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Southern African Journal of HIV Medicine. 2015; 16(1): p.Condoms are one of the cornerstones to any response to the HIV epidemic. However, targeted marketing strategies that make condoms more attractive to people at high risk of infection are often overlooked. The South African National Department of Health has recently purchased more attractive condoms to distribute in higher-education settings free of charge, targeting at-risk youth including young women. The authors applaud this move but note the importance of expanding better branded condoms to young people elsewhere – for example, via youth clinics and in high schools. Exploratory, routine data from Médecins Sans Frontières in Khayelitsha are presented, showing the popularity of alternatives to the government’s ‘Choice’ brand.
Psychology Research and Behavior Management. 2012; 5:11-8.Among those who are sexually active, condom use is the only method of protection against HIV/AIDS. Poor condom skills may lead to condom use failures, which can lead to risk of exposure. Despite the wide availability of condom use instructional leaflets, it is unclear whether these instructions sufficiently teach condom use skills. Ninety-two male and 113 female undergraduates were randomly assigned to a control condition (read non-condom instructions) or a treatment condition (read condom instructions). Participants completed self-report measures related to condom use and performed a condom demonstration task. Participants who read the condom instructions did not perform significantly better on the demonstration task, F (1, 203) = 2.90, P = 0.09, eta(2) = 0.014. At the item level, those who read the condom instructions better performed two of the seven condom use steps correctly. These data suggest that condom packaging instructions do not effectively teach condom use skills.
[The consideration and several suggestions on the national standard GB 7544 natural latex rubber condoms--requirements and test methods]
Zhongguo Yi Liao Qi Xie Za Zhi. 2010 Nov; 34(6):448-9.It was found that several problems exist in the implementation of GB 7544-2004 in the aspects of requirements of natural latex materials and safety of rubber condom products, microorganisms to be controlled and the packaging and label. As a result, the suggestions were put forward.
[Washington, D.C., PSI], 2010 May.  p.FoQus on Traders is a pilot methodology intended to better understand retailers’ decision-making about stocking and selling PSI products. To streamline the distribution and sales of PSI condoms, PSI / Zimbabwe investigated why retailers did not consistently stock Protector Plus condoms. Bottle shops were included in this study, which helped PSI / Zimbabwe shift its sales and distribution emphasis towards wholesalers.
American Journal of Public Health. 2009 Oct 15; 99(12)We assessed awareness and experience with the NYC Condom via surveys at 7 public events targeting priority condom distribution populations during 2007. Most respondents (76%) were aware of NYC Condoms. Of those that had obtained them, 69% had used them. Most (80%) wanted alternative condoms offered for free: 22% wanted ultra-thin, 18% extra-strength, and 14% larger-size. Six months after the NYC Condom launch, we found high levels of awareness and use. Because many wanted alternative condoms, the Department of Health and Mental Hygiene began distributing the 3 most-requested alternatives.
Arlington, Virginia, JSI, DELIVER, 2009.  p. (USAID Contract No. GPO-I-01-06-00007-00)USAID's Public Health Product Catalog 2010 is a catalog of condoms and contraceptives provided by USAID.
