To be used in foods and dietary supplements, ingredients must: be determined to be Generally Recognized as Safe (GRAS), be approved as a New Dietary Ingredient (NDI), be considered an Old Dietary Ingredient (ODI), or be approved by way of a food additive petition.
One of the most critical steps before marketing foods and dietary supplements in the USA is correctly classifying your ingredients and finished products. Proper classification involves identifying whether you should use the GRAS pathway, the dietary ingredient (NDI/ODI) pathway, or the food additive pathway to bring your product or ingredient to market. Classifying incorrectly could mean that you are selling a novel ingredient that is adulterated (not safe for use), or you are complying with the wrong set of Good Manufacturing Practices (GMP) regulations, both of which could result in enforcement from the FDA, including warning letters and costly recalls.
Imagine for example you are selling a protein powder product: if you have classified the protein powder product as food and some of the ingredients in the product are only permitted as dietary ingredients, this may cause the product to be classified as a dietary supplement instead of food. Also, chances are you are only complying with Food GMPs instead of dietary supplement GMPs. This is a huge difference in regards to the expensive quality control system that will have to be put in place for a dietary supplement in order to comply with dietary supplement GMPs.
Which pathway should I choose?
We have outlined a few starting points below to help you decide whether the GRAS pathway, the NDI or ODI pathway or the Food Additive pathway is right for your ingredient or product.
GRAS determinations can be used for both food ingredients and for dietary supplement ingredients.
A GRAS-affirmed ingredient is one that has been evaluated by qualified experts and deemed to be safe under the conditions of its intended use, based on publicly available scientific evidence. There are two types of GRAS statuses you can obtain for your ingredient(s).
The FDA will generally respond within 180 days of a GRAS submission, however, reserves the right to extend the review period by 90 days, for a total of 270 days.
It is possible to have GRAS on a finished food combination product; GRAS applications tend to focus on individual raw ingredients which can then be sold on their own as finished products or used in food combination products.
New Dietary Ingredient & Old Dietary Ingredient Pathways
A dietary ingredient (i.e. vitamins, minerals, herbs, botanicals, amino acids, enzymes) may only be used in dietary supplements unless the ingredient also has GRAS status.
If there is no evidence of a dietary ingredient being marketed before October 1994, then a “new dietary ingredient” (NDI) notification must be filed to FDA. This ingredient cannot be used in a product until at least 75 days after a Premarket Notification is sent regarding the NDI. If evidence exists that a dietary ingredient was marketed prior to October 1994, then the ingredient can be marketed as an Old Dietary Ingredient (ODI) and no prior approval is required.
Food Additive Pathway
Any substance that is reasonably expected to become a component of food is a food additive, and subject to premarket approval by FDA unless that substance is GRAS affirmed. A food additive petition can be submitted to the FDA to request the issuance of a regulation allowing new uses of the additive. This pathway requires considerable supportive data and can take upwards of 24 months to complete. While you may be thinking it would make more sense to pursue the GRAS pathway due to the time spent and complexity of this pathway, you may not have a choice, depending on your ingredient. For example, if your ingredient is currently listed on 21 CFR 182.1(b)(2) and you wish to use your ingredient for another use than which it was intended, you would need to submit a food additive petition.
In summary, whether you choose the GRAS, NDI, or Food Additive pathway will depend on your ingredient and its intended use. Choosing the right pathway will not only forestall costly non-compliance issues with the FDA but will also boost consumer confidence in your brand. This is where partnering with a regulatory expert at dicentra becomes a competitive advantage. Leverage our GRAS, NDIN, and Food Additive expertise and get to market faster.
Competitive advantage takes much more than just establishing the safety of your product or ingredient. Setting yourself apart from your competitors also includes demonstrating that your product or ingredient is effective. A product’s efficacy is demonstrated through human clinical trials necessary to substantiate health claims.
dicentra assists with all phases of ingredient and product development, from GRAS, NDI, and Food Additive Petition filing to full-service contract research operations that support the design and conduct of human clinical trials.
Get in Contact with us today to find out how we can help bring your products and ingredients to market.