IA#53-03 --- 2/13/91 REVISED
TYPE OF ALERT: AUTOMATIC DETENTION
PRODUCT : Oral Tanning tablets which contain the ingredient
canthaxanthin (Alternate names: C.I. 40850 Canthaxanthin (C.I.
Food Orange 8)
PRODUCT CODE : 53ML-99
HARMONIZED
CODE : N/A
PROBLEM : Unsafe color additive - canthaxanthin (UCCT)
COUNTRY : All (999)
MANUFACTURER/
SHIPPER : All
MANUFACTURER
SHIPPER I.D.#: N/A
IMPORTER'S
I.D.# : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain a color
additive (canthaxanthin) which is unsafe within the meaning of
Section 706(a) [Adulteration, Section 601(e)]."
RECOMMENDING
OFFICE : Import Operations Branch (HFC-131)
REASON FOR
ALERT : Import Alert #53-03 originally issued in 1981 in response to a
number of inquiries concerning the status of oral tanning
tablets. Recently inquires about these tablets have surfaced
again. These products are classified as cosmetics.
Canthaxanthin, the major ingredient, is a color additive which
has not been approved by the agency for this or any other
cosmetic use. Therefore this product contains an unsafe color
additive and is deemed adulterated and subject to regulatory
action.
INSTRUCTIONS : Automatically detain all shipments of oral tanning tablets
that contain canthaxanthin from all manufacturers.
ANALYTICAL
METHODS: : LIB 3263 (January '89), Food Chemical Codex 3rd edition;
monograph p. 67.
KEYWORDS : Oral Tanning Tablets, Canthaxanthin, Cosmetic, Unsafe Color
Additive
FOI : No purging required.
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