How FDA Regulates Food Additives? Security Assessment of Food Additives Anna P. Shanklin, Ph.D. Division of Health and Human Services U.S. Sustenance and Drug Administration Center for Food Safety and Applied Nutrition Food Advisory Committee Additives and Ingredients Subcommittee LATEX ALLERGY August 26-28, 2003Slide 3
OVERVIEW Introduction Food & Drug Law Evaluation of Safety Natural Rubber Latex (NRL) Latex Allergy and Food Safety ConclusionSlide 4
CFSANâs Mission To advance and secure the general ensuring so as to well that: The nourishment supply is sheltered and wholesome and makeup are protected Food and corrective items are genuinely and precisely marked OFAS - Food IngredientsSlide 5
Direct Food Ingredients Color Additives GRAS Ingredients Foods/Ingredients created utilizing current biotechnology Processing Aids Food Irradiation Equipment Food Packaging/Food Contact Substances OFASâs âFood Ingredientsâ Universe Sweeteners; Preservatives; Fat; Nutrients; Texturizers (thickeners, Emulsifiers, and so on.); Flavors Antimicrobials(meat and poultry Processing); Defoamers; Ion trade saps In sustenance, creature food, drugs, cosmetics,medical devices(i.e. sutures and contact lenses) To process nourishment To assess sustenance Enzymes; Fiber; Proteins; Lipids; Sugars; MSG; Antimicrobials; Phytosterols/stanols; Flavors; Infant equation fixings Coatings (paper, metal, and so on); New/reused plastics including both polymers and monomers; Paper; Adhesives; Ingredients in Pkgs.(i.e. colorants, antimicrobials, antixoxidants, etc.);Packaging material for utilization amid sustenance illumination,; Food bundling âformulationsâ Plants w/herbicide resistance or creepy crawly resistance, postponed maturing, and so forth.; regularly utilize GRAS ideaSlide 6
Federal Food, Drug, And Cosmetic Act Food and Drug Law Federal, Food, Drug, and Cosmetic Act FFDCASlide 7
FDA Authority FFDCA âThe LAWâSlide 8
OFAS & FFDCA Food Additive Provisions Sec. 409 Federal Food, Drug, And Cosmetic Act 409Slide 9
21 CFR Food Additive Regulations ï¹ NOT LAW FFDCASlide 10
âPRE-MARKETâ APPROVAL 1958 Food Additives Amendment of FFDCA Sec. 409Slide 11
What is a Food Additive ? Sec. 201(s) FFDCA: Definition The term \'\'sustenance added substance\'\' implies any substance the intended utilization of which results or may sensibly be expected to come about, specifically or in a roundabout way , in its becoming a segment or generally influencing the characteristics of any nourishment ( including any substance proposed for utilization in creating, assembling, pressing, handling, planning, treating, bundling, transporting, or holding nourishment; â¦. on the off chance that such substance is not Generally Recognized As Safe, 21 CFR 170.3(e)(1)Slide 12
What is a Food Additive ? Sec. 201(s) FFDCA: Definition IN SHORT Any substance, that is sensibly anticipated that would turn into a segment of nourishment as an aftereffect of its expected utilization, If such use in not Generally Recognized As Safe (GRAS)Slide 13
Food and Drug Law Sec. 409 Unsafe Food Additives : the utilization of a nourishment added substance is perilous, unless that utilization fits in with a regulation, warning, or exclusion issued by FDA under Sec. 409. Sec. 402 Adulterated Food : a sustenance is adulteratedâ¦if it is, or on the off chance that it contains any nourishment added substance that is dangerous. Sec. 301 Prohibited Acts : the presentation or conveyance into interstate trade of any nourishment that is corrupted or misbranded. FFDCASlide 14
MOMâS Apple Pies Sweetner Unapproved Food Additive Maryland ï Virginia Interstate Commerce FDA Enforcement Adulterated Food and Drug LawSlide 15
Daveâs Candy [A] FDA Enforcement New cell reinforcement âUnapprovedâ Antioxidant moves Adulterated Food Interstate Commerce Food and Drug LawSlide 16
Why are sustenance added substances managed? FDA has power to avert debasement of Food (FFDCA) Unsafe Food Additive = Adulterated Food Unapproved Food Additive = Unsafe Food Additive Unapproved Food Additive = Adulterated FoodSlide 17
Food Drug & Cosmetic Act (As corrected, 1958) Defines âfood additiveâ w/GRAS exception Requires premarket approbation of new employments of sustenance added substances Establishes the standard of survey Establishes the standard of wellbeing Establishes formal rulemaking methodology Sec. 409 FFDCASlide 18
Food Drug & Cosmetic Act (As corrected, 1958) Defines âfood additiveâ w/GRAS exclusion Requires premarket approbation of new employments of nourishment added substances Establishes the standard of audit Establishes the standard of wellbeing Establishes formal rulemaking strategies Sec. 409 FFDCASlide 19
