WITHDRAWAL OF PERMISSION TO USE COLOR ADDITIVE
F. D. & C. VIOLET NO. 1
Proprietors of distilled spirits plants,
manufacturers of nonbeverage products,
users of specially denatured alcohol,
and others concerned:
The purpose of this circular is to advise you that as of April 10,
1973, the Food and Drug Administration has terminated the provisional listing
and certification of F. D. & C. Violet No. 1 for use in foods, drugs, and
cosmetics. This action is being taken on the basis of scientific evidence
casting doubt on the safe use of such color additive.
Accordingly, until such time as the additive may be established as being
safe for food, drug, or cosmetic use, the Commissioner, Food and Drug Administration, will consider as being adulterated, within the meaning of the Federal
Food, Drug and Cosmetic Act, any such products containing F. D. & C. Violet
No. 1 after April 10, 1973.
Formulas on Forms 27-B Supplemental, 1479-A or 1678 calling for use of
the aforementioned color additive will not be approved by the Director, Bureau
of Alcohol, Tobacco and Firearms. Proprietors, manufacturers, and users should
examine their approved formulas to determine whether such additive is among the
ingredients listed thereon. New formulas on Forms 1479-A or 1678 or amended
formulas or riders on Forms 27-B Supplemental must be filed to delete F. D. & C.
Violet No. 1 from any existing formulas which call for its use, if the products
produced under such formulas are foods, drugs, or cosmetics. (For this purpose,
any alcoholic beverage product is considered to be a food product). New or
amended formulas so submitted may, of course substitute an approved color additive.
Inquiries regarding this circular should refer to its number and be addressed
to the Director, Bureau of Alcohol, Tobacco and Firearms, 1111 Constitution
Avenue, N. W., Washington, D. C. 20226.