State of FDA’s Food Additives Program

Dennis Keefe, PhD

Director, Office of Food Additive Safety

U.S. Food and Drug Administration

October 14, 2015

Food Packaging Law Seminar

Washington, DC

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Office of Food Additive Safety

• Our Mission

• Who We Are

• What We Regulate

• What We Have Accomplished

• Where We Are Going: Stewardship Challenges

• Bridge Building

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Our Mission

To assure that the use of food ingredients is safe by:

Evaluating new applications efficiently & effectively

Expediting applications that mitigate food hazards

Meeting high performance standards with strong science and modern infrastructure

Directing resources to issues of greater public health importance while anticipating future trends

Maintaining data to monitor safety over time

Conducting research that supports the FDA regulatory agenda

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Who We Were: The People

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Who We Are: The People

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Who We Are: Organizational Structure

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Our Numbers: OFAS Human Capital: FTEs 1998-2015

0

20

40

60

80

100

120

140

160

180

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What We Regulate: The Food “Ingredient” Universe

• Added Directly to Food for an Intended Effect

– Direct Additives: Sweeteners; preservatives;

nutrients; fat substitutes; texturizers (e.g., thickeners,

emulsifiers); flavors

– Color Additives: In food (also includes animal feed,

drugs, cosmetics, and medical devices (e.g., sutures,

contact lenses))

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The Food “Ingredient” Universe (continued)

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• Indirect Additives

– Food Contact Substances: Coatings (paper, metal,

etc.); new/recycled plastics including polymers and

monomers; paper; adhesives; colorants,

antimicrobials, and antioxidants in packaging;

packaging materials used during food irradiation;

packaging “formulations”

– Processing Aids: Antimicrobials (meat

and poultry processing); defoamers;

ion exchange resins

The Food “Ingredient” Universe (continued)

• Other “Ingredients”:

– Food Irradiation Equipment: To Process food or to

inspect food

– GRAS Substances: Enzymes; fibers; proteins; lipids;

sugars; MSG; antimicrobials; phytosterols/stanols;

flavors; infant formula ingredients

– Foods/Ingredients Produced Via Biotechnology:

Plants w/ herbicide resistance or insect resistance;

delayed ripening, etc.

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Accomplishments Since 1958

• Food Additive Petitions > 4800

• Color Additive Petitions > 300

• GRAS Affirmation Petitions > 400

• Food Contact Notifications > 1550

• GRAS Notifications ~600 (since 1998)

Total: >7700 petitions/notifications

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What We’ve Accomplished: Code of Federal Regulation Listings

• Regulations/Effective Notifications

– Food Additive >700

– Affirmed GRAS ~ 350

– Color Additive > 200

– FCNs > 1170

– Total: ~2500

• Substances

– Direct Food Additives > 800

– Indirect Food Additives ~ 3500

– GRAS Substances > 1000

– Color Additives ~ 300

– Total: > 5600 12

Submissions Completed by Fiscal Year

0

20

40

60

80

100

120

140

2007 2008 2009 2010 2011 2012 2013 2014 2015

FCN

C/FAP

GRN

BNF

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Submissions Completed by Fiscal Year

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0

20

40

60

80

100

120

140

160

180

200

2007 2008 2009 2010 2011 2012 2013 2014 2015

BNF

GRN

C/FAP

FCN

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ChallengesScience

• Validating in silico, in vitro, and high throughput screening assays in

risk assessment.

• Applying emerging methodologies for risk assessments (e.g., read

across, AOPs, threshold approaches).

• Role of epidemiology studies in risk assessments.

• Utilization of risk factors for chronic disease vs frank organ/tissue

lesions as endpoints

• Updating risk assessments based on new data and information

(e.g., cyclic review)

• Updating Redbook Guidance

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ChallengesPolicy

• Public Health Protection Priorities

– Reduction of Foodborne Illnesses

– Chronic disease and food ingredients (e.g., PHOs,

sugar, sodium, saturated fats)

• Science-based cyclic review of approved uses

– Priority ranking

– Access to supporting information

– Creation of administrative record to support action

• Resources/Priorities

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ChallengesLaw

• Statutory Timeframes for Premarket Review– Food Additive and Color Additive Petitions

– Food Contact Notifications

• Implementation of the GRAS Exclusion

• Safety Standard: Reasonable Certainty of No Harm

• Delaney Clause: “. . .no additive shall be deemed to be safe if

it is found to induce cancer when ingested by man or animal, or if it

is found, after tests which are appropriate for the evaluation of the

safety of food additives, to induce cancer in man or animal. . .”

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ChallengesRecent Events of Note

• GAO: “Food Safety: FDA Should Strengthen Is Oversight of Food Ingredients

Determined to Be Generally Recognized as Safe” (GAO-10-246) (2010)

• Citizen Petitions to initiate FDA rulemaking to amend existing food additive or color

additive regulations (e.g., BPA, BHA, certified color additives) or to prohibit the use of

a food ingredient (e.g., PHOs).

• Litigation to compel FDA to respond to Citizen Petitions (e.g., BPA, PHOs) or to

finalize proposed rules (e.g., FSMA, GRAS Notification program).

• Food Additive Petitions (2) to revoke food additive regulations based on

abandonment (e.g., BPA).

