Amazon Seller Compliance

Self-affirmed GRAS

Our team of compliance experts can help you with the requirements of self-affirmed GRAS (Generally Recognized as Safe), such as determining if GRAS status is necessary for your ingredient, preparing a self-affirmed GRAS dossier, and ensuring that your ingredient meets safety requirements for commercial sale in the US market.

The Generally Recognized as Safe (GRAS) self-affirmation process under the Food Safety Modernization Act (FSMA) offers certain benefits to food and ingredient manufacturers. GRAS self-affirmation allows a company to determine, based on scientific evidence, that a substance is safe for its intended use in food and does not require pre-market approval from the U.S. Food and Drug Administration.

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Benefits of GRAS self-affirmation under FSMA:

  1. Expedited Process: GRAS self-affirmation provides a potentially faster and more streamlined pathway for establishing the safety of an ingredient compared to the formal GRAS notification process that involves FDA review.

  2. Flexibility and Autonomy: Companies have the autonomy to conduct their own safety assessments and make determinations about the safety of their ingredients. This allows for greater flexibility in the evaluation process.

  3. Cost Savings: Avoiding the formal GRAS notification process can result in cost savings, as companies do not need to engage in the extensive data compilation and submission required for FDA review.

  4. Confidentiality: The GRAS self-affirmation process may allow companies to keep proprietary information and trade secrets confidential, as the information submitted to the FDA is not subject to public disclosure in the same way as a formal GRAS notification.

  5. Customization: Companies can tailor their safety assessments and evaluation processes to their specific ingredients and intended uses, allowing for a more customized approach.

  6. Timely Market Entry: The ability to self-affirm GRAS status can enable companies to bring new ingredients to market more quickly, as there is no waiting period for FDA review.

  7. Innovation: The GRAS self-affirmation process encourages innovation by allowing companies to introduce new and innovative ingredients to the food supply without the need for extensive regulatory review.

  8. Expertise Utilization: Companies can engage their own qualified experts to conduct safety assessments, ensuring that those with the most knowledge about the ingredient are involved in the determination process.

GRAS self-affirmation places the responsibility on companies to conduct thorough and credible safety assessments. It’s advisable to ensure that the safety assessment process follows established scientific principles and that the conclusions are well-supported by scientific evidence. Companies considering GRAS self-affirmation should also be prepared to provide documentation and evidence of their safety assessment if requested by regulatory authorities.

Self-affirmed gras database

Self-affirmed GRAS Overview

With self-affirmed GRAS, a company convenes a panel of professionals to evaluate the safety of a specific ingredient and then informs the FDA (through a “GRAS Notification”) of their findings. With self-affirmation, the FDA then evaluates the information provided in the GRAS notification and responds to the company with their decision on whether or not they agree with the basis of GRAS determination. Nonetheless, the GRAS notification procedure involves a rigorous process and criteria to conclude that the use of a substance in food is safe.

Why GRAS Ingredients are Important

GRAS ingredients ensure safety of the food supply and ultimately, consumers. Non-GRAS food additives require the company to notify the FDA a minimum of 75 days before the food or supplement enters the market. In the notification, manufacturers are required to disclose a wealth of information such as the amount to be consumed, history of the use of the ingredient,  conditions for use and published articles and citations or other evidence that prove that the product containing the non-GRAS ingredient is safe to use. When it comes to GRAS ingredients, no further notification to the FDA is required because the ingredient is already deemed safe to use.

self-affirmed GRAS list

The experts at QSS can help with self-affirmed GRAS

It’s important to stay informed about updates to FSMA regulations and FDA guidance related to GRAS self-affirmation. As a leading scientific and regulatory consulting and compliance firm, we provide assistance with self-affirmed GRAS dossiers and services. Our experienced team assesses the safety of ingredients to be added to foods.

We are able to create a fulsome self-affirmed GRAS dossier for your product. Self-affirmed GRAS contains a complete introduction of your product, extensive literature reviews and references, and all available safety data and toxicology. For more information on GRAS self-affirmation solutions check out our dedicated GRAS page.

Frequently Asked Questions

In Self Affirmed GRAS, a company convenes a panel of professionals to evaluate safety of a specific ingredient and then informs the FDA (through a “GRAS Notification”) about their affirmation that the use of a substance is GRAS. With self-determination, FDA then evaluates the information given in the GRAS Notification and responds to the company whether it agrees with the basis of GRAS determination. Nonetheless, the procedures to GRAS involve rigorous processes and criteria to conclude that the use of a substance in food is GRAS.

GRAS ingredients ensure safety of food supply and the safety of consumers. Non-GRAS-approved additives require the company to notify FDA a minimum of 75 days before the food or supplement enters the market. In the notification, manufacturers are required to disclose a wealth of information such as the dose, history of the use of the ingredient, conditions for use, published articles and citations or other evidence that prove that the product containing the non-GRAS ingredient is safe to use. When it comes to GRAS ingredients, it does not involve submitting a GRAS dossier to the FDA because the ingredient is already deemed safe to use.

These ingredients have undergone extensive safety evaluations to be classified as an ingredient that is guaranteed to not cause harm when used as it is supposed to be used.

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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