[Federal Register Volume 64, Number 98 (Friday, May 21, 1999)]
[Notices]
[Page 27798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12854]



[[Page 27798]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 78N-0038]


Revocation of Advisory Opinion Entitled ``FD&C Act Trade 
Correspondence 61''

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; revocation.

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SUMMARY: The Food and Drug Administration (FDA) is revoking an advisory 
opinion entitled ``FD&C Act Trade Correspondence, TC-61,'' (hereinafter 
called TC-61) dated February 15, 1940, because it is out of date with 
current scientific knowledge and is superseded by the final rule for 
over-the-counter (OTC) sunscreen drug products. As an advisory opinion, 
this correspondence was not published in the Federal Register.

EFFECTIVE DATE: June 21, 1999.
FOR FURTHER INFORMATION CONTACT: John D. Lipnicki, Center for Drug 
Evaluation and Research (HFD-560), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION: TC-61 is a 1940 advisory opinion regarding 
the drug and/or cosmetic status of sunburn and suntan preparations. TC-
61 states that a product promoted for prevention of damage from the sun 
is a drug, and a product that is promoted solely for the purpose of 
acquiring an even tan can be considered a cosmetic. The agency updated 
this policy in 1976, by stating that a product containing a sunscreen 
ingredient, even when labeled solely as a tanning aid, is both intended 
and understood to be a sunburn preventive and, therefore, is a drug 
under the Federal Food, Drug, and Cosmetic Act (the act).
    In the Federal Register of May 12, 1993 (58 FR 28194), FDA 
published a proposed rule for OTC sunscreen drug products. That 
document included a proposal to revoke TC-61 (58 FR 28204). One comment 
was received in response to the proposal to revoke TC-61. That comment 
did not change the agency's position and is addressed elsewhere in the 
rule section of this issue of the Federal Register. Therefore, under 
the act and under authority delegated to the Commissioner of Food and 
Drugs, TC-61 is revoked.

    Dated: May 10, 1999.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 99-12854 Filed 5-20-99; 8:45 am]
BILLING CODE 4160-01-F