Maged Sharaf, PhD, American Herbal Products Association06.02.14
October 2014 marks the 20-year anniversary of the Dietary Supplement Health and Education Act of 1994 (DSHEA), a law that established a regulatory framework for supplements and helped ensure continued access to safe, high-quality products.
For the herbal and supplement products industry, DSHEA helped formalize these products into a new class of goods and increased resources for research, new technology and standards.
Consumer demand for herbal products and dietary supplements in the 1980s and early 1990s sparked a grassroots effort to create DSHEA. The resulting law and regulations built on the grassroots momentum and helped strengthen and advance the supplement and herbal products industry to meet consumers’ demand for a wide variety of high-quality products.
Rationale
In the preamble of DSHEA, U.S. Congress offered 15 “findings” that outline the rationale for the law, the goals of DSHEA and the importance of dietary supplements in promoting wellness.
Among the findings, Congress stated that:
Impacts & Effects
These Congressional findings combined with the provisions in DSHEA helped institutionalize herbs and supplement products into a new, regulated class of goods. It also formally stated the U.S. federal government’s support of these products and the industry that produced them.
This helped expand the industry and increase the popularity and acceptance of supplements, including herbs. Sales of U.S. dietary supplements grew from approximately $4 billion to $12 billion within four years of DSHEA.
By 2004, annual supplement sales eclipsed $20 billion, and today they exceed $30 billion. The percentage of the U.S. population who used at least one dietary supplement increased from roughly 42% in 1988–1994 to as much as 69% today, with 48% to 53% regularly using these products.
In addition to helping the supplement industry grow, DSHEA also served to increase resources to research supplements. Congressional findings in DSHEA emphasized the importance of research on supplements, stating: “Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements.”
DSHEA also established the Commission on Dietary Supplement Labels to conduct a study on dietary supplement label claims and “evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families.” In addition, the Office of Dietary Supplements was established within the U.S. National Institutes of Health to coordinate research on dietary supplements and disease prevention, develop a database of supplement research and advise the Secretary of Health and Human Services on supplement regulation, safety and health claims.
DSHEA also created a host of regulations to help the federal government ensure the safety and quality of this new class of goods. It required supplement and herbal products to be manufactured in a manner that guarantees what is on the label is in the product. This helped increase the amount of government and industry resources dedicated to developing technology and methods to ensure compliance with new regulations and consumer demand for high-quality products.
Standardization
The standards of the U.S. Pharmacopeial Convention (USP) illustrate how DSHEA helped strengthen the supplement industry.
The first USP compendium (USP I) was published in 1820, as a compilation of standards of medicines of that era. It consisted mostly of simple herbal recipes, many of which are now considered dietary ingredients in the U.S.
One hundred years later, in 1920, herbal standards in USP X had advanced compared to 1820, but were still relatively simple and insufficient to meet today’s needs.
Soon after in 1938, the newly enacted U.S. Federal Food, Drug and Cosmetic Act (FD&C Act) recognized the “official compendium” as the USP compendium, the National Formulary, the Homeopathic Pharmacopeia of the United States or any supplement to them.
Around the same time, herbal standards began disappearing from the USP compendium in favor of chemical medicines. By the time DSHEA was enacted, few herbal standards existed in the USP compendium and these were mostly for herbs with known pharmacological activities such as digitalis, belladonna and opium.
After DSHEA was passed, USP began reintroducing standards for what it now called dietary ingredients and dietary supplements. Today, there are USP standards of identity, quality, purity and potency for more than 240 vitamins, minerals, amino acids, herbals and other dietary supplements.
The USP is just one example of an organization dedicating more resources to herbals and dietary supplements following DSHEA. Passage of DSHEA added momentum that resulted in advances in quality, standardization and technology that has reverberated around the globe to strengthen the discipline internationally.
Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA’s membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products. Before AHPA, Dr. Sharaf was the director, Foods, Dietary Supplements and Herbal Medicines at the United States Pharmacopeial Convention (USP). Before USP, he was pharmacy associate professor; and has preceding experience conducting bioanalytical assay development and validation, and human bioequivalence studies in support of the pharmaceutical industry; and quality control and manufacturing of pharmaceutical dosage forms. He can be reached at 301-588-1171; E-mail: msharaf@ahpa.org; Website: www.ahpa.org.
For the herbal and supplement products industry, DSHEA helped formalize these products into a new class of goods and increased resources for research, new technology and standards.
Consumer demand for herbal products and dietary supplements in the 1980s and early 1990s sparked a grassroots effort to create DSHEA. The resulting law and regulations built on the grassroots momentum and helped strengthen and advance the supplement and herbal products industry to meet consumers’ demand for a wide variety of high-quality products.
