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Public comment on the DSIP review can be submitted to FDA docket FDA-2025-N-6895 by July 9, 2026

Proper storage conditions ensure stability and maintain biological activity throughout multi-phase research studies, supporting consistent data collection

Because of this, the RDA when breastfeeding is higher than for pregnancy

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Until stereoisomer-specific studies and formal pharmacovigilance data are available, any long-term or high-dose use carries unknown risk

That approval does not extend to general fat-loss use, off-label protocols, or any use outside the approved patient population and clinical oversight