Dietary Supplement Sector Warnings Jump With FDA 'Program Alignment'

Some stakeholders complained FDA inspectors unfamiliar with Part 111 inappropriately held supplement firms to drug or food product manufacturing regulations, but the agency's assignment of inspectors with greater expertise on the regulations could be turning up compliance problems in the sector that other ORA officials might have missed.

The number of FDA warning letters to firms manufacturing and marketing dietary supplements has increased by more than 30 to 81 during the year the agency began assigning Office of Regulatory Affairs inspectors to certain facilities based on their areas of expertise.

The "program alignment" ORA has implemented in 2017 sends inspectors more knowledgeable about FDA's supplement good manufacturing practices regulations, Part...