IA #53-16 - 3/1/95, "AUTOMATIC DETENTION OF RIO HAIR NATURALIZER"
TYPE OF ALERT: Automatic Detention
PRODUCT : Rio Hair Naturalizer System, neutral and color
enhanced.
PRODUCT CODE : 53E[][]03
HARMONIZED
CODE : 2106.90.6999
3304.91.0050
3305.90.0050
3305.20.0000
PROBLEM : Injurious to Health
PAC FOR
COLLECTION : 29002
COUNTRY : Brazil, (BR, 220)
MANUFACTURER/
SHIPPER : De Classe Cosmeticos Ltd.
Estrada De Timbo 156-180
Rio De Janeiro, Brazil
MANUFACTURER/
SHIPPER I.D.#: BRDECLA1561RIO
IMPORTER'S
I.D. # : N/A
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).]"
**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).]"**
RECOMMENDING
OFFICE : LOS-DO (HFR-PA256)
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.**
INSTRUCTIONS : Automatically detain, without physical sampling and
analysis, all shipments of Rio Hair Naturalizer,
Neutral and Color Enhanced, bulk and in packaged
form, from De Classe Cosmeticos, Ltd., Rio De
Janeiro, Brazil.
**Other hair relaxer/neutralizer products from
Brazil or imported by World Rio Corp/Pantron I
Corp., should receive intensified sampling.**
PRIORITIZATION
GUIDANCE : I
FOI : No purging required.
KEYWORDS : Rio, Hair Naturalizer, De Classe Cosmeticos,
scalp, hair loss, hair relaxer, color enhancer.
PREPARED BY : Doug Randes, DIOP, 301-443-6553
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