Helix

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking

U.S. Judge Stays Helix, NJOY Challenge to FDA PMTA Rule Pending New Rulemaking Court Stays Altria's Helix, NJOY Challenge to PMTA Rule as FDA Prepares New Rulemaking

A federal judge in Texas on Oct. 8 granted a joint request by the FDA and plaintiffs including Altria subsidiaries Helix Innovations and NJOY to stay litigation challenging the agency's 2021 PMTA rule. The court cited FDA's anticipated rulemaking concerning the regulation at issue. FDA announced on Sept. 28 that it intends to reassess the PMTA framework and could initiate new rulemaking to replace it. The parties must file a joint status report within 45 days and every 45 days thereafter. A motion by three Reynolds American companies to intervene remains pending.