Closure Medical Corp.; Withdrawal of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97C-0171]

Closure Medical Corp.; Withdrawal of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the

withdrawal, without prejudice to future filing, of a color additive

petition (CAP 7C0250) proposing that the color additive regulations be

amended to

[[Page 64513]]

provide for the safe use of D&C Violet No. 2 to color 2-octyl

cyanoacrylate topical tissue adhesives.

FOR FURTHER INFORMATION CONTACT: Ellen M. Waldron, Center for Food

Safety and Applied Nutrition (HFS-215), Food and Drug Administration,

200 C St. SW., Washington, DC 20204, 202-418-3089.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal

Register of May 1, 1997 (62 FR 23781), FDA announced that a color

additive petition (CAP 7C0250) had been filed by Closure Medical Corp.,

5265 Capital Blvd., Raleigh, NC 27616 (currently 5250 Greens Dairy Rd.,

Raleigh, NC 27616). The petition proposed to amend the color additive

regulations in Sec. 74.3602 D&C Violet No. 2 (21 CFR 74.3602) to

provide for the safe use of D&C Violet No. 2 to color 2-octyl

cyanoacrylate topical tissue adhesives.

With the passage of the Medical Device Amendments of 1976 (Pub. L.

94-295), Congress mandated the listing of color additives for use in

medical devices when the color additive in the device comes into direct

contact with the body for a significant period of time (21 U.S.C.

379e(a)). Since the filing of this petition, the agency has determined

that the proposed use of the subject topical tissue adhesives, and

therefore, any color additive used in these adhesives, would not

contact the body for a significant period of time (Ref. 1).

Consequently, the petitioned use of D&C Violet No. 2 is exempt from the

statutory listing requirement. Therefore, Closure Medical Corp. has now

withdrawn the petition without prejudice to a future filing (21 CFR

71.6(c)(2)) (Ref. 2).

The agency received two comments on the safety of D&C Violet No. 2

in response to the notice of filing for this petition. Arts, Crafts &

Theater Safety, Inc. (ACTS) commented that D&C Violet No. 2 could

possibly be a carcinogen, based on studies of other anthraquinone dyes

and structurally related compounds that concluded those substances were

reasonably anticipated to be human carcinogens. They stated that the

petition should be denied unless D&C Violet No. 2 is studied for cancer

effects and found to show no evidence of carcinogenicity. In response

to ACTS'' comment, Flamm Associates commented that in addition to a

consideration of the general chemical class of a substance, other

structural features need to be evaluated in determining the

carcinogenic potential of a substance. They further stated that D&C

Violet No. 2 has been tested for carcinogenicity and found to be

noncarcinogenic.

The agency concludes that, although the subject petition is being

withdrawn, the safety of the currently approved uses of D&C Violet No.

2 (21 CFR 74.1602, 74.2602 and 74.3602) is supported by an extensive

body of toxicity testing data and that the comments provide no basis

for a safety concern.

References

The following references have been placed on display in the Dockets

Management Branch (HFA-305), 5630 Fishers Lane, Rockville, MD 20852 and

may be seen by interested persons between 9 a.m. and 4 p.m., Monday

through Friday.

1. Memorandum from Office of Device Evaluation, Program

Operations Staff (Center for Devices and Radiological Health, FDA),

to Division of Petition Control (Center for Food Safety and Applied

Nutrition, FDA), concerning ``CAP 7C0250'', dated October 23, 1998.

2. Letter from Hyman, Phelps & McNamara, P.C., to Office of

Premarket Approval (FDA), dated August 25, 1998.

Dated: November 3, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket Approval, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98-31030 Filed 11-19-98; 8:45 am]

BILLING CODE 4160-01-F