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It looks more like a new rule that should have gone through notice-and-comment rulemaking

It's still used by hundreds of thousands of children and adults with diabetes today

They are not drugs, foods, supplements, or cosmetics, are not approved by the FDA, and are not intended to diagnose, treat, cure, or prevent any disease, or for human or veterinary consumption

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However, Melanotan II itself is not approved for this purpose due to limited safety data and possible side effects such as flushing and increased blood pressure

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