FALCPA and \"advisory labelling\"

Posted on: Wed, 01/04/2006 - 10:10pm
MommaBear's picture
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Joined: 09/23/2002 - 09:00

Does "FALCPA" require the use of "advisory labelling"?

As in "Processed on", "May Contain", "Manufactured In", etc......

Posted on: Wed, 01/04/2006 - 10:20pm
MommaBear's picture
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whoops.... just found this:
[url="http://www.cfsan.fda.gov/~dms/alrguid2.html"]http://www.cfsan.fda.gov/~dms/alrguid2.html[/url]
to quote:
[b]"16. Does FALCPA require food manufacturers to label their products with advisory statements, such as "may contain [allergen]" or "processed in a facility that also processes [allergen]?"[/b]
[i]"No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in food products resulting from the food manufacturing process. FALCPA does require FDA to submit a report to Congress, a part of which assesses the use of, and consumer preferences about, advisory labeling. In earlier guidance, FDA advised that advisory labeling such as "may contain [allergen]" should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as "may contain [allergen]" must be truthful and not misleading."[/i]
edit to add:
[b]"18. [Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA's labeling requirements?" [/b]
[i]"No. FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, "cross-contact" occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment."[/i]
Is this accurate? Is this current? Just wondering.
General Disclaimer: I am not offering advice in any manner or form. I do not guarantee the accuracy, currentness, or content of the link in this post.
[This message has been edited by MommaBear (edited January 05, 2006).]

Posted on: Wed, 01/04/2006 - 11:42pm
Greenlady's picture
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Joined: 06/30/2004 - 09:00

This matches my understanding of FALCPA - I read it pretty closely when I submitted comments on the draft threshold level paper FDA published last summer.
FYI - the threshold levels are important, too. Even if a manufacturer uses an allergen as an ingredient, they can petition FDA to allow them to not label if the levels of the allergen are low enoungh to not cause a risk to human health. Of course, the key will be whether the levels FDA picks are really "low enough."
I think in balance FALCPA will be very good for the allergic community, but it doesn't cure everything, and one worry I have is that people will start getting used to the bold allergen warnings and not read the ingredients carefully.

Posted on: Thu, 01/05/2006 - 12:20am
TNAmom's picture
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Joined: 11/29/2005 - 09:00

This is my main unhappiness with the new law. I want to see the "may contain" warnings if there is any possibility of cross-contamination. Though I suppose a lot of companies do it just to cover their booties.
Every little bit of info helps though. It's too often still a guessing game out there.

Posted on: Thu, 01/05/2006 - 12:39am
ElleMo's picture
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Joined: 06/19/2003 - 09:00

Yes, if you scroll to the bottom of the page, you will see:
* This is a revision of the first edition of the FDA guidance "Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 ," which FDA issued on [b]October 5, 2005.[/b]
Quote:Originally posted by MommaBear:
Is this accurate? Is this current? Just wondering.
General Disclaimer: I am not offering advice in any manner or form. I do not guarantee the accuracy, currentness, or content of the link in this post.
[This message has been edited by MommaBear (edited January 05, 2006).][/B]

Posted on: Thu, 01/05/2006 - 12:45am
Naturemom's picture
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Joined: 09/30/2004 - 09:00

There is a provision under FALCPA to re-visit this issue in a certain amount of time (I believe it was 10 months following the Jan. 1 date). This is an issue that is left to interpretation by the manufacturers. Although the issue of cross-contamination is left vague, it seems that most of the major manufacturers are considering it and labeling accordingly, with may contains and made-ins. When called recently, the major brands state that if there is any chance that the allergen would end up in the product, ie same production line, facility, etc, it would be labeled on the product.

Posted on: Thu, 01/05/2006 - 12:55am
Carefulmom's picture
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Joined: 01/03/2002 - 09:00

However, note that the manufacturer`s definition of "any chance the allergen would end up in the product" is not necessarily the same definition as ours. For example, if they use shared lines and clean them, many manufacturers believe there is no chance of the allergen being in the product. Yet many pa people, including my dd, have had reactions due to the shared lines plus cleaning which did not remove all allergen. When a manufacturer answers the question of shared lines with the response that there is no risk of the allergen being present, that is a non-answer. The lines may still be shared, which is enough for many pa people to have a reaction, despite cleaning. The reason for this is that if a fraction of a peanut gets lodged in the equipment, they can clean all they want, but the peanut fragment may still be sitting there. Then it gets released many batches later, causing a reaction. Shared lines is shared lines.

Posted on: Thu, 01/05/2006 - 2:01am
Naturemom's picture
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Joined: 09/30/2004 - 09:00

Yes, that is where the change seems to be occurring. The major manufacturers are taking that step to include warnings of the allergens from the shared lines. Many realize that this will be the next step coming and are including it in the Jan. 1 changes. Yes, they may be doing it to cover their butts, but at least they are beginning to realize what we have known all along. One problem for those with MFA's is that we will be left will very few choices for products, and then need to discern level of risk.

