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it means the substance has not gone through the drug-approval process, so claims about therapeutic effectiveness should be read critically

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Food & Drug Administration (FDA) includes epitalon in its group of peptides that pose a risk of immunogenicity, in which the body reacts to a substance as though it were a threat and mounts an immune response against it.37 The FDA warns that such immune responses can be life-threatening, so epitalon isnt completely safe for everyone.38 In addition, the healthcare providers weve consulted suggest that women who are pregnant or breastfeeding should avoid epitalon, along with other therapeutic peptides, since there isnt enough research to confirm safety for them or their fetus/child