Safety assessment of food additives
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How FDA Regulates Food Additives?. Safety Assessment of Food Additives. Anna P. Shanklin, Ph.D. Department of Health and Human Services U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition. Food Advisory Committee Additives and Ingredients Subcommittee

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Safety Assessment of Food Additives

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Safety assessment of food additives

How FDA Regulates Food Additives?

Safety Assessment of Food Additives

Anna P. Shanklin, Ph.D.

Department of Health and Human Services

U.S. Food and Drug Administration

Center for Food Safety and Applied Nutrition

Food Advisory Committee

Additives and Ingredients Subcommittee

LATEX ALLERGY

August 26-28, 2003


Overview

OVERVIEW

  • Introduction

  • Food & Drug Law

  • Evaluation of Safety

  • Natural Rubber Latex (NRL)

  • Latex Allergy and Food Safety

  • Conclusion


Cfsan s mission

CFSAN’s Mission

  • To promote and protect the public health by ensuring that:

  • The food supply is safe and wholesome and cosmetics are safe

  • Food and cosmetic products are honestly and accurately labeled

OFAS --- Food Ingredients


Ofas s food ingredients universe

Direct Food Ingredients

Color Additives

GRAS Ingredients

Foods/Ingredients produced using modern biotechnology

Processing Aids

Food Irradiation Equipment

Food Packaging/Food Contact Substances

OFAS’s “Food Ingredients” Universe

Sweeteners; Preservatives; Fat;

Nutrients; Texturizers (thickeners,

Emulsifiers, etc.); Flavors

Antimicrobials(meat and poultry

Processing); Defoamers; Ion exchange

resins

In food, animal feed, drugs,

cosmetics,medical devices(i.e. sutures

and contact lenses)

To process food

To inspect food

Enzymes; Fiber; Proteins;

Lipids; Sugars; MSG; Antimicrobials;

Phytosterols/stanols; Flavors;

Infant formula ingredients

Coatings (paper, metal, etc);

New/recycled plastics including both

polymers and monomers; Paper;

Adhesives; Ingredients in Pkgs.(i.e.

colorants, antimicrobials, antixoxidants,

etc.);Packaging material for use during

food irradiation,; Food packaging

“formulations”

Plants w/herbicide resistance or insect

resistance, delayed ripening, etc.;

often use GRAS concept


Food and drug law

Federal Food, Drug,

And Cosmetic Act

Food and Drug Law

  • Federal, Food, Drug, and Cosmetic Act

    FFDCA


Fda authority

FDA Authority

FFDCA

“The LAW”


Ofas ffdca

OFAS & FFDCA

Food Additive Provisions

Sec. 409

Federal Food, Drug,

And Cosmetic Act

409


Regulations

21 CFR

Food Additive

Regulations

NOT

LAW

FFDCA


Pre market approval

“PRE-MARKET” APPROVAL

1958 Food Additives Amendment

of FFDCA

Sec. 409


Safety assessment of food additives

What is a Food Additive?

Sec. 201(s) FFDCA: Definition

The term ''food additive'' means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food;….

if such substance is not Generally Recognized As Safe,

21 CFR 170.3(e)(1)


Safety assessment of food additives

What is a Food Additive?

Sec. 201(s) FFDCA: Definition

IN SHORT

  • Any substance, that is reasonably expected to become a component of food as a result of its intended use,

  • If such use in not Generally Recognized As Safe (GRAS)


Food and drug law1

Food and Drug Law

  • Sec. 409 Unsafe Food Additives:the use of a food additive is unsafe, unless that use conforms to a regulation, notification, or exemption issued by FDA under Sec. 409.

  • Sec. 402 Adulterated Food: a food is adulterated…if it is, or if it contains any food additive that is unsafe.

  • Sec. 301 Prohibited Acts: the introduction or delivery into interstate commerce of any food that is adulterated or misbranded.

FFDCA


Safety assessment of food additives

MOM’S Apple Pies

Sweetner

Unapproved

Food Additive

Maryland  Virginia

Interstate Commerce

FDA

Enforcement

Adulterated Food

Food and Drug Law


Safety assessment of food additives

Dave’s Candy

[A]

[A]

FDA

Enforcement

New antioxidant

“Unapproved”

Antioxidant migrates

Adulterated Food

Interstate Commerce

Food and Drug Law


Safety assessment of food additives

Why are food additives regulated?

