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The Regulatory Landscape: What You Should Know The FDA's position on peptides has evolved

But in practice, and especially with regard to synthetic and recombinant peptide forms, there are some considerable potential safety concerns: Immunogenicity Most notably, per a 2020 assessment on therapeutic peptide safety, synthetic and recombinant peptides pose the risk of immunogenicity the ability of a substance to provoke an immune response.15 An immunogenicity-inducing peptide, when introduced to the body, would cause the bodys immune system to perceive the peptide not as a medication but as a threat