1. No category

Algae Biomass Summit
October 2013
Orlando, FL
Shifting focus from fuels to foods:
How to enter the food, feed, and
nutraceutical markets.
Greg Sower, PhD
Meghan McKelvey, MBA, HACCP certified
Gavin Thompson, PhD
The Regulatory World of Food in the U.S.
Food
Additive
Traditional
Food
Dietary
Dietary
Supplements Ingredients
GRAS
Ingredients
The Food Market.
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Getting to Market: Key Questions
• What is your product?
• Is it well characterized?
• Is there a history of use?
• Are there safety data?
• Who is the intended consumer?
• What is your intended timeline?
The answers affect your path to market.
3
Food Safety Modernization Act:
Heads Up
Preventive Controls
Product Tracing
•FDA to establish and receive information from a
food tracking/tracing system
Foreign Supplier
Verification
•Responsibility of the importer to verify suppliers
Voluntary Qualified
Importer
Small Entity Guidance
& Flexibility
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•Hazard assessment and risk-based preventive
controls (HACCP-lite)
•Program to expedite review and importation
•Plain language guide to new regulations
•Phased implementation
High Risk Foods
•Designation and new recordkeeping requirements
Enforcement
•Recordkeeping violations result in denial of entry
Regulatory Options in the U.S.
Food
Animal
Feed
Food Additive Petition
AAFCO
GRAS
GRAS
New Dietary Ingredient
Infant Formula
Color Additive Petition
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AGRN
Color Additive
The Basic Path to Market
Facility Registration
Production under cGMP
Characterization
Safety Dossier
Panel Review or
Notification
Market
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Common Paths to Market: GRAS & NDI
Proposed Ingredient
Data Gaps Review
Product Dossier
NDIN to FDA
FDA non-response
(75 days)
NDI or GRAS
GRAS Determination
Self-determined
GRN to FDA
FDA response
(180 days)
Dietary Supplement Market
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Food Ingredient Market
GRAS
Ingredients
(Self-determined
or GRN)
X
Traditional
Food
Dietary
Supplements
Dietary
Ingredients
(NDIN)
A GRAS ingredient can be used in a dietary supplement.
A NDIN does not permit use in traditional food.
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New Dietary Ingredient Notification
Develop Safety
Dossier
1
FDA Review
(75 days)
2
3
Submit to FDA
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To
market
4
Objection/
No Objection
GRAS Determination & Notification
To market
Develop
Safety
Dossier
1
2
3
Expert Panel Review
(if GRAS, then to market
or FDA)
10
“No questions”
(or withdrawal)
Submit to FDA
(voluntary)
5
4
FDA Review
(180 days)
Components of a Product Dossier
Identity & Characterization
History of Use
Product Dossier
Dietary Intakes
Toxicology/Clinical Studies
The product dossier defends the safe use of the product.
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Product Identity & Characterization
•
•
•
•
•
•
Chemical name/CASRN
Phys/chem properties
Product specifications
Manufacturing Process
Batch data
Impurities
Both GRAS ingredients and NDIs require
adequate characterization and specifications.
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Relative Weight of Components
1. History of Use
2. Identity
3. Toxicology
4. Clinical
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The Stats: Updated for 2013!
Factor
Pre-market notification
FDA review duration
Safety review by:
Unsuccessful notices*
Algae notices (total)
Algae successful
Algae unsuccessful
GRAS
NDI
Exempt
Yes
180 days (voluntary)
75 days
“qualified experts”
(FDA optional)
FDA
20%*
70%
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--
10 (53%)
--
9 (47%)
--
*As of Sep 27, 2013. Includes those withdrawn at the notifier’s request & those FDA determined did not provide a basis for a GRAS determination.
Sources: FDA TRACK website (http://www.fda.gov/AboutFDA/Transparency/track/default.htm) and
FDA GRAS Notice Inventory (http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=grasListing)
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Case Study: Solazyme Chlorella Flour
From the FDA’s public GRAS Notice Inventory:
Solazyme has a successful GRAS Notification,
but it took some work.
Source: http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=graslisting
:Note: ENVIRON had no involvement with Solazyme or the GRAS submission.
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Identity – Increased Information
• Original Submission: Genotyping of the organism
appears to be provided to the Expert Panel only.
• Final Submission: Genotyping provided in the
publicly available dossier/notification.
The notification is specific to Solazyme’s product.
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Intended Uses –
Revised Estimates & Uses
GRN 330
GRN 469
More categories and modified amounts
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Manufacturing Process and
Toxicology
1. Modified the raw materials:
“In response to FDA concern, the formulation was modified to
eliminate cobalt as a trace mineral in the media used in the
production …” –GRN 450
2. Performed and published toxicity studies:
Szabo et al. 2013:
– 90 day feeding study in rats
– Mutagenicity
– Genotoxicity
– Allergenicity
Safety must be based on publicly available information.
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Solazyme GRN Summary
Identity
Use
Manufacturing
Process
Toxicology
GRN 330
GRN 450
GRN 469
Genotyping
not released
Genotyping included
Same as
GRN 450
3.5 – 50% of RACC
10 – 120 g/kg
5 – 120 g/kg
Cobalt as a
raw material
Cobalt removed
Same as
GRN 450
No mutagenicity or
genotox studies; no
modern 90-d feeding
study
Mutagenicity, genotox,
90-d feeding, &
allergenicity studies
Source: http://www.accessdata.fda.gov/scripts/fcn/fcnNavigation.cfm?rpt=graslisting
19
Same as
GRN 450
Expert Panel Conclusion
No cGMP = not GRAS
Doesn’t meet specs = not GRAS
Different conditions of use = not GRAS
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Lessons from Solazyme Submissions
1. FDA raised concerns that the Expert Panel did
not.
2. Solazyme got help and addressed the issues.
3. GRN 469 is also a marketing tool for Solazyme.
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Getting Your Product to Market:
Key Questions
• What is your product?
• Is it well characterized?
• Is there a history of use?
• Are there safety data?
• Who is the intended consumer?
• What is your intended timeline?
The answers affect your ability
to get to market.
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Getting Your Product to Market
Take home:
What are you making, from what
and for whom?
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Greg Sower, PhD
Gavin Thompson, PhD
[email protected]
602-734-7738
[email protected]
602-734-7704