Regulatory Compliance & Certifications⁠

RS Labs Microplastic testing falls under the CLIA / COLA jurisdiction established by the U.S. Congress in 1988. Under CLIA and COLA regulations, RS Labs testing and partner laboratories are certified compliant. As confirmed in U.S. Federal Court, this testing does not fall under the jurisdiction of the FDA.

Laboratory-Developed Tests (LDTs) Status

These tests are classified as Laboratory-Developed Tests (LDTs) for regulatory purposes. As LDTs, these tests are clinical laboratory services and not in vitro diagnostic medical devices regulated by the U.S. Food and Drug Administration (FDA).On March 31, 2025, the U.S. District Court for the Eastern District of Texas vacated the FDA's final rule intended to regulate LDTs, ruling that the FDA lacked statutory authority to regulate LDTs as medical devices. The court concluded that LDTs are fundamentally different from traditional medical devices, as they are professional clinical services performed within a laboratory rather than physical products distributed in interstate commerce.The court emphasized that Congress intended for the Clinical Laboratory Improvement Amendments of 1988 (CLIA)—not the Federal Food, Drug, and Cosmetic Act—to govern clinical laboratory testing, and that the FDA's attempt to expand its jurisdiction violated both the text and legislative history of these laws (American Clinical Laboratory Association [ACLA] v. FDA and Association for Molecular Pathology [AMP] v. FDA).

The FDA chose not to appeal the court decision, concluding its effort to regulate LDTs under the medical device regulatory regime

Dietary Supplement Manufacturing Standards

RS Labs dietary supplements are produced exclusively in cGMP (Current Good Manufacturing Practice) certified facilities using brand-name, research-backed components to reflect the exact raw materials validated in published clinical studies.