Navigating GRAS Panels: A Guide to Best Practices

When it comes to introducing new substances into the world of food and dietary supplements, ensuring safety is paramount. The GRAS (Generally Recognized as Safe) designation plays a critical role in this process. The U.S. Food and Drug Administration (FDA) provides guidance on how to convene a GRAS panel effectively and responsibly, ensuring that the substances used are indeed safe for human and animal consumption. In this summary blog, we’ll explore the key takeaways from the FDA’s guidance on “Best Practices for Convening a GRAS Panel.

Understanding the GRAS Provision

GRAS, or “Generally Recognized as Safe,” is a designation that signifies that a substance is deemed safe for its intended use in food. However, obtaining this status is no small feat. The FDA offers valuable insights into this process, specifically when a GRAS panel’s input may be needed.

When Is a GRAS Panel Necessary?

In many cases, a proponent, the entity seeking GRAS status for a substance, may not require a GRAS panel to determine the safety of a new ingredient. The proponent can evaluate existing data and information independently. However, there are instances where the proponent might opt to consult a GRAS panel. This decision depends on the complexity of the substance or the potential need for expert opinions.

The Role of a GRAS Panel

A GRAS panel serves as a valuable resource, offering an expert assessment of the safety and suitability of a substance for its intended use. Importantly, the panel’s conclusion does not inherently establish general recognition of the substance’s safety. Instead, it serves as evidence that there is general acceptance within relevant scientific communities based on generally available information.

Choosing the Right GRAS Panel

The FDA emphasizes the importance of assembling a qualified and balanced panel. Members should possess subject matter expertise relevant to the scientific considerations associated with the intended conditions of use of the food substance. Only when a panel adequately represents a larger scientific community can its conclusions be considered “generally accepted.”

The Need for Expertise

A “GRAS panel” opinion carries weight only if its members have the expertise appropriate to address the safety questions specific to the substance in question. A panel consisting of scientists without the requisite expertise cannot establish “generally accepted” conclusions.

When a GRAS Panel May Not Be Necessary

In most cases, a robust GRAS conclusion can be reached without the input of a GRAS panel. Therefore, proponents should carefully assess whether the resources and efforts required to convene such a panel are warranted for their specific case.

FDA’s Guidance Recommendations

The FDA’s guidance offers recommendations for those considering GRAS panels:

  1. Identifying Panel Members: Ensure that GRAS panel members have appropriate expertise in the relevant field.
  2. Mitigating Bias: Take steps to reduce any potential bias or conflicts of interest among panel members to maintain the credibility of the panel’s output.
  3. Limiting Data and Information: Only provide GRAS panels with public information, avoiding trade secret data.


In summary, the FDA’s guidance on convening GRAS panels provides essential insights into the complex process of establishing the safety of food substances. The right choice between seeking a GRAS panel’s input or relying on independent evaluation depends on the circumstances. Ensuring that the panel is composed of qualified experts and that potential biases are minimized is crucial. Ultimately, the GRAS process plays a pivotal role in protecting the safety of consumers and maintaining the quality of the food supply.


Navigating the Regulatory Landscape: Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices

Navigating the Regulatory Landscape: Understanding FDA FURLS, FDA Approved, and FDA Registered Medical Devices


The process of bringing a medical device to market in the United States involves stringent regulations imposed by the Food and Drug Administration (FDA). Understanding the distinction between FDA FURLS (FDA Unified Registration and Listing System), FDA Approved, and FDA Registered is crucial for manufacturers and distributors seeking to comply with these regulations. This article explores the differences between these designations and provides insights into how to obtain the necessary licenses for medical devices.

Device Registration and Listing Requirements

Since October 1, 2012, specific medical device listing requirements have been in effect. It is imperative for all stakeholders to adhere to these regulations:

  • All proprietary names under which a device is marketed must be reported during initial listing and in the annual update of registration and listing information.
  • Combination products, which include devices and biological products or drugs, must be clearly identified, specifying the type of combination product, such as convenience kit or prefilled drug delivery device, through the FDA Unified Registration and Listing System (FURLS).
  • Regardless of commercial distribution, all contract manufacturers and sterilizers of finished devices are obligated to register and list their products.
  • Initial importers must identify the manufacturers of the devices they import.
  • Foreign establishments exporting devices to the United States must identify all known U.S. importers of their devices.
  • Devices must be listed by the manufacturer, specification developer, single-use device reprocessor, remanufacturer, or re-packer/re-labeler before a foreign exporter, contract manufacturer, or contract sterilizer can list them.
  • Establishments handling complaints, previously registered as manufacturers or specification developers, should update their establishment type to “Complaint File Establishment.”

FDA Approved: Ensuring Safety and Efficacy

FDA approval refers to the process by which a new medical device undergoes rigorous evaluation to ensure its safety and efficacy before it can be marketed in the United States. The approval process involves the submission of a premarket approval (PMA) application or a 510(k) premarket notification, depending on the device’s classification. PMA applications are required for Class III devices, which are high-risk devices such as implantable pacemakers and certain diagnostic imaging devices. 510(k) premarket notifications are for devices that are equivalent to a legally marketed device (predicate device) and are typically lower risk.

