IA#53-10 --- 12/18/89
TYPE OF ALERT: Automatic Detention
PRODUCT : Cosmetic products containing methylene chloride as an
ingredient (i.e., aerosol products such as hair sprays)
PRODUCT CODE : 53[][][][][]
PROBLEM : Methylene chloride
PAC : 29002
COUNTRY : All (ZZ)
MANUFACTURER/
SHIPPER : All
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(3) in that it appears to contain methylene
chloride, a poisonous and deleterious substance which may
render it injurious to users under the conditions of use
prescribed in its labeling or under such conditions of use as
are customary or usual [adulteration, Section 601(a)]".
RECOMMENDING
OFFICE : CFSAN/Field Programs Branch, HFF-26
REASON FOR
ALERT : Methylene chloride has been used as an ingredient of aerosol
cosmetic products (principally hair sprays). Pursuant to a
two year inhalation study in animals, FDA concluded that the
use of methylene chloride in cosmetic products poses a
significant cancer risk to consumers.
Therefore, in accordance with 21 CFR 700.19 (FR, Vol. 54, No.
124, June 29, 1989, pgs. 27328-27342), any cosmetic product
that contains methylene chloride as an ingredient is deemed
adulterated and subject to regulatory action. This applies to
any such products initially introduced or delivered for
introduction into interstate commerce on or after August 28,
1989.
INSTRUCTIONS : Automatically detain all cosmetic products, such as aerosol
hair sprays which contain methylene chloride as an ingredient.
contact the Division of Field Science 8-443-3320 for
analytical methology.
FOI : No purging is necessary
KEYWORDS : Methylene, chloride, cosmetic, aerosol, spray
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