Acidity Regulators (Citric Acid, Sodium Citrates, Calcium Phosphates, Diphosphates), Thickeners (Xanthan Gum, Sodium Alginate, Calcium Alginate), Gelling Agent (Pectins), Ethanol, Potato Starch

[kconf]

Genuine question - If it's a bag of wheat flour, does it have to say "contains wheat" or Allergens - Wheat? 

[jfrey123]

Genuine question - If it's a bag of wheat flour, does it have to say "contains wheat" or Allergens - Wheat? 

 

Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act (Edition 5)

 

P18, question D2.  They even use Flour with a "Contains Wheat" image as the example figure.  A single ingredient product isn't required to have an Ingredient Panel on the back if it is clearly identified in the name of product (say a bag with "Raw Peanuts" on the front panel).  But it still has to say "Contains: Peanuts" on the back, or if you do list the Ingredient Panel with just the single ingredient, apparently the "Contains" section is strongly recommended.  FDA, clear as mud as always.

 

D.2 Are single-ingredient foods required to comply with the food allergen labeling requirements of the FD&C Act?

 

Yes. Single-ingredient foods must comply with the food allergen labeling requirements in section 403(w)(1) of the FD&C Act. A single-ingredient food that is, or contains, protein derived from milk, egg, fish, Crustacean shellfish, tree nuts, wheat, peanuts, sesame, or soybeans may identify the food source from which the major food allergen is derived in the statement of identity (or name of food), e.g., “All-purpose wheat flour,” or use the “Contains” statement format. Because a single-ingredient food does not require an ingredient list, FDA recommends that if a “Contains” statement format is used for a retail package, the statement be placed immediately above the manufacturer, packer, or distributor statement. For singleingredient foods intended for further manufacturing where the “Contains” statement format is used, we recommend that the “Contains” statement be placed on the front of the package of the food near the statement of identity. See Figure 5.

[bkrjones]

Thank you for the good discussion everyone!

This product is frozen chocolate chip cookie dough. The almond flour and meal are definitely atypical ingredients. 

Product trace complete; client contacted.