GMO Labeling
January 15, 2015
Evangelia C. Pelonis
Counsel
Keller and Heckman LLP
1001 G Street NW, Suite 500 West
Washington, DC 20001
202.434.4106
[email protected]
Washington, D.C. ● Brussels ● San Francisco ● Shanghai
Evangelia C. Pelonis
Evangelia C. Pelonis joined Keller and Heckman in 2003
as a Food and Drug Associate. Ms. Pelonis' practice
focuses on all regulatory and compliance matters of the
U.S. Food and Drug Administration and the U.S.
Department of Agriculture relating to human food, animal
feed, food additives and ingredients, and dietary
supplements. Ms. Pelonis' works with clients to achieve
their marketing goals within the applicable legal
frameworks. She counsels clients in all aspects of food
development and marketing, from product formulation and
manufacturing considerations to food labeling and
advertising.
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Preliminary Word
This presentation provides information about the law. Legal information is not the same as legal advice, which
involves the application of law to an individual’s specific circumstances. The interpretation and application of the
law to an individual’s specific circumstance depend on many factors. This presentation is not intended to provide
legal advice.
The information provided in this presentation is drawn entirely from public information. The views expressed in
this presentation are the author’s alone and not those of the author’s clients.
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GMO Labeling
 GMO labeling under current Federal law
and guidance
 Possible future GMO labeling under
Federal and State bills
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GMO Labeling-Federal
 FDA does not currently mandate labeling
of food that contain GMO ingredients
under 21 U.S.C. 321(n)
 Reason:
• GMO ingredients pose no safety risks to human
beings; and
• Food derived from GMO ingredients does not
differ in any meaningful way from other food.
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GMO Labeling
http://areweeatingfishyfood.com/
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GMO Labeling-Federal
 FDA published draft guidance regarding
voluntary GM labeling in 2001
 FDA concerned with “GMO Free”/”NonGMO” claims because of potential ability
to mislead consumers
See FDA Guidance for Industry: “Voluntary Labeling Indicating Whether Foods
Have or Have Not Been Developed Using Bioengineering; Draft Guidance”
(released January 2001), available at
http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinfor
mation/labelingnutrition/ucm059098.htm
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GMO Labeling-Federal
 FDA took issue with the following:
1. Use of acronyms such as “GMO” and “GM”
– terms not understood by consumers
2. Claims of no genetic modification
– most food crops genetically modified in some
manner
3. A statement that a product is “free” of
bioengineered material, unless made in a
context that a zero level of bioengineered
material is not implied
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GMO Labeling- Federal
4. A statement that the product is “GMO free”
on foods that ordinarily do not contain
organisms
5. A statement that an ingredient was not
bioengineered if there is another ingredient
in the food that was bioengineered
6. A statement that a food was not
bioengineered or does not contain
bioengineered ingredients when there are no
marketed bioengineered varieties of that
category of foods or ingredients
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GMO Labeling-Federal
 Guidance says statement that a food was
not GM or does not contain GM ingredients
may be misleading if:
• “it implies that the labeled food is superior to foods that
are not so labeled. FDA has concluded that the use or
absence of use of bioengineering in the production of a
food or ingredient does not, in and of itself, mean that
there is a material difference in the food. Therefore, a
label statement that expresses or implies that a food is
superior (e.g., safer or of higher quality) because it is
not bioengineered would be misleading.”
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GMO Labeling-Federal
 Statements to minimize misleading
implications:
• “We do not use ingredients that were
produced using biotechnology”;
• “This oil is made from soybeans that were not
genetically engineered”; or
• “Our tomato growers do not plant seeds
developed using biotechnology.”
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GMO Labeling-Federal
 2005 Warning Letters
 FDA took issue with the following claims:
• “GMO Free”
• “Non GMO”
• “Contains no GMOs”
 “Not technically accurate and may be
misleading”
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GMO Labeling-Federal
 Despite activity in 2005, no other FDA
enforcement
 Current Advice
• Follow FDA draft guidance to make truthful,
non-misleading GM claims
• Substantiate claims
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How to Substantiate GM Claims
 Use validated testing methods when
available to identify GM foods or food
ingredients
 Where validated testing is not available or
reliable, use other methods, such as• Recordkeeping as to sources and
• Handling and segregation practices and
procedures
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How to Substantiate GM Claims
 Testing methods usually too limited to support
“GMO free” type claims
 Also, high risk of contamination of seeds,
crops, ingredients and products impact
reliability of “GMO free” claim
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How to Substantiate GM Claims
 One third-party evaluator, the “Non-GMO
Project,” doesn’t test finished product but the
ingredients
 Frequency of the testing depends on the risk
level of the ingredient
• High risk ingredients: alfalfa, canola, corn, cotton, papaya,
soybeans, sugar beets, zucchini, and yellow summer squash
• Ongoing testing for high risk ingredients
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Federal GMO Bills
 Safe and Accurate Food Labeling Act
(H.R. 4432; GMA Bill)
• Introduced by Rep. Mike Pompeo (R-Kan.) on April 9, 2014
• Establishes mandatory premarket biotechnology notification
program
• Permits label claims that bioengineering either was or was not
used in the production of the food, subject to specific conditions
• Gives FDA authority to require mandatory GMO labeling if the food
is found to be unsafe or materially different from foods produced
without GMO ingredients
• Preempts state laws that prohibit/restrict the sale, distribution, or
marketing of GMO foods and state laws that mandate GM labeling
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Federal GM Bills
 Genetically Engineered Food Right-to-Know
Act (S. 809; Boxer Bill; H.R. 1699)
• Introduced by Sen. Barbara Boxer (D-CA) and
Rep. De Fazio (D-OR) in April 2013
• Requires labeling for any food that has been
genetically engineered or contains one or more
GM ingredients
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GMO Labeling-States
 State Labeling Laws
 FDA labeling requirements generally preempt
inconsistent state regulations
• No preemption if state regulations basically same as federal, or not
covered by federal
• Exemptions – states may petition FDA to exempt certain state
requirements
 3 states passed GM labeling laws in 2013-2014
 Oregon and Colorado considered GM ballot
initiatives on November 4, 2014 – Failed
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GMO Labeling-States
http://www.centerforfoodsafety.org/fact-sheets/3067/ge-food-labelingstates-take-action#
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GMO Labeling-States
 Connecticut
• GM bill signed into law on June 26, 2013
• Delayed implementation – after 4 northeastern states
(one must border CT) enact GM labeling laws
 Maine
• GM bill signed into law on January 9, 2014
• Delayed implementation – after 5 contiguous states
enact GM labeling laws
 Vermont
• GM bill signed into law on May 8, 2014
• No delayed implementation – effective July 2016
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CT: What Does the Label Have to Say?