AIDS and Behavior. 2008 May; 12(3):452-458.The aim of this article is to examine the impact of the FDA's proposed condom package labeling on HIV-related beliefs about condom effectiveness, on intentions to recommend condoms for friends to use, and intentions to use condoms. Using a nationally representative survey we randomized 1,194 adults ages 18-65 years into one of three condom label conditions: the current label on condom packaging; a label with the proposed FDA language; and a label with CDC language on condom effectiveness. In short, there are no significant differences between the proposed FDA label and the current label on HIV-related beliefs and intentions. In contrast, from an HIV prevention perspective, the CDC condom language appears to offer a better alternative to the current condom label for unmarried populations. (author's)
Reproductive Health Matters. 2006 Nov; 14(28):63-67.DKT International is a non-profit social marketing enterprise whose mission is to provide safe, affordable options for family planning and STI/HIV prevention. In Brazil, DKT sells male and female condoms to mostly lower-income couples nationwide. This paper is about the introduction of a ribbed, lubricated, latex condom called Affair to the Brazilian market in 2000. Sales were initially very low, but based on reports that Affair was well liked by some men who have sex with men, we took the opportunity to give Affair that positioning. We worked with our advertising agency, a local research company and Dignidade, a Brazilian NGO working for the rights of men who have sex with men. Two new products - a baggy condom called Affair Sensation and a complimentary lubricating gel called Affair Personal Lubricant - with new packaging and a promotional campaign were launched in February 2006. The billboard advertisement generated controversy in Sao Paulo, where the Advertising Council required it to be taken down due to complaints. However, the controversy helped promotion and at the same time generated public debate on sexuality and human rights. Our overall experience has been positive, sales are up and we have received messages of support for the products and their promotion from consumers. (author's)
BOLETIN OFICIAL DE LA REPUBLICA ARGENTINA. 1992 Nov 12; Sec 2(27513):5.This Resolution of the Ministry of Health of Argentina creates a National Register of Businesses manufacturing, packaging, and importing condoms and a Register of Devices, which has responsibility for the registration of condoms manufactured or imported into Argentina. Both Registers are under the control of the Directorate of Drugs, Medicaments, and Food. The Resolution also approves standards for testing condoms and places the Institute of Medicaments in charge of carrying out such testing to ensure the quality and safety of condoms. All businesses manufacturing, packaging, or importing condoms are required to register with the National Register and to petition the Register of Devices for approval of their condoms.
[Interministerial Order No. 232 MSPS/MEFCP of 16 September 1991 relating to the quality control of imported condoms distributed in Ivory Coast] Arrete interministerial No. 232 MSPS/MEFCP du 16 septembre 1991 relatif au controle qualitatif des preservatifs importes et distribues en Cote d'Ivoire.
JOURNAL OFFICIEL DE LA REPUBLIQUE DE COTE D'IVOIRE. 1991 Sep 26; (39):633.Interministerial decree number 232 of September 16, 1991, states that condoms or lots of condoms sold or distributed in the Ivory Coast must undergo preliminary quality control testing. The testing must be done in an independent laboratory approved by the World Health Organization or the Ministry of Public Health. The laboratory tests are to be interpreted according to the annexed specifications, conforming to Ivory Coast norms. The tests and controls concern packaging and labeling, the water and pneumatic inflation tests, tests of the integrity and watertightness of the packaging, and measures of length, diameter, and thickness. The exterior and interior packaging should meet World Health Organization specifications and must indicate the brand name, the lot number, the name and address of the manufacturer, country of origin, dates of manufacture and expiration, and the size of the product. Quality control tests are required every six months for stored lots of more than 10,000 condoms. The average sample for testing is 500 units for a lot of 35,000 to 150,000 condoms and 150 units for smaller lots. The National Public Health laboratory is the reference laboratory for quality control of condoms in the Ivory Coast. Other laboratories may be approved by the Minister of Public Health.
BOLETIN OFICIAL DEL ESTADO. 1991 Nov 29; (286):8102-13.Spain's royal decree 1688/1991 of November 22, 1991, establishes technical standards for condoms marketed in Spain and declares their approval obligatory. The technical specifications for characteristics and testing methods for condoms were defined in norm UNE 53-625-89, whose previously voluntary observation was declared obligatory by the 1991 decree. The specifications of UNE 53-625-89 are presented as an annex. The decree outlines the requirements and procedures for approval, to be granted by the General Office of Pharmacy and Health Products in accordance with the criteria spelled out in this decree. Packaging and product information requirements, regulations governing inspection, marketing, and advertising, and infractions and their sanctions are addressed as well. A form for requesting approval is included.
An Act (No. 72 of 1987) to prescribe the law in relation to the sale of condoms and related matters and to repeal the Police Offences (Contraceptives) Act 1941 and the Police Offences (Contraceptives) Repeal Act 1976. Date of assent: 27 November 1987. (The Sale of Condoms Act 1987).
