10 Fast Facts about the FDA
Gluten-Free Food Labeling Rule
Covered:
All FDA-regulated foods
Dietary Supplements (vitamins, minerals, herbs, amino
acids)
Food products imported from other countries that are
subject to FDA regulations
Not Covered:
Meat, poultry and unshelled eggs (products regulated by
the USDA)
Distilled spirits, wines that contain 7 percent or more
alcohol by volume*
Malted beverages made with malted barley and hops*
* These alcoholic beverages are regulated by the Alcohol
and Tobacco Tax and Trade Bureau (TTB.) The FDA says it will work with the TTB
to "harmonize" gluten-free labeling requirements between the two
agencies.
A food product regulated by the FDA may be labeled
gluten-free if:
1. It does NOT contain wheat, rye, barley or their
crossbred hybrids like triticale (a gluten-containing grain) OR
2. It contains a gluten-containing grain or an ingredient
derived from a gluten-containing grain that has been processed to less than 20
parts per million (ppm) of gluten.
3. May food products that are naturally gluten-free be
labeled "gluten-free"?
Yes. Food products that are naturally gluten-free, like
bottled spring water, or tomatoes may be labeled "gluten-free."
Oats that contain less than 20 ppm of gluten may be
labeled "gluten-free." Oats do NOT need to be certified gluten-free.
5. Will there be a symbol to identify foods that meet the
FDA definition of gluten-free?
No. The FDA has determined that consumers favor the label
"gluten-free" to communicate that a food is free of gluten.
Manufacturers are allowed to include a symbol as long as it is truthful and not
misleading.
6. Are manufacturers required to test for gluten to label
a product "gluten-free"?
No. For food products labeled "gluten-free"
manufacturers are not required to test for the presence of gluten in the
ingredients used or the finished food product. However, they are responsible
for ensuring that the food product meets all labeling requirements.
Manufacturers will need to determine how they will assure this.
The FDA may perform food label reviews, follow-up on
consumer and industry complaints, and analyze food samples. Consumers and
manufacturers may report a complaint to an FDA Consumer Complaint Coordinator
in the state where the food was purchased. Click Here for a list of FDA
Consumer Complaint Coordinators.
8. Why did the FDA adopt < 20 ppm of gluten as the
standard instead of zero ppm? Why does CDF support this?
The FDA adopted the standard based upon the
recommendations of the scientific and medical communities, and because there
are no analytical methods available that are scientifically validated to
reliably detect gluten below 20 ppm. The CDF Medical Advisory Board supports
the < 20 ppm of gluten standard for gluten-free labeling. According to Dr.
Peter Green, director of the Celiac Disease Center at Columbia University,
"The 20 ppm is a scientifically determined level of gluten that has been
shown to be tolerated by those with celiac disease. It is in line with
standards in other countries."
Dr. Alessio Fasano, of the Center for Celiac Research
states, "Twenty parts per million, or 20 parts of gluten per one million
parts of food sample, is an accepted standard in many parts of the world for
products that are labeled gluten-free. The evidence-based research published by
our Center, which has been confirmed by studies from colleagues around the
world, conclusively supports the 20 ppm level as a suitable safety threshold
for gluten-free products." According to the Center's website,
"research from the Center has shown that 10 milligrams per day of gluten
consumption is a safe level for the vast majority of individuals with celiac
disease." The Center's website goes on to state that 10 milligrams is
roughly the equivalent of one-eighth of a teaspoon of flour, or 18 slices of
bread with each slice containing 20 ppm of gluten.
9. Does the FDA rule gluten-free labeling rule apply to
foods served in restaurants and other retail food service establishments?
The FDA suggests that restaurants and other retail food
service establishments use the same definition for gluten-free. There is no
requirement.
10. What are the FDA and CDF doing about
gluten-containing ingredients in drug products?
The FDA's Center for Drug Research and Evaluation (CDER)
is reviewing the public comments it has received regarding options to limit
gluten exposure from consumption of drug products.
CDF is asking the public to support the HR 2003: Gluten
in Medicine Disclosure Act of 2013 sponsored by Representatives Tim Ryan (D-OH)
and Nita Lowey (D-NY) which requires drug labels to contain a parenthetical
statement identifying the source of any ingredient constituting or derived from
a grain or starch.
Carolanne Le Blanc
FaceBook: http://www.facebook.com/glutenfree.inflorida
Meeting: 4th Saturday of every month except December
Imperial Palms, East Clubhouse, 101 Imperial Palm Drive, Largo, Florida 33771
Meeting: 4th Saturday of every month except December
Imperial Palms, East Clubhouse, 101 Imperial Palm Drive, Largo, Florida 33771
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