New exemptions from Food Allergen Labeling

[LinksEtc]

"Inventory of Notifications Received under 21 U.S.C. 343(w)(7) for Exemptions from Food Allergen Labeling"
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Allergens/ucm076656.htm#

I thought I'd start a thread just to keep an eye on food allergy labeling exemptions that appear to be approved by FDA:


2013

The Unilever notification informed the U.S. Food and Drug Administration (FDA or "we") of Unilever's conclusion that ice structuring protein (ISP) preparation from a bioengineered strain of Saccharomyces cerevisiae that contains a synthetic gene encoding ice structuring protein Type III HPLC12 from the species Macrozoaraces americanus (ocean pout) does not contain allergenic protein derived from fish.

[Ciel]

Seems backwards to me, complete disclosure of ingredients should be the default standard. Allergies or no, people should know what we are putting in or on our bodies. We should know where those ingredients came from and how they were derived.

[LinksEtc]

I guess I can see the point of the exemptions, but I have a few concerns ...

Relying too heavily on data provided by the companies themselves may not be a great idea as the below link illustrates ...
"FDA secretly retests 100 different drugs after testing company admits its work was all fraudulent"
http://www.rawstory.com/rs/2013/04/15/fda-secretly-retests-100-different-drugs-after-testing-company-admits-its-work-was-all-fraudulent/

FDA can't seem to keep up with the responsibilities it already has (FDA - FSMA implementation, budget cuts, etc.) so is it going to have the resources to independently and critically review the exemption requests?  Is there any FA advocacy org that is going to look out for our interests on this?

Thresholds (concerns about the most sensitive consumers seem relevant here also)
Survey on Thresholds from FARE

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This doesn't seem to affect me personally as we deal with sesame which isn't labeled for anyway + my dd seems to have a high threshold.

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"Evaluating Labeling Exemptions for Food Allergens"
By Stefano Luccioli M.D., and Jeremiah Fasano, Ph.D.  2008

http://www.foodsafetymagazine.com/magazine-archive1/octobernovember-2008/evaluating-labeling-exemptions-for-food-allergens/

[LinksEtc]

"Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications"
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm395494.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

This guidance is being distributed for comment purposes only.

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance within 120 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.  Submit electronic comments to http://www.regulations.gov.  Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments should be identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For questions regarding this draft document contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-1056.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition

May 2014

[LinksEtc]

http://www.gpo.gov/fdsys/pkg/FR-2014-05-08/pdf/2014-10578.pdf

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration [Docket No. FDA–2014–D–0052]

Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled ''Draft Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications.'' The draft guidance, when finalized, will explain our current thinking on the preparation of regulatory submissions for obtaining exemptions for ingredients from the labeling requirements for major food allergens in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) through submission of either a petition or a notification.

[LinksEtc]

"FDA Issues Draft Guidance Regarding Food Allergen Labeling Exemption Petitions and Notifications"
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2014/05/fda-issues-draft-guidance-regarding-food-allergen-labeling-exemption-petitions-and-notifications.html

[LinksEtc]

Just FYI ...



Food and Drug Administration [Docket No. FDA–2014–N–1030]

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Allergen Labeling and Reporting

http://www.gpo.gov/fdsys/pkg/FR-2014-12-01/pdf/2014-28185.pdf

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–NEW and title ''Food Allergen Labeling and Reporting''. Also include the FDA docket number found in brackets in the heading of this document.

[LinksEtc]

FDA Issues Guidance on Food Allergen Labeling Exemptions

Constituent Update

June 18, 2015

The U.S. Food and Drug Administration has issued final guidance to help food manufacturers provide adequate data to support exemptions from the labeling requirements for ingredients derived from major food allergens.

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm446273.htm


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Guidance for Industry: Food Allergen Labeling Exemption Petitions and Notifications

http://tinyurl.com/pw8lyx7

[ninjaroll]

It's here in official form if this was not completed prior. I didn't see this exact .pdf in the other links posted. http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM395660.pdf