Posted on: Thu, 01/05/2006 - 2:26am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

Quote:Originally posted by ElleMo:
[b]Yes, if you scroll to the bottom of the page, you will see:
[/b]
yes I did. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] Thank you. I just don't know how many changes ride in on the "tails" of finalizing things. (I mean, sometimes, it seems to be the rule rather than the exception.) (I watch CNN congressional debates a lot. [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img] )

Posted on: Thu, 01/05/2006 - 2:29am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

Quote:Originally posted by Greenlady:
[b]
FYI - the threshold levels are important, too. Even if a manufacturer uses an allergen as an ingredient, they can petition FDA to allow them to not label if the levels of the allergen are low enoungh to not cause a risk to human health. Of course, the key will be whether the levels FDA picks are really "low enough."[/b]
Yes. I am concerned as well.
Quote:[b]I think in balance FALCPA will be very good for the allergic community, but it doesn't cure everything, and one worry I have is that people will start getting used to the bold allergen warnings and not read the ingredients carefully.[/b]
completely understand. I had some similiar thoughts. I mean, I wasn't expecting things would be perfect, but was optimisitc. (Although I find myself reading more than usual at the grocery story now. Again. I mean, I routinely check and recheck labels, but find myself scrutinizing more now than ever. Just to see what changes have or are taking place. Interpretation of guidelines, I mean.

Posted on: Thu, 01/26/2006 - 12:00am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

reraising.

Posted on: Fri, 03/03/2006 - 7:25am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

reraising.

Posted on: Mon, 03/13/2006 - 9:36am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

reraising.

Posted on: Mon, 07/24/2006 - 9:16am
Corvallis Mom's picture
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Joined: 05/22/2001 - 09:00

raising

Posted on: Wed, 01/04/2006 - 10:20pm
MommaBear's picture
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Joined: 09/23/2002 - 09:00

whoops.... just found this:
[url="http://www.cfsan.fda.gov/~dms/alrguid2.html"]http://www.cfsan.fda.gov/~dms/alrguid2.html[/url]
to quote:
[b]"16. Does FALCPA require food manufacturers to label their products with advisory statements, such as "may contain [allergen]" or "processed in a facility that also processes [allergen]?"[/b]
[i]"No. FALCPA does not address the use of advisory labeling, including statements describing the potential presence of unintentional ingredients in food products resulting from the food manufacturing process. FALCPA does require FDA to submit a report to Congress, a part of which assesses the use of, and consumer preferences about, advisory labeling. In earlier guidance, FDA advised that advisory labeling such as "may contain [allergen]" should not be used as a substitute for adherence to current Good Manufacturing Practices (cGMPs). In addition, any advisory statement such as "may contain [allergen]" must be truthful and not misleading."[/i]
edit to add:
[b]"18. [Added December, 2005] Is a major food allergen that has been unintentionally added to a food as the result of cross-contact subject to FALCPA's labeling requirements?" [/b]
[i]"No. FALCPA's labeling requirements do not apply to major food allergens that are unintentionally added to a food as the result of cross-contact. In the context of food allergens, "cross-contact" occurs when a residue or other trace amount of an allergenic food is unintentionally incorporated into another food that is not intended to contain that allergenic food. Cross-contact may result from customary methods of growing and harvesting crops, as well as from the use of shared storage, transportation, or production equipment."[/i]
Is this accurate? Is this current? Just wondering.
General Disclaimer: I am not offering advice in any manner or form. I do not guarantee the accuracy, currentness, or content of the link in this post.
[This message has been edited by MommaBear (edited January 05, 2006).]

Posted on: Wed, 01/04/2006 - 11:42pm
Greenlady's picture
Offline
Joined: 06/30/2004 - 09:00

This matches my understanding of FALCPA - I read it pretty closely when I submitted comments on the draft threshold level paper FDA published last summer.
FYI - the threshold levels are important, too. Even if a manufacturer uses an allergen as an ingredient, they can petition FDA to allow them to not label if the levels of the allergen are low enoungh to not cause a risk to human health. Of course, the key will be whether the levels FDA picks are really "low enough."
I think in balance FALCPA will be very good for the allergic community, but it doesn't cure everything, and one worry I have is that people will start getting used to the bold allergen warnings and not read the ingredients carefully.

Posted on: Thu, 01/05/2006 - 12:20am
TNAmom's picture
Offline
Joined: 11/29/2005 - 09:00

This is my main unhappiness with the new law. I want to see the "may contain" warnings if there is any possibility of cross-contamination. Though I suppose a lot of companies do it just to cover their booties.
Every little bit of info helps though. It's too often still a guessing game out there.

