Import Alert 66-13
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert # 66-13
Published Date: 03/18/2011
Type: DWPE
Import Alert Name:
"Eagle Brand Medicated Oil"
Reason for Alert:
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.
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:
Districts may continue to detain old formulated product, containing 12% chloroform and 20% methyl salicylate.
Product Description:
Eagle Brand Medicated Oil
Charge:
"The article is violative within 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)"
OASIS Charge Code - UNAPPROVED
and
"it appears to contain chloroform which is a carcinogen or is otherwise a deleterious substance."
OASIS Charge Code - UNAPPROVED
and
"it appears to contain chloroform which is a carcinogen or is otherwise a deleterious substance."
Countries
SINGAPORE
(66 V - - 99) Miscellaneous Patent Medicines, Etc.
SINGAPORE
Borden Company Pte Ltd
Date Published : 09/10/2009
9 Jalan Kilang , Singapore, SINGAPORE
66 V - - 99 Miscellaneous Patent Medicines, Etc.
Date Published: 09/10/2009
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