How FDA GRAS Compliance Helps Grow Your Business

If you manufacture or import food ingredients, supplements, or food additives, you may need to obtain GRAS (Generally Recognized as Safe) notice. If you are considering seeking FDA GRAS notice, we can help you navigate the complex GRAS process. Our team of experienced GRAS consultants can help you prepare your GRAS submission, navigate you through FDA GRAS notification process and ensure that it meets FDA standards.

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Why do You Need GRAS Notice?

GRAS stands for “Generally Recognized as Safe,” and it refers to substances that experts have deemed safe for human consumption based on scientific evidence and widespread usage. If your product ingredients aren’t in FDA GRAS notice inventory, then you may need a GRAS notice for sale in the US. GRAS substances can be either direct food additives or indirect food additives.

What are GRAS Substances?

As of November 2023, FDA’s Inventory for Human Food lists over 10,000 substances as GRAS. The most common GRAS substances include: ·

Direct food additives: Salt, sugar, spices, vitamins, minerals, enzymes, preservatives, flavourings, colourings, and processing aids.
Indirect food additives: Substances that migrate from food packaging materials or that are used in the manufacturing of food processing equipment.

How GRAS Protects and Grows Your Business?

Companies submit GRAS notices for diverse reasons, including gaining consumer confidence, reducing regulatory risk, and expanding market reach globally.

Bring New Products to Market Faster

GRAS status is recognized by regulatory agencies around the world, which means that food manufacturers can be confident that their products are safe if they contain GRAS substances. GRAS status can help expedite the approval process for new food ingredients and additives and bring new products to market more quickly.

Regulatory Compliance

With 2,441 GRAS notices submitted to the FDA, the importance of this voluntary safety standard cannot be overstated. In 2022 alone, 247 companies sought GRAS approval, emphasizing the continuous commitment to safety and consumer trust. The most common type of notice, often for new food additives, reflects the dynamism of the food, beverage, and dietary supplement industries.

Importance of GRAS for Food Safety

The GRAS process is designed to ensure that only substances that have been thoroughly evaluated and deemed safe are allowed to be used in food. GRAS substances are based on a rigorous scientific evaluation. Substances that are considered GRAS have been subjected to extensive scientific testing and evaluation to ensure that they are safe for human consumption

Gain Consumer Confidence

GRAS notice is not just a regulatory requirement; it's a powerful tool to gain consumer confidence. In an era where consumers prioritize safety, demonstrating that your products meet the FDA's high safety standards is paramount.

What are GRAS Notice Timelines?

The GRAS notice review timeline varies, influenced by substance complexity and data completeness. Expedite your submission with high-quality data and prompt responses to FDA queries. Consulting with our GRAS experts is a strategic move to optimize submissions, increasing the likelihood of a favourable outcome.

Starting with meticulous preparation, our experts guide you through the comprehensive notice submission within the FDA’s electronic portal. Within 30 days, the FDA acknowledges receipt, initiating a thorough 180-day evaluation process.

Transparency is paramount as the FDA may issue requests for additional information. Our consultants assist you in crafting a robust response, expediting the FDA’s final response. Whether it’s a letter of non-objection, denial, or an extension, our experts navigate these outcomes with precision, ensuring compliance and success.

FDA GRAS Compliance Solutions We Offer for Your Food & Beverages Business

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Connect with FDA Compliance Experts

With Quality Smart Solutions as your trusted partner, you can navigate the GRAS notice process with confidence, knowing that your company is in capable hands.

We are committed to helping companies achieve GRAS recognition and bring safe, innovative food ingredients to North American market.

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