gras associates corporate overview

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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

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• 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)



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• 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



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• 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



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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.



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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.diteb.comwww.gras-associates.com GRAS ASSOCIATES LLC

Dr. Richard Kraska, Ph.D., DBAT


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.


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


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.

What is GRAS status?


• 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?


• 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


• 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.

Other Regulatory Services


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)


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


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

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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.


Have the confidence that your medical food is compliant with FDA requirements before going to market

Food Additive and Color Petitions

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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.


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


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.


Contact us today at [email protected] to discuss your product goals.

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