The Dietary Supplement Health and Education Act (DSHEA) was passed by into law by the Congress of the United States in 1994. The Act was itself the product of a long period of intense lobbying by both the broadly based nutritional supplements industry as well as a number of American consumer groups, whose goal was to have established a consistent legal framework for the regulation of the dietary supplement industry.
It is believed that members of Congress received as much constituent commentary about the need to pass the proposed DSHEA as it did regarding any other national legislation at the time. The Act references indicators of this intense public interest, citing American surveys that determined that almost 50% of then 260 million citizens regularly consumed dietary supplements, including vitamins, minerals, or herbal products.
Dietary supplements had been a part of the American commercial food industry for decades prior to the passage of the DSHEA. In the 1938 predecessor to the DSHEA, the Food, Drug, and Cosmetics Act, dietary supplements were generally regarded as "foods for special dietary use," but the definitions employed in the 1938 law did not contemplate many of the modern supplements. For this reason, many forms of dietary supplements occupied a legislative netherworld until 1994, as they were not regulated food additives, such as coloring or tenderizing compounds, nor were they perceived as drugs, those substances used as medicines or as narcotics. Prior to 1994, many dietary supplements were regulated as pharmaceuticals by the U.S. Food and Drug Administration (FDA). This federal government agency had assumed responsibility for dietary supplement regulation by advancing the position that all supplements without a defined nutritional value were a food additive, and were to be regulated as such. The industry and consumers desired legislation that created a clear division between prescription drugs and dietary supplements.
There were other societal factors that impacted upon the development and the passage of the DSHEA. American society, in step with most others in the Western world, was increasingly affected by the speed of change in all aspects of life. The lack of time available to many American citizens to prepare food in the home had, in part, contributed to the development of the sprawling fast food industry. The prevalence of relatively high-fat, low-nutrient fast food products sparked concerns regarding the nutritional needs of Americans, which in turn contributed to the desire to remedy dietary deficiencies with readily available supplements.
The preamble to the DSHEA sets out many of the findings of the U.S. Congress that supported the enactment of a comprehensive dietary supplement law. The first of the key Congressional determinations in support of the legislation was that the weight of current scientific research underscored the importance of nutrition and dietary supplements in the general promotion of good health and disease prevention in the United States.
The preamble also identified the proven linkages between the ingestion of certain dietary supplements and the prevention of chronic diseases such as cancer. Congress stated that healthful diets may mitigate the need of expensive medical procedures (when the DHSEA was passed in 1994, the United States was estimated to spend over one trillion dollars on health care, approximately 12% of its gross national product, with increases in this amount forecast if efforts such as the promotion of health were not successful).
Congress also stressed the fact that American consumers were placing an increasing reliance upon non-traditional health care providers. Further, it was clear that consumers were taking a far greater degree of initiative in personal health care, through their own decisions concerning the use of appropriate dietary supplements.
The legislative preamble also noted the economic aspects of the dietary supplements legislation. In 1994, the dietary supplements industry represented an integral part of the economy of the United States, with a positive balance of trade generated in a multi-billion dollar industry. The industry required a proper balance between regulation of its activities and the ability of its members to effectively market and distribute its products.
In an overarching manner, Congress also recognized in the preamble that dietary supplements had been determined to be safe for use in a broad range of circumstances, and safety concerns expressed about such products by members of the public were relatively rare.
Many states created high-profile task forces or agencies to coordinate health and wellness issues at a state level, in the wake of the DHSEA. The New York State Taskforce of Life and the Law is one such example.
As passed by Congress, the DSHEA balanced the continued availability of a very broad range of safe, high-quality dietary supplements, consumer access to better, more complete information about the products, and governmental enforcement. The first portion of the legislation seeks to clearly define the term dietary supplement. This term had been used interchangeably with expressions such as nutritional supplements, vitamin supplements, and protein supplements.
The legislation defines a dietary supplement as a product, other than tobacco, that supplements the diet, containing either alone or in combination one of the following components: vitamins, minerals, herbs, amino acids, or any concentrates or extracts of these substances.
