(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 Name:
Reason for Alert:
**Review of labeling for the naturalizer with color enhancer, an item subject to a seizure action, revealed the product is also promoted to restore the natural black color to hair. The colorant, identified as "concentrate extract of coulteria tinctoria" in the ingredient declaration, is a vegetable dye for which no color additive regulation has been established.**
**Other hair relaxer/neutralizer products from Brazil or imported by World Rio Corp/Pantron I Corp., should receive intensified sampling.**
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at email@example.com .
All requests for removal from detention without physical examination should be address to DIOP 301-796-0356.
OASIS charge code - POISONOUS
(for the color enhanced product):
"The article is subject to refusal of admission pursuant to Section 801(a) in that it appears to bear or contain a color additive which is unsafe within the meaning of Section 721(a) [Adulteration, Section 601(e).]"**
OASIS charge code - COSM COLOR
(53 E - - 03) Hair Straighteners (Hair Preparations, Non-coloring)Desc: Rio Hair Naturalizer system
List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)