GMO Labeling Labeling Presentation.pdfthis presentation are the author’s alone and not those of ... • Gives FDA authority to require mandatory GMO labeling if the ... pick your

Washington, D.C. ● Brussels ● San Francisco ● Shanghai

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]

│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 2

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.


│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 3

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.

│ www.khlaw.com │ KELLER AND HECKMAN LLP Copyright © 2015 4 4

GMO labeling under current Federal law

and guidance

Possible future GMO labeling under

Federal and State bills

GMO Labeling


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.

GMO Labeling-Federal


GMO Labeling

http://areweeatingfishyfood.com/





FDA published draft guidance regarding

voluntary GM labeling in 2001

FDA concerned with “GMO Free”/”Non-

GMO” 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



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



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

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.”



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.”



2005 Warning Letters

FDA took issue with the following claims:

• “GMO Free”

• “Non GMO”

• “Contains no GMOs”

“Not technically accurate and may be

misleading”



Despite activity in 2005, no other FDA

enforcement

Current Advice

• Follow FDA draft guidance to make truthful,

non-misleading GM claims

• Substantiate 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

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



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



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

Federal GMO 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

Federal GM Bills


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

GMO Labeling-States


GMO Labeling-States

http://www.centerforfoodsafety.org/fact-sheets/3067/ge-food-labeling-

states-take-action#

http://www.centerforfoodsafety.org/fact-sheets/3067/ge-food-labeling-states-take-action
















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

GMO Labeling-States


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

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

CT: What Does the Label Have to Say?


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

CT: Exemptions


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”

ME: What Does the Label Have to Say?


Exemptions from Labeling Requirements

• Animals fed GMO food

• Un-knowing sale of product containing GMO

ingredients



ingredients

• Medical food

• Restaurants

ME: Exemptions


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”

VT: What Does the Label 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”)

VT: What Does the Label Not Have to Say?


Exemptions from Labeling Requirements • Animals fed GMO food

• Un-knowing sale of product containing GMO ingredients



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

VT: Exemptions


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

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

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

GMO Labeling-States

mailto:[email protected]

http://ago.vermont.gov/assets/files/Consumer/GE_Food/Proposed Rule CP 121.pdf





Be careful when making non-GMO claims

Claim must be truthful and not misleading-

use FDA 2001 Draft Guidance

Substantiate claim

Concluding Remarks

www.khlaw.com

Washington, D.C. ● Brussels ● San Francisco ● Shanghai

Thank You!


202-434-4106

[email protected]

Follow me on Twitter @EvePelonis

Documents

GMO Labeling Labeling Presentation.pdfthis presentation are the author’s alone and not those of ... • Gives FDA authority to require mandatory GMO labeling if the ... pick your