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