For businesses in the food and dietary supplement industries, regulatory compliance with the U.S. Food and Drug Administration (FDA) is critical. Two key pathways to ensure the safety of ingredients are the GRAS (Generally Recognized As Safe) notification and the NDIN (New Dietary Ingredient Notification). While both serve to protect consumers, they differ in terms of requirements, scope, and legal frameworks. This guide will help you better understand the distinctions, but also identify the risks of not complying correctly with the FDA. Setting your business up for regulatory success and avoiding costly delays or errors is what we will achieve so let’s get started.
What is GRAS (Generally Recognized As Safe)?
GRAS is a designation by the FDA that allows certain substances to be added to food if they are proven safe based on scientific research or long-term common use. GRAS status means a company can use these ingredients without needing to go through the more rigorous and expensive food additive approval process.
Key Elements of GRAS:
- Legal Framework: GRAS falls under the Federal Food, Drug, and Cosmetic Act (FD&C Act), which governs food additives.
- Basis for GRAS: A substance can qualify for GRAS status if it has a long history of common use in food (before 1958) or if scientific experts agree that it is safe for its intended use.
- Self-Determination: Companies can self-determine a substance’s GRAS status without submitting a notification to the FDA. This means that a company can use an ingredient based on its own scientific evaluations without involving the FDA.
- Voluntary Notification: While it’s not required, many companies submit a GRAS notification to the FDA. This allows the FDA to review the safety data and either raise no objections or ask for more information. However, the FDA does not “approve” GRAS substances.
- Use in Foods: GRAS is primarily intended for substances used in conventional foods. Some GRAS substances can also be used in dietary supplements, but only if they meet specific supplement requirements.
Examples of GRAS Substances:
- Common examples include salt, sugar, and natural flavoring agents. These ingredients have been safely used in foods for decades, which is why they qualify for GRAS status.
What is NDIN (New Dietary Ingredient Notification)?
NDIN is a requirement for new ingredients used in dietary supplements. If a dietary ingredient wasn’t marketed in the U.S. before October 15, 1994, companies must notify the FDA before selling it. This ensures that the new ingredient is safe for consumers.
Key Elements of NDIN:
- Legal Framework: NDIN falls under the Dietary Supplement Health and Education Act (DSHEA) of 1994, which regulates dietary supplements separately from conventional foods.
- New Dietary Ingredients (NDIs): Any dietary ingredient not sold in the U.S. before October 15, 1994, is considered a new dietary ingredient (NDI). These could include vitamins, minerals, herbs, enzymes, or other dietary substances.
- Mandatory Notification: Unlike GRAS, submitting an NDIN is required by law. Companies must submit an NDIN to the FDA at least 75 days before marketing a supplement containing a new dietary ingredient.
- Safety Data: Manufacturers must provide safety data, such as toxicology studies or human trials, to show that the NDI is reasonably safe under its intended use.
- FDA Review: After receiving an NDIN, the FDA reviews the safety data and may either acknowledge the notification, request more information, or raise safety concerns. If there are concerns, the product cannot be marketed until they are resolved.
Examples of NDIN Ingredients:
- New botanical extracts, probiotics not marketed before 1994, or newly synthesized vitamins are typical examples of NDIs that require an NDIN submission.
Key Differences Between GRAS and NDIN
While both GRAS and NDIN ensure ingredient safety, they are different in several ways:
1. Legal Framework and Scope
- GRAS: Applies to food additives and substances used in conventional foods, regulated under the FD&C Act.
- NDIN: Applies to new dietary ingredients used in supplements, regulated under DSHEA.
2. Notification Requirement
- GRAS: Submitting a notification to the FDA is voluntary. Companies can self-determine GRAS status without involving the FDA.
- NDIN: Notification is mandatory for any dietary supplement ingredient that wasn’t marketed before 1994.
3. Product Type
- GRAS: Used for ingredients in conventional foods.
- NDIN: Used for new ingredients in dietary supplements.
4. Basis for Safety
- GRAS: Based on a history of safe use or agreement among scientific experts.
- NDIN: Requires new safety data to prove that the ingredient is safe.
5. FDA Involvement
- GRAS: FDA involvement is optional. If companies notify the FDA, the agency reviews the data but does not formally approve the substance.
- NDIN: The FDA must review and respond to all NDINs. If the FDA has safety concerns, the product cannot be marketed.
6. Review Timeframe
- GRAS: Since GRAS notifications are voluntary, there is no required timeline for FDA review. However, if notified, the FDA typically responds within 180 days.
- NDIN: The FDA is required to review NDINs within 75 days, and the product cannot be sold until the FDA responds.
Choosing Between GRAS and NDIN: When to Use Each Pathway
It’s important for companies to understand when to use the GRAS pathway versus the NDIN pathway.
Use GRAS if:
You are introducing a food additive or substance that will be used in conventional foods, and the ingredient has a long history of safe use or scientific backing.
Use NDIN if:
You are introducing a new dietary ingredient in a supplement that wasn’t marketed before 1994, and new safety data is needed to prove its safety.
The Cost of Failing FDA Regulations
Understanding the difference between GRAS and NDIN is essential for regulatory compliance. Failing to comply with FDA regulations can lead to product recalls, legal issues, or considerable financial penalties. Consulting with regulatory experts will help businesses avoid these risks and ensure that their products meet FDA safety standards.
GRAS Experts Can Help You Navigate Regulatory Compliance Successfully
Navigating the GRAS and NDIN pathways can be complicated and expensive if not done correctly. GRAS Experts, a division of Quality Smart Solutions, provides the expertise needed to guide companies through these regulatory processes, helping them avoid unnecessary expenses and costly delays. With their help, your business can achieve compliance efficiently, ensuring that your products meet FDA standards while saving both time and money. Reach out to GRAS Experts to streamline your journey through regulatory compliance today.
