SlideShare a Scribd company logo
www.nutrasource.ca www.gras-associates.com
YOUR PARTNERS IN FOOD, DIETARY SUPPLEMENT
AND MEDICAL FOOD SAFETY & COMPLIANCE
Delivering customized and focused regulatory
solutions for U.S. market access
www.gras-associates.com GRAS ASSOCIATES LLC
GRAS Associates – Your Partners in Food Safety
www.diteb.com
• Founded by Dr. Robert S. McQuate and Dr. Richard C.
Kraska, two seasoned regulatory veterans with over
60 years’ collective experience working for and with
the FDA, GRAS Associates provides customized food
safety and compliance regulatory consulting
solutions for products regulated by the U.S. Food and
Drug Administration (FDA), including products which
may be considered to be Generally Recognized as
Safe (GRAS)
www.gras-associates.com GRAS ASSOCIATES LLC
GRAS Associates – Your Partners in Food Safety
www.diteb.com
• As the functional food industry continues to grow,
and new additives are being investigated, GRAS
ingredients have become more valuable
• Our experienced team of scientists in the fields of
toxicology, microbiology, biochemistry and regulatory
compliance can assist you with bringing your product
to market and meeting U.S. FDA regulations
www.gras-associates.com GRAS ASSOCIATES LLC
GRAS Associates – Your Partners in Food Safety
www.diteb.com
• We specialize in preparing self-determined and FDA-
notified GRAS submissions as well as regulatory
compliance reviews for dietary supplements and
medical foods
• Areas of specialization include:
• Generally Recognized as Safe (GRAS) ingredients
• Medical Food Ingredients
• Food contact notifications
• Animal Feed Ingredients
• New Dietary Ingredient Notifications
• Food Additives
• 21 CGR Part 110 and 111 cGMP compliance Strategies
• Infant Formula ingredient Compliance
www.gras-associates.com GRAS ASSOCIATES LLC
GRAS Associates – Your Partners in Food Safety
www.diteb.com
Through our successful delivery of GRAS evaluations and
ingredient safety assessments, our clients gain access to
greater marketplace opportunities through innovative
and expanded product offerings
Our years of experience guarantees efficient and cost-
effective solutions to enter new markets, introduce
new products and comply with changes in the
regulatory landscape.
www.gras-associates.com GRAS ASSOCIATES LLC
GRAS Associates – Your Partners in Food Safety
www.diteb.com
GRAS Associates has submitted approximately
15% of all GRAS notices received by the FDA since
the company was founded in 2008, with a 90%
success rate
www.gras-associates.com GRAS ASSOCIATES LLC
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Dr. Richard Kraska, Ph.D., DBAT
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Dr. Richard Kraska began his career at FDA in food additives and moved on to
GRAS Review. At FDA, he participated in safety evaluations on sensitive topics
such as aspartame, cyclamate and salt. For the next twenty-two years he had
numerous assignments with three major chemical companies where he
integrated critical toxicology aspects into a wide variety of regulatory
matters. This included intensive coordination with corporate
acquisitions. Since becoming an independent consultant, Richard as helped
dozens of clients with product safety and regulatory projects covering food
additives, food processing aids, animal feed additives and food packaging
materials.
Dr. Robert McQuate, Ph.D.
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Dr. Robert McQuate started his regulatory career within FDA's GRAS Review
Branch prior to serving in technical management positions in the private sector
with The Dial Company and the National Soft Drink Association. While in the
private sector, he addressed numerous high visibility food safety issues
including caloric and non-nutritive sweeteners, sulfiting agents, and caffeine.
As an independent consultant since 1988, Robert has assisted scores of clients
from North America, Asia, and Europe achieve marketplace success for their
food products and dietary supplements by fostering the acquisition of the
scientific documentation to fulfill the requisite regulatory requirements.
Cheryl Dicks, MS, RAC
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Cheryl has 30 years of experience in business management and product quality
management and over 14 years of experience in FDA regulatory in supplement,
nutraceutical, pharmaceutical and device development. She has been involved
in the successful submission of all phases of clinical development Phase I
through IV to the FDA and has established relationships with federal
representatives at the FDA and represented a diverse sponsor base in Orphan
Drug designations, Type A, B and C meetings, fast track designation and
medical devices. Additionally, Cheryl is regarded as an industry expert on
Quality Management Systems connecting GCP and GLP for RAPS
webcast. Cheryl has been a lecturer for Biomedical and Regulatory Affairs at
Hood College as well as a researcher and clinical trial project leader with the US
Army Medical Research and Medical Command.