• Food Additive Petitions to revoke food additive regulations based on safety (e.g.,

perfluoroalkyl ethyl compounds and perchlorate, 7 synthetic flavoring agents).

• Color Additives: Increased interested in biological vs. coal tar starting materials

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ChallengesPublic Perception/Confidence

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ChallengesPublic Perception/Confidence

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ChallengesPublic Perception/Confidence

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ChallengesPublic Perception/Confidence

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Stewardship

“. . . conducting, supervising, or managing of

something; especially: the careful and responsible

management of something entrusted to one's

care”

Miriam Webster

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Food Safety Stewardship It is Important to All of Us

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Food Safety StewardshipWho is Responsible?

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FDA

Industry Stakeholders

Advocates

Consumers

All of the Above!

Food Safety StewardshipAssuring Food Safety through Action

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Communication

• FDA

• Food Industry

• Advocates

• Consumers

Food Safety

• Adherence to Regulations

• New Products and Technologies

• New Uses

Transparency

• Clear Processes

• Data Sharing

Regulatory Stewardship

• “Cleaning up” 21 CFR

• Voluntary Submissions

Stewardship

StewardshipFood Ingredient Oversight Expectations

Consumers: Accessible, Safe and Affordable Food

– Access to affordable food

– Access to safe food

– Access to truthful labeling

– Able to make informed choices

– Confidence that FDA is neutral, science-based arbiter of food

safety

– Full disclosure of ingredients added to food.

• “Clean labels”

• “Chemicals” in food

• “Natural” ingredients

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StewardshipFood Ingredient Safety Expectations

FDA: Rigorous, Responsive, Science-based, Process

Premarket

– Regulations should reflect industry’s current best practices

– Regulations should be based on the best available science

Postmarket

– Allows for post-market resources to focus on actual vs.

hypothetical or perceived chemical risks

– Enhances FDA’s ability to focus its finite resources on public

health priorities

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StewardshipFood Ingredient Safety Expectations

Industry: Science-based, Efficient, Predictable,

Consistent

– Safe food

– Market access

– Level playing field

– Promotes technical innovations

– Promotes use of best available technology

– Demonstrates responsible corporate citizenship

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StewardshipFood Ingredient Oversight Expectations

Advocates: Transparency, Independent assessments

– Safe food

– Predictable, science-based process

– Diverse interests that may or may not be directly related to food

safety (e.g., sustainability, production practices - organic, animal

welfare, antibiotic use, pesticide use, nutritional quality,

marketing practices)

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StewardshipWhere Are We Going?

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StewardshipGoing Forward

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StewardshipPremarket Needs:

Update Regulations

– Science-based

– Reflect current market practice

– Systematic/efficient process

– Maximize resource allocations

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StewardshipPostmarket Needs:

Food Chemical Knowledgebase:

– Food ingredient use information (foods & levels)

– Food consumption information

– Updated toxicology information

– Integration of in silico risk assessment tools based on QSAR,

Mode of Action, high throughput screening data, in vitro assays,

etc. to prioritize hazards.

Food Chemical Safety Communications

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StewardshipProviding Data to FDA: Rewards

Create Public Value

– Continued assurance that use is safe

– FDA is better informed, and thereby better able to

timely respond to real and imagined safety concerns

– Increases likelihood for evidence-based risk

assessments, decision-making, dialogue and policy

– Finite resources can be focused on ensuring the safe

use of chemicals in food and premarket review

program.

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Bridge Building I: Information Sharing MOUs

• OFVM/FDA and EPA’s Office of Chemical Safety and

Pollution Prevention

(http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-

2003-0004-0095)

• Updated MOU/SOP on interactions between OFAS and

FSIS/USDA

(http://www.fda.gov/aboutfda/partnershipscollaborations/memorand

aofunderstandingmous/domesticmous/ucm441552.htm)

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Bridge Building II: E-submissions

Advantages of Electronic Submission

Secure and more efficient processing

Less wasted energy

Reduced physical storage

Fast delivery - same day upload

No cost for paper, binding and delivery

For a more comprehensive list of advantages visit the FDA Web Site:

FDA Electronic Submission Gateway: Impact of the Gateway

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Resources for Electronic Submissions

FDA Electronic Submissions Gateway:

http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm

OFAS Guidance:

http://www.fda.gov/FoodIngrPkgSubmissions

OFAS Training videos:

http://www.fda.gov/Food/IngredientsPackagingLabeling/ucm368958.htm

OFAS Quick links to forms, instructions and downloadable folders:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInf

ormation/IngredientsAdditivesGRASPackaging/ucm199174.htm

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Bridge Building III:Redbook

• Public Docket and Meeting (Dec. 9, 2014) soliciting

comment on our update of Redbook1. What components of the Redbook should receive priority for review and update?

2. What aspects of the safety and risk assessment of food ingredients or other

CFSAN-regulated products are not addressed and should be considered for

incorporation in the Redbook?

3. How can the Redbook be updated to more fully support the development and

submission of safety assessments for substances introduced into food?

4. How should we balance the desire for transparency and consistency in risk

assessment as described in the Redbook, with the goal of flexibility in applying

the most appropriate analysis for specific contexts?

• Outreach plans for professional meetings in 2016.

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Questions?

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