Source: http://www.foodsafetymag-digital.com/foodsafetymag/february_march_2020?pg=11
Timestamp: 2020-04-03 20:18:45
Document Index: 289756240

Matched Legal Cases: ['art 117', 'art 117', '§ 117', '§ 117', '§ 117', '§ 117', '§ 117']

could pose for consumers with food allergies, FALCPA amended the FD&C Act to require label disclosure by specific name of incidental additives containing one of the eight listed foods/food groups.
FDA explained the reasoning behind this change in its 1996 “Notice to Manufacturers”:
FDA reminds manufacturers that to qualify for the exemption from ingredient declaration provided for incidental additives and processing aids, a substance must meet both of the requirements of 101.100(a) ( 3), i.e., it must be present in the food at an insignificant level, and it must not have any technical or functional effect in the finished food.
The recent adverse reaction reports indicate that some manufacturers have… incorrectly interpreted what constitutes an insignificant level of a substance. Clearly, an amount of a substance that may cause an adverse reaction is not insignificant.
The FDA Allergen Guidance makes a
subtle distinction with respect to pack-
aged foods provided by foodservice
locations, such as cafeterias and restau-
rants, and retailers of freshly prepared
• FALCPA applies if the food is placed
in a package for future consumption,
independent of an order from a con-
In 2018, FDA denied a Citizen Petition that urged the agency to issue regulations requiring the specific label disclosure of rye and barley. 4
The Center for Science in the Public Interest submitted a Citizen Petition in 2014 asking FDA to add sesame to the FD&C Act’s list of eight major food allergens. FDA issued a request for comments in October 2018. Over 4,800 comments were submitted. So far, FDA has not taken further action. 5
The FDA misclassified coconut, which is causing confusion for a lot of people because it shouldn’t be classified with tree nuts. Consumers with a tree nut allergy, but not a coconut allergy, are being deprived of this fruit. And, industry is being greatly impacted as contract manufacturers wanting to use coconut have to unnecessarily classify their facility as a tree nut facility when they’re not. 6
FDA’s regulations implementing
FSMA include 21 C.F.R. Part 117,
Section 117.3 defines “Allergen cross-
contact” to mean “the unintentional
incorporation of a food allergen into a
Subpart B of Part 117 establishes
Current GMPs. Each of the following
sections within that subpart imposes
• § 117.20 – Plant and
• § 117.35 – Sanitary
• § 117.40 – Equip-
ment and utensils
• § 117.80 – Processes
• § 117.93 – Ware-
housing and distri-
FDA’s 1996 “Notice
to Manufacturers”
explains that label
statements such as “may contain pea-
nuts” are not an acceptable substitute
for GMPs:
“…FDA imposed
its allergen-related
FSMA regulations to