What Is GRAS?
•
9 likes•4,582 views
The term GRAS, Generally Recognized as Safe, has been in the news quite a bit lately. But there still isn’t much clarity what GRAS really means, who oversees GRAS efforts, and what “safe” actually means. Join us for a webinar with Jim Lassiter, COO, of Ingredient Identity, which a firm is committed to providing Food, Animal and Dietary Supplement, Homeopathic, and Cosmetic companies with exceptional FDA regulatory consulting and quality support services. On this webinar Jim will discuss GRAS and NDIN (New Dietary Ingredients Notification) strategies for ingredient innovators and suppliers. Learn about: -Industry insights -Regulatory challenges -Current agency positions -Guidance to help you avoid major and predictable pitfalls, and how to evaluate timing and define the appropriate budgets.
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (12)
Similar to What Is GRAS?
Similar to What Is GRAS? (20)
More from TraceGains
More from TraceGains (18)
Recently uploaded
Recently uploaded (6)
What Is GRAS?
- 1. #tgwebinar
- 3. Today’s Presenters Gary Nowacki CEO TraceGains Jim Lassiter COO Ingredient Identity #tgwebinar
- 4. Founder, President & COO - Jim Lassiter, M.Sc. MBA©2015 INGREDIENT IDENTITY GUIDANCE DEVELOPMENT COMPLIANCE© GRAS vs. New Dietary Ingredient Notifications Strategies and Approaches
- 5. F.A. vs. D.I. FOOD ADDITIVES vs. DIETARY INGREDIENTS Food Additives Substances Added to Foods Controlled by Regulations All 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 GRAS This is the “unless” portion of the Food Additive Regulations Generally recognized among qualified experts as having been adequately shown to be safe Under The Conditions of Its Intended Use Dietary Ingredients Exempt from Food Additive Regulations Separate notification process Old versus New Dietary Ingredients Dietary Supplements remain a Class of Food
- 6. NDI vs. GRAS THE FIRST DETERMINATION What is the substance? Mixture? Extract? Synthetic? Something Completely Different? Where is it to be Used? Dietary Supplements Exclusively? Foods Exclusively? Both?
- 7. Mixture Extracted Group of compounds Blend of compounds Extract An article in food? An article from other than food? The Substance - I
- 8. Synthetic “Nature Identical” Carry over from the flavor industry Applicable to “natural flavors” Does NOT work for Other Substances Something Completely Different Chemical modification of a substance Physical modification of a substance The Substance - II
- 9. Where Is Important Dietary Ingredients are Exempt Until July 2011(?) What Other Foods? Inclusion in Foods Exclusively GRAS is the Determined Approach Inclusion in Dietary Supplements Exclusively GRAS appears available NDI Notification To Be Included In…
- 10. THE NEXT DETERMINATIONS Characterization Source Identification Method of Manufacture Processing as a Food Item Use of Unacceptable Materials Equipment Employed How Much? Next Determinations
- 11. The GRAS Proposal April, 1997 Proposed Rule December, 2010 Extension of the Comment Period June, 2012 Electronic Submission Procedures It is a Voluntary Process Three Responses The agency does not question the basis for the determination The agency concludes the notice does NOT establish a basis The agency states the notifier has withdrawn the notice The Process - GRAS
- 12. Two Paths Scientific Procedures Experience Scientific Procedures Same as required to obtain food additive approval Experience A substantial history of consumption The Paths - GRAS
- 13. Actually a Notice of GRAS exemption Components Declaration of Exemption Basis (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
- 14. Comprehensive discussion of the cumulative effect and probable consumption Comprehensive discussion of inconsistent information The basis for the conclusion Scientific Basis - GRAS
- 15. Comprehensive discussion of the substantial history of consumption Comprehensive discussion of any inconsistent information Consensus statement The voluntary submission goes to the Office of Food Safety Experience Basis - GRAS
- 16. General Study Time frame: 4-6 months Within 30 Days – Acknowledgement Within 90 Days Available for public viewing Ongoing Review Questions and Answers Amendments GRAS Timing
- 17. FIRST Determine if it’s Old or New SECOND Determine if it Requires Notification Must be an An Article of Food Food from anywhere in the world Not just sticks and twigs or special dirt NOT voluntary Notification – NOT Approval Either rejected or silence The Process - NDI
