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BPC-157 is not approved by Health Canada or the FDA for human use and remains an experimental research compound

B12 fortified foods, such as cereals, nondairy milk, and nutritional yeast

Finally, as we did not receive any comments on the proposal, we are finalizing the proposal that we would exclude quality measures that do not have a benchmark in the calculation of the quality ASM performance category score as proposed at 512.725(f)(3)

The agency cited immunogenicity concerns, saying there was limited data on the quality, stability and consistency of the compounds