The Minister of the U.S. Department of Health & Human Services has directed the acting FDA Commissioner to take steps to explore possible rule-making to amend its Final Rule on Generally Recognized as Safe (GRAS) Substances and related guidelines, with the aim of eliminating self-GRAS and enhancing the transparency and supervision of approval of food ingredients.

The latest move is part of the "Make America Healthy Again" (MAHA) campaign, which includes attacking ultra-processed foods, genetically modified ingredients, cultured meat and plant-based foods. This could have a significance on synthetic biology food companies.

Self-GRAS: a fast approval channel for precision fermented foods

All along, the self-GRAS certification has been a fast approval channel for the launch of novel food globally. Companies choosing this approach are not required to notify the FDA or make public disclosures. Instead, they only need to conduct a safety assessment by a scientific panel which can include in-house and external experts. Once the safety assessment is passed, the products can enter the U.S. market.

This method is cheaper, simpler, and faster (the application cycle is 6-9 months, while obtaining a "no questions" letter from the FDA usually takes 1-3 years), and it can keep proprietary information and trade secrets confidential, enabling a large number of precision fermentation companies to commercialize rapidly. Examples include TurtleTree's lactoferrin, Impossible Burger's heme, Perfect Day's milk protein and Solar Foods' Solein protein.

Tightening of supervision

The U.S. Department of Health stated that abolishing the self-affirmation procedure will require companies to publicly inform the FDA of their intended uses and basic safety data before introducing new ingredients, that is, to complete the full GRAS certification process. In addition, it also said that it will cooperate with Congress to "explore ways to legislate and completely close the GRAS loophole".

The complete GRAS certification process requires formally submitting application materials to the FDA, which will conduct a comprehensive assessment of various aspects such as the safety of the substance, and then reply to the application. If the FDA's reply is "FDA has no questions", it proves that the substance is GRAS (Generally Recognized as Safe). This approach is more stringent, transparent and authoritative.

Generally speaking, synthetic biology companies will carry out the complete GRAS certification either after or simultaneously with the self-GRAS certification, aiming to generate early-stage revenue.

If only the complete GRAS certification process is carried out, start-up companies will have to bear higher financial costs (including increasing safety tests to provide the required data) before generating revenue, and the approval cycle is also much longer (1-3 years or even more). According to the past data, the FDA only evaluates about 75 GRAS notifications each year, and each notification may take 6 to 12 months to be approved.

Prior to this, the U.S. Food and Drug Administration (FDA) had also been undergoing reforms and restructured its organizational structure last year. Recently, the FDA put forward a draft of label guidelines for plant-based meat, suggesting that enterprises indicate the source of raw materials on the package. One month before Trump returned to the White House, the agency updated the label standard for enterprises to promote foods as "healthy" foods.

Source: Synbio

Note: This article is compiled by Antion. Please indicate the source for reprint.