- 18. Letter of the Law Submission Basis of belief that material is safe Interpretation of the Law Submission Strong Demonstration of Safety Data July, 2011 Guidance Law vs. Guidance - NDI
- 19. MUST Be Notified BEFORE Marketing Components Characterization Demonstration of “Article of Food” Maximum Level of Consumption Basis for Belief that material is safe How To – NDI
- 20. Comprehensive characterization of the material Demonstration that it is an article of food – real documentation Maximum level is YOUR call – focus on safety data Basis for belief: Read this now as short and long-term tox studies The Particulars – NDI
- 21. At LEAST 75 Days PRIOR to Introduction Within 30 Days – Acknowledgement Within 90 Days Available for public viewing Within 90 Days No objection Rejection NDIN Timing
- 22. Recognize Where You Want the Material Placed Determine HOW MUCH you want to deliver GRAS is cumulative through all foods NDIN is Specific for Dietary Supplements Determine What Your Characterization Data Are Determine What Your Safety Data Are GRAS vs. NDIN Determinations
- 23. Original Law Exempted NDIs from Food Additive Regs Could Come Back Was removed in the July, 2011 Draft Guidance Determine Article of Food Status GRAS if synthetic may be more promising NDIN if a simple extract How Much? GRAS limits apply to the Dietary Ingredient Use How Well Characterized is it? Single entity – relatively straightforward Complex extract – must address 100% of the composition for GRAS Why Not Just GRAS?
- 24. Either submission Critical Factors Safety Data – Referential Data consider GRAS Composition – More complex may lean toward NDIN Manufacturing Processes – The more in line with Food GMPs, the more you should consider GRAS Strategic Approach
- 25. GRAS tends to be more forgiving NDIN tends to be faster to market Amendments to GRAS more common Q&A on submission more common with GRAS Determination based on the nature of the data being presented Timings
- 26. Greater Rate of Success with GRAS Potentially owed to accounting Potentially a result of the voluntary nature of the filings Potentially owed to different parts of the Agency reviewing Potentially owed to the determinations being made by Experts Success in Approach
- 27. GRAS Notifications Take Longer to Prepare Food Consumption Data Analysis Characterization of 100% of substance Convening of Expert Panel Review Edits Dossier Finalization The Prejudice against NDIN’s Co-Determinant Factors
- 28. Level of Controversy of the Material Source of the Material What the Data looks like i.e. the Quality Can 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
- 29. Heavily Reliant on the Initial Determinations Understanding and applying a defined Strategic Approach Preparation of the Dossier Early discussions with FDA Answering ALL the questions without being asked Taking a Phased Approach to reduce risk and mitigate costs/delays Keys to Success
- 30. Approach the Project in Phases Evaluation Up Front to identify/save costs Determine NOT to prepare too soon Fill in All the Blanks First Dialog with the Agency Let them know what’s coming Let them know it’s complete DATA – DATA – DATA Critical Takeaways
- 31. Jim Lassiter Headquarters: 208 N. Bush St. Santa Ana, CA 92701 Main: (949) 485-2112 Email: jim@ingredientidentity.com The Regulatory Management Consultancy
- 33. Turning Data Into Information Typical 24/7 Detection & Compliance TraceGains Automatic Score-carding / Risk Difficult to search, analyze, and take action Instant eNotification Alerts No More Spreadsheets: Documents to Data Static Data COAsSupplier Documents Finished Goods Quality Machine Maint. Receiving Receiving Inspections Lab Results Auto. P.O. Acknowl. Plant Floor Feedback Finished Goods QA COA ActionForm™
- 34. TraceGains Automation Solves Many Problems GFSI Labeling FSMA Audits #tgwebinar
- 35. TraceGains Products #tgwebinar Specification Publishing Create, maintain, and publish your company’s unique specifications to ensure compliance on incoming items. Supplier Compliance Automate lot-by-lot compliance across purchasing, COAs, receiving, testing, and plant floor. Finished Goods COAs Generate finished goods COAs, manage customer-specific formats, and send to customers on demand. Supplier Management Automatically manage supplier qualification, documents, and relationships. Quality Management Automate compliance to GFSI, FSMA, safety, and quality.