In 2020, SolnulTM (Trademark of MSP Starch Products Inc.) reached out to The FDA’s Office of Nutrition and Food Labeling for guidance on the appropriate common name for their branded ingredient in the labeling of dietary supplements and conventional food.
Based on the SolnulTM specifications provided in the submission, this was the FDA’s Response:
This is in response to your inquiry on proper labeling of a product containing resistant starch. The question was submitted through the Food and Cosmetics Information Center (FCIC)/Technical Assistance Network (TAN) on 08/18/2020.
In June 2018, FDA issued an enforcement discretion guidance for industry to identify eight isolated or synthetic non-digestible carbohydrates that we intend to propose to be added to our regulatory definition of dietary fiber, including resistant starch 2 or RS2. In March 2019, FDA added “cross linked phosphorylated RS4”, regardless of source, to the existing list of isolated or synthetic non-digestible carbohydrates that FDA intends to propose to be added to the definition of dietary fiber.
Digestion resistant starch can be RS2 which is a native starch or is produced through starch modification (such as RS4). If your product is the RS2 type from potato, then we would likely not object to a name like ‘resistant potato starch’ as long as that name is appropriately descriptive of your actual product.
Alternatively, if the resistant starch in your product is the RS4 type which is produced through chemical modification, then in accordance with 21 CFR 172.892, to ensure safe use of the food starch-modified, the label of the food additive container shall bear the name of the additive ‘food starch- modified’ in addition to other information required by the Act.
Thank you for contacting FDA’s FCIC/TAN.