INTERNATIONAL DIGEST OF HEALTH LEGISLATION. 1988; 39(2):387.This Act comprises the following Parts: I. Preliminary (Secs. 1-5); II. Sale of condoms (Secs. 6-8); III. Licenses (Secs. 9-22); IV. Advertising (Secs. 23-24); and V. Miscellaneous (Secs. 25-33). 1 of the provisions in Sec. 6 lays down that a person may not sell or supply a condom unless it complies with the standards prescribed by regulations. Details are given in Part IV of the procedures for the monitoring, by the Publications Classification Board, of advertisements relating to condoms. Details are given in Sec. 32 of the matters in respect to which the Governor may make regulations for the implementation of this Act. Such regulations may, inter alia, deal with the labelling, packaging, information provided in or on packages, and storage of condoms, as well as the procedures to be followed, and the action that may be taken, to prevent the sale or supply of condoms that do not comply with the prescribed standards. It is likewise laid down that, with respect to standards for condoms, the regulations may adopt either wholly or in part and with or without modification (either specifically or by reference) any of the standard rules, codes, or specifications of any prescribed authority (defined to mean (a) the Standards Association of Australia; (b) the British Standards Institution; (c) the International Organization for Standardization; and (d) such other body, organization, or Government department or agency as is specified in the regulation. (full text)
[Unpublished] 1981 Sep 12. 8 p.The product line of Bangladesh's successful social marketing program should be expanded to include Panther condoms. Bangladesh's social marketing program was implemented in 1975 by Population Services International, and in 1976 the Project Council was established and given responsibility for developing policies and operational guidelines for the program. The program has 4 regional sales divisions, and each division is headed by an areas sales manager. Project products are sold in about 65,000 retail outlets. Products currently distributed are 1) Raja, a condom; 2) Maya, a standard dose oral contraceptive (OC); 3) Ovacon, a low dose OC; and 4) Joy, a foam tablet. Prior to the introduction of the Raja condom, a number of commercially marketed condom brands were available in the country. These other brands have almost disappeared from the market. In commercial marketing it is widely recognized that when several brands compete for the consumers' attention, total sales increase. Variety sells for a number of reasons. Consumer tastes and needs vary, and this is the reason Baskin and Robbins sells 31 flavors of ice cream. Professional marketers are keenly aware of the need to offer brands that sell for different prices. For example, soap companies offer brands tailored to the income level of all segments of the population in order to capture a broad market for their products. The addition of new products also leads to an increase in product promotion. If there is only 1 product on the market, advertisers run out of things to say about the product. The addition of competing products gives advertisers new things to say about their product. As a result, public exposure to the entire product line is increased. Commercial marketers also recognize the advantages of introducing a premium, or high priced brand. These products lend status to the entire product line. Social marketers must overcome their hesitancy about introducing products which appeal primarily to middle and upper class or urban segments of the population. If elite groups use a product, the popularity of the product will increase in the general population. In summary, commercial marketing guidelines indicate that the introduction of a higher priced condom into the product line of Bangladesh's social marketing program will not only increase total condom sales but will increase sales of the Raja condom. The Panther condom should be introduced as a luxury brand. The current price of a Raja condom is US$0.01, and the price of a Panther condom should set somewhere between Ta.2.50-Ta.3.00. Sales from the Panther condom will reduce the operating deficit of the program. Panther condoms can be produced by Akwell Industries for about the same price that the company now manufactures Raja condoms. Packaging for the product should be developed locally, and the package should be designed to appeal to the middle and upper classes. An initial supply of 3.5 million Panther condoms should be obtained from the US. This purchase and the intial cost of designing an appropriate package and sample promotional material can be covered by the program's current budget.