 Mandated disclosure always the same:
“Produced with Genetic Engineering”
 Disclosure must be same size or larger than
font used in the nutrition facts panel
• But location of labeling mandate varies
depending on context and type of food sold:
– Wholesale food: labeling required to appear on
bill of sale
– Retail packaged processed food and RAC’s:
on the packaging
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CT: What Does the Label Have to Say?
 But location of labeling mandate varies
depending on context and type of food sold
(continued…):
• Retail RAC’s not separately packaged: on the bill of
sale and on the retail shelf
• Seed or seed stock sold wholesale or retail: on the
container holding the seed or on a label identifying
ownership or possession of the commodity
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CT: Exemptions
 Exemptions from Labeling Requirements
• Un-knowing sale of product containing GMO
ingredients
• Food containing less than 0.9% by weight GMO
ingredients (until 2019)
• Alcoholic beverages
• Food intended for immediate human consumption
and food served in restaurants
• Food sold by a farmer or an agent of the farmer at a
farmer’s market, pick your own farm, roadside stand,
or on-farm market
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ME: What Does the Label Have to Say?
 Hybrid of the CT and VT labeling schemes
• Like CT: mandated disclosure always the
same: “Produced with Genetic Engineering”
• Like VT:
- disclosure only applies to retail food
- disclosure can appear on packaging or shelf if
food not separately packaged
- if product subject to GMO labeling mandate,
then manufacturer cannot also label or
advertise product as “natural”
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ME: Exemptions
 Exemptions from Labeling Requirements
• Animals fed GMO food
• Un-knowing sale of product containing GMO
ingredients
• Alcoholic beverages
• Food containing less than 0.9% by weight GMO
ingredients
• Medical food
• Restaurants
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VT: What Does the Label Have to Say?
 Mandate only applies to the following
products sold at RETAIL:
• Processed Food: choice of “partially produced with
genetic engineering,” “may be produced with genetic
engineering” or “produced with genetic engineering”
• Raw Agricultural Commodities (RAC): “produced
with genetic engineering ”
• must appear on packaging or shelf if RAC not separately
packaged
• NOTE: If product subject to GMO labeling mandate,
then manufacturer cannot also label or advertise
product as “natural”
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VT: What Does the Label Not Have to Say?
 The identity of the GMO ingredient
 The placement of the term “genetically
engineered” immediately preceding the
common name or descriptor of the product
(e.g. “GE syrup”)
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VT: Exemptions
 Exemptions from Labeling Requirements
•
•
•
•
•
•
•
•
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Animals fed GMO food
Un-knowing sale of product containing GMO ingredients
Alcoholic beverages
Food containing less than 0.9% by weight GMO
ingredients
3rd Party Certification that food is GMO free
Food produced using enzymes or processing aids
derived from GMO material
Medical food
Food intended for immediate human consumption and
food served in restaurants
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GMO Labeling-States
 June 2014: Legal challenge of VT GM Law
by GMA and other trade associations
• Trade Associations: Law unconstitutional
because it violates compelled commercial
speech rights under the First Amendment
– State must show that they have a “substantial
interest” to compel commercial speech
• Vermont: Law not unconstitutional
– it only requires disclosure of fact
– manufacturer can add information to provide context
for consumers
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GMO Labeling-States
 Oral arguments held on January 7
• Plaintiff (trade associations) are immediately
seeking preliminary injunction to prevent
implementation until the lawsuit is resolved
• Expected that judge will issue written order on
whether to grant injunction in a few weeks
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GMO Labeling-States
 Final proposed rules to implement law
sent by VT Attorney General to Secretary
of State
• Send comments to AG office at,
[email protected]
• Public hearing on January 20
See Proposed Consumer Protection Rule 121,
available at,
http://ago.vermont.gov/assets/files/Consumer/G
E_Food/Proposed%20Rule%20CP%20121.pdf
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Concluding Remarks
 Be careful when making non-GMO claims
 Claim must be truthful and not misleadinguse FDA 2001 Draft Guidance
 Substantiate claim
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Thank You!
Evangelia C. Pelonis
202-434-4106
[email protected]
Follow me on Twitter @EvePelonis
www.khlaw.com
Washington, D.C. ● Brussels ● San Francisco ● Shanghai