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Strengthen Your Self-Affirmed GRAS

 Leverage SGS Nutrasource's scientific and regulatory expertise to help strengthen evidence packages, and prepare for evolving FDA expectations. 

 

Visit booth 5165 at SupplySide Global to Meet our Regulatory Team

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Have regulatory questions about your ingredient? Our team looks forward to connecting at SupplySide to discuss topics such as: 

Which pathway is right for your ingredient (GRAS or NDIN)?
Our team needs to understand what exactly your ingredient is, how it’s produced, and how it’s intended to be used in the U.S. before we can recommend the pathway that will provide you with the highest likelihood of a successful notification to the FDA. 
Are you looking to convert a self-affirmed GRAS into an FDA-notified GRAS?
Our team of regulatory scientists and toxicologists can evaluate your current dossier and determine if a sufficient data set exists to progress directly into an FDA-notified GRAS, or if additional data are needed to support a stronger and more current GRAS conclusion. 
Can you leverage existing toxicology data, or do you need your own studies?
Our team can review existing toxicology studies, as well as the details and composition of your ingredient, to determine whether the existing data is sufficient to support a new GRAS or NDIN submission, or if additional studies are needed. This determination relies not only on the quality of the existing studies, but also on the quantitative and qualitative similarities between the ingredients which have been studied and the ingredient of interest. 
Do you already have a notified GRAS, but are looking to make significant changes?
Our team has extensive experience submitting GRAS supplements to the FDA. A supplement can allow you to make changes to the intended use or manufacturing process while maintaining the safety and compliance of your ingredient in the U.S. food supply. 

Prepare for potential FDA changes

The FDA has proposed changes that could significantly increase oversight and transparency for GRAS determinations. For companies relying on self-affirmed GRAS conclusions, now is the time to evaluate whether the scientific evidence supporting your conclusion is complete, current, and robust. 

From Self-Affirmed to Regulatory Ready

 SGS Nutrasource brings the expertise to guide you every step of the way. 

Step 1 - Assess

Unsure if your self-determined GRAS can withstand scrutiny? Our team of scientists and board certified toxicologists will review your existing GRAS dossier and scientific data to evaluate the strength of your current safety foundation and identify potential gaps. During this first step, we will take into account your ingredient, intended use, exposure, toxicology data, and relevant scientific literature to determine whether additional evidence may be needed.

The goal is to identify gaps before they become costly roadblocks.

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Step 2 - Plan

Based on the assessment of your existing data, SGS Nutrasource develops a targeted research strategy to address identified gaps and answer outstanding safety questions. Where additional evidence is needed, our experts determine the appropriate studies and approach to generate it.

Step 3 - Strengthen

When existing data leaves unanswered safety questions, SGS Nutrasource develops a tailored nonclinical and toxicology program around your ingredient and objectives. Our team of board-certified toxicologists and scientists can guide the process from study strategy and GLP-compliant planning through laboratory coordination, study oversight, and evaluation - helping you generate the right evidence while avoiding unnecessary studies. 

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Step 4 - Finalize with Confidence

SGS Nutrasource brings your updated safety and scientific data together to revise and strengthen your GRAS dossier - creating a comprehensive, scientifically supported document that reflects your current evidence, and is ready to file if needed. 

 One Team. One Strategy. One Clear Direction. 

Trusted By

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“We are very excited to see Eriomin achieve self-GRAS status. The reception of this goes to show our continued investment and focus, as a leading manufacturer and supplier of citrus flavonoids, on developing and researching these beneficial ingredients.” IBN USA
“GRAS Associate (GA)’s team was highly professional, providing clear guidance appropriate tothe situation on the materials required for the submission. Their experts, with diversebackgrounds, offered valuable insights, particularly on safety considerations, ensuring ourapplication was robust and well-prepared. Additionally, GA's extensive experience incommunicating with the FDA was invaluable. They expertly managed amendments and guidedus through the complexities of the process with confidence and efficiency.” BTC Corporation (South Korea)
“The scientists at GRAS Associates did an excellent job pulling together all the sources of information to present a clear methodical assessment of the safety profile for our product. They also assembled a first rate peer review team to evaluate all the analysis and conclusions prior to sending it in to FDA. Once they provided it all to the FDA, they professionally dealt with any questions that came back and worked with me to provide the best answers possible. I would highly recommend GRAS Associates for similar applications to FDA.” Fresh Inset (USA)
“Working closely with the dedicated Nutrasource team for this completed CuminUP60® GRAS affirmation opens the door for conventional food usage, like nutritional beverages, protein powders, sport and energy drinks, condiments and sauces, et al. We are excited about all the possibilities with CuminUP60®.” Chenland Nutritionals (China)
“We are excited to receive the Letter of No Objection from the FDA to our Enzyme Modified Steviol Glycosides (EMSG) GRAS notification. The response underscores the safety of HOWTIAN's EMSG products, opening the opportunity to use them in a wide range of applications.” HOWTIAN (China)
“GRAS Associates was selected to prepare the GRAS dossier and notification to FDA due to having a higher than industry average success rate along with the expectation of smooth communication through Nutrasource Asia, which is based in Korea. Our expectations were correct, and we are pleased to say that this is the first GRAS notified strain to FDA as an oral probiotic in Korea. We believe this lays the foundation for entering the global market.” OraTicx (South Korea)

Why Leading Brands Choose Us

Having submitted 90+ GRAS Notifications to the FDA, our team boasts unparalleled experience.

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More FDA experience
than any other provider
as #1 GRAS notifier of 2025

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Experience across Asia, North America, and global markets.

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90% of GRAS notifications received no questions letters.

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Direct experience communicating with the FDA.

Get Started - Connect with Us