C.T. Guilford
Claudette T. Guilford is the Director of the Consumer Affairs and Information Staff, Office of Regulatory Affairs, United States Food and Drug Administration, Washington, DC.
History of FDA's process to integrate consumer interests
Impact and effectiveness of consumer organizations
Responding to consumers' demand for good nutrition
Initiatives to provide access
Challenges ahead
Consumer involvement has been an inherent aspect of food control in the United States since 1906 when the Food and Drug Act was passed. Since 25 percent of the goods purchased by Americans are regulated by the Food arid Drug Administration (FDA), the public clearly has a strong interest in the agency's policies and activities. In its efforts to provide access, information, education and assistance to consumers, FDA has initiated a number of activities. The consumer education mission of FDA is to inform and educate consumers about FDA's policies and programmes and the impact they have on public health; to facilitate a dialogue between consumers and the agency; and to ensure that consumer views are included in FDA's decision-making process.
In 1952, the Commissioner of FDA sought new ways to develop communication between consumers and the agency. There was particular concern that an agency that was responsible for protecting consumers had no organized means or procedure for determining the consumers' need for protection. Furthermore, it was believed that people could help protect themselves if they knew more about the mission of FDA. As a result, the FDA Consumer Consultant Program was initiated in November 1952. The overall purpose of the programme was to direct FDA's work to be more responsive to consumer needs. To carry out this work, FDA sought consultants with "... a breadth of knowledge of consumer habits, expectations and preference in the purchase of foods and drugs... who know how the ordinary consumer approaches the purchase of a particular food, what is expected, what is important, what information on the label is of value, and why it is of value" (Commissioner Charles Crawford, speech to a consumer organization, 9 November 1952).
Initially, home economists were hired as consumer consultants to work two to four days each month in eight FDA district offices. Later this work was expanded. The part-time consultants' major function was to conduct consumer surveys. By doing this, they established close contact with the buying public.
As technology and the human environment became more complex in the 1950s and 1960s, all things concerning the consumer - drinking water and air as well as purity of foods and drugs - became of pressing public concern. A number of questions had to be dealt with in administering the consumer consultant programme. How were consumers to protect their health in a free economy where they are faced with myriad choices and where such choices could affect the entire environment and people's reaction to it? How was the consumer to protect his or her pocketbook in such ah economy? What were the most fertile fields for consumer education so that people could inform and protect themselves, without resorting to the kind of protection that can only be given by means of scientific knowledge and equipment? How could education be used to reduce the size of the enormous job that heeded to be done? Was the voice of the consumer too weak?
In the early 1960s, a special effort was made to strengthen the consumer voice, and the total Interest of the consumer became a political concern. In March 1962, President John F. Kennedy crystallized the philosophy of this special effort in a speech to Congress on consumer rights. He emphasized four major consumer rights; the right to safety, the right to be informed, the right to choose and the right to be heard. During that same year, a citizens' advisory committee took a thorough look at FDA and realized the tremendous impact that the FDA consumer consultants made by just working a few days a month. This advisory committee recommended that a full-time programme be established.
In November 1963, the Food and Drug Administration was reorganized to improve its efficiency and strengthen its ability to cope with new and changing responsibilities. At this time the importance of FDA's educational functions was realized. The new Bureau of Education and Voluntary Compliance included a Division of Consumer Education and a Division of Industry Advice. Both divisions were devoted to the use of modern communication techniques to promote the objectives of the food and drug law. The basic philosophy then, as now, was that if consumers and industry are well informed, there will be a maximum of consumer protection and a minimum of law violations.
In 1964, President Lyndon Johnson reaffirmed recognition of the four basic consumer rights presented by President Kennedy. He then announced that there should be "active representation of the consumer - in a loud, clear voice - at the topmost levels of government". In subsequent messages to Congress the President continued to propose consumer rights and to enlist careful and deliberate consideration by Congress and diligent efforts by the Executive Branch once proposals were enacted. He pledged his ability and determination to carry through these recommendations and asked support of his consumer rights proposals from business, labour and consumers.
In 1964, funds were appropriated to step up consumer education efforts in FDA. A full-time consumer specialist (home economist) was employed to meet the public and plan an efficient local work programme, based on headquarters' recommendations, for each of the 18 FDA district offices. Today, there are 42 consumer educators, known as Public Affairs Specialists, located in 31 locations throughout the United States. When the programme started, the major emphasis was on food safety and food labelling. Programme activities have expanded to include all products regulated by FDA: foods, human and veterinary drugs, medical devices, biological products and radiation-emitting devices.
Consumer participation
In 1985 the agency established a structured programme for public participation which was designed to be an extension of ongoing consumer affairs activities. The objective of this programme was to establish and maintain a continuous dialogue with FDA's varied constituencies. Formal and informal opportunities and fora were provided for communication and exchange of information with consumers. The intent was to ensure public access to the agency's decision-making process on a regular and consistent basis and to ensure that creative approaches to consumer education be shared and utilized on a broad scale.