Food Drug & Cosmetic Act (As changed, 1958) Defines âfood additiveâ w/GRAS exclusion Requires premarket regard of new employments of nourishment added substances Establishes the standard of survey Establishes the standard of security Establishes formal rulemaking methodology Sec. 409 FFDCASlide 20
Standard of Review âFair assessment of the information â¦âSlide 21
From the Senate Report on the âFood Additives Amendment of 1958â âThe board of trustees has tried to recommend another statutory measure obliging that an exclusive expectation of reasonableness be seen in managerial principle making under this bill. Individual demeanors or inclinations of authoritative authorities couldn\'t win on the premise of being upheld by generous proof picked from the record without respect to other confirmation of probative quality in the record.âSlide 22
House of Representatives, Report No. 2284, âFood Additives Amendment of 1958â Committee on Interstate & Foreign Commerce, 85 th Congress, 2 nd Session, July 28, 1958 âThe board of trustees feels that the Secretaryâs discoveries of reality and requests ought not be founded on separated confirmation in the record, which prove all by itself may be viewed as generous without making note of the opposing proof of equivalent or considerably more noteworthy substanceâ¦âSlide 23
Standard of Safety âReasonable conviction of no harmâSlide 24
Standard of Safety âReasonable assurance of no harmâSlide 25
Standard of Safety âReasonable sureness of no harmâSlide 26
Standard of Safety âReasonable sureness of no harmâSlide 27
Standard of Safety âReasonable assurance of no harmâSlide 28
Equal Emphasis on Each Word Commissioner David Kessler - November 1995 Standard of Safety âReasonable sureness of no harmâSlide 29
Standard of Safety "SAFE" âReasonable conviction of no harmâ 21 CFR 170.3(i)Slide 30
âReasonable sureness of no Harm â What is Harm? - Harm alludes to Health Man or Animal Standard of SafetySlide 31
âReasonable sureness of no Harm â Standard of Safety What is Harm? - Harm alludes to Health Man or AnimalSlide 32
âReasonable sureness of no Harm â Standard of Safety What is Harm? - Harm alludes to Health Man or AnimalSlide 33
Standard of Safety Petitioner weight to exhibit a âreasonable assurance of no harmâ FDA AssessmentSlide 34
REASONABLE CERTAINTY OF NO HARM Legislative History of the FFDCA The idea of wellbeing utilized as a part of this enactment includes the subject of whether a substance is perilous to the strength of man or creature. Wellbeing obliges evidence of a sensible conviction that no mischief will come about because of the proposed utilization of an added substance. It does notâand cannotârequire confirmation past any conceivable uncertainty that no damage will come about under any possible condition. H.R. Report, No. 2284, 85 th Congress (1958)Slide 35
REASONABLE CERTAINTY OF NO HARM Legislative History of the FFDCA The idea of security utilized as a part of this enactment includes the subject of whether a substance is unsafe to the wellbeing of man or creature. Security obliges verification of a sensible sureness that no damage will come about because of the proposed utilization of an added substance. It does notâand cannotârequire evidence past any conceivable uncertainty that no mischief will come about under any possible situation. H.R. Report, No. 2284, 85 th Congress (1958)Slide 36
Federal Food, Drug, And Cosmetic Act 409 Section 409Slide 37
Section 409 Requirements Any individual may appeal to set up security "Food Additive Petition Process"Slide 38
Food Additive Petition Review The Safety Decision What the assessment is NOT : It is NOT planned to guarantee, nor is it conceivable to guarantee, wellbeing with total assurance: (âReasonable Certainty of No Harm instead of âCertainty of No Theoretical Possibility of Harmâ) Does NOT measure dangers and advantages It is NOT expected to uphold or limit customer decisions.Slide 39
Food Additive Petition Review The Safety Decision It DOES , truth be told, guarantee security It IS an accord choice made under instability that gives a reasonable assessment of all the information of recordâ¦ -That must ensure the general wellbeing -That will withstand investigative, procedural, and lawful challenge from all sidesSlide 40
Safety Standard Highlights Approvals are Safety Based Only Reasonable Certainty of No Harm alludes to Health of Man or Animal Fair Evaluation of the Entire Record Benefits not said something Safety DecisionSlide 41
CSO C T Key Players Consumer Safety Officer (CSO) C hemistry T oxicology E nvironmental ESlide 42
Data Requirements Identity Conditions of proposed utilization Intended specialized impact Method for deciding âquantityâ Full reports of security studies (information) Manufacturing strategies Environmental data (NEPA) Sec. 409
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