FDA has

authority to

prevent adulteration of Food

(FFDCA)

Unsafe Food Additive = Adulterated Food

Unapproved Food Additive = Unsafe Food Additive

Unapproved Food Additive = Adulterated Food


Safety assessment of food additives

Food Drug & Cosmetic Act

(As amended, 1958)

  • Defines “food additive” w/GRAS exemption

  • Requires premarket approval of new uses of food additives

  • Establishes the standard of review

  • Establishes the standard of safety

  • Establishes formal rulemaking procedures

Sec. 409 FFDCA


Safety assessment of food additives

Food Drug & Cosmetic Act

(As amended, 1958)

  • Defines “food additive” w/GRAS exemption

  • Requires premarket approval of new uses of food additives

  • Establishes the standard of review

  • Establishes the standard of safety

  • Establishes formal rulemaking procedures

Sec. 409 FFDCA


Safety assessment of food additives

Food Drug & Cosmetic Act

(As amended, 1958)

  • Defines “food additive” w/GRAS exemption

  • Requires premarket approval of new uses of food additives

  • Establishes the standard of review

  • Establishes the standard of safety

  • Establishes formal rulemaking procedures

Sec. 409 FFDCA


Standard of review

Standard of Review

“Fair evaluation of the data …”


From the senate report on the food additives amendment of 1958

From the Senate Report on the“Food Additives Amendment of 1958”

“The committee has endeavored to prescribe a new statutory criterion requiring that a high standard of fairness be observed in administrative rule-making under this bill. Personal attitudes or preferences of administrative officials could not prevail on the basis of being supported by substantial evidence picked from the record without regard to other evidence of probative value in the record.”


Safety assessment of food additives

House of Representatives, Report No. 2284,“Food Additives Amendment of 1958”

  • Committee on Interstate & Foreign Commerce, 85th Congress, 2nd Session, July 28, 1958

  • “The committee feels that the Secretary’s findings of fact and orders should not be based on isolated evidence in the record, which evidence in and of itself may be considered substantial without taking account of the contradictory evidence of equal or even greater substance…”


Standard of safety

Standard of Safety

“Reasonable certainty of no harm”


Standard of safety1

Standard of Safety

“Reasonable certainty of no harm”


Standard of safety2

Standard of Safety

“Reasonable certainty of no harm”


Standard of safety3

Standard of Safety

“Reasonable certainty of no harm”


Standard of safety4

Standard of Safety

“Reasonable certainty of no harm”


Standard of safety5

Equal Emphasis on Each Word

Commissioner David Kessler --- November 1995

Standard of Safety

“Reasonable certainty of no harm”


Standard of safety6

Standard of Safety

"SAFE"

“Reasonable certainty of no harm”

21 CFR 170.3(i)


Reasonable certainty of no harm

“Reasonable certainty of no Harm”

What is Harm?

- Harm refers to Health

Man or Animal

Standard of Safety


Reasonable certainty of no harm1

“Reasonable certainty of no Harm”

Standard of Safety

What is Harm?

- Harm refers to Health

Man or Animal


Reasonable certainty of no harm2

“Reasonable certainty of no Harm”

Standard of Safety

What is Harm?

- Harm refers to Health

Man or Animal


Standard of safety7

Standard of Safety

  • Petitioner burden to demonstrate a “reasonable certainty of no harm”

  • FDA Assessment


Reasonable certainty of no harm legislative history of the ffdca

REASONABLE CERTAINTY OF NO HARMLegislative History of the FFDCA

The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that noharm will result from the proposed use of an additive.

It does not—and cannot—require proof beyond any possible doubt that no harm will result under any conceivable circumstance.

H.R. Report, No. 2284, 85th Congress (1958)


Reasonable certainty of no harm legislative history of the ffdca1

REASONABLE CERTAINTY OF NO HARMLegislative History of the FFDCA

The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal. Safety requires proof of a reasonable certainty that noharm will result from the proposed use of an additive.

It does not—and cannot—require proof beyond any possible doubt that no harm will result under any conceivable circumstance.

H.R. Report, No. 2284, 85th Congress (1958)


Section 409

Federal Food, Drug,

And Cosmetic Act

409

Section 409


Section 409 requirements

Section 409 Requirements

  • Any person may petition to establish safety

"Food Additive Petition Process"


Food additive petition review the safety decision

Food Additive Petition ReviewThe Safety Decision

What the evaluation is NOT:

  • It is NOT intended to ensure, nor is it possible to ensure, safety with absolute certainty:

    (“Reasonable Certainty of No Harm rather than

    “Certainty of No Theoretical Possibility of Harm”)

  • Does NOT weigh risks and benefits

  • It is NOT intended to enforce or limit consumer choices.