In providing public access to decision-making and consumer education activities, FDA had to respond to many issues. How can the regulatory and scientific responsibilities, activities and deliberations of the agency be clarified for the public? How can citizens, whose levels of education are diverse, participate effectively in deciding issues of public policy that have important scientific and technological components? How can the agency effectively generate and sustain meaningful or substantive dialogue with its consumer constituents?
In seeking answers to these questions, FDA asked district offices to design and implement programmes with the following goals: to increase the number and variety of local consumers reached by the programmes; to make them knowledgeable about FDA's administrative practices and procedures, as well as legislative authorities; to provide these local consumers with skills needed to participate in agency decision-making processes; to encourage consumers to contribute constructive viewpoints to the agency's decision-making process; and to provide health promotion messages to diverse populations.
A number of programmes were developed, for example a student-oriented public participation programme and a teachers' guide based on FDA-approved information. Target audiences were selected and programmes and graphics were designed to meet the needs of those specific audiences. Small conferences were conducted for youth and the elderly which focused on agency information such as nutrition labelling. Consumer exchange meetings were held on issues such as "food safety in the home". A course on FDA administrative practices and procedures and access mechanisms was conducted. All of these programmes had a long duration and included many audiences.
There were also programmes of limited duration, such as bilingual fora on food safety for elderly Hispanic people; fora for people who are economically disadvantaged; and meetings on children's issues of high relevance such as Reye's syndrome and poisoning prevention. FDA cosponsored programmes with community organizations which contained a component that presented FDA consumer education messages for Spanish-speaking consumers. Low-literacy consumer education programmes on important FDA health issues were held. The agency cosponsored local consumer health information projects with state organizations for training and information purposes. At the state and local level, FDA conferences about food safety, consumer awareness projects in FDA, the role of the agency and the products regulated were cosponsored by federal and state governments. At the community level, services were provided by various organizations serving particular ethnic groups.
These efforts were enthusiastically received by district offices. Routine reports and evaluations of the projects were prepared and submitted to headquarters. These reports reflected the effectiveness and accomplishments of the programmes, the problems encountered and methods of solving them and the behavioural impact on participants.
Today, consumer advocacy organizations, as well as individual consumers who interact with FDA, are highly sophisticated and influential as a result of FDA's public participation initiatives. This increase in sophistication is evident in a trend towards more specialization among consumer groups as exemplified by those representing multicultural populations, patient concerns and special interest groups. Through these organizations, consumers are empowered as never before. They have the money and scientific background to affect policy decisions. They serve on FDA advisory boards and committees. Many consumer organizations join together to form coalitions that present a united position on regulatory policy issues. These coalitions have powerful lobbying capabilities and they are very effective in dealing with Congress on consumer issues.
Consumer advocacy groups have expanded their constituency to include European, South American and Asian consumer organizations. To accommodate the cultural and linguistic diversity in the consumer world, FDA is altering its staff and preparing to meet the increased need for materials that reflect different cultures. Publications are being prepared in several different languages. FDA is also providing continuous training programmes on cultural diversity and sensitivity to move forward on international issues with greater understanding.
The agency is creating stronger partnerships with consumer affairs professionals in industry and other government agencies, health care professionals and consumer organizations. These partnerships help FDA to serve consumers better. For example, two years ago, in anticipation of the passage of new food labelling regulations, FDA formed a relationship with the Food Marketing Institute (FMI), an association for retail grocery stores, and the National Urban League, an African-American community organization. This partnership among FDA, FMI and the Urban League supported a consumer education programme that links diet and health and educates the African-American community on how to use the information on food labels effectively. The reaction to this programme from the community as well as the participating organizations was extremely positive, FMI's Vice President for Consumer and Community Relations remarked in a meeting that although FMI already felt in touch with the community, working together with FDA and the Urban League provided valuable insight on how to convert understanding and sensitivity to cultural diversity into a positive educational tool.
According to FMI's 1992 survey of consumer attitudes, taste remains the product attribute consumers say is most important in food selection, but nutrition ranks second, slightly ahead of price and product safety and well above the convenience attributes that once seemed to be the central force driving change in the supermarket.
The Grocery Manufacturers of America (GMA) also sponsored a survey of consumers in 1992 to learn what consumers want from the food industry over the next five years, increased nutrition headed the list, and more nutritional information was a close second. Over 85 percent of the consumers surveyed placed nutrition and nutrition information at the top or near the top of their personal lists of priorities for the food industry. Consumers demanded better nutrition and more nutritional choices, and the food industry responded. The market was soon filled with products that were improved nutritionally in various respects and/or had new label claims and statements about the product's nutritional attributes.
The food industry did what it is very good at; it responded swiftly and directly to what consumers said they wanted. However, the food industry's response did not fully satisfy the public's expectations and demands, especially the demand for more and better nutritional information. The industry's response was highly imperfect as regarded the information provided to consumers. Since the provision of basic nutrition information was not legally required, some product labels had it and some did not. There had not been an agreement about the definition of key terms such as "low-fat" and "light", so the terms had different meanings for different products, which was confusing for consumers. Finally, health claims began filtering into the market in ways that many consumers found puzzling: one source of dietary fibre seemed to be popular one month for disease prevention, only to fade the next month in favour of a different fibre source.
