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