Import Alert 53-16
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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 # 53-16
Published Date: 10/12/2011
Type: DWPE
Import Alert Name:
"Detention Without Physical Examination of Rio Hair Naturalizer"
Reason for Alert:
FDA has received consumer complaints throughout the country reporting burning of the scalp and hair loss as a result of using the Rio Hair Naturalizer System. These complaints are continuing. Although the product is labeled as having a pH of 3.4, FDA and California State analyses of the product have found a pH range from below 1 to 2. Seizure of a product lot in Los Angeles has been accomplished. Another product lot was embargoed by the state of Nevada in Las Vegas. Reportedly the product is imported in bulk (powder) form by World Rio Corp., and packaged in the United States. The product is marketed nationally via television info-mercials, and sold mail order.
**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.**
**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.**
Guidance:
Districts may detain, without physical sampling and analysis, all shipments of Rio Hair Naturalizer, Neutral and Color Enhanced, bulk and in packaged form, as identified in the attachment for this alert.
**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 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.
**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 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:
Rio Hair Naturalizer System, neutral and color enhanced.
Charge:
"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or, under such conditions of use as are customary or usual [Adulteration, Section 601(a).]"
OASIS charge code - POISONOUS
**and
(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
OASIS charge code - POISONOUS
**and
(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
Countries
BRAZIL
(53 E - - 03) Hair Straighteners (Hair Preparations, Non-coloring)
Desc:Rio Hair Naturalizer system
BRAZIL
De Classe Cosmetics Ltd
Date Published : 09/18/2009
Estrade do Timbo 156-180 , Rio de Janero, BRAZIL
53 E - - 03 Hair Straighteners (Hair Preparations, Non-coloring)
Date Published: 09/18/2009
Notes:review of label listed concentrate extract of coulteria tinctoria vegetable
dye for which no color additive regulation has been established.
Problems:
COLOR NOT CONTAINED IN TABLE (ENTER NAME IN REMARKS);
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