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
What is GRAS status?
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
• GRAS is an acronym for Generally Recognized as Safe
• It is a regulatory designation set by the U.S. Food and Drug
Administration (FDA) that applies to any substance intentionally
added to a food (e.g., a food additive)
• First introduced as part of the 1985 Food Additives Amendment to
the Federal Food, Drug and Cosmetic Act (FD&C Act)
• In order to be compliant with the FDA's regulations, companies
typically choose the GRAS determination pathway for a substance if
they feel there is substantial consensus among scientific experts,
outside the FDA, that the ingredient is safe for use as intended.
• GRAS determinations are performed by appropriately qualified
scientific entities, such as GRAS Associates, on behalf of sponsoring
firms.
Why secure GRAS status for an
ingredient?
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
• According to the FDA, "any substance that is
intentionally added to food is a food additive, that is
subject to premarket review and approval by FDA,
unless the substance is generally recognized, among
qualified experts, as having been adequately shown to
be safe under the conditions of its intended use, or
unless the use of the substance is otherwise excluded
from the definition of a food additive."
How to secure GRAS status
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
• To attain GRAS status for an ingredient, the sponsor must be
able to demonstrate that the substance in question is not likely
to cause harm when used as intended. This requires a
complete review of the safety evidence for the ingredient and
the submission of a GRAS filing with the FDA. The findings
result in establishing compliance with FDA regulations for the
food ingredient.
• A GRAS determination can be either self-determined,
independent of the FDA, or submitted to the FDA in the form of
a notification for the Agency’s assessment.
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Other Regulatory Services
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
In addition to helping companies secure GRAS status for their ingredient, GRAS
Associates offers an array of focused food safety consulting services that assist
clients to obtain, maintain and defend GRAS opinions for success in the
marketplace. These services include:
• New Dietary Ingredient Notifications (NDIN)
• Regulatory Compliance and Product Development Consulting
• Medical Foods Compliance
• Food and Color Additive Petitions
• Food Contact Notifications (FCN)
• cGMP Compliance
• Technical Writing
• Literature Surveillance
• Research & Product Testing
New Dietary Ingredient Notification (NDIN)
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Section 413(c) of the Federal Food, Drug, and Cosmetic Act requires the
submission of a notification for a dietary ingredient that was not marketed in
the United States as a dietary supplement before October 15, 1994.
The NDI notification process is complex. In fact, more than 80% of NDI
notifications are rejected by the FDA. The team at GRAS Associations is well
versed with NDI requirements and has assisted many clients in preparing and
submitting notifications.
Ensure the information needed to prepare and submit your
NDIN is complete to an exceptional degree of quality
Regulatory Compliance and Product
Development Consulting
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
With the FDA, the Federal Trade Commission (FTC) and other regulators and
lawmakers strictly enforcing regulations, food and dietary supplement
organizations today must use discretion when it comes to ensuring compliance.
Regulatory compliance and product development issues are extremely complex
and without a thorough understanding of today’s regulatory landscape, many
organizations are unable to succeed.
Let us support your regulatory and product development
efforts to gain a competitive edge while remaining compliant
with industry regulations
Medical Foods Compliance
www.diteb.com
Medical foods have become a hot product category in recent years. The FDA
defines medical foods as foods “formulated to be consumed or administered
enterally under the supervision of a physician and which is intended for the
specific dietary management of a disease or condition for which distinctive
nutritional requirements, based on recognized scientific principles, are
established by medical evaluation.”
While medical foods do not require pre-market approval by the FDA, they must
comply with all applicable FDA requirements for foods.
www.gras-associates.com GRAS ASSOCIATES LLC
Have the confidence that your medical food is compliant with
FDA requirements before going to market
Food Additive and Color Petitions
www.diteb.com
Not every GRAS determination is successful and some substances are more
suited for food additive petitions. A similar petition process is available for
color additives that are intended to impart color to foods, drugs, cosmetics and
medical devices.
www.gras-associates.com GRAS ASSOCIATES LLC
We will guide you through the FDA review process and ensure
that your food additive or color petition documentation is
complete to the highest level of quality and compliance
Food Contact Notifications
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Food contact materials are intended or have the potential to come in contact
with food. When these materials come in contact with food, there is the
possibility of the chemical substances migrating from the food contact material
to the food, which could be potentially harmful to human health.
