21 CFR 111.455: What requirements apply to holding components, dietary supplements, packaging, and labels?
Requires dietary supplement firms to hold components, finished products, packaging, and labels under suitable temperature, humidity, and light conditions that prevent mixups, contamination, deterioration, or changes to identity, purity, strength, and composition.
Part 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements · Subpart M, Holding and Distributing
Recent 483s citing 111.455
- Safrel Pharmaceuticals LLC · Dayton, New JerseyYou did not hold dietary supplements under appropriate conditions of temperature,… Jan 30, 2026
- Quality Formulation Laboratories, Inc. · Paterson, New JerseyOn 12111/2008, upon examination of five bags of Alkalized Cocoa with Lecithin, lot… Jan 13, 2009
The regulation text
§ 111.455 What requirements apply to holding components, dietary supplements, packaging, and labels?.
(a)You must hold components and dietary supplements under appropriate conditions of temperature, humidity, and light so that the identity, purity, strength, and composition of the components and dietary supplements are not affected.
(b)You must hold packaging and labels under appropriate conditions so that the packaging and labels are not adversely affected.
(c)You must hold components, dietary supplements, packaging, and labels under conditions that do not lead to the mixup, contamination, or deterioration of components, dietary supplements, packaging, and labels.
Questions
What does 21 CFR 111.455 require?
Requires dietary supplement firms to hold components, finished products, packaging, and labels under suitable temperature, humidity, and light conditions that prevent mixups, contamination, deterioration, or changes to identity, purity, strength, and composition.
Which sections are cited alongside 111.455?
In the same 483s, investigators most often also cite 111.103 (What are the requirements under this subpart F for written procedures?), 111.15 (What sanitation requirements apply to your physical plant and grounds?), 111.27 (What requirements apply to the equipment and utensils that you use?), 111.553 (What are the requirements under this subpart O for written procedures?).