Posted on: Thu, 01/05/2006 - 12:39am
ElleMo's picture
Offline
Joined: 06/19/2003 - 09:00

Yes, if you scroll to the bottom of the page, you will see:
* This is a revision of the first edition of the FDA guidance "Questions and Answers Regarding Food Allergens, including the Food Allergen Labeling and Consumer Protection Act of 2004 ," which FDA issued on [b]October 5, 2005.[/b]
Quote:Originally posted by MommaBear:
Is this accurate? Is this current? Just wondering.
General Disclaimer: I am not offering advice in any manner or form. I do not guarantee the accuracy, currentness, or content of the link in this post.
[This message has been edited by MommaBear (edited January 05, 2006).][/B]

Posted on: Thu, 01/05/2006 - 12:45am
Naturemom's picture
Offline
Joined: 09/30/2004 - 09:00

There is a provision under FALCPA to re-visit this issue in a certain amount of time (I believe it was 10 months following the Jan. 1 date). This is an issue that is left to interpretation by the manufacturers. Although the issue of cross-contamination is left vague, it seems that most of the major manufacturers are considering it and labeling accordingly, with may contains and made-ins. When called recently, the major brands state that if there is any chance that the allergen would end up in the product, ie same production line, facility, etc, it would be labeled on the product.

Posted on: Thu, 01/05/2006 - 12:55am
Carefulmom's picture
Offline
Joined: 01/03/2002 - 09:00

However, note that the manufacturer`s definition of "any chance the allergen would end up in the product" is not necessarily the same definition as ours. For example, if they use shared lines and clean them, many manufacturers believe there is no chance of the allergen being in the product. Yet many pa people, including my dd, have had reactions due to the shared lines plus cleaning which did not remove all allergen. When a manufacturer answers the question of shared lines with the response that there is no risk of the allergen being present, that is a non-answer. The lines may still be shared, which is enough for many pa people to have a reaction, despite cleaning. The reason for this is that if a fraction of a peanut gets lodged in the equipment, they can clean all they want, but the peanut fragment may still be sitting there. Then it gets released many batches later, causing a reaction. Shared lines is shared lines.

Posted on: Thu, 01/05/2006 - 2:01am
Naturemom's picture
Offline
Joined: 09/30/2004 - 09:00

Yes, that is where the change seems to be occurring. The major manufacturers are taking that step to include warnings of the allergens from the shared lines. Many realize that this will be the next step coming and are including it in the Jan. 1 changes. Yes, they may be doing it to cover their butts, but at least they are beginning to realize what we have known all along. One problem for those with MFA's is that we will be left will very few choices for products, and then need to discern level of risk.

Posted on: Thu, 01/05/2006 - 2:26am
MommaBear's picture
Offline
Joined: 09/23/2002 - 09:00

Quote:Originally posted by ElleMo:
[b]Yes, if you scroll to the bottom of the page, you will see:
[/b]
yes I did. [img]http://uumor.pair.com/nutalle2/peanutallergy/smile.gif[/img] Thank you. I just don't know how many changes ride in on the "tails" of finalizing things. (I mean, sometimes, it seems to be the rule rather than the exception.) (I watch CNN congressional debates a lot. [img]http://uumor.pair.com/nutalle2/peanutallergy/wink.gif[/img] )

Posted on: Thu, 01/05/2006 - 2:29am
MommaBear's picture
Offline
Joined: 09/23/2002 - 09:00

Quote:Originally posted by Greenlady:
[b]
FYI - the threshold levels are important, too. Even if a manufacturer uses an allergen as an ingredient, they can petition FDA to allow them to not label if the levels of the allergen are low enoungh to not cause a risk to human health. Of course, the key will be whether the levels FDA picks are really "low enough."[/b]
Yes. I am concerned as well.
Quote:[b]I think in balance FALCPA will be very good for the allergic community, but it doesn't cure everything, and one worry I have is that people will start getting used to the bold allergen warnings and not read the ingredients carefully.[/b]
completely understand. I had some similiar thoughts. I mean, I wasn't expecting things would be perfect, but was optimisitc. (Although I find myself reading more than usual at the grocery story now. Again. I mean, I routinely check and recheck labels, but find myself scrutinizing more now than ever. Just to see what changes have or are taking place. Interpretation of guidelines, I mean.

Posted on: Thu, 01/26/2006 - 12:00am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

reraising.

Posted on: Fri, 03/03/2006 - 7:25am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

reraising.

Posted on: Mon, 03/13/2006 - 9:36am
MommaBear's picture
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Joined: 09/23/2002 - 09:00

reraising.

Posted on: Mon, 07/24/2006 - 9:16am
Corvallis Mom's picture
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Joined: 05/22/2001 - 09:00

raising

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