FDA Registered: Establishment Compliance

FDA registration is a mandatory requirement for all medical device establishments. It involves providing detailed information about the facility, its operations, and the devices it manufactures, processes, packs, or holds. FDA-registered establishments are subject to inspections to ensure compliance with FDA regulations, including good manufacturing practices (GMP). Registration is a prerequisite for selling medical devices in the U.S. market, and failure to register can lead to serious consequences, including legal actions and fines.

How to Obtain Licenses? Step-by-Step Guide

  1. Determine Device Classification: Identify the correct classification of your medical device according to the FDA’s classification system (Class I, II, or III).
  2. Prepare Necessary Documentation: Depending on the device classification, prepare the required documentation, such as a 510(k) premarket notification or a PMA application. Work closely with regulatory experts and consultants to ensure the accuracy and completeness of the submission.
  3. Submit Application: Submit the application to the FDA along with the required fees. The FDA will review the submission and provide feedback or request additional information if necessary.
  4. Facility Registration: Concurrently, ensure that your establishment is registered in the FDA FURLS database. Update registration information annually to maintain compliance.
  5. Quality System Requirements: Implement a quality management system compliant with FDA regulations, including GMP. Prepare for FDA inspections to demonstrate compliance with quality system requirements.
  6. Post-Market Surveillance: Establish a post-market surveillance system to monitor the performance and safety of your device after it enters the market. Report adverse events and product issues promptly to the FDA.


Navigating the intricate regulatory landscape of medical device approval and registration demands a deep understanding of FDA FURLS, FDA Approved, and FDA Registered designations. By aligning with expert consultants and regulatory professionals, manufacturers and distributors can successfully obtain the necessary licenses, providing safe and effective medical devices to enhance healthcare outcomes for patients across the United States.

Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license.  We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.


What is a CCP in HACCP? Understanding Critical Control Points and Regulatory Compliance

What is a CCP in HACCP Introduction

In food safety management, Hazard Analysis and Critical Control Points (HACCP) is a systematic approach that ensures the production of safe food products.

At the heart of HACCP lies the identification and management of Critical Control Points (CCPs). This article delves into the significance of CCPs in HACCP, exploring their definition, importance, and the regulatory standards governing their implementation.

Defining Critical Control Points (CCPs)

A Critical Control Point (CCP) in HACCP refers to a step in the food production process where control can be applied to prevent, eliminate, or reduce food safety hazards to acceptable levels. These hazards include biological, chemical, or physical factors that can lead to contamination if not properly managed.

Importance of CCPs in HACCP

  1. Risk Reduction: CCPs are pivotal in reducing the risks associated with foodborne illnesses. Identifying and controlling these points significantly diminishes the likelihood of hazardous contamination.
  2. Quality Assurance: Implementing CCPs ensures consistency in product quality. Businesses can offer consumers reliable and safe food products by maintaining strict control at critical points.
  3. Compliance with Regulations: Regulatory bodies worldwide mandate the adoption of HACCP principles in the food industry. Identifying and managing CCPs not only ensures safety but also aids in complying with international food safety standards.

Regulatory Standards Governing CCPs

  1. FDA Food Safety Modernization Act (FSMA): Enforced in the United States, the FSMA emphasizes preventive measures. Businesses must implement HACCP-based food safety plans, including CCP identification and management.
  2. European Food Safety Authority (EFSA): The EFSA sets guidelines for CCP identification within the European Union, ensuring that food businesses adhere to rigorous safety standards.
  3. Codex Alimentarius Commission: This international body establishes food standards and guidelines. Codex HACCP principles, including CCP identification, serve as a benchmark for global food safety practices.

CCP Implementation Process

  1. Conducting a Hazard Analysis: The first step involves identifying and assessing potential hazards in the production process. These can include biological risks like pathogens, chemical hazards, or physical contaminants.
  2. Determining Critical Control Points: Based on the hazard analysis, businesses identify CCPs. These are specific points in the production process where control measures are applied to mitigate the identified risks.
  3. Establishing Critical Limits: CCPs must operate within specific limits to ensure safety. Establishing critical limitations involves setting boundaries for factors such as temperature, time, pH levels, and microbial counts.
  4. Implementing Monitoring Procedures: Continuous monitoring of CCPs is essential. This involves regular checks, measurements, and observations to maintain critical limits.
  5. Corrective Actions: Protocols are established to address deviations from critical limits. When a CCP falls out of the acceptable range, disciplinary actions are taken to bring the process back under control.
  6. Verification and Record-Keeping: The effectiveness of CCPs is regularly verified through methods like testing and audits. Detailed records of monitoring, corrective actions, and verification activities are maintained as proof of compliance.


Understanding Critical Control Points (CCPs) in the context of HACCP is paramount for ensuring food safety, quality, and regulatory compliance. By systematically identifying, monitoring, and controlling CCPs, food businesses can uphold the highest standards, safeguard consumers, and thrive in an industry where safety is paramount. Compliance with established regulations is a legal requirement and a commitment to consumers’ well-being, making CCPs a cornerstone in the global food industry.


HACCP Process and CCP

The evolution of food safety standards

Why are HACCP consultants important?

7 principles of HACCP and how they impact food safety

HACCP to CCPs Food Standards Evolution

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent. 

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