Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is considered approved (and the product will not be considered adulterated upon formulation) for use, you have a decision to make: Do you wish to obtain ingredient approval through GRAS (Generally Recognized As Safe) or via NDI (New Dietary Ingredient)?
This blog will explore the concepts and requirements surrounding both GRAS and NDI to help you navigate your ingredients into the US food supply. We will discuss each pathway and reasons why your company may want to favour one over the other.
What Does GRAS stand for?
GRAS stands for “Generally Recognized As Safe”. GRAS is the more flexible option as these decisions allow use in foods and dietary supplements no additional processing is applied to the ingredient.
How Do I Classify my Ingredient as GRAS?
Ingredients can be self-affirmed GRAS or submitted via notification to the FDA for approval.
Self-Affirmed – The ingredient must be widely used in the food supply to meet the self-affirmed criteria. GRAS assessments require the substantiation/evidence to be made available to the public upon approval, thus limiting discretion. The requirement for proof is use in conventional foods for a long period of time and/or the food is considered safe by experts. Essentially you need to prove safe historical use.
Notification to the FDA – FDA reserves the right to take 180 days or longer to evaluate a GRAS notification. Once an ingredient is approved via the GRAS route, it can be used in both food and dietary supplements. GRAS ingredients must meet the safety standard: reasonable certainty of no harm under the intended use conditions. GRAS ingredients must meet the lower GMP standards set out in 21 CFR 110. To summarize, this notification process takes longer to obtain, but allows for use of the ingredient in food and dietary supplements.
What Does NDI Stand For?
NDI stands for “New Dietary Ingredient”. Unless considered an ‘old dietary ingredient’ (used in dietary supplement products prior to October 15, 1994), an NDIN (New Dietary Ingredient Notification) must be sent to and approved by the FDA. NDI approved ingredients are only approved for use within Dietary Supplements, thus limiting applications and uses of your ingredient.
The NDI notification process will keep your submitted documentation largely between you and the regulator and is a good option for proprietary research/documentation. The NDI review standard is within 75 days, a considerably shorter timeline. NDI ingredients must meet the safety standard: does not present a significant or unreasonable risk of illness or injury. NDI ingredients must meet the higher GMP standards set out in 21 CFR 111. To summarize, this notification process is shorter in overall length, but only allows your ingredient to be used in dietary supplements.
In conclusion, although the GRAS notification process takes longer on average it allows the most flexibility for end use (ie. use in dietary supplements and in food). NDI allows you to keep your documentation private, has a shorter review period but only allows you to market your ingredient within Dietary Supplements. There are pros and cons to each. Ultimately, how you wish to position your finished goods is the best deciding factor to choose GRAS or NDIN. The self-affirmed pathway allows for the quickest pathway to market, but you are still required to have significant evidence/proof.
How Quality Smart Solutions can help:
Please contact our team for more information on food classification, ingredient feasibility questions, ingredient submissions, and food labelling projects. Our specialists are here to help!