The Rio Hair Naturalizer System was a hair relaxer distributed by the World Rio Corporation Inc. It was available in two types; "Neutral", and one that claimed to have a "Color Enhancement Formula" that contained a black hair dye. [1] As a product designed for home use, it was promoted through infomercials in the early to mid-1990s.
The U.S. Food and Drug Administration (FDA) and state government offices began receiving complaints about the Rio hair products in mid-1994. Many complainants said they had bought the hair relaxers by mail after viewing a 30-minute TV infomercial targeted to African Americans.
Some complainants reported that their hair began falling out immediately after applying the products, while others said they had problems after multiple applications. Some said they had seen doctors for treatment of scalp irritation. Many women said they had to cut their hair short to deal with bald spots.
November 6 and 8, 1994 FDA collected samples of the hair relaxers, at a Los Angeles-based affiliate, Pantron I Corp., of World Rio. Most of the products, which were imported from Brazil, were in the possession of Product Packaging West, also known as Pic 'N' Pac West, of North Hollywood, California.
November 23, 1994 the California Department of Health embargoed the products held in Los Angeles and North Hollywood, essentially blocking their sale in the United States.
December 21, 1994 FDA advised against use of the products after laboratory findings identified the low pH and the number of consumer complaints indicated that the hair relaxers were causing adverse reactions. About the same time, World Rio stated it would stop all sales of the products, but the FDA received reports from consumers that the company may still have been taking orders and billing customers through a mail-order company: Addressing and Mailing Inc., in North Las Vegas, Nevada.
January 23, 1995, at FDA's request, U.S. marshals seized the entire lot of products at Product Packaging West in California.
January 24, 1995 an investigator with FDA's San Francisco district office went to Addressing and Mailing to inspect the firm and found more than 8,000 cases of the Rio hair relaxers, worth about $500,000 in retail value. FDA notified the State of Nevada Division of Health, which, in turn, embargoed the products, thus preventing their sale.
June 14, 1995 World Rio voluntarily destroyed the 8,000 cases of Rio hair relaxers held at Addressing and Mailing in Nevada. [2]
Despite the claims of the relaxer being safe and natural, the product contained copper, ammonium, and chloride salts and a pH of less than the listed level of 3. [3] Due to these factors, people using the product suffered from hair loss, scalp burns, and (in some cases) green hair color. [4] By 1995, there were over 3,000 complaints lodged with the Food and Drug Administration. Eventually, the product was barred from being imported into the U.S., and all remaining company stocks were destroyed. [5] Several victims (about 53,000) filed a class action lawsuit against World Rio Corporation, resulting in a judgment of US$4.5 million. The incident also raised questions about the issue of relaxing afro-textured hair in general. [6]
Ephedra is a medicinal preparation from the plant Ephedra sinica. Several additional species belonging to the genus Ephedra have traditionally been used for a variety of medicinal purposes, and are a possible candidate for the soma plant of Indo-Iranian religion. It has been used in traditional Chinese medicine, in which it is referred to as Ma Huang, for more than 2,000 years. Native Americans and Mormon pioneers drank a tea brewed from other Ephedra species, called "Mormon tea" and "Indian tea".
A health claim on a food label and in food marketing is a claim by a manufacturer of food products that their food will reduce the risk of developing a disease or condition. For example, it is claimed by the manufacturers of oat cereals that oat bran can reduce cholesterol, which will lower the chances of developing serious heart conditions. Vague health claims include that the food inside is "healthy," "organic," "low fat," "non-GMO," "no sugar added," or "natural".
Anti-aging creams are predominantly moisturizer-based skin care products marketed with unproven claims of making the consumer look younger by reducing, masking or preventing signs of skin aging. Anti-aging supplements are ingestible products promoted to diminish the effects of aging, including vitamin supplements, powders, and teas.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Frances Kathleen Oldham Kelsey was a Canadian-American pharmacologist and physician. As a reviewer for the U.S. Food and Drug Administration (FDA), she refused to authorize thalidomide for market because she had concerns about the lack of evidence regarding the drug's safety. Her concerns proved to be justified when it was shown that thalidomide caused serious birth defects. Kelsey's career intersected with the passage of laws strengthening FDA oversight of pharmaceuticals. Kelsey was the second woman to receive the President's Award for Distinguished Federal Civilian Service, awarded to her by John F. Kennedy in 1962.
