Are Serious Adverse Cardiovascular Events an Unintended Consequence of the Dietary Supplement Health and Education Act of 1994?

2002 ◽  
Vol 77 (1) ◽  
pp. 7-9 ◽  
Author(s):  
Bruce D. Lindsay
Keyword(s):  
Dietary Supplement ◽  
Cardiovascular Events ◽  
Unintended Consequence ◽  
Education Act

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.

scholarly journals A Pilot Randomized Crossover Trial Assessing the Safety and Short-Term Effects of Walnut Consumption by Patients with Chronic Kidney Disease

2019 ◽  
Author(s):  
Pilar Sanchis ◽  
Marilisa Molina ◽  
Francisco Berga ◽  
Elena Muñoz ◽  
Regina Fortuny ◽  
...  
Keyword(s):  
Risk Factors ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Dietary Supplement ◽  
Cardiovascular Events ◽  
Inositol Phosphates ◽  
Control Diet ◽  
Fibroblast Growth Factor 23 ◽  
Short Term ◽  
Daily Consumption

The aim of this study of patients with chronic kidney disease (CKD) is to assess the safety of daily consumption of walnuts on the physiological levels of phosphorous, potassium, parathyroid hormone (PTH), and fibroblast growth factor 23 (FGF23), and to assess the short-term benefits of this intervention on risk factors associated with cardiovascular events. This led us to perform a prospective, randomized, cross-over, pilot clinical trial examined 13 patients with chronic kidney disease (CKD). Subjects were randomly assigned to a diet of 30 g of walnuts per day or the control diet. After 30 days, each group was given a 30-day washout period, and then switched to the alternate diet for 30 days. Urinary and serum levels of phosphorous and potassium, multiple vascular risk factors, and urinary inositol phosphates (InsPs) were measured at baseline and at the end of the intervention period. Our results showed that the walnut dietary supplement led to reduced blood pressure, LDL cholesterol, and serum albumin, but had no effect on the physiological levels of phosphorous, potassium, PTH, and FGF23. This is the first report to show that daily consumption of walnuts by patients with CKD does not alter their physiological levels of phosphorous, potassium, PTH, and FGF23. Consequently, this dietary supplement may prevent cardiovascular events in patients with CKD.

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.

scholarly journals What is the research base for the use of dietary supplements?

1999 ◽  
Vol 2 (1) ◽  
pp. 35-38 ◽  
Author(s):  
Malden C Nesheim
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Health Professionals ◽  
Nutrition Support ◽  
The Public ◽  
Us Congress ◽  
Public Health Professionals ◽  
The Us ◽  
The Usa ◽  
Education Act

AbstractThe market for dietary supplements in the USA was estimated as about 11.8 billion dollars in 1997 with a growth rate of 10–14 % projected in the next 3 years. Data from the Food and Drug Administration collected in 1995 indicate that over 55 % of adults surveyed used some type of dietary supplement. The marketing of dietary supplements in the USA has been essentially deregulated by the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This legislation defined dietary supplements, made manufacturers responsible for the safety of supplements and allowed certain statements of nutrition support to be made on supplement labels. The US Congress in passing the DSHEA indicated that supplements should be available on the market so that consumers could make decisions about their use for themselves and their families. Unfortunately, information about the research base for supplement claims is not readily accessible to health professionals and consumers. There is a need for authoritative reviews of the data underlying supplement claims to assist public health professionals in their role of providing advice to the public about dietary supplements.

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