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SciPoll 893: Infant Nutrition Science Coalition (INSC) Roundtable Discussion #2: Followup Poll

An FDA/NIH workshop proposed a definition of bioactive ingredients as “Synthetic or non-human milk-derived ingredients that may mimic components typically present in human milk, and that are not traditionally considered essential nutrients but are hypothesized to have physiological activity … and intended to be added to infant formula, either alone or in combination, with awareness of the hypothesized biological activity.” Do you agree with this definition?

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Results
(14 Answers)

Expert Opinion Summary: The proposed FDA/NIH definition of bioactive ingredients receives mixed support, with experts divided approximately 60% in favor and 40% opposed.

Points of Agreement: Nine experts accept the definition as proposed, suggesting it provides a workable framework for distinguishing bioactive ingredients in infant formula.

Key Areas of Disagreement:

  • Exclusion of Essential Nutrients: Multiple experts argue that essential nutrients (particularly vitamins) should be considered bioactive since they clearly have physiological activity, making their exclusion from the definition problematic.
  • Scope Too Narrow: Critics note the definition is overly restrictive by excluding human milk-derived bioactives and limiting sources to "synthetic or non-human milk-derived" ingredients, which may not accommodate future ingredient sources.
  • Evidence Standards: One expert suggests replacing "hypothesized to have physiological activity" with stronger language requiring "demonstrated physiological effect in the target population."
  • Regulatory Necessity: Some experts question whether a formal definition is needed at all, given existing regulatory frameworks don't require defining substances this way.
  • Context Specificity: Several experts emphasize the definition should either be food category agnostic or explicitly labeled as "bioactive ingredients in infant formula" since these ingredients may be added to foods beyond infant formula.
Summary Generated by AI

Answer Explanations

  • No
    user-641377
    It really depends on the context of how this would be used. 

    What I don't like about this definition is that it provides little differentiation between ingredients added to infant formula, at the same time eliminating essential nutrients from the definition, which are the clearest example of substances known to have physiological activity. 
  • No
    user-487133
    While a useful starting point, the definition is overly restrictive. It excludes human milk-derived bioactives used in formula. The phrase "hypothesized to have physiological activity" is also problematic; it should require a higher standard of evidence, such as "demonstrated to have a physiological effect in the target population." The definition should be inclusive of all ingredient sources while being more evidence-based.

  • No
    user-685
    Some essential nutrients should be considered "bioactives" e.g. vitamins
  • No
    user-519519
    • Question if a definition is required given existing regulatory framework would not require us to define a substance in this way.
    • We consider any definition should be food category agnostic to ensure it could be used across the food supply. 
    • If a definition is progressed it should amend the above FDA/NIH workshop proposals of "bioactive ingredients" to "bioactive ingredients in infant formula" given these could be added to ingredients beyond infant formula and this proposal is specific as it relates to infant formula. 
    • Consider that 'synthetic or 'non-human milk.....human milk' to be unnecessarily narrow in the context of where bioactive ingredients may be sourced from in the future.
    • Physiological activity/Biological activity - needs to be teased out further and which term should be used given FDA concerns at the food:drug interface.

  • No
    user-457378
    A regulatory definition should not be required as existing regulatory frameworks do not formally refer to the term "Bioactive." The FDA/NIH definition as proposed is specific for an infant formula context, therefore this should be made clear in the commentary. Bioactive ingredients may be added to all types of foods, therefore a definition should acknowledge this. Another issue with the definition is the exclusion of essential nutrients which could be argued are also "bioactive."