Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Alert 53-10
  • Print
  • Share
  • E-mail
-

(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 # 53-10
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Cosmetic Products Containing Methylene Chloride as an Ingredient"

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.

Guidance:
Districts may detain, without physical examination, all cosmetic products, such as aerosol hair sprays which contain methylene chloride as an ingredient. Contact the Division of Field Science for analytical methology.

For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Division of Field Science at (301) 796-6600.

All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.

Product Description:
Cosmetic products containing methylene chloride as an ingredient (i.e., aerosol products such as hair sprays)

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)]".

OASIS charge code - POISONOUS

Countries

MULTIPLE COUNTRIES (PODS ONLY)
(53 E - - 02) Hair Sprays (Aerosol Fixatives) (Hair Preparations, Non-coloring)
Desc:aerosol products such as hair sprays
Problems: METHYLENE CHLORIDE;
(53 - - - --) Cosmetics
Problems: METHYLENE CHLORIDE;
-
-