IA#66-13 --- 12/30/87
BACKGROUND
During the past several years the subject product has been detained when it
was encountered in import entries of Chinese medicines.
FDA has recently learned that the product has been reformulated. However, the
old formulation of the product containing among other ingredients, 12%
chloroform and 20% methyl salicylate, is being manufactured and supplied to
other foreign countries. Under these circumstances, it is possible that the
old formulation of the product may be offered for import into the United
States. The product constitutes a consumer hazard in view of the carcinogenic
nature of chloroform and its ban as a drug ingredient by 21 CFR 310.513 (and
as a cosmetic ingredient by 21 CFR 700.18) and because the product contains a
high level of a potentially toxic ingredient, methyl salicylate without
bearing any warning statements required by 21 CFR 201.314 and 369.20.
The new formulation of the product, which contains menthol (13.5%), ethyl
alcohol (13%), methyl salicylate (4.5%), chlorophyll, mineral oil, and otto of
roses and is offered for external use for relief of minor aches and pains of
muscles, etc., would be acceptable for import on the firm's own responsibility
pending completion of the OTC Drug Review.
Exclusive United States distributor for the new formulated Eagle Brand
Medicated Oil manufactured by the Borden Company (PTE) Limited, of Singapore,
is Anhing Corporation, Los Angeles, California. The new formulated product is
labeled on the carton with the statement "Anhing as sole agent". Entries by
importers, other than Anhing Corporation, may be of the old formula and/or
counterfeit product.
GUIDANCE
Continue to detain old formulated product, containing 12% chloroform and 20%
methyl salicylate, charging: "The article is violative wihtin the meaning of
801(a)(3) because it appears to be a new drug without an effective New Drug
Application pursuant to Section 505; is misbranded under Section 502(f)(1) and
(2); and it appears to contain chloroform which is a carcinogen or is
otherwise a deleterious substance."
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