Allergen Labeling of Nutrition bars, shakes and powders
I was reading the labels of a brand of energy bars, shakes, smoothies and powders and was shocked to see they contained allergens like peanut, but no allergen statements or warnings. I guess I always just considered them food because they resemble granola bars. Are these Items under 21 CFR 111? when I perform a "control-F" search of 111 for "allergen" or "allergens", the search term is not found. Are these items non-compliant or are they exempt from mandatory allergen statements?
Regards
If you put an allergen in your ingredient statement, you don't have to put a warning on the label. Warnings are for situations where there is no indication on the label that it contains an allergen, but that there is the possibility of an allergen.
You don't have to tell people that bread made from wheat flour contains gluten, they already know that. :)
Martha
Dear xylough,
statement will become voluntary when the allergen has been already mentioned in label.However, It depends on businesses.
so if there isn't an advice statement on the label, one should not assume the product is free from the food or ingredient that is sensitive.
Regards
Satya
If you put an allergen in your ingredient statement, you don't have to put a warning on the label. Warnings are for situations where there is no indication on the label that it contains an allergen, but that there is the possibility of an allergen.
You don't have to tell people that bread made from wheat flour contains gluten, they already know that. :)
Martha
Martha,
Are you going by 21 CFR for food or for nutritional supplements?
regards
Martha,
Are you going by 21 CFR for food or for nutritional supplements?
regards
I'm going by the Food Allergen Labeling and Consumer Protection Act of 2006. that is the statutory mandate to include the specific name of an allergen within the list of ingredients if that ingredient contains the allergen. It mandates that when you say flour, you must have the word "wheat" along with it so people know that there is wheat in it. It specifies the exact name.
The FDA regulations say that all the ingredients must be on the label. So if it's in there, it must say so. Allergen or not allergen, the customer has to know what was put into the box. The FALCPA says that the ingredient name must clearly communicate that an ingredient contains an allergen in a way that the consumer can recoginze. All this is to be part of the list of ingredients (which follows the word "Contains".)
I've attached a guidance document for you. Guidance for Industry.pdf 215.17KB 24 downloads
It has some FAQ that do a good job of explaining it. But I've read the statute as well, and you are welcome to read it. The text is on the FDA website.
http://www.fda.gov/F.../ucm106187.htm
So the original FDA labeling requirements for food always required that all ingredients had to be listed whether they contained an allergen or not. The FALCPA required that the terminology be standardized so that consumers know that a mixture contains an allergen in a recognizable manner. But you don't have to include a statement that a bar that has peanuts in the list of ingredients "may have peanuts." That makes you the fodder for commedians.
Many manufacturers put warning statements if there is a chance that the product has small amounts of an allergen as a contaminant. That's not mandatory, it's done to protect the corporation from lawsuits. The FDA says that if it's in the box, it has to be on the label. If you don't include potential allergens and it is discovered in the box, you are not in compliance. It's very simple, if it's in the box, it has to be on the label.
Martha
Yet in fluid milk we have to put "contains milk" and most peaunt butter states it containes peanuts, so I would not be surprized if my loaf of bread says containes wheat
MWidra
My Summary of the US situation – (Allergenic) Buyer Beware !
(I daresay other locations are equally/much more questionable)
I get the impression that an additional one or two simple "requirements" within the FALCPA labelling rules would have offered a significant benefit from the consumer POV but at a potentially (and possibly legally) major cost to “Industry”.
These selected publications analysing some of the caveats, loopholes, evasions, etc speak far more eloquently than I can. (The last one is OT, directed to GMO labelling issues).
http://www.whenpeanu...de-food-labels/
http://blog.fooducat...s-and-dilemmas/
Thank you to all for your contributions to my question. The mind can be so fallible; I got it in my head that the alternative, optional "Contains" statement was not an optional alternative to allergen declaration within the ingredient list. . I was so wrong. Both are equally compliant. It seems like for a lengthy ingredient list with many allergens, the ingredient list allergen declaration option requires so much more package area with all the parentheses and spaces.
Interesting and unknown to me prior to this fresh reading of FALCPA and its guidance document; incidental process aids that may migrate to the food lose their exemption if they contain an allergen and must be listed. Recently there was a post regarding the SQF requirement to perform risk assessment for food-grade lubricants; it's nice to see some alignment.
Has anyone ever run into an allergen-containing process aid, in particular an allergen-containing food-grade lubricant?
Kind Regards