Comment from Obelisk Tech Systems Inc. Submitted on May 23, 2026 by James H. Poole

Comment of Obelisk Tech Systems Inc. on Docket FDA-2026-N-2642-0001 (Harmful and Potentially Harmful Constituents in Tobacco Products). Obelisk — which previously prevailed on an FDA citizen petition resulting in amended spirulina heavy-metal threshold standards — identifies fourteen procedural defects under the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31), the FDCA (21 U.S.C. § 387d), FDA tobacco regulations (21 C.F.R. Parts 1100, 1140, 1141, 1143), the APA, the PRA, the Information Quality Act (Pub. L. 106-554 § 515), the RFA (5 U.S.C. §§ 601–612), the CRA (5 U.S.C. §§ 801–808), and Executive Orders 12866, 13045, 13272, and 14094. Defects include no documented FDCA § 904(d) HPHC criteria application constituent-by-constituent; no Information Quality pre-dissemination review; no best available scientific evidence documentation; no EO 13045 children's health analysis; no § 603 IRFA; no PRA OMB Control Number documentation; no OIRA review; no CRA submission planning; no test method validation under 21 U.S.C. § 387d(e); no CCI handling protocols under 21 U.S.C. § 387f(c); and no reasoned-explanation basis under State Farm, Discount Tobacco City, R.J. Reynolds Vapor Co. v. FDA, or Loper Bright. Obelisk requests that FDA withhold final HPHC list action until defects are cured. Full comment attached. — James H. Poole, Executive Chairman & CEO, Obelisk Tech Systems Inc.