The New Dietary Ingredient Safety Provision of DSHEA: A Return to Congressional Intent

2005 ◽  
Vol 31 (2-3) ◽  
pp. 285-304 ◽  
Author(s):  
Scott Bass ◽  
Emily Marden
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Consumer Demand ◽  
Food And Drug Administration ◽  
Safety Standards ◽  
Education Act ◽  
Definition Of ◽  
Preventative Healthcare

In the ten years since the passage of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), dietary supplements have become a widely available and important element of individualized preventative healthcare. Congress created DSHEA in response to great consumer demand, thereby embracing the dietary supplement category and opening the door for the growth of the dietary supplement industry. DSHEA introduced an expansive definition of dietary supplements and laid out available claims and strict safety standards for such products.While the statute has remained unchanged since its passage in 1994, the Food and Drug Administration (“FDA”) appears to be in the process of re-interpreting sections of DSHEA in ways that could fundamentally limit the availability of dietary supplements. Specifically, FDA has been utilizing DSHEA's “new dietary ingredient” (“NDI”) safety provision to narrow the scope of ingredients that can be considered, even before addressing their safety, for use in dietary supplements.

Drugs or Dietary Supplements: FDA's Enforcement of DSHEA

1998 ◽  
Vol 17 (2) ◽  
pp. 296-302 ◽  
Author(s):  
Marlys J. Mason
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Health Claims ◽  
Education Act ◽  
Definition Of

The Dietary Supplement Health and Education Act broadened the definition of a dietary supplement and loosened the restrictions for health claims on supplement labeling. The Act has left an unclear boundary between supplements and drugs. In this article, the author examines the legal debate surrounding the definition and regulation of drugs and supplements. The author also discusses recent Food and Drug Administration enforcement activities and court challenges.

Why Consumers Need More Protection Against Claims for Dietary Supplements and Herbs

2003 ◽  
Vol 22 (5) ◽  
pp. 391-392 ◽  
Author(s):  
Stephen Barrett
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Federal Agencies ◽  
Health Food ◽  
Enormous Amount ◽  
Education Act

Federal agencies have never had enough resources to cope with the enormous amount of deception in the supplement and health-food marketplace. Passage of the 1994 Dietary Supplement Health and Education Act (DSHEA) has worsened the situation by encouraging dubious claims and weakening the Food and Drug Administration (FDA)'s ability to ban dangerous products.

The Dietary Supplement and Health Education Act and Supplements: Dietary and Nutritional Supplements Need No More Regulations

2003 ◽  
Vol 22 (5) ◽  
pp. 387-390 ◽  
Author(s):  
Bernd Wollschlaeger
Keyword(s):  
Health Education ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Federal Trade Commission ◽  
Food And Drug Administration ◽  
Nutritional Supplements ◽  
Consumer Access ◽  
Education Act ◽  
Enforcement Authority

The Dietary Supplement and Health Education Act (DSHEA) of 1994 was intended to ensure consumer access to safe dietary supplements, e.g., herbs, minerals, and vitamins. It granted the Food and Drug Administration (FDA) considerable enforcement authority to regulate dietary supplement industry. This article discusses relevant components of the DSHEA, explains the division of regulatory responsibilities between the FDA and the Federal Trade Commission (FTC), and refutes the often cited allegation that the herb and dietary supplement industry are unregulated.

What Lies Beneath: An Examination of the Underpinnings of Dietary Supplement Safety Regulation

2005 ◽  
Vol 31 (2-3) ◽  
pp. 269-284 ◽  
Author(s):  
Dana Ziker
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Scientific Research ◽  
The Internet ◽  
Safety Regulation ◽  
Health And Nutrition ◽  
Consumer Access ◽  
Education Act

In response to the increasing attention to the link between health and nutrition, a wealth of information—and misinformation—is becoming available, especially via the Internet. Consumers are advised to carefully assess the reliability of information they use to determine whether a product is safe. Meanwhile, regulators are sorting out the facts themselves, but despite the ever-increasing availability of scientific research, our evolving understanding of nutrition is still supplemented by our perceptions about risk.The primary framework for the regulation of dietary supplements is the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). Underlying DSHEA is the congressional intent to support two goals: “(1) to facilitate consumer access to dietary supplements, given that many dietary supplements are used by consumers to help them maintain and improve their health; and (2) to give the Food and Drug Administration (“FDA”) the authority to step in where safety problems arise and to ensure proper labeling.”