Stockholm, Social Welfare Board, . 2 p.In Sweden the condoms sold shall be approved by the Social Welfare Board and are part of a batch satisfying the requirements of paragraphs 8-10 of this report. The manufacturer shall provide the Social Welfare Board with information required for quality testing, including the nature of the condom material. The manufacturer shall also provide evidence that the condom is suitably powdered or treated and that its lubricant and preservative are suited to the purpose, do not damage the condom, and do not have practically significant toxic, sensitizing or locally irritating effects. Condoms, or their packets, shall be marked with the manufacturers name, the quality test batch number, and a date of expiration. Condoms may only be imported for sale if evidence is submitted to the customs that their nature and marking conform with Social Welfare Board requirements. Such evidence shall be provided by the State Testing Laboratory, the Pharmacist's Central Laboratory, or other testing establishment authorized by the Social Welfare Board. Condom importers shall provide the testing establishment with 2 copies of details of each consignment, stating the manufacturer's and importer's names and addresses, and the size and marking or name of each batch. Each quality test batch shall belong to 1 manufacturing batch, be homogeneous, and not exceed 72,000 condoms. A total sample of at least 410 condoms shall be taken from each batch, unless otherwise specified by the Social Welfare Board. The length of each condom shall be at least 17 centimeters. The circumference of each condom, up to 8.5 centimeters from the rim, shall also lie between 9.8 and 11.2 centimeters. 10 condoms, after removing the lubricant and preservative, shall be weighed; the total weight shall not exceed 17 grams. 100 condoms shall be tested for bursting volume. The open end of each condom shall be affixed to the outlet of a suitable inflation device, and the condom inflated with air at room temperature to bursting. 30 condoms shall be tested for holes. Each condom shall be unrolled, preferably with the help of a pneumatic device and fixed with the rim upwards in a suitable holder. 300 milliliters of water at room temperature shall be poured into the condom, preferably with the help of a device preventing water from reaching the outside of the condom. After 1 minute, the outside of the condom shall be inspected in a suitable light. If no hole is detected, the water filled condom shall be closed by twisting 2 centimeters from the rim, and the condom rolled over thin absorbent paper of a suitable color. Small holes in the condom can thus be detected as wet spots on the absorbent paper.
Standard specifications for rubber contraceptives (condoms). American National Standard ANSI/ASTM D 3492-77.
In: American Society for Testing and Materials [ASTM]. Annual book of ASTM standards. Part 38. Philadelphia, Pennsylvania, ASTM, 1980. 13-6.This document describes the requirements for condoms made of rubber latex intended for single use as specified by the American Society for Testing and Materials (ASTM) in 1977. Condoms must be manufactured from good quality rubber latex; they may be transparent, translucent, opaque, or colored. Condoms must not liberate toxic or otherwise harmful substances. The open end of condoms must end with an integral rim. 10 condoms out of a batch of 144,000 at most must be tested for design, including length, width, thickness, and mass or weight. Length must be from 160 mm to 180 mm +or- 10 depending on smooth or textured surface and on width; width must be from 49 mm to 52 mm +or- 2-3, again depending on type of surface; thickness must be 0.04 mm +or- 0.07-0.09, and maximum weight must be from 1.50 g to 1.95 g depending on smooth or textured surface. 25 condoms out of a batch of 144,000 at most must be tested for tensile properties, including tensile strength and elongation at breaking. Inspection for leakage must follow ISO 2859, General Inspection Level 1 for an acceptable quality level of 0.4%. Each condom must be filled with 300 cu cm of water and inspected for holes. Each condom must be marked with the manufacturer's name and date of manufacture. Every package must have name and address of manufacturer or distributor, and the name of the country of manufacture. Proper packaging should protect condoms for 10 years or more. Condoms should not be kept in storage longer than necessary, and should be stored in a cool place. One retest is possible before final rejection of lots not conforming to design and physical requirements. No retest is permissible for lots not conforming to test for quality assurance (leakage).
Triton quarterly analysis of FOF [Family of the Future] plans, fiscal report and funding request for September-November 1981 (Quarter 3).
