[Title 21 CFR 250.203]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter C - DRUGS: GENERAL]
[Part 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS]
[Subpart C - Requirements for Drugs and Foods]
[Sec. 250.203 - Status of fluoridated water and foods prepared with fluoridated water.]
[From the U.S. Government Printing Office]


21FOOD AND DRUGS41996-04-011996-04-01falseStatus of fluoridated water and foods prepared with fluoridated water.250.203Sec. 250.203FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,DRUGS: GENERALSPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGSRequirements for Drugs and Foods
Sec. 250.203   Status of fluoridated water and foods prepared with fluoridated water.

    (a) The program for fluoridation of public water supplies 
recommended by the Department of Health and Human Services, through the 
Public Health Service (Centers for Disease Control), contemplates the 
controlled addition of fluorine at a level optimum for the prevention of 
dental caries.
    (b) Public water supplies do not ordinarily come under the 
provisions of the Federal Food, Drug, and Cosmetic Act. Nevertheless, a 
substantial number of inquiries have been received concerning the status 
of such water under the provisions of the act and the status, in 
interstate commerce, of commercially prepared foods in which fluoridated 
water has been used.
    (c) The Department of Health and Human Services will regard water 
supplies containing fluorine, within the limitations recommended by the 
Environmental Protection Agency, as not actionable under the Federal 
Food, Drug, and Cosmetic Act. Similarly, commercially prepared foods 
within the jurisdiction of the act, in which a fluoridated water supply 
has been used in the processing operation, will not be regarded as 
actionable under the Federal law because of the fluorine content of the 
water so used, unless the process involves a significant concentration 
of fluorine from the water. In the latter instance the facts with 
respect to the particular case will be controlling.

[40 FR 14033, Mar. 27, 1975, as amended at 48 FR 11426, Mar. 18, 1983]