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Trace metals and formaldehyde appear even in the "cleanest" products

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In ORCA-2 and ORCA-3, safety was assessed at weekly visits during treatment (Weeks 1-12), and through an additional 12-week follow-up, by measurement of vital signs and participant self-report of adverse events and concomitant medications

However, the FDA has no control over the products and commercial practices of this segment, so unacceptably high toxic contaminant levels from poorly designed and manufactured products are possible