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Their approach is designed to pinpoint the underlying causes of weight gainsuch as hormonal imbalances, metabolic issues, or lifestyle factorsand build a tailored plan that integrates nutrition counseling, behavior modification, physical-activity guidance, and, when appropriate, approved medications

Critics, including the FDA's own scientific staff, argue that insufficient evidence exists to ensure these compounds are safe for human use

Failure of translation to patients may be associated with the mechanism of action of treatments under study

FDA reviewers questioned whether existing clinical data sufficiently establish BPC-157s safety profile or demonstrate meaningful clinical benefit