21 CFR Part 105 - Foods for Special Dietary Use

What it says

Part 105 contains labeling requirements for foods represented as being for special dietary use, meaning foods that supply a particular dietary need arising from a physical, physiological, pathological or other condition, such as reduced sodium or low calorie foods and hypoallergenic foods. It sets out information that labeling must carry so users can understand the food's purpose.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Representing a food as suitable for a special dietary use brings in specific labeling expectations.
• Claims must be accurate and supported by the composition of the food.
• The part works alongside the general nutrition labeling rules in Part 101.

What FDA inspectors look for

• Whether labeling makes dietary use claims that are supported.
• Whether required information is on the label.
• Whether the product's composition matches the claim.

Related regulations