[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.405]

[Page 23-24]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 801--LABELING--Table of Contents
 
          Subpart H--Special Requirements for Specific Devices
 
Sec. 801.405  Labeling of articles intended for lay use in the repairing and/or refitting of dentures.


    (a) The American Dental Association and leading dental authorities 
have advised the Food and Drug Administration of their concern regarding 
the safety of denture reliners, repair kits, pads, cushions, and other 
articles marketed and labeled for lay use in the repairing, refitting, 
or cushioning of ill-fitting, broken, or irritating dentures. It is the 
opinion of dental authorities and the Food and Drug Administration that 
to properly repair and properly refit dentures a person must have 
professional knowledge and specialized technical skill. Laymen cannot be 
expected to maintain the original vertical dimension of occlusion and 
the centric relation essential in the proper repairing or refitting of 
dentures. The continued wearing of improperly repaired or refitted 
dentures may cause acceleration of bone resorption, soft tissue 
hyperplasia, and other irreparable damage to the oral cavity. Such 
articles designed for lay use should be limited to emergency or 
temporary situations pending the services of a licensed dentist.
    (b) The Food and Drug Administration therefore regards such articles 
as unsafe and misbranded under the Federal Food, Drug, and Cosmetic Act, 
unless the labeling:
    (1)(i) Limits directions for use for denture repair kits to 
emergency repairing pending unavoidable delay in obtaining professional 
reconstruction of the denture;
    (ii) Limits directions for use for denture reliners, pads, and 
cushions to temporary refitting pending unavoidable delay in obtaining 
professional reconstruction of the denture;
    (2) Contains in a conspicuous manner the word ``emergency'' 
preceding and modifying each indication-for-use statement for denture 
repair kits and the word ``temporary'' preceding and modifying each 
indication-for-use statement for reliners, pads, and cushions; and
    (3) Includes a conspicuous warning statement to the effect:
    (i) For denture repair kits: ``Warning--For emergency repairs only. 
Long term use of home-repaired dentures may cause faster bone loss, 
continuing irritation, sores, and tumors. This kit for emergency use 
only. See Dentist Without Delay.''
    (ii) For denture reliners, pads, and cushions: ``Warning--For 
temporary use only. Longterm use of this product may lead to faster bone 
loss, continuing irritation, sores, and tumors. For Use Only Until a 
Dentist Can Be Seen.''
    (c) Adequate directions for use require full information of the 
temporary and emergency use recommended in order for the layman to 
understand the limitations of usefulness, the reasons

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therefor, and the importance of adhering to the warnings. Accordingly, 
the labeling should contain substantially the following information:
    (1) For denture repair kits: Special training and tools are needed 
to repair dentures to fit properly. Home-repaired dentures may cause 
irritation to the gums and discomfort and tiredness while eating. Long 
term use may lead to more troubles, even permanent changes in bones, 
teeth, and gums, which may make it impossible to wear dentures in the 
future. For these reasons, dentures repaired with this kit should be 
used only in an emergency until a dentist can be seen. Dentures that 
don't fit properly cause irritation and injury to the gums and faster 
bone loss, which is permanent. Dentures that don't fit properly cause 
gum changes that may require surgery for correction. Continuing 
irritation and injury may lead to cancer in the mouth. You must see your 
dentist as soon as possible.
    (2) For denture reliners, pads, and cushions: Use of these 
preparations or devices may temporarily decrease the discomfort; 
however, their use will not make the denture fit properly. Special 
training and tools are needed to repair a denture to fit properly. 
Dentures that do not fit properly cause irritation and injury to the 
gums and faster bone loss, which is permanent and may require a 
completely new denture. Changes in the gums caused by dentures that do 
not fit properly may require surgery for correction. Continuing 
irritation and injury may lead to cancer in the mouth. You must see your 
dentist as soon as possible.
    (3) If the denture relining or repairing material forms a permanent 
bond with the denture, a warning statement to the following effect 
should be included: ``This reliner becomes fixed to the denture and a 
completely new denture may be required because of its use.''
    (d) Labeling claims exaggerating the usefulness or the safety of the 
material or failing to disclose all facts relevant to the claims of 
usefulness will be regarded as false and misleading under sections 
201(n) and 502(a) of the Federal Food, Drug, and Cosmetic Act.
    (e) Regulatory action may be initiated with respect to any article 
found within the jurisdiction of the act contrary to the provisions of 
this policy statement after 90 days following the date of publication of 
this section in the Federal Register.