[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called TC-61) dated February 15, 1940, because it is out of date with
current scientific knowledge and is superseded by the final rule for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