Washington, D.C., Triton, 1981. 28 p. (Contract No. NEB-0029-C-1037-00, Egypt)The report details plans for the activities and expenditures related to the promotion and sale of contraceptive devices in Egypt for the 3rd quarter of 1981. Family of the Future (FOF) is a nongovernmental agency which operates on a US Agency for International Development grant of $27,200. Major activities from the previous quarter are summarized and plans for each of the 6 FOF departments are provided. The Medical Promotion and Distribution department will develop distribution strategies including locating new cities and establishing sales targets for IUDs, condoms, and spermicides; prepare information booklets for doctors and pharmacists on devices as they are added to the product line; and oversee warehousing details and sponsor conferences for pharmacists and doctors. These activities are expected to consume 25.6% of the proposed budget. The advertising and art department will determine communication strategies for all products. Copy and time slots will be suggested for mass media promotion of FOF and of available family planning methods to be aired on television stations and 6 radio stations. Inserts for 6 newspapers, 7 weekly magazines, 5 bi-monthly or monthly magazines, and 4 special audience publications will be prepared. This department will operate on 31.3% of the budget. Other promotional activities will include the design and production of multi-product countertop displays and of giveaway items. The medical and scientific department will sponsor a symposium for influential university affiliated obstetricians and gynecologists from 4 cities to stimulate interest in family planning and in FOF and its products. Training programs on IUD insertions will be provided. Volunteers and social affairs departments will use 25 volunteers to organize 110 rallies reaching 2500 people each that are gathered in crowded places or through door-to-door contact. Volunteers will also continue to collect interview data. Volunteer training is planned to target seasonal vacation areas. Samples of condoms and spermicides, booklets, and pamphlets will be distributed during upcoming festivals. A central location will be established from which volunteers can answer questions. The market research department plans to conduct 19 group sessions and continue data collection for the pharmacy intercept study. Market research training in the US is arranged for an FOF employee. No changes are planned which would affect the administration department. A detailed financial analysis of quarterly projections and expenditures is provided. Revenues from sales of contraceptive devices are also included in the report. An evaluation of the planned activities and recommendations for additional activities are detailed.
Columbia, Maryland, Westinghouse Health Systems (AID/pha-C-1063). 1977 Dec; 68.In July 1974, Westinghouse Health Systems began the process of establishing a contraceptive retail sales program (CRS) to market condoms and oral contraceptives in Jamaica. The program, designed to utilize existing retail distribution systems, had as its major focus the development of indigenous resources to augment the existing clinic activities of the Jamaica National Family Planning Board, and centered on 5 major areas: 1) advertising and promotion; 2) product pricing and packaging; 3) distribution; 4) consumer and retailer education; and 5) program evaluation and monitoring. Initial research was aimed at educating the public, distributors, and retailers in the availability, usage, and potential side effects of oral contraceptives. A major advertising campaign involving radio, television and the press was directed at promoting the 2 contraceptive brands - Perle oral contraceptives and Panther condoms. In September, 3 years after implementation, management of the program was turned over to the Jamaican National Family Planning Board. Annual program sales had reached 184,000 cycles of pills, and 880,000 condoms through 267 Perle outlets and 1108 Panther outlets, nearly doubling and tripling pill and condom sales. Introduction of the new brands has had no effect on sales of competitive brands, nor has there been a negative impact on distribution of condoms and oral contraceptives through the public clinic sector. In addition, the cost per acceptor has been less when compared to costs per acceptor in the public sector clinics. By 1979, the projected costs per acceptor will be $262 in the CRS program versus $32.73 in the public sector program.
In: Westinghouse Population Center. Survey of global patterns of contraceptive distribution in the private sector in selected developing countries, pt. 1. Columbia, Maryland, Westinghouse, 1972. (Contract CSD 3319) p. 385-463Estimation of Thailand's contraceptive market potential in the light of the country's socioeconomic background; family planning efforts; commercial market for contraceptives and attitudes of manufacturers and consumers indicate that government regulations regarding Thai import, trade and pharmaceutical activities are generally not very restrictive compared with those of other developing countries. Problems encountered by pill manufacturers are the low retail prices of pills (the Schering Company plans to increase retail prices through local production of the pills) and the possibility of a massive free contraceptive distribution through government family planning programs. Overall, trade prospects for the pills are seen by all concerned as bleak. In the private sector, no major cultural factors are expected to hamper contraceptive sales. There is in fact a high level of interest and motivation among Thai women to practice contraception due to family tradition and their participation in the labor force (in 1966, it was estimated that 42% of the female population was actively employed). Problems in marketing the condom include the "illicit sex" image associated with its use and the widespread belief regarding the inferiority of local products to improted products. Empirical evidence indicate tht Thailand's potential market for condoms consist of about 1,500,000 males and a corresponding annual market of 180 million condoms, or 10 times that of the current market. However, in the light of the limited purchasing power of the Thais and a free government family planning program, more realistic estimtes would be an annual sales potential of 86 million pieces, or a 400% increase over the current market.