This was a classic case of market failure. Although the market had delivered a great deal in response to the consumer interest in nutrition, consumers, as well as many in the food industry who sought to compete fairly in the marketplace, were dissatisfied. They turned to the political process, and the result was the Nutrition Labelling and Education Act of 1990 (NLEA).
Although imperfect, the NLEA provides an excellent example of government and industry collaborating to satisfy consumer expectations. The public turned to government for better information, which the market could not deliver on its own. Congress, in turn, gave FDA a very strong role in regulating the flow of information by making basic nutrition information mandatory and requiring that nutrition and health-related claims conform to FDA's definitions. The food industry will now have to operate in a market greatly improved by more reliable nutrition information.
Access to FDA is provided through a wide range of programmes and activities such as public participation, information and outreach programmes, community-based programmes and public health initiatives. All the programmes and activities are designed to inform consumers about the safety and effectiveness of products the agency regulates. They are targeted to reach all consumers, including Hispanics, African Americans, youth, women, older individuals and the handicapped. The information presented is designed to emphasize messages relevant to the unique health aspects of products regulated by FDA.
Under public participation programmes, national and local meetings are held to enable a broad spectrum of key consumer leaders, individuals and interested organizations to discuss their views with agency officials. At the local level these meetings are referred to as "consumer exchange meetings". Information is provided on public health problems in which FDA is involved or on proposed Federal Register announcements that ask for comment within a specified time frame. Consumers are encouraged to submit written views, to testify at public meetings or to present the consumer perspective at agency advisory committee meetings. Since public participation is a two-way process, information of high interest to consumers is provided to them and they in turn communicate their views, attitudes and reactions to FDA. In this process, consumer opinions are considered in the policy-making decisions at FDA.
Meetings are also convened with consumer leaders, individual consumers and FDA key personnel at the local and national levels for in-depth discussion of health and policy issues important to FDA or consumer representatives. From these meetings FDA is able to determine areas of consumer support for or conflict with agency policy. Local grassroots issues and concerns are also identified. The results are improved understanding and communication, if not agreement, between FDA and consumers and a greater balance in FDA's decision-making process. These meetings require careful preparation and identification of suitable topics and appropriate agency and consumer participants.
Since the enactment of the Federal Advisory Committee Act in 1972, FDA has provided consumers with the opportunity to serve as members on its advisory committees and panels. Currently, consumers serve on 36 of these advisory bodies. The consumer representatives on advisory committees provide the agency with the consumer perspective on many policy and health issues that affect the public.
The consumer constituency interacting with FDA is a diverse group. It includes organizations that represent a broad spectrum of national and local interests, such as the Consumer Federation of America, the American Association of Retired Persons (AARP) and the National Consumers League. These organizations often participate in joint projects with FDA, industry and health professional groups to further consumer protection goals.
Printed material such as brochures, pamphlets and press releases as well as "talk papers" and "backgrounders" which provide more detailed information are used to convey FDA's message to the public. These publications are developed by the Office of Public Affairs. Reprinted articles from the magazine FDA Consumer are also used.
All field public affairs specialists work with the electronic and print media. Several of them have weekly or monthly programmes highlighting FDA activities or appear as regular guests on radio and television programmes. As a result, more and more consumers are getting the word on important health and safety issues. The format for media interaction varies depending on the demographic characteristics of the area. The benefit of working with the media cannot be overemphasized: public affairs specialists reach millions of consumers who may not get FDA's message any other way. It is the greatest way to reach the most people in the shortest time.
FDA is facing an onslaught of new technologies, changing demographic situations and new social agendas of increasingly sophisticated consumers. Technological innovation is challenging all sectors of FDA. While reviewers in the FDA centres must accommodate breakthroughs in genetic engineering of foods, drugs and biological products, FDA must also deal with consumer acceptance of these products, consumer understanding of science and consumer participation in development of regulatory policy. Consumer organizations have become better organized, more politically adept and more effective in campaigns to influence consumers, FDA must therefore maintain effective dialogue that will promote mutual understanding of the reasoning behind its actions as well as the limits to its purview.
The need is to balance scientific technology with improved communications technology and improved methods of responding to consumers. FDA must ensure that current information on agency issues is provided expeditiously to consumers. International agreements on product approval standards, testing and manufacturing methodologies, safety and quality assessments are reshaping regulatory strategies as well as consumer strategies.
FDA has provided a forum and the mechanism for consumers to raise their voice in public policy and regulatory decisions. It has broadened the base for education and information that supports federal regulatory actions. A major barrier is the need for additional resources to continue to support expectations and expand public participation opportunities. These are the challenges awaiting the United States Food and Drug Administration as we move into the twenty-first century.
