[Code of Federal Regulations] [Title 21, Volume 5] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR312.6] [Page 60] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--Continued PART 312--INVESTIGATIONAL NEW DRUG APPLICATION--Table of Contents Subpart A--General Provisions Sec. 312.6 Labeling of an investigational new drug. (a) The immediate package of an investigational new drug intended for human use shall bear a label with the statement ``Caution: New Drug--Limited by Federal (or United States) law to investigational use.'' (b) The label or labeling of an investigational new drug shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.