Rationale
In the preamble of DSHEA, U.S. Congress offered 15 “findings” that outline the rationale for the law, the goals of DSHEA and the importance of dietary supplements in promoting wellness.
Among the findings, Congress stated that:
- “The importance of nutrition and the benefits of dietary supplements to health promotion and disease prevention have been documented increasingly in scientific studies”;
- “There is a link between the ingestion of certain nutrients or dietary supplements and the prevention of chronic diseases such as cancer, heart disease, and osteoporosis; and clinical research has shown that several chronic diseases can be prevented simply with a healthful diet, such as a diet that is low in fat, saturated fat, cholesterol, and sodium, with a high proportion of plant-based foods”;
- “Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health care expenditures”;
- “The nutritional supplement industry is an integral part of the economy of the United States”;
- “Although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers.”
Impacts & Effects
These Congressional findings combined with the provisions in DSHEA helped institutionalize herbs and supplement products into a new, regulated class of goods. It also formally stated the U.S. federal government’s support of these products and the industry that produced them.
This helped expand the industry and increase the popularity and acceptance of supplements, including herbs. Sales of U.S. dietary supplements grew from approximately $4 billion to $12 billion within four years of DSHEA.
By 2004, annual supplement sales eclipsed $20 billion, and today they exceed $30 billion. The percentage of the U.S. population who used at least one dietary supplement increased from roughly 42% in 1988–1994 to as much as 69% today, with 48% to 53% regularly using these products.
In addition to helping the supplement industry grow, DSHEA also served to increase resources to research supplements. Congressional findings in DSHEA emphasized the importance of research on supplements, stating: “Consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements.”
DSHEA also established the Commission on Dietary Supplement Labels to conduct a study on dietary supplement label claims and “evaluate how best to provide truthful, scientifically valid, and not misleading information to consumers so that such consumers may make informed and appropriate health care choices for themselves and their families.” In addition, the Office of Dietary Supplements was established within the U.S. National Institutes of Health to coordinate research on dietary supplements and disease prevention, develop a database of supplement research and advise the Secretary of Health and Human Services on supplement regulation, safety and health claims.
DSHEA also created a host of regulations to help the federal government ensure the safety and quality of this new class of goods. It required supplement and herbal products to be manufactured in a manner that guarantees what is on the label is in the product. This helped increase the amount of government and industry resources dedicated to developing technology and methods to ensure compliance with new regulations and consumer demand for high-quality products.
Standardization
The standards of the U.S. Pharmacopeial Convention (USP) illustrate how DSHEA helped strengthen the supplement industry.
The first USP compendium (USP I) was published in 1820, as a compilation of standards of medicines of that era. It consisted mostly of simple herbal recipes, many of which are now considered dietary ingredients in the U.S.
One hundred years later, in 1920, herbal standards in USP X had advanced compared to 1820, but were still relatively simple and insufficient to meet today’s needs.
Soon after in 1938, the newly enacted U.S. Federal Food, Drug and Cosmetic Act (FD&C Act) recognized the “official compendium” as the USP compendium, the National Formulary, the Homeopathic Pharmacopeia of the United States or any supplement to them.
Around the same time, herbal standards began disappearing from the USP compendium in favor of chemical medicines. By the time DSHEA was enacted, few herbal standards existed in the USP compendium and these were mostly for herbs with known pharmacological activities such as digitalis, belladonna and opium.
After DSHEA was passed, USP began reintroducing standards for what it now called dietary ingredients and dietary supplements. Today, there are USP standards of identity, quality, purity and potency for more than 240 vitamins, minerals, amino acids, herbals and other dietary supplements.
The USP is just one example of an organization dedicating more resources to herbals and dietary supplements following DSHEA. Passage of DSHEA added momentum that resulted in advances in quality, standardization and technology that has reverberated around the globe to strengthen the discipline internationally.
Maged Sharaf, PhD, is the chief science officer of the American Herbal Products Association (AHPA), the national trade association with a focus primarily on herbs and herbal products. AHPA’s membership represents U.S. and international growers, processors, manufacturers, marketers and institutes specializing in botanicals and herbal products. Before AHPA, Dr. Sharaf was the director, Foods, Dietary Supplements and Herbal Medicines at the United States Pharmacopeial Convention (USP). Before USP, he was pharmacy associate professor; and has preceding experience conducting bioanalytical assay development and validation, and human bioequivalence studies in support of the pharmaceutical industry; and quality control and manufacturing of pharmaceutical dosage forms. He can be reached at 301-588-1171; E-mail: msharaf@ahpa.org; Website: www.ahpa.org.
