What is the right US regulatory pathway for your food and dietary supplement ingredient?
Food and dietary supplements must be safe, and many markets enforce complex systems of regulations to protect human health. When accessing US markets, products must comply with requirements set by the Food and Drug Administration (FDA) or Department of Agriculture (USDA), as well as the Food Safety Modernization Act (FSMA) and strict labeling conditions concerning nutrition, allergens, claims and ingredients.
If you plan to launch a food product or dietary supplement containing a new ingredient onto the US market, typically you will need to choose one of two pathways to demonstrate compliance – generally recognized as safe (GRAS) notification or new dietary ingredient notification (NDIN). Which route you choose will depend on several factors, including the type of product, potential safety concerns and the proprietary nature of the substance.
Is your ingredient safe?
Most ingredients in your product’s formulation will be well known and understood by the authorities, meaning there shouldn’t be a problem in gaining market access. However, new product formulations may contain innovative ingredients that are unknown to the authorities. In these cases, the ingredient may be considered an adulteration, which could lead to the product being recalled, refused entry or seized. There is even the possibility that the FDA will issue a warning letter, seek a court injunction or file criminal charges.
GRAS and NDIN are the two routes to regulatory compliance, and it is therefore important to understand them and their nuances and differences.
What is GRAS?
Applies to any chemical or substance added to either a food product or dietary supplement, so long as it has been properly evaluated by qualified experts and found to be generally recognized as safe for its intended use. FDA GRAS designation exempts the ingredient from the usual food additive petition process under the Federal Food, Drug and Cosmetics Act (FFDCA).
Two pathways to achieving GRAS status:
1. Self-affirmed GRAS: the manufacturer conducts their own safety assessment using qualified experts for the determination
2. FDA-notified GRAS: the manufacturer notifies the FDA of their self-affirmed GRAS. The FDA reviews the submission and, if it has no questions regarding safety, issues a ‘no questions’ letter
What is NDIN?
Only applies to dietary supplements. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), an ingredient not marketed in the US before October 15, 1994, is designated a new dietary ingredient (NDI). Examples might include a new plant extract or isolated compound.
You are required to submit a new dietary ingredient notification (NDIN) to the FDA at least 75 days prior to the introduction of your product onto the US market. This must contain:
GRAS or NDIN?
Which route is best for you depends on your product and strategic goals. You should start by considering whether the product qualifies as a dietary supplement under DSHEA. If it does, then you will need to know whether the ingredient was used in dietary supplements before October 5, 1994. Consideration should also be given to the level of safety evidence that exists, the proprietary nature of the formulation, target populations and potential safety concerns regarding specific groups (e.g. pregnant women or young children). Finally, you will need to think about the product’s organoleptic properties, specific ingredient factors (e.g. probiotics or nature-identicals), and your desired approval timeline.
Manufacturers of food products and dietary supplements where the ingredients have a long history of use and there is publicly available expert-created safety data may well consider the GRAS route. Under this system, you will be required to select the food categories and provide consumption analysis that shows the maximum daily intake. You must also supply safety data that supports the intended level of use. While FDA notification is voluntary, it is recommended, and you will normally receive a response within 180 days from the filing date.
If your ingredient qualifies under the definition for an NDI, and it was not used in a dietary supplement before October 15, 1994, and supporting safety data is not publicly available, then you may choose the NDIN route. Under this scheme, use is based on recommended intake. This route has the benefit that you can exclude higher-risk populations (young children, pregnant mothers, etc.). FDA notification is mandatory, and the FDA will respond within 75 days.
There are advantages to both routes, but choosing the wrong one for your business could result in unnecessary delays. To choose the best route, it is advisable to seek expert support.
SGS solutions
SGS offers unrivaled expertise in filing GRAS and NDIN. We work alongside your team, helping you choose the right route, conducting gap analysis, overseeing necessary testing, assembling safety and manufacturing data, and helping with the preparation and review of the final dossier for submission.
We offer this service as part of a comprehensive range of food ingredient regulatory compliance solutions, which also covers:
· Claim substantiation
· Master file submissions to Health Canada
· Intellectual property protection strategies
· Laboratory-based product certifications
· Novel food dossiers for the UK, EU, Canada and South Korea
· Branded ingredient strategies
· Efficacy study design and execution for global markets
Partner with us and enjoy the benefits of working with a global leader that enjoys a 90% success rate in helping food and dietary supplement businesses achieve seamless regulatory compliance.
Learn more about our food ingredient regulatory compliance solutions .
For more information, contact:
Amy Mozingo
Vice President of US Nutra Regulatory Sciences
SGS Nutrasource
Email: nutrasource@sgs.com