FDA Updates DSHEA Enforcement Priorities for 2026: What Supplement Manufacturers Need to Know

The FDA has announced updated enforcement priorities under the Dietary Supplement Health and Education Act (DSHEA) for 2026. These priorities directly impact supplement manufacturers, brand owners, and distributors operating in the U.S. market.

2026 FDA Enforcement Focus Areas:

1. 1Adulterated Products — — The FDA is increasing scrutiny on supplements containing undeclared pharmaceutical ingredients, particularly in weight loss, sexual enhancement, and bodybuilding categories.

1. 1Unapproved New Dietary Ingredients (NDIs) — — Any ingredient not marketed in the U.S. before October 15, 1994 requires a New Dietary Ingredient Notification (NDIN) 75 days before marketing. The FDA is actively enforcing this requirement.

1. 1Misleading Structure/Function Claims — — Claims that suggest a product can diagnose, treat, cure, or prevent disease are prohibited for dietary supplements. The FDA is targeting products with disease claims on labels, websites, and social media.

1. 1cGMP Compliance — — Continued focus on manufacturing facility compliance with 21 CFR Part 111, including proper testing, documentation, and quality control procedures.

Dovita Nutrition Health LLC maintains full compliance with all current and proposed regulations. We provide regulatory guidance to all OEM partners to ensure label claims, ingredient sourcing, and manufacturing processes meet FDA standards.