Vitamins are a broad group of naturally occurring substances that enhance human function, growth, and development. Minerals, the naturally occurring elements required for the function of many body systems, are often consumed in combination with vitamins, as the function of some minerals is dependent upon the presence of a specific vitamin. The relationship between the mineral calcium and vitamin D is an example.
Herbs or other botanical products may be dietary supplements either in their natural state or as extracts added to a supplement. Amino acids are the chemicals that function as the building blocks within the body to form proteins, essential to muscle development.
The DSHEA also defines any product to be a dietary supplement that is not represented to be the sole meal in any diet or when the product is labeled as a dietary supplement, to meet the definition. The definitions also provide that a dietary supplement shall be deemed to be a food (as opposed to a drug), for the purposes of the DSHEA.
The DSHEA set out its definitions of how a dietary supplement could be ingested. Powder forms, gels, gel capsules, and tablets were all permitted as forms of these products.
In addressing the consumer protection aspects of the dietary supplement industry, the DSHEA provides a number of specific rules concerning the role of the FDA and the obligation upon the manufacturers of dietary supplements who make claims about the qualities of a supplement, and to properly label all products as to both the nature and the content of the package. With regard to the sale of a new product suspected of being a dangerous dietary supplement, the DHSEA establishes that the government, through the FDA, bears the burden of proof of establishing all such risks.
The DHSEA permits manufacturers to use documentation such as academic articles or other publications or statements as to the value of the supplement, so long as the statements are not suggesting a medical treatment or cure may be affected through usage. Manufacturers are also required to list all ingredients and their quantities present as contained in a dietary supplement; failure to have 100% of the quantity of a stated ingredient or to otherwise misbrand or mislabel a product is an offense under the DSHEA.
The DHSEA also provides for the enforcement of good manufacturing practices by the FDA among the members of the dietary supplement industry in the United States. The failure of a manufacturer to prepare, package, or store its products in reasonably safe conditions is a violation of the statute. The DSHEA sets out a mechanism by which the government may from time to time establish regulations to govern all aspects of the supervision of the manufacturing and distribution process.
The dietary supplement industry has continued to grow since the enactment of DSHEA. As with many aspects of government legislation, the legislative framework and the actual relationship between the industry, consumers, and government are not mirrored in real life. The FDA, while active in the monitoring of false or misleading claims about the efficacy of numerous products such as weight loss programs that often include a dietary supplement component, has initiated prosecutions regarding dietary supplements on an infrequent basis. The most notable instance was the FDA ban on the sale of ephedra in 2004, after a long and acrimonious exchange between the FDA and various producers of ephedra or ephedra-related products.
Ephedra in its natural form is a plant, in which the known stimulant ephedrine naturally occurs. Ephedra has been a mainstay of traditional Chinese medicines for centuries, and it has been used for a variety of purposes, including colds, asthma, and headaches. Ephedra had been used more recently as an ingredient in various herbal weight loss supplements. Considerable controversy in relation to ephedra products developed in 2002, and after a lengthy study, the FDA banned ephedra on the basis of what was referred to as a "risk/benefit analysis." The FDA determined that there was significant consumer risk in the ingestion of ephedra in these supplements, citing scientific research regarding increased risk of heart attack as one aspect. In April 2005, the Federal Court of the State of Utah overturned the FDA ban as it related to ephedra quantities of less than 10 mg per day. The court determined that the FDA had a specific obligation, as the overseer of the legislative framework and the regulations, to establish that low amounts of ephedra presented a specific and definable risk. The court specifically interpreted the DHSEA as providing no basis to conduct a risk/benefit analysis, but rather that the FDA was required to establish an unreasonable risk to the consumer through the ingestion of the product.
The DSHEA in 1994 did not contemplate the sweeping purchasing powers available to consumers through the Internet and the corresponding ability of Americans to obtain all manner of dietary or other supplements offshore, in a manner not within the scope of the DHSEA.