Food additive petition review the safety decision1

Food Additive Petition ReviewThe Safety Decision

  • It DOES, in fact, ensure safety

  • It IS a consensus decision made under uncertainty that provides a fair evaluation of all the data of record…

    -That must protect the public health

    -That will withstand scientific, procedural, and legal challenge from all sides


Safety standard

Safety Standard

Highlights

  • Approvals are Safety Based Only

  • Reasonable Certainty of No Harm

  • Harm refers to Health of Man or Animal

  • Fair Evaluation of the Entire Record

  • Benefits not weighed in Safety Decision


Key players

CSO

C

T

Key Players

  • Consumer Safety Officer (CSO)

  • Chemistry

  • Toxicology

  • Environmental

E


Data requirements

Data Requirements

  • Identity

  • Conditions of proposed use

  • Intended technical effect

  • Method for determining “quantity”

  • Full reports of safety studies (data)

  • Manufacturing methods

  • Environmental information (NEPA)

Sec. 409 FFDCA


Safety evaluation

Safety Evaluation

A “full blown” exhaustive

safety evaluation of all

appropriate studies, with agency ownership of safety decision.

Standard of Review


Safety evaluation1

“Key Determinant”

Safety Evaluation

  • Estimation of Exposure

  • Proposed Conditions of Use

  • Concentration (safe)

  • Level with no adverse effects observed toxicologically

“ The dose makes the poison”


Technical review

Key Players

Technical Review

  • FDA scientist review data and evaluate petitioner’s safety argument

  • FDA communicates with petitioner to resolve any questions and/or additional data needs

  • FDA review, documentation

  • FDA reaches a scientific conclusion and makes a recommendation


Fda s action on the petition

Section 409 Requirements

FDA’s Action on the Petition

  • Complete the review

  • Establish a Regulation

  • Deny the Petition


Other legal requirements

Section 409 Requirements

Other Legal Requirements

  • Objections and Public Hearings

  • Judicial Review

  • Amendment or Repeal of Regulations


Amendment or repeal

IN

Regulation

OUT

Regulation

Amendment or Repeal

Food Additives

=

FDA Responsibility


Legal aspects of food additive approvals

Legal Aspects of Food Additive Approvals

  • Food Additives unsafe until FDA decision

  • Regulations stipulate an identity, specifications and conditions of safe use

  • Regulations do not provide specific product approvals

  • Direct additives or Food-contact substance


Food additive regulations 21 cfr parts 170 189

Food Additive Regulations21 CFR Parts 170-189

  • General Provisions170 & 171

  • Direct Food Additive Regulations172 & 173

  • Indirect Food Additive Regulations174-178

  • Irradiation of Foods179

  • Substances permitted on interim basis180

  • Prior Sanctioned Substances181

  • GRAS Ingredients182-186

  • Prohibited Substances189

Title 21 CFR 177.2600 Rubber articles intended for repeat use


Safety assessment of food additives

Food Drug & Cosmetic Act

(As amended, 1958, 1997)

  • Defines “food additive” w/GRAS exemption

  • Requires premarket approval of new uses of food additives

  • Establishes the standard of review

  • Establishes the standard of safety

  • Establishes formal rulemaking procedures

  • -----As amended 1997(FDAMA)-----

  • Defines “food contact substance”(FCS)

  • Establishes a premarket notification program for FCSs

Sec. 409(h) of FFDCA


Safety assessment of food additives

Food Drug & Cosmetic Act

(As amended, 1958, 1997)

  • Defines “food additive” w/GRAS exemption

  • Requires premarket approval of new uses of food additives

  • Establishes the standard of review

  • Establishes the standard of safety

  • Establishes formal rulemaking procedures

  • -----As amended 1997(FDAMA)-----

  • Defines “food contact substance”(FCS)

  • Establishes a premarket notification program for FCSs

Sec. 409(h) of FFDCA


Safety assessment of food additives

Food Drug & Cosmetic Act

(As amended, 1958, 1997)

  • Defines “food additive” w/GRAS exemption

  • Requires premarket approval of new uses of food additives

  • Establishes the standard of review

  • Establishes the standard of safety

  • Establishes formal rulemaking procedures

  • -----As amended 1997(FDAMA)-----

  • Defines “food contact substance”(FCS)

  • Establishes a premarket notification program for FCSs

Sec. 409(h) of FFDCA


Safety assessment of food additives

What is a Food Contact Substance?

