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Labelling Laws

9 replies [Last post]
By nopeanuts on Sat, 01-12-02, 02:08

Does anyone have a reference or place to obtain actual labelling laws for food, especially related to food allergens? I have heard so many bits and pieces about labelling requirements, but I would like to get the whole picture and be better informed about it. Thanks!

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By nopeanuts on Tue, 01-15-02, 18:22

Just re-raising this question.

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By abers on Wed, 01-16-02, 14:28

A quick search revealed this website - which seems to be run by a division of the FDA. It seems to have some interesting info.


But I'd like to find a one-stop listing of applicable statutes and regulations...I'll keep looking.

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By nopeanuts on Fri, 01-18-02, 19:50

Thanks! I will look into it!

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By Kami's Mom on Fri, 01-18-02, 23:32

As an attorney who specializes in food labeling, I can tell you that the regulations pertaining to food labeling in general can be found in Title 21 of the Code of Federal Regulations (primarily section 101). Reading the regs is extremely tedious, however.

The regs that pertain to labeling of allergens are very weak. As you probably know, the law requires that most all ingredients be listed on the label by common name. However, there are a few exceptions. For example, an ingredient may be listed as a natural flavor without specifying what the flavor is. Also, the regulations do not explicitly deal with the issue when ingredients are present as the result of cross-contamination. (The regs state that ingredients do not need to be listed if they are present in the food at an insignificant level and have no technical or functional effect on the food. Clearly an allergen that may cause an adverse reaction is not insignificant -- but apparently many food companies disagree.)

In response to these loopholes, Fred Shank (who was the director at CFSAN, the division of FDA that regulates food labeling) sent a notice to manufacturers in 1996 urging them to voluntarily provide this ingredient information to consumers. FDA has yet to amend their regulations and any proactive action by food companies remains voluntary.

However, the agency is considering a petition by the state attorneys general filed in May 2000. The petition would greatly improve the current labeling regulations. FDA held a public meeting on this issue last August. Hopefully, they will take action on this soon.

Hope this helps.

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By nopeanuts on Tue, 01-22-02, 19:17

Thanks Kami's Mom! I have heard conflicting information, so it is good to read the basics. So it sounds like the law definitely does not require companies to list the main allergens (pn, tn, egg, milk, wheat, fish) when it is a "natural ingredient". Is this your understanding?

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By Kami's Mom on Wed, 01-23-02, 22:16

Yes, that's correct. It's perfectly legal just to state "natural flavor." However, I am fairly confident that the FDA will close this loophole soon. But I'm not so sure what they will choose to do on the cross-contamination issue. I'll keep you informed.

By the way, feel free to send your opinion on this matter to the FDA. Although the formal comment period on this ended last October, it couldn't hurt to weigh in.

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By nopeanuts on Thu, 01-24-02, 02:22

Kami's mom - Do you know how I contact the FDA?

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By Kami's Mom on Thu, 01-24-02, 22:18

If you want to submit a written comment to the FDA, you can address it to:

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Room 1061
Rockville, MD 20852

You should reference docket no. 00P-1322, which specifically pertains to the allergy labeling issue. As I mentioned before, the comment period formally ended October 29, 2001. However, until FDA takes action and comes our with a proposed rule, it couldn't hurt to weigh in.

If you're interested in speaking with someone at the FDA on this, I would call Ken Falci. The number I have for him is (202) 205-5817. I haven't called him in over a year, so it's possible his number has changed. Ken is the director of the Office of Scientific Analysis and Support at FDA, and one of the lead people on this issue.

Also, if you're interested, I believe the FDA is still posting a transcript from the proceedings they held on this issue last August. Check their website at FDA.gov.

Good luck.

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By Cayley's Mom on Thu, 01-24-02, 22:37

nopeanuts - I was in touch with Dr. Ken Falci last year via e-mail. If you would like his e-address at the FDA, send me an e-mail and I'll pass it along.

P.S. Kami's mom - that's the same phone # I have for Dr. Falci and we communicated in June 2001. It should still be valid.

[This message has been edited by Cayley's Mom (edited January 24, 2002).]

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