[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR105.66]

[Page 182-183]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 105_FOODS FOR SPECIAL DIETARY USE--Table of Contents
 
                       Subpart B_Label Statements
 
Sec.  105.66  Label statements relating to usefulness in reducing or 
maintaining body weight.

    (a) General requirements. Any food that purports to be or is 
represented for special dietary use because of usefulness in reducing or 
maintaining body weight shall bear:
    (1) Nutrition labeling in conformity with Sec.  101.9, or, where 
applicable, Sec.  101.36 of this chapter, unless exempt under that 
section; and
    (2) A conspicuous statement of the basis upon which the food claims 
to be of special dietary usefulness.
    (b) Nonnutritive ingredients. (1) Any food subject to paragraph (a) 
of this section that achieves its special dietary usefulness by use of a 
nonnutritive ingredient (i.e., one not utilized in normal metabolism) 
shall bear on its label a statement that it contains a nonnutritive 
ingredient and the percentage by weight of the nonnutritive ingredient.
    (2) A special dietary food may contain a nonnutritive sweetener or 
other ingredient only if the ingredient is safe for use in the food 
under the applicable law and regulations of this chapter. Any food that 
achieves its special dietary usefulness in reducing or maintaining body 
weight through the use of a nonnutritive sweetener shall bear on its 
label the statement required by paragraph (b)(1) of this section, but 
need not state the percentage by weight of the nonnutritive sweetener. 
If a nutritive sweetener(s) as well as

[[Page 183]]

nonnutritive sweetener(s) is added, the statement shall indicate the 
presence of both types of sweetener, e.g., ``Sweetened with nutritive 
sweetener(s) and nonnutritive sweetener(s).''
    (c) ``Low calorie'' foods. A food purporting to be ``low calorie'' 
must comply with the criteria set forth for such foods in Sec.  
101.60(b)(2) and (b)(3) of this chapter.
    (d) ``Reduced calorie'' foods and other comparative calorie claims. 
A food purporting to be ``reduced calorie'' or otherwise containing 
fewer calories than a reference food must comply with the criteria set 
forth for such food in Sec.  101.60(b)(4) and (b)(5) of this chapter.
    (e) Label terms suggesting usefulness as low calorie or reduced 
calorie foods. (1) Except as provided in paragraphs (e)(2) and (e)(3) of 
this section, and in Sec.  101.13(q)(2) of this chapter for soft drinks, 
a food may be labeled with terms such as ``diet,'' ``dietetic,'' 
``artificially sweetened,'' or ``sweetened with nonnutritive sweetener'' 
only if the claim is not false and misleading, and the food is labeled 
``low calorie'' or ``reduced calorie'' or bears another comparative 
calorie claim in compliance with part 101 of this chapter and this 
section.
    (2) Paragraph (e)(1) of this section shall not apply to any use of 
such terms that is specifically authorized by regulation governing a 
particular food, or, unless otherwise restricted by regulation, to any 
use of the term ``diet'' that clearly shows that the food is offered 
solely for a dietary use other than regulating body weight, e.g., ``for 
low-sodium diets.''
    (3) Paragraph (e)(1) of this section shall not apply to any use of 
such terms on a formulated meal replacement or other food that is 
represented to be of special dietary use as a whole meal, pending the 
issuance of a regulation governing the use of such terms on foods.
    (f) ``Sugar free,'' and ``no added sugar.'' Criteria for the use of 
the terms ``sugar free'' and ``no added sugar'' are provided for in 
Sec.  101.60(c) of this chapter.

[58 FR 2430, Jan. 6, 1993]

Subpart C [Reserved]

Subpart D--Standards of Identity [Reserved]