Consequently, many regulatory bodies have implemented food contact
regulations to ensure food safety.
We deliver comprehensive regulatory support to help you
submit food contact notifications.
It’s time to discover your full
market potential
Partner with GRAS Associates to uncover greater
market opportunities through innovative,
expanded product offerings – starting with food
safety and regulatory compliance.
www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC
Contact us today at info@gras-associates.com to discuss
your product goals.

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GRAS Associates Corporate Overview

  • 1. www.nutrasource.ca www.gras-associates.com YOUR PARTNERS IN FOOD, DIETARY SUPPLEMENT AND MEDICAL FOOD SAFETY & COMPLIANCE Delivering customized and focused regulatory solutions for U.S. market access
  • 3. GRAS Associates – Your Partners in Food Safety www.diteb.com • Founded by Dr. Robert S. McQuate and Dr. Richard C. Kraska, two seasoned regulatory veterans with over 60 years’ collective experience working for and with the FDA, GRAS Associates provides customized food safety and compliance regulatory consulting solutions for products regulated by the U.S. Food and Drug Administration (FDA), including products which may be considered to be Generally Recognized as Safe (GRAS) www.gras-associates.com GRAS ASSOCIATES LLC
  • 4. GRAS Associates – Your Partners in Food Safety www.diteb.com • As the functional food industry continues to grow, and new additives are being investigated, GRAS ingredients have become more valuable • Our experienced team of scientists in the fields of toxicology, microbiology, biochemistry and regulatory compliance can assist you with bringing your product to market and meeting U.S. FDA regulations www.gras-associates.com GRAS ASSOCIATES LLC
  • 5. GRAS Associates – Your Partners in Food Safety www.diteb.com • We specialize in preparing self-determined and FDA- notified GRAS submissions as well as regulatory compliance reviews for dietary supplements and medical foods • Areas of specialization include: • Generally Recognized as Safe (GRAS) ingredients • Medical Food Ingredients • Food contact notifications • Animal Feed Ingredients • New Dietary Ingredient Notifications • Food Additives • 21 CGR Part 110 and 111 cGMP compliance Strategies • Infant Formula ingredient Compliance www.gras-associates.com GRAS ASSOCIATES LLC
  • 6. GRAS Associates – Your Partners in Food Safety www.diteb.com Through our successful delivery of GRAS evaluations and ingredient safety assessments, our clients gain access to greater marketplace opportunities through innovative and expanded product offerings Our years of experience guarantees efficient and cost- effective solutions to enter new markets, introduce new products and comply with changes in the regulatory landscape. www.gras-associates.com GRAS ASSOCIATES LLC
  • 7. GRAS Associates – Your Partners in Food Safety www.diteb.com GRAS Associates has submitted approximately 15% of all GRAS notices received by the FDA since the company was founded in 2008, with a 90% success rate www.gras-associates.com GRAS ASSOCIATES LLC
  • 9. Dr. Richard Kraska, Ph.D., DBAT www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC Dr. Richard Kraska began his career at FDA in food additives and moved on to GRAS Review. At FDA, he participated in safety evaluations on sensitive topics such as aspartame, cyclamate and salt. For the next twenty-two years he had numerous assignments with three major chemical companies where he integrated critical toxicology aspects into a wide variety of regulatory matters. This included intensive coordination with corporate acquisitions. Since becoming an independent consultant, Richard as helped dozens of clients with product safety and regulatory projects covering food additives, food processing aids, animal feed additives and food packaging materials.
  • 10. Dr. Robert McQuate, Ph.D. www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC Dr. Robert McQuate started his regulatory career within FDA's GRAS Review Branch prior to serving in technical management positions in the private sector with The Dial Company and the National Soft Drink Association. While in the private sector, he addressed numerous high visibility food safety issues including caloric and non-nutritive sweeteners, sulfiting agents, and caffeine. As an independent consultant since 1988, Robert has assisted scores of clients from North America, Asia, and Europe achieve marketplace success for their food products and dietary supplements by fostering the acquisition of the scientific documentation to fulfill the requisite regulatory requirements.
  • 11. Cheryl Dicks, MS, RAC www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC Cheryl has 30 years of experience in business management and product quality management and over 14 years of experience in FDA regulatory in supplement, nutraceutical, pharmaceutical and device development. She has been involved in the successful submission of all phases of clinical development Phase I through IV to the FDA and has established relationships with federal representatives at the FDA and represented a diverse sponsor base in Orphan Drug designations, Type A, B and C meetings, fast track designation and medical devices. Additionally, Cheryl is regarded as an industry expert on Quality Management Systems connecting GCP and GLP for RAPS webcast. Cheryl has been a lecturer for Biomedical and Regulatory Affairs at Hood College as well as a researcher and clinical trial project leader with the US Army Medical Research and Medical Command.
