According to the FDA if a product is labeled Gluten Free it can potentially contain
20ppm or less per serving of gluten. So you know that entire bag of potato chips
you just ate which states it has 3 servings in it? Ya that one, right? You just
potentially ate 60ppm of gluten just then. This 20ppm is per serving, not per
bag. Makes you think differently about eating a bag of chips or anything else
with more than one serving. Imagine that tiny bag of pretzels that says there
are 3 small pretzels to a serving and you just ate the whole bag with 30 small
pretzels... 100ppm of gluten... AHHHHHHHHHHHHHHHHHHH!
I found this useful information below on some site (I don't remember. I think I
did a Google search to find it). Click
here to see the original document, otherwise you can read below.
FDA RELEASES FINAL RULE ON “GLUTEN-FREE” LABELING OF FOODS
On August 2, 2013, FDA released a long-awaited final rule
explaining when a company may
voluntarily label a food “gluten-free.”1
FDA promulgated the final rule pursuant to the Food Allergen Labeling and
Consumer Protection Act of 2004’s (FALCPA’s) directive that FDA define and
permit the use of the term “gluten-free” on food labels. The agency issued a
proposed rule in January 2007 and subsequently reopened the comment period in
August 2011. The final rule contains many of the same provisions as the proposed
rule, but with a few notable distinctions, detailed below.
The final rule is intended to benefit the approximately 3
million Americans with celiac disease, an autoimmune disorder of the small
intestine for which the only treatment is adherence to a gluten-free diet. It
establishes a national, uniform standard for the use of “gluten-free” claims in
food labeling. If manufacturers choose to make “gluten-free” labeling claims,
they must comply with the requirements of the final rule beginning
August 5,
2014, although FDA anticipates that manufacturers may choose to follow the
requirements as soon as possible.
REQUIREMENTS FOR “GLUTEN-FREECLAIMS
The final rule defines the term “gluten” to mean “the
proteins that naturally occur in a gluten-containing grain and that may cause
adverse health effects in persons with celiac disease (e.g., prolamins and
glutelins).”
The term
“gluten-containing grain” is defined as wheat (meaning any species belonging to
the genus
Triticum), rye (meaning any species belonging to the genus
Secale), barley (meaning any species belonging to the genus
Hordeum),
and any crossbred hybrid of these grains.
Under the final rule, a “gluten-free” food labeling claim
can be made only
if both of the following requirements are met:
1. The food is either (a) inherently free of gluten; or (b) does not contain
any of the following ingredients:
- An ingredient that is a gluten-containing grain. (Examples include
wheat, barley, rye, spelt wheat, and triticale.)
- An ingredient that is derived from a gluten-containing grain and
has not been processed to remove gluten. (Examples include wheat flour,
semolina, and farina.)
- An ingredient that is derived from a gluten-containing grain and
has been processed to remove gluten, if the use of that ingredient results in 20
parts per million (ppm) or more gluten in the food. (Examples include wheat
starch and modified food starch.)
2. Any unavoidable presence of gluten in the food is below 20 ppm.
KEY ASPECTS OF THE FINAL RULE
There are three synonyms for “gluten-free”: FDA considers the
labeling claims “
no gluten,” “free of gluten,” and “without gluten” to be
equivalent to a “gluten-free” claim. A food that bears any of these claims must
also meet the final rule’s requirements.
The rule retains the proposed less than 20 ppm gluten standard: The proposed
rule set forth a less than 20 ppm gluten standard for “gluten-free” labeling claims
because, as FDA explained, available gluten detection methods could only
reliably and consistently detect gluten at 20 ppm or above. FDA subsequently
conducted a gluten safety assessment and concluded that the estimated level of
concern for individuals with celiac disease ranges from 0.01 to 0.06 ppm gluten,
but that these numbers represent “a conservative, highly uncertain estimation of
risk.” Currently
available analytical methods, the ease of enforcement, and the fact that
“lowering the gluten level below 20 ppm [would] make it far more difficult for
manufacturers to make food products that could be labeled as ‘gluten-free’”
influenced FDA’s decision to adopt a less than 20 ppm gluten standard in the final rule.
Oats are not considered to be a “gluten-containing grain”: As in
the proposed rule, the final rule does not include oats in the definition of a
“gluten-containing grain.” Thus, oats can be used as an ingredient in a food
labeled as “gluten-free,” so long as the oats contain less than 20 ppm gluten. In the
preamble, FDA explains that the commingling of oats with gluten-containing
grains is preventable and that “for most individuals with celiac disease, oats
can add whole grain options, nutrient enrichment, and dietary variety.”
