BPC 157 has a decades long safety record with zero deaths or hospitalizations. Yet, it's unapproved because the FDA process is too expensive and the business model doesn't allow for profit. Approved drugs with US Smoking Cessation: Your Gateway to the $24.8B NRT Market Regulatory Alert: FDA's April 2026 Update on BPC 157 and GHK Cu Holt Law When will the FDA reclassify BPC 157 to Category 1? Odds & Predictions