GRAS, Dietary Ingredients, and Food Additives – Is Your Product Classified Correctly?

August 25, 2014 By

Ingredients used in foods and dietary supplements must be determined to be GRAS, old dietary ingredients (ODI), or approved NDI prior to use.

One of the most important jobs in marketing foods and dietary supplements in the USA is to classify your ingredients and finished products correctly by identifying GRAS (Generally Recognised As Safe) status, dietary ingredient status, and food additive status for each ingredient used.  Classifying incorrectly could mean that you are selling a novel ingredient that is not safe for use or you are complying with the wrong set of GMP regulations.  For example if you are selling a protein powder product, have you classified it as a food or dietary supplement? If you have classified the protein powder product as a food and some of the ingredients in the product are only permitted as dietary ingredients, this may cause the product to be a dietary supplement instead of a food. Also, if you classified the protein powder product as a food, 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. 

So how do you know if your product is classified correctly?  We have outlined a few starting points below to get you started on classifying GRAS, dietary ingredients, and food additives.

1.  A food ingredient must be self-affirmed GRAS or FDA approved GRAS before it can be sold in any food product.  However, a food product must contain only GRAS or approved food additive ingredients. Note: An ingredient with GRAS status can also be used in dietary supplements. 

It is possible to have GRAS on a finished food combination product, however, it seems that GRAS applications are usually focused on individual raw ingredients which can then be sold on their own as finished products or used in food combination products.

2.  A dietary ingredient (i.e. vitamins, minerals, herbs, botanicals, amino acids, enzymes) may be used only in dietary supplements unless the ingredient also has GRAS status.  If a dietary ingredient has GRAS status it may be used as a food ingredient and in a dietary supplement.

 If there is no evidence of a dietary ingredient 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 a Notification is sent regarding the NDI (this takes 75 days).  If a dietary ingredient is marketed prior to October 1994 then no prior approval is required. 

3.  Regarding food additives, any substance that is reasonably expected to become a component of food is a food additive and is subject to premarket approval by FDA, unless the substance is GRAS among experts qualified by scientific training and experience to evaluate its safety under the conditions of its intended use.

Classifying GRAS ingredients, dietary ingredients, and food additives can be a tricky venture and for assistance dicentra can help to classify all of your raw material ingredients and finished products.  We can  also help with identifying if your dietary ingredient will require a NDI notification and can help to submit a NDI if required. As an added benefit, dicentra can help to review claims made on your raw materials and finished product and help to provide the substantiation for those claims as required by FDA.

dicentra provides sought-after regulatory and scientific guidance on product and marketing compliance, quality assurance, research and development, new ingredient assessments and overall regulatory strategies for health-related products sold in North American marketplaces. Contact us at info@dicentra.com or at 1-866-647-3279.