In: Westinghouse Population Center. Survey of global patterns of contraceptive distribution in the private sector in selected developing countries, pt. 1. Columbia, Maryland, Westinghouse, 1972. (Contract CSD 3319) p. 107-161This is an analysis of the family planning and contraceptive supply situation in Jamaica. A general treatment of the socioeconomic background of the country precedes the discussion. The governmental health care program and family planning services, as well as services offered in the private sector, are described. Legal requirements and regulations regarding contraceptive import, manufacture, advertising, export, and distribution are described. Companies, contraceptive cycles, and pricing costs involved are tabulated. Private and commercial sector distribution of contraceptives supplement the governmentally-sponsored program. Commercial market potential is assessed. All data is tabulated. During the year 1971, almost 20% of the nearly 300,000 potential customers used some contraceptive product. Almost 60% of them were supplied by public sector agencies; the rest purchased contraceptives through the private sector. Pills, condoms, spermicides, and injections are used in that order of importance.
Columbia, Maryland, Westinghouse Population Center (AID Con tract #csd/3319). 1974 Apr; 164.The Westinghouse Population Center, Columbia, Maryland, under contract to the United States Agency for International Development, has investigated the current and potential distribution of contraceptives through available commercial channels in Turkey as well as in 8 other developing nations. It is believed that commercial sector contraceptive distribution can have a significant effect on fertility patterns. The purpose of the investigation is to identify and evaluate the existing contraceptive market, the channels of distribution, and the potential for increasing private sector participation in expanding the availability and usage of contraceptive products. The private sector currently supplies a larger percentage of the couples using contraceptives in Turkey than does the public sector. The private sector's distribution capability is such that it can reach people who do not reside within a reasonable distance of a pharmacy or clinic as well as make a wider range of products and information available so that consumers can choose the brand and/or method they wish to use. Included in the findings of the report are recommendations for action. It is recommended that the government eliminate duties and taxes on the importation of finished condoms and of raw materials for producing oral pills and vaginal contraceptives, streamline the procedures for importing condoms, and increase the number of retail outlets for contraceptive products. The government and manufacturers should initiate physician education programs. At the manufacturer's level, pharmacists and other retail outlet operators who sell contraceptive products need to be supplied with accurate information. Mass media should be used at the consumer level to inform the public about the proper use of contraceptives, for the majority of couples has limited knowledge of how to obtain and use contraceptives. Promotion of contraceptives should be targeted to both male and female audiences. A research strategy should be incorporated which makes a series of quick evaluations of various elements of the program possible.
Distribution of contraceptives in the commercial sector of selected developing countries. Summary report.
Columbia, Maryland, Westinghouse Population Center, Health Systems Division. 1974 Apr; 135.The role of the commerical sector in delivering contraceptive products (primarily the pill and condom) is examined in the following 8 developing countries: Turkey, Iran, Thailand, Korea, the Philippines, Venezuela, Panama, and Jamaica. Current status of distribution was obtained from surveys of fertile couples. Recommendations are given for action at both the national and international level: an illustrative marketing plan for increasing commercial distribution is presented. The commerical sector is considered a needed component in helping to meet national population policies; it is suggested that governments and donor agencies help eliminate barriers to increased commercial distribution, and that commercial companies cooperate with these organizations. Major findings are detailed by examining the distribution systems, marketing activities, pricing policies, and consumer attitudes, knowledge and behavior. Major factors which impede or facilitate contraceptive usage and current commerical distribution are given for each country.