scholarly journals Brewing Green Beer

2021 ◽  
Vol 8 (4) ◽  
pp. 9-26
Author(s):  
Daniel Pashang Withers
Keyword(s):  
Drug Administration ◽  
New Technologies ◽  
Food And Drug Administration ◽  
Brewing Industry ◽  
Environmental Burden ◽  
Beer Brewing ◽  
Competitive Disadvantage ◽  
Tobacco Tax ◽  
Definition Of

New beer brewing technologies provide brewers with options to produce beer in more eco-friendly, less resource-intensive ways; however, as brewers adopt these technologies, they may find themselves straddling between the regulatory schemes of the Alcohol and Tobacco Tax and Trade Bureau (“TTB”) and the Food and Drug Administration (“FDA”). The two agencies have divided control over beers based on their ingredients, which places some beers under the TTB’s purview as “malted beverages” and others under the FDA’s purview. These distinctions have implications for the regulatory hurdles that brewers must overcome to market their products. Additional regulations that eco-friendly, green beers may face could provide higher hurdles than standard beers face, putting them at a competitive disadvantage. This Comment explores the relationships between beer brewing and the environment, new technologies that ease the environmental burden of beer brewing, and the regulatory boundaries affected by adopting these new technologies. By expanding its definition of “malted beverages,” the TTB can encourage the adoption of new eco-friendly technologies, avoid a regulatory quandary, and promote a healthy beer brewing industry.

scholarly journals Dietary Supplements: Knowledge and Adverse Event Reporting Practices of Department of Defense Health Care Providers

2020 ◽  
Vol 185 (11-12) ◽  
pp. 2076-2081
Author(s):  
Melissa Rittenhouse ◽  
Jonathan Scott ◽  
Patricia Deuster
Keyword(s):  
Health Care ◽  
Adverse Event ◽  
Dietary Supplements ◽  
Drug Administration ◽  
Health Care Providers ◽  
Department Of Defense ◽  
Food And Drug Administration ◽  
Clinical Care ◽  
Care Providers ◽  
Reporting Practices

Abstract Introduction The purpose of the study was to assess the knowledge of dietary supplements (DS) and adverse event (AE) reporting practices of the Department of Defense health care providers. AEs related to use of DS are not uncommon. However, it is estimated that less than 2% of AEs are reported. This is problematic given the Food and Drug Administration relies on AE reports to identify and ultimately remove unsafe products from the market. Inadequate reporting of AE puts all DS users at risk. Materials and Methods Cross-sectional design was used. Electronic surveys were sent to the Department of Defense health care professionals (HCPs) and Emergency Medicine (EM) physicians asking questions about practices regarding DS and AE knowledge and reporting behaviors. The surveys were open for 5 months. During this period of time, HCPs received three email reminders following the initial email to enhance participation. The computer package IBM SPSS version 25 software (IBM Corp. Released 2017. IBM SPSS Statistics for Windows, Version 21.0, Armonk, New York) was used for statistical analysis. Frequency distributions of the responses were analyzed. Results Of the 1,700 surveyed, 270 HCPs and 68 EM physicians completed the surveys. At least 39% of HCPs reported never receiving formal DS training. Seventy-two percent of HCPs reported asking their patients about the use of DS. However, when asked if they knew where to report an AE, only 40% of HCPs knew where to report an AE and only 38% knew how to report an AE. Of the EM physicians, only 38% asked their patients about DS. However, a majority (78%) reported that they had encountered an AE. EM physicians also reported they lacked knowledge regarding where (87%) and how (87%) to report AE. Conclusions It is clear that physician and nonphysician HCPs would benefit from additional training about DS and how and where to report suspected AE. Providing regular training on risks, common AE, and how and where to report an AE would help fill the knowledge gap in the ever-changing DS industry. Addressing these issues and coming up with a solution to integrating AE reporting into clinical care could improve health care practices and increase AE reporting to the Food and Drug Administration, which would have a beneficial impact on patient care, public safety, and mission readiness.

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