SGS, the world’s leading testing, inspection and certification company, guides food product and dietary supplement manufacturers in choosing the optimal path for compliance in the US market when introducing new ingredients. 

Food and dietary supplement manufacturers operating in the US market face a critical decision when introducing products with new ingredients: should they pursue generally recognized as safe (GRAS) status or submit a new dietary ingredient notification (NDIN)? Choosing the right path is vital for ensuring regulatory compliance and the successful launch of products into the market. 

Safety is paramount in the food and dietary supplement industries. New products must navigate a complex regulatory landscape governed by the Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). This includes compliance with the Food Safety Modernization Act (FSMA) and adherence to strict labeling requirements relating to nutrition, allergens, claims and ingredients.  

The two primary pathways for bringing new ingredients to US markets are GRAS and NDIN. The best route for the manufacturer or importer depends on factors such as product type, potential safety concerns and the proprietary nature of the formulation. 

GRAS is a designation by the FDA. It signifies that an ingredient is considered safe by qualified experts. There are two options for achieving GRAS status:

• Self-affirmed GRAS – the manufacturer conducts the safety assessment using qualified experts

• FDA-notified GRAS – the manufacturer notifies the FDA of their self-affirmed GRAS, the FDA reviews it and issues a ‘no questions’ letter if there are no safety concerns 

Alternatively, dietary supplement manufacturers can choose the NDIN route under the Dietary Supplement Health and Education Act of 1994 (DSHEA). If an ingredient was not marketed in the US before October 15,1994, it is labeled a new dietary ingredient (NDI). For these ingredients, an NDIN must be submitted to the FDA at least 75 days before market introduction, including detailed information on the identity, composition, manufacturing process and safety data. 

Choosing the optimal path – GRAS or NDIN - for a new ingredient requires careful gap analysis and strategic consideration. Key factors include whether the ingredient qualifies as a dietary supplement under DSHEA, its usage prior to October 15, 1994, the availability of publicly available evidence of safety, the nature of the formulation and its organoleptic properties. 

SGS offers specialized support to manufacturers of food and dietary supplement products operating in US markets. Their experts assist businesses in selecting the right pathway to optimize market access, offering comprehensive gap analysis, overseeing testing, assembling safety and manufacturing data, and preparing final dossiers for submission. 

These solutions are part of SGS’s extensive range of food ingredient regulatory compliance solutions, which include claim substantiation, master file submissions to Health Canada, intellectual property protection strategies and laboratory-based product certification.