Even so, to help individuals with celiac disease who cannot tolerate
oats, FDA encourages “manufacturers of foods labeled ‘gluten-free’ that use an
oat-derived ingredient where the word ‘oat’ does not appear in the ingredient
list . . . to indicate in their labeling that an oat-derived ingredient is
present.”
Claims are not allowed for food that has less than 20 ppm gluten but contains
a “gluten-containing grain”: Consistent with the proposed rule, the final
rule does not allow a “gluten-free” claim on food made with small amounts of a
gluten-containing grain or ingredients derived from such grains that were not
processed to remove gluten, even if the food product itself contains less than
20 ppm gluten. This requirement “helps ensure that the finished product has the
lowest amount of gluten that is reasonably possible.”
There are no format requirements: The final rule does not impose
requirements related to format, the use of symbols, or the use of third-party
certification logos for “gluten-free” claims. Manufacturers may choose where to
place a “gluten-free” claim on a food label, provided that all applicable legal
requirements are met. Manufacturers also may use a third-party certification
logo to indicate that a product is free of gluten, provided that its use is
truthful and not misleading.
The rule applies only to FDA-regulated foods: The final rule
applies to all FDA-regulated foods, including dietary supplements and imported
foods. It does not apply to drugs or cosmetics, or to foods regulated by the
U.S. Department of Agriculture (USDA) (meat, poultry, and egg products) or by
the Alcohol and Tobacco Tax and Trade Bureau (TTB) (alcoholic beverages).
SIGNIFICANT CHANGES FROM THE PROPOSED RULE
Additional language is required on foods containing wheat: In the
preamble, FDA agreed with several comments that noted that consumers would
receive a confusing message if foods bear a “gluten-free” claim and also contain
wheat as an ingredient. The final rule addresses this concern by requiring foods
that bear a “gluten-free” claim and also include wheat as an ingredient to add
after the term “wheat” an asterisk linked to this nearby statement: “The wheat
has been processed to allow this food to meet the Food and Drug Administration
(FDA) requirements for gluten-free foods.”
No qualifying language is required for claims on inherently
gluten-free foods: The proposed rule provided that foods that do not
inherently contain gluten that bear a “gluten-free” claim must state that all
foods of the same type are inherently gluten-free (e.g., “all milk is
gluten-free”). Many comments noted that the proposed qualifying language would
cause consumer confusion, as not all versions of a product may be gluten-free.
FDA agreed and concluded that a “gluten-free” claim on a food that is inherently
gluten-free, without qualifying language, is not misleading.
Analytical testing is not necessarily required: In the preamble,
FDA clarifies that the final rule does not
require manufacturers to
conduct analytical testing to determine that their products bearing
“gluten-free” claims contain less than 20 ppm. Manufacturers may develop their own
methods that best suit their particular needs to determine the gluten content of
their products. For instance, manufacturers may use quality control tools, such
as requesting certificates of gluten analysis from ingredient suppliers.
The rule preempts state law: A state may not establish a
requirement that is different from the rule’s requirements for the use of a
“gluten-free” claim. The rule is not intended to preempt other state
requirements with respect to statements about gluten, such as information about
how the food was processed.
FUTURE ACTION
The agency may reevaluate the 20 ppm standard as new
information becomes available. FDA plans to issue a proposed rule to address how
it will assess compliance with this final rule with respect to fermented or
hydrolyzed foods or ingredients, for which there are no scientifically valid
methods for detecting intact gluten proteins. Also, FDA intends to work with
USDA and TTB on the issue of gluten-free food labeling to harmonize requirements
for food products regulated by these agencies, where possible.
LEGAL RISK MANAGEMENT ISSUES
Failure of a product labeled “gluten-free” to comply with
the new gluten-free standard would cause the product to be deemed misbranded.
FDA intends to enforce the gluten-free standard through firm inspections,
examination of imports, label reviews, and analytical testing of food samples.
This labeling standard likely will be cited as the standard by which
“gluten-free” claims by restaurants should be evaluated. In addition, this rule
could have regulatory compliance and product liability implications for
promotional claims made not only in labeling, but for advertising and promotions
more generally under both the Federal Trade Commission Act and state consumer
protection statutes.
Happy eating, learning and living! Gluten Free... (after this... my
goodness! More like be careful eating, learning and living Gluten Free)
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