Recipe ingredient changes and ingredient labeling
I was wondering if anyone could offer advice for dealing with recipe formula changes that don't match ingredients listed on the product bag. I work as a QC manager for a smaller company so our company president is also the product developer and in charge of product packaging. He tends to make spur of the moment ingredient alterations while using the same packaging causing our products to have undeclared ingredients (not usually allergens) and claims companies do this all the time and made me feel like I was overreacting for being concerned about this. Can anyone offer me an example or something of their protocol for formula changes? Does this actually happen all the time with ingredient changes or is there some sort of planning that goes into it?
Any advice would be helpful
Thanks!
I'm sure you've seen this guidance, but here it is just the same. It maybe considered adulterated product under the FDA regs
"(b)Absence, substitution, or addition of constituents
www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM265446.pdf
(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products.
Generally speaking, product reformulation goes through alot of steps prior to making the new formula (costing, sensory, shelf life etc.) and that is when the new revised label would be approved.
Dear QC Manager,
No, your not overreacting. It's a dangerous game.
Most of the recalls are about allergens which aren't appearing on the product label. This is just one of the causes that it happens.
Your probably working in a growing company. That means that it's necessary to move fastly away from such practices. All to avoid that your company lands in troubles:
- Unsatisfied customers
- Legal issues
- Nutritional declarations that are incorrect
- Losses, because of more expensive ingredients
- Food safety issues
- Loss of your quality certificate (for example, for IFS this topic is a Knockout criterion!)
I hope, the above gives you a clearer vision of the situation.
Kind regards,
Gerard Heerkens
I'm sure you've seen this guidance, but here it is just the same. It maybe considered adulterated product under the FDA regs
"(b)Absence, substitution, or addition of constituents
(1)If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has been substituted wholly or in part therefor;"
www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM265446.pdf
(a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products.
Generally speaking, product reformulation goes through alot of steps prior to making the new formula (costing, sensory, shelf life etc.) and that is when the new revised label would be approved.
Thanks for your response. I probably should have mentioned we manufacture pet food but I am familiar with the FDA regulations, which is why I brought it up. Since we are a small company and don't have a product development department we don't have an official protocol for reformulation so it happens whenever without planning, I usually find out after the product has been packaged. I was just wondering if this is a common occurrence and how I should go about the situation since I don't have much control over what happens.
I attached a copy of our procedure and form for recipe chenges.
Explain to the people in charge that it is still illegal to mislabel product. What if you started added peanuts and a family with a deadly peanut allergy brought this item into the house AFTER reading the ingredients??? This sounds like an ethical debate with the folks in charge.....because if they knowingly use labels that are not correct they have contravened the law.
from the FDA
There is no requirement that pet food products have premarket approval by the FDA. However, the Federal Food, Drug, and Cosmetic Act (FFDCA) requires that pet foods, like human foods, be pure and wholesome, safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled.Oct 19, 2017
Perhaps you could start a recipe checklist against packaging that needs completed prior to batching? That may help....
Unfortunetly is sounds like you're between a rock and a hard place. All you really can do besides the suggestion above is educate the owners on the law
Perhaps you could elaborate on the written procedure to include the FDA labeling requirement. If you have a senior member obligated to sign off on all procedures, you have proof that they knew what was required and that should help your cause