Nutrasource Blog

IGEN™ Certification: Flexibility for Suppliers, Transparency for Consumers

Posted by Nutrasource on Thu, Apr 13, 2017

Consumers have become increasingly concerned about the use of genetically modified organisms (GMOs) in food production — an occurrence that has contributed to the popularity of products that have not been genetically engineered (GE) through modern biotechnology. 

While third-party non-GMO certification programs have been in place for quite some time, the recently released IGEN™ Program enables suppliers to obtain different levels of non-GMO certification from a third party faster while still providing the transparency that many consumers demand about the products they consume.   

Recognizing the complexity of the dietary supplement supply chain in particular, one of the nation’s largest retailers of natural and organic products has given its approval to the IGEN Program for use with dietary supplement products. Whole Foods Market, which has more than 450 stores in North America and the U.K., has authorized the IGEN™ Program to verify non-GMO-related label claims for dietary supplements. 

Until the IGEN Program was introduced, non-GMO verification programs required complex paper trails documenting that the product and the raw materials used to make it were not GMO. While this may be realistic for food products containing only a few ingredients, it becomes more complex and often impossible for dietary supplements, some of which may have 50 ingredients, each of which could be made from at least 50 raw materials. At times, it may be simply impossible to obtain full non-GMO documentation on an ingredient or there may not be an alternative available — this leaves the developer no alternative but to reformulate or forego certification.

In contrast, the three-tiered IGEN Program allows companies to obtain tier-one certification in as little as two to three months. Using the proprietary IGEN™ Testing Panel — a broad spectrum of more than 20 tests developed by Nutrasource— the program focuses on science, along with quality documentation review to certify products. With Tier One certification, companies can showcase that their tested finished products do not contain detectable amounts of common GMO genes or proteins below very low detection limits, e.g., in the parts per billion range for GMO proteins. Additionally, they can work toward a full Tier Three certification if desired.

Tier One — Certification that the product does not contain GMO/GE genes or proteins. The product is tested three times annually — two sample batches or lots are submitted by the company and one is pulled directly from the market. Additionally, there is some documentation review to ensure, for example, that the product was made in a Good Manufacturing Practices certified facility or an equivalent quality management system. For example, Tier One certified products can use the following logo and label claim:


This product does not contain common GMO/GE genes or proteins.

Tier Two — Certification that the product and its ingredients do not contain common GMO/GE genes or proteins. In this phase, both the product and the ingredients in it undergo testing and quality document review. For example, Tier Two certified products can use the following logo and label claim:


This product and its ingredients do not contain common GMO/GE genes or proteins.

Tier Three — Certification that the product was not made using genetically engineered raw materials. To obtain the full tier-three certification, suppliers must submit the product, ingredients and raw/source materials for testing, and undergo quality document review. For example, Tier Three certified products can use the following logo and label claim:


This product was not made using GE source materials.

While the certification program often provides a faster verification route than other programs, the program is a rigorous one, based on science. By allowing developers and suppliers to choose which level of certification is necessary and cost-effective for their products, the IGEN Program provides flexibility to companies while still giving consumers transparency on the GMO status of the products they consume.


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Topics: Dietary Supplements/Natural Health Products