  • 13. What is GRAS status? www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC • GRAS is an acronym for Generally Recognized as Safe • It is a regulatory designation set by the U.S. Food and Drug Administration (FDA) that applies to any substance intentionally added to a food (e.g., a food additive) • First introduced as part of the 1985 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act (FD&C Act) • In order to be compliant with the FDA's regulations, companies typically choose the GRAS determination pathway for a substance if they feel there is substantial consensus among scientific experts, outside the FDA, that the ingredient is safe for use as intended. • GRAS determinations are performed by appropriately qualified scientific entities, such as GRAS Associates, on behalf of sponsoring firms.
  • 14. Why secure GRAS status for an ingredient? www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC • According to the FDA, "any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive."
  • 15. How to secure GRAS status www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC • To attain GRAS status for an ingredient, the sponsor must be able to demonstrate that the substance in question is not likely to cause harm when used as intended. This requires a complete review of the safety evidence for the ingredient and the submission of a GRAS filing with the FDA. The findings result in establishing compliance with FDA regulations for the food ingredient. • A GRAS determination can be either self-determined, independent of the FDA, or submitted to the FDA in the form of a notification for the Agency’s assessment.
  • 17. Other Regulatory Services www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC In addition to helping companies secure GRAS status for their ingredient, GRAS Associates offers an array of focused food safety consulting services that assist clients to obtain, maintain and defend GRAS opinions for success in the marketplace. These services include: • New Dietary Ingredient Notifications (NDIN) • Regulatory Compliance and Product Development Consulting • Medical Foods Compliance • Food and Color Additive Petitions • Food Contact Notifications (FCN) • cGMP Compliance • Technical Writing • Literature Surveillance • Research & Product Testing
  • 18. New Dietary Ingredient Notification (NDIN) www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC Section 413(c) of the Federal Food, Drug, and Cosmetic Act requires the submission of a notification for a dietary ingredient that was not marketed in the United States as a dietary supplement before October 15, 1994. The NDI notification process is complex. In fact, more than 80% of NDI notifications are rejected by the FDA. The team at GRAS Associations is well versed with NDI requirements and has assisted many clients in preparing and submitting notifications. Ensure the information needed to prepare and submit your NDIN is complete to an exceptional degree of quality
  • 19. Regulatory Compliance and Product Development Consulting www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC With the FDA, the Federal Trade Commission (FTC) and other regulators and lawmakers strictly enforcing regulations, food and dietary supplement organizations today must use discretion when it comes to ensuring compliance. Regulatory compliance and product development issues are extremely complex and without a thorough understanding of today’s regulatory landscape, many organizations are unable to succeed. Let us support your regulatory and product development efforts to gain a competitive edge while remaining compliant with industry regulations
  • 20. Medical Foods Compliance www.diteb.com Medical foods have become a hot product category in recent years. The FDA defines medical foods as foods “formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” While medical foods do not require pre-market approval by the FDA, they must comply with all applicable FDA requirements for foods. www.gras-associates.com GRAS ASSOCIATES LLC Have the confidence that your medical food is compliant with FDA requirements before going to market
  • 21. Food Additive and Color Petitions www.diteb.com Not every GRAS determination is successful and some substances are more suited for food additive petitions. A similar petition process is available for color additives that are intended to impart color to foods, drugs, cosmetics and medical devices. www.gras-associates.com GRAS ASSOCIATES LLC We will guide you through the FDA review process and ensure that your food additive or color petition documentation is complete to the highest level of quality and compliance
  • 22. Food Contact Notifications www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC Food contact materials are intended or have the potential to come in contact with food. When these materials come in contact with food, there is the possibility of the chemical substances migrating from the food contact material to the food, which could be potentially harmful to human health. Consequently, many regulatory bodies have implemented food contact regulations to ensure food safety. We deliver comprehensive regulatory support to help you submit food contact notifications.
  • 23. It’s time to discover your full market potential Partner with GRAS Associates to uncover greater market opportunities through innovative, expanded product offerings – starting with food safety and regulatory compliance. www.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC Contact us today at info@gras-associates.com to discuss your product goals.