Kevin Trudeau is an American author, salesman, and television personality known for promotion of his books and resulting legal cases involving the US Federal Trade Commission. His ubiquitous late-night infomercials, which promoted unsubstantiated health, diet, and financial advice, earned him a fortune but resulted in civil and criminal penalties for fraud, larceny, and contempt of court.
A relaxer is a type of lotion or cream generally used by people with tight curls or very curly hair which makes hair easier to straighten by chemically "relaxing" the natural curls. The active agent is usually a strong alkali, although some formulations are based on ammonium thioglycolate or formaldehyde.
Proactiv is an American brand of skin-care products developed by two American dermatologists, Katie Rodan and Kathy A. Fields, and launched in 1995 by Guthy-Renker, a California-based direct marketing company, that was endorsed by famous celebrities The range includes moisturizers, body washes and treatment products, but the brand is known for its three-step anti-acne Solutions 3-step routine consisting of a BPO cleanser, glycolic toner and treatment lotion. Proactiv+, a reformulation of the three-step kit, was introduced in 2013, and in 2017, ProactivMD launches powered by Adapalene.
Hair care or haircare is an overall term for hygiene and cosmetology involving the hair which grows from the human scalp, and to a lesser extent facial, pubic and other body hair. Hair care routines differ according to an individual's culture and the physical characteristics of one's hair. Hair may be colored, trimmed, shaved, plucked or otherwise removed with treatments such as waxing, sugaring and threading. Hair care services are offered in salons, barbershops and day spas, and products are available commercially for home use. Laser hair removal and electrolysis are also available, though these are provided by licensed professionals in medical offices or speciality spas.
Natural Cures "They" Don't Want You To Know About is a 2005 self-published book by American author Kevin Trudeau, promoting various purported non-drug and non-surgical cures for many diseases, primarily in support of his business selling such products. Trudeau accuses pharmaceutical companies and the United States government of censoring these products and methods on the basis that it would cut into their profit margin. The book is the subject of widespread allegations of fraud.
Donald D. Lapre was an American multi-level marketing and infomercial salesman. His work involved product packages such as "The Greatest Vitamin in the World" and "Making Money Secrets".
Zicam is a branded series of products marketed for cold and allergy relief whose original formulations included the element zinc. The Zicam name is derived from a portmanteau of the words "zinc" and "ICAM-1". It is labelled as an "unapproved homeopathic" product and as such has no evidence of effectiveness.
Kinky hair, also known as afro-textured hair, is a human hair texture prevalent in the indigenous populations of many regions with hot climates, mainly sub-Saharan Africa, some areas of Melanesia, and Australia. Each strand of this hair type grows in a repeating pattern of small contiguous kinks. These numerous kinks make kinky hair appear denser than straight, wavy, and curly hair types.
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in 1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process. The Act provided that the FDA was entitled to collect a substantial application fee from drug manufacturers at the time a New Drug Application (NDA) or Biologics License Application (BLA) was submitted, with those funds designated for use only in Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) drug approval activities. In order to continue collecting such fees, the FDA is required to meet certain performance benchmarks, primarily related to the speed of certain activities within the NDA review process.
The Weight Loss Cure "They" Don't Want You to Know About is a weight loss book written by salesman and convicted fraudster Kevin Trudeau. It was released in April 2007 by Alliance Publishing.
The United States Food and Drug Administration has published certain product recall policies applicable to consumer products.
Seasilver is the trademarked name of a commercial dietary supplement produced and sold by the companies Seasilver USA, Inc. and Americaloe, Inc.
The regulation of food and dietary supplements by the U.S. Food and Drug Administration is a process governed by various statutes enacted by the United States Congress and interpreted by the U.S. Food and Drug Administration ("FDA"). Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling about both the composition and the health benefits of foods.
Citizens for Health is a U.S. non-profit organization which advocates on issues affecting nutrition, obesity, dietary supplements, food labeling and other health matters.
Monat Global Corp., or simply Monat, is a privately-held American multi-level marketing company headquartered in Doral, Florida, which sells haircare, skincare, and wellness products. It is a subsidiary of the Alcora Corporation, a private-labeling company formed in 2001. Monat operates in the U.S., Canada, the U.K., Ireland, Poland, Spain, Australia, New Zealand, Lithuania, France, Mexico, and Colombia.