The organizations – International Probiotics Association (IPA), the European Food and Feed Cultures Association (EFFCA) and the International Food Additive Council (IFAC) – issued a position paper to FDA explaining their view on when probiotic bacteria should be considered New Dietary Ingredients under the Dietary Supplement Health and Education Act (DSHEA).
“It is the position of the [the three organizations] that individual strains belonging to microbial species with a history of safe use as starter culture used for food fermentation or as a probiotic in food (together termed MFC, “Microbial Food Cultures”) are not New Dietary Ingredients under [DSHEA],” stated the paper.
“Microbial species without such safe history either as a dietary supplement before October 15, 1994 or as a food must be demonstrated to be safe for use in Dietary Supplements and a NDIN to the U.S. Food and Drug Administration (FDA) is required.
“It is our position that each strain or isolate of such microbial cultures, which is intended for use in food or Dietary Supplements must be considered and evaluated individually.”
Under the 1994 Dietary Supplements Health & Education Act (DSHEA), firms are required to notify the FDA if they intend to market a dietary supplement in the US that contains a ’new dietary ingredient’ (which has not been marketed in the US dietary supplements market before October 15, 1994) and demonstrate that it is safe.
Dietary ingredients used in dietary supplements before this date were ‘grandfathered in’ and considered safe.
Svend Laulund, Manager of External Affairs, Compliance at Chr. Hansen, and head of the IPA's Regulatory Affairs Committee, told NutraIngredients-USA.com that the organizations consider NDIs to be a safety issue, and therefore considerations should be kept on the species level, not the strain level.
“From a scientific perspective, the Genus/species designation refers to the characteristics of a population which are defined by sufficient similarity, as commonly measured by their 16SrRNA sequences: the ‘type’ strain of the species,” explains the paper.
“Therefore, if members of a Genus/species of a MFC are deemed to have a safe history of use in food, then each isolate or strain of one such group is properly deemed to have a safe history of use in food,” it adds.
FDA currently focuses exclusively on safety when evaluating a NDI, and for MFCs this is based on safety data and safe history of use of microorganisms identified at the Genus/species level. In other words, the Genus/species name indicates that this population of organisms are deemed to be safe for the given use.
“The concept that individual isolates or strains of a given MFC are members of a population of organisms described by the Genus/species designation can be used to determine whether an MFC is new under DSHEA and the Food, Drug and Cosmetic Act.
“If a strain/isolate of a Genus/species population is currently and appropriately used in dietary supplement applications in the US and that Genus/species has a safe history of use in food before October 15, 1994 then other strains/isolates of the Genus/species population should not be considered new and do not require a NDIN.”