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Even where the agency accepts a recommendation, the substance is only added to the 503A list through formal notice-and-comment rulemaking

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Reported or theoretically plausible side effects of CJC 1295 and ipamorelin include: Water retention and peripheral oedema Flushing, headache, and dizziness, particularly after injection Tingling or numbness in the extremities Elevated IGF-1 levels, which over time may theoretically increase the risk of certain cancers, though a direct causal link has not been established in clinical studies [13] [14] Impaired glucose tolerance or insulin resistance GH excess and GH secretagogues are more commonly associated with raised blood glucose rather than hypoglycaemia