(Section 409(h)(6) of the FFDCA)

Any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such

use is not intended to have any technical effect in food.

FCS

Indirect Food Additives


Food contact notifications

Food Contact Notifications

Food Additive that is subject of an effective notification

Safe food additive


Brief summary food additive approvals

Brief SummaryFood Additive Approvals

  • Mechanism:FFDCA---Sec. 409---Necessary Tools

  • Process:Safety Evaluation---Scientific review team

  • Result:Regulations, notifications, and exemptions


Brief summary food additive approvals1

Brief SummaryFood Additive Approvals

  • Petitioner is responsible for demonstrating safety

  • FDA is responsible for

    • Conducting a full and fair evaluation of the data and information

    • Issuing a regulation if FDA scientists conclude the requested use is “SAFE”

FDA

Petitioner


Food additive regulations 21 cfr parts 170 1891

Food Additive Regulations21 CFR Parts 170-189

  • General Provisions170 & 171

  • Direct Food Additive Regulations172 & 173

  • Indirect Food Additive Regulations174-178

  • Irradiation of Foods179

  • Substances permitted on interim basis180

  • Prior Sanctioned Substances181

  • GRAS Ingredients182-186

  • Prohibited Substances189

Title 21 CFR 177.2600 Rubber articles intended for repeat use


Natural rubber latex nrl

Natural Rubber Latex“NRL”

Regulations

  • § 172.615Chewing gum base

  • § 175.105Adhesives

  • § 175.125Pressure-sensitive adhesives

  • § 175.300Resinous and polymeric coatings


Natural rubber latex nrl1

Natural Rubber Latex“NRL”

Regulations

  • § 177.1010Acrylic and modified acrylic plastics, semirigid and rigid

  • § 177.1200Cellophane

  • § 177.1210Closures with sealing gaskets for food containers

  • § 177.2600Rubber articles intended for repeated use


Natural rubber latex nrl2

Natural Rubber Latex“NRL”

  • 21 CFR 177.2600 (Feb. 1, 1963)

  • Manufacture of Latex Food Service Gloves

    • Acceptable “indirect” food additive---FCS

  • FDA Position

    • NRL currently “safe” food additive


  • Natural rubber latex nrl3

    Natural Rubber Latex“NRL”

    The Issues

    • Exposure ---- Response

    • Allergic Reactions

    • Latex Proteins


    Latex allergy and food safety

    Latex Allergyand Food Safety

    Problem: Food Mediated Latex Allergic Reactions


    The glove

    The Glove

    • Barrier to Infectious Agents

    • Food Contact Material

    • Subject to the Law (FFDCA)

    • Approval

      Intended Use

      Fair Evaluation

      Reasonable Certainty of No Harm

    Latex Allergy and Food Safety


    Latex allergenic proteins

    Latex Allergenic Proteins

    • Indicated in Food Mediated Allergic reactions

    • Constituents of an Indirect Food Additive

    • FFDCA (Sec. 409)---Food & Drug Law

    • Evaluation---General Safety Standard

    Latex Allergy and Food Safety


    Standard of safety8

    Standard of Safety

    “Reasonable certainty of no harm”


    Latex allergy and food safety1

    Latex Allergyand Food Safety

    Food Mediated Latex Allergic Reactions

    How do we address the Problem


    Latex allergy and food safety2

    Latex Allergy and Food Safety

    Addressing the Problem

    • Safety First

    • FDA must operate under the Law (FFDCA)

    • Approval --- Issuance of a Regulation

    • Approvals are “safety” based only

    • No explicit balancing of risks/benefits

    • Amendment or Repeal --- Issuance of a Regulation

    Use of additive = Unsafe food?


    Summary

    SUMMARY

    • Sec. 409 FFDCA---Food Additive Provisions

    • Review Process

    • Fair Evaluation of the Data --- “Review”

    • Reasonable Certainty of No Harm --- “Safety”

    • NRL---21 CFR 177.2600


    Conclusions

    CONCLUSIONS

    Food and Drug Law

    Evaluation of Safety

    Latex Allergy and Food Safety


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