In: 1st Pacific Regional HIV / AIDS and STD Conference, Nadi, Fiji, 23-25 February 1999. Conference proceedings, [compiled by] Pacific Community. Secretariat. Noumea, New Caledonia, Pacific Community, Secretariat, 2000. 172-6.This paper covers social marketing in general, answers frequently asked questions and addresses the potential for condom social marketing in the Pacific. Social marketing is becoming increasingly important in efforts to assure developing countries have access to the health products and services they need. The key to successful social marketing is effective communications. Oceania is a vast space with small populations; however, commercial wholesale and retail networks and mass media communications are well developed. Social marketing may be the best means to promote healthy sexual behavior and to ensure access to condoms. (author's)
Geneva, Switzerland, ISO, 1990 Aug 15.  p. (International Standard ISO 4074-10)In this document the International Organization for Standardization specifies the requirements for packaging and labeling rubber condoms supplied in consumer packages. In packaging, each condom must be packaged in an individually sealed container, and these must in turn be packaged together in a consumer package. Except where condoms with different colors are packaged together, all condoms must be of the same batch number. Both the individual and the consumer packages must be opaque to light. For labeling, individual containers must bear the manufacturer's/distributor's identity and the manufacturer's identifying reference, while the consumer package must have the condom's description (e.g., color, tip type, ribbing), numbers contained, nominal width, manufacturer, packager or distributor's name, expiry date (month and year), instructions for storage as based on annex C of ISO 4074-1, and whether it is lubricated or dry. A leaflet contained within the consumer package should bear the manufacturer, re-packager or distributor's address, instructions for condom use, disposal instructions, and a statement that the condom is for single use.
British Journal of Family Planning. 1996 Oct; 22(3):139-41.Faced with an annual increase in the number of individuals infected by heterosexual transmission of HIV in Scotland, health authorities in Lothian have sought innovative ways to reduce the threat of HIV transmission. One such measure is the "Take Care Campaign," which presents individuals with a range of safe and safer sex behavior choices to choose from at different stages of their life (abstinence, choosing to avoid penetrative intercourse, using a condom, and remaining in a longterm monogamous relationship with an uninfected partner). In 1992, a pilot study was initiated which involved providing doctors with a special pack containing oral contraceptives (OCs) and condoms. The purpose of this study was to make it easier for physicians to discuss HIV prevention while prescribing OCs, to link the prescription of OCs with the condom in the minds of the physicians and clients, and to provide women with a way to carry condoms in their handbags. The 92 women involved in the study all found the pack acceptable, and, at 3-month follow-up, nearly half kept it in their handbags. All 16 physicians found the pack helpful in raising the topic of HIV prevention, and 14 women stated that it helped them raise the subject with their partners. The success of this pilot program led to development of a pill/OC pack that would accommodate 3 condoms, a leaflet, and 80% of the brands of OCs available locally. The pack is intended to be given to first-time OC users. More than half of the general practitioners in the Lothian area have ordered packs.
FDA: polyurethane condom carries "extremely misleading" label. Federal agency allows distribution for public health's sake.
CONTRACEPTIVE TECHNOLOGY UPDATE. 1995 Feb; 16(2):17-20.The labeling of the Avanti polyurethane condom selling in 10 Western states makes misleading claims about protection from pregnancy and sexually transmitted diseases (STDs) according to officials at the US Food and Drug Administration (FDA). Avanti is sold in a foil package printed with the claim that it is effective against pregnancy, HIV, and STDs. However, polyurethane condoms have not undergone clinical efficacy testing for contraception or STDs, according to officials. The manufacturer of the condom refuted this allegation, stating that latex condoms have the same claims on them. In early 1995 the FDA met with the manufacturer and other companies developing plastic condoms, and concluded that these condoms could not make such claims, nor any claims about slippage and breakage rates. Despite warnings in 1993 to the manufacturer of Avanti about labeling restrictions, the company printed pregnancy and STD efficacy claims on the boxes and individual packages. The FDA later worked out a compromise with the firm in which only the boxes had to be reprinted with the generic label. The FDA had to weigh the risk of the public health cost of delaying sale of the condom, which is the first impermeable condom proven safe for people with latex allergies. In 1991 the FDA was defining standards for clinical testing and labeling of polyurethane condoms under congressional mandate, but the manufacturer of Avanti began mass production based on a preliminary approval determining that the condom was equivalent to latex condoms already on the market. 7000 Avanti condoms were subsequently tested in five countries, but these user tests did not compare Avanti to latex condoms and did not test for pregnancy and STD protection. Test results submitted to the FDA by the company indicated that, although Avanti is more than 1/3 less elastic than latex condoms, it did not break more frequently in an in-use study involving 187 couples.