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Today’s Presenters

Gary NowackiCEOTraceGains

Jim LassiterCOOIngredient Identity

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Founder, President & COO - Jim Lassiter, M.Sc. MBA©2015 INGREDIENT IDENTITY

GUIDANCE DEVELOPMENT COMPLIANCE©

GRAS vs. New Dietary Ingredient NotificationsStrategies and Approaches

F.A. vs. D.I.

FOOD ADDITIVES vs. DIETARY INGREDIENTS

Food AdditivesSubstances Added to FoodsControlled by RegulationsAll substances whose use results in their becoming a component of a food or otherwise affecting the characteristics of a food [21CFR §170.3(e)(1)]Must have premarket review and approval

GRASThis is the “unless” portion of the Food Additive RegulationsGenerally recognized among qualified experts as having been adequately shown to be safe Under The Conditions of Its Intended Use

Dietary IngredientsExempt from Food Additive RegulationsSeparate notification processOld versus New Dietary Ingredients

Dietary Supplements remain a Class of Food

NDI vs. GRAS

THE FIRST DETERMINATIONWhat is the substance?

Mixture?Extract?Synthetic?Something Completely Different?

Where is it to be Used?Dietary Supplements Exclusively?Foods Exclusively?Both?

MixtureExtracted Group of compoundsBlend of compounds

ExtractAn article in food?An article from other than food?

The Substance - I

Synthetic“Nature Identical”

Carry over from the flavor industryApplicable to “natural flavors”Does NOT work for Other Substances

Something Completely DifferentChemical modification of a substancePhysical modification of a substance

The Substance - II

Where Is ImportantDietary Ingredients are ExemptUntil July 2011(?)What Other Foods?

Inclusion in Foods ExclusivelyGRAS is the Determined Approach

Inclusion in Dietary Supplements ExclusivelyGRAS appears availableNDI Notification

To Be Included In…

THE NEXT DETERMINATIONSCharacterization

SourceIdentification

Method of ManufactureProcessing as a Food ItemUse of Unacceptable MaterialsEquipment Employed

How Much?

Next Determinations

The GRAS ProposalApril, 1997 Proposed RuleDecember, 2010 Extension of the Comment PeriodJune, 2012 Electronic Submission Procedures

It is a Voluntary ProcessThree Responses

The agency does not question the basis for the determinationThe agency concludes the notice does NOT establish a basisThe agency states the notifier has withdrawn the notice

The Process - GRAS

Two PathsScientific ProceduresExperience

Scientific ProceduresSame as required to obtain food additive approval

ExperienceA substantial history of consumption

The Paths - GRAS

Actually a Notice of GRAS exemptionComponents

Declaration of ExemptionBasis (Scientific Procedures or Experience)Agree to allow review (regardless of whether it is notified)

Details of the identity of the substance (characterization)Information on self-limiting levels of use

How To - GRAS

Comprehensive discussion of the cumulative effect and probable consumptionComprehensive discussion of inconsistent informationThe basis for the conclusion

Scientific Basis - GRAS

Comprehensive discussion of the substantial history of consumptionComprehensive discussion of any inconsistent informationConsensus statementThe voluntary submission goes to the Office of Food Safety

Experience Basis - GRAS

General Study Time frame: 4-6 monthsWithin 30 Days – AcknowledgementWithin 90 Days

Available for public viewing

Ongoing ReviewQuestions and AnswersAmendments

GRAS Timing

FIRST Determine if it’s Old or NewSECOND Determine if it Requires NotificationMust be an An Article of Food

Food from anywhere in the worldNot just sticks and twigs or special dirt

NOT voluntaryNotification – NOT Approval

Either rejected or silence

The Process - NDI

Letter of the LawSubmissionBasis of belief that material is safe

Interpretation of the LawSubmissionStrong Demonstration of Safety DataJuly, 2011 Guidance

Law vs. Guidance - NDI

MUST Be Notified BEFORE MarketingComponents

CharacterizationDemonstration of “Article of Food”Maximum Level of ConsumptionBasis for Belief that material is safe

How To – NDI

Comprehensive characterization of the materialDemonstration that it is an article of food – real documentationMaximum level is YOUR call – focus on safety dataBasis for belief:

Read this now as short and long-term tox studies

The Particulars – NDI

At LEAST 75 Days PRIOR to IntroductionWithin 30 Days – AcknowledgementWithin 90 Days

Available for public viewing

Within 90 DaysNo objectionRejection

NDIN Timing

Recognize Where You Want the Material PlacedDetermine HOW MUCH you want to deliver

GRAS is cumulative through all foodsNDIN is Specific for Dietary Supplements

Determine What Your Characterization Data AreDetermine What Your Safety Data Are

GRAS vs. NDIN Determinations

Original Law Exempted NDIs from Food Additive RegsCould Come BackWas removed in the July, 2011 Draft Guidance

Determine Article of Food StatusGRAS if synthetic may be more promisingNDIN if a simple extract

How Much?GRAS limits apply to the Dietary Ingredient Use

How Well Characterized is it?Single entity – relatively straightforwardComplex extract – must address 100% of the composition for GRAS

Why Not Just GRAS?

Either submissionCritical Factors

Safety Data – Referential Data consider GRASComposition – More complex may lean toward NDINManufacturing Processes – The more in line with Food GMPs, the more you should consider GRAS

Strategic Approach

GRAS tends to be more forgivingNDIN tends to be faster to marketAmendments to GRAS more commonQ&A on submission more common with GRASDetermination based on the nature of the data being presented

Timings

Greater Rate of Success with GRASPotentially owed to accountingPotentially a result of the voluntary nature of the filingsPotentially owed to different parts of the Agency reviewingPotentially owed to the determinations being made by Experts

Success in Approach

GRAS Notifications Take Longer to PrepareFood Consumption Data Analysis

Characterization of 100% of substanceConvening of Expert Panel

ReviewEditsDossier Finalization

The Prejudice against NDIN’s

Co-Determinant Factors

Level of Controversy of the MaterialSource of the MaterialWhat the Data looks like i.e. the QualityCan you proceed without notification?Can you achieve the level you wish?Do you want to outsource based on expertise and what can you expect?

What To Look Out For

Heavily Reliant on the Initial DeterminationsUnderstanding and applying a defined Strategic Approach

Preparation of the DossierEarly discussions with FDAAnswering ALL the questions without being asked

Taking a Phased Approach to reduce risk and mitigate costs/delays

Keys to Success

Approach the Project in PhasesEvaluation Up Front to identify/save costsDetermine NOT to prepare too soonFill in All the Blanks First

Dialog with the AgencyLet them know what’s comingLet them know it’s complete

DATA – DATA – DATA

Critical Takeaways

Jim LassiterHeadquarters:208 N. Bush St.Santa Ana, CA 92701Main: (949) 485-2112Email: jim@ingredientidentity.com

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Q&A

Gary Nowacki

gary.nowacki@tracegains.com

Jim Lassiter

jim@ingredientidentity.com

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