[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 Publishing Office]
21
FOOD AND DRUGS
4
1996-04-01
1996-04-01
false
Status of fluoridated water and foods prepared with fluoridated water.
250.203
Sec. 250.203
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION,
DRUGS: GENERAL
SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
Requirements 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]