Warning Letter — Phuoc Loc Tho Herbals, Inc.
The FDA issued a warning letter to Phuoc Loc Tho Herbals, Inc. following an investigation by the Center for Drug Evaluation and Research (CDER). The source indicates regulatory concerns regarding the company's products or marketing practices, though specific violation details are not fully enumerated in the provided excerpt.
This affects Phuoc Loc Tho Herbals, Inc. and personnel responsible for product labeling, regulatory submissions, and quality management within the herbal and dietary supplement industry.
The involvement of CDER suggests that the firm's products may be positioned as unapproved new drugs due to therapeutic claims. This typically signifies a risk of enforcement actions if the firm does not align its marketing and manufacturing standards with drug-level regulatory requirements.
Review all product labeling and website claims to ensure they do not imply therapeutic benefits for specific diseases. Audit current manufacturing or distribution practices against drug-specific requirements if products are marketed as treatments.
FDA Warning Letter issued to: Phuoc Loc Tho Herbals, Inc.. 10/26/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/phuoc-loc-tho-herbals-inc-736860-10262026
Open in openFDA / FDA.gov