284 IMPACT OF THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994 ON MAGAZINE ADVERTISING AND SALES OF WEIGHT LOSS AND DIETARY SUPPLEMENTS

2005 ◽  
Vol 53 (1) ◽  
pp. S128.2-S128
Author(s):  
J. Kennedy-Darling ◽  
N. Ferris ◽  
K. Kuehl ◽  
D. Elliot
Keyword(s):  
Weight Loss ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Education Act

FDA to Ban Sales of Dietary Supplements Containing Ephedra

2004 ◽  
Vol 32 (1) ◽  
pp. 184-186
Author(s):  
Amy G. Ling
Keyword(s):  
Weight Loss ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Athletic Performance ◽  
Scientific Evidence ◽  
Federal Food ◽  
Education Act

On December 30, 2003, the FDA announced that it will publish a rule banning sales of ephedra - a dietary supplement often utilized for weight loss, increased energy, and enhanced athletic performance - because it poses an unreasonable health risk.The ban will be issued under the auspices of the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA), in response to a process that began in June of 1997, when the FDA first proposed a mandatory warning statement on dietary supplements containing ephedra. FDAs analysis of the scientific evidence has led it to conclude that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act?

scholarly journals Dietary supplements in the USA: problematic trends

2021 ◽  
pp. 1-5
Author(s):  
Bryan E Denham
Keyword(s):  
Weight Loss ◽  
Erectile Dysfunction ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Prescription Drugs ◽  
Anabolic Steroids ◽  
Federal Courts ◽  
Safety And Efficacy ◽  
The Usa ◽  
Education Act

Abstract More than 25 years have passed since the Dietary Supplement Health and Education Act of 1994 classified dietary supplements as a subcategory of food, thereby exempting manufacturers from providing premarket evidence of product safety and efficacy. In this commentary, I discuss problems in the supplement industry through an examination of cases introduced or decided in US federal courts between 2010 and 2019. More than half the cases located involved defendants charged with introducing misbranded food or drugs into interstate commerce. Contaminants included anabolic steroids, erectile dysfunction medications, weight-loss drugs, workout stimulants and mind-altering substances. As the article points out, raw powders obtained in bulk quantities facilitate the practice of ‘home brewing’ and the introduction of prescription drugs into dietary supplements.

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.

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.

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.

Anaphylactic Reaction to a Dietary Supplement Containing Willow Bark

2003 ◽  
Vol 37 (6) ◽  
pp. 832-835 ◽  
Author(s):  
Joseph I Boullata ◽  
Patrick J McDonnell ◽  
Cynthia D Oliva
Keyword(s):  
Weight Loss ◽  
Adverse Effects ◽  
Dietary Supplements ◽  
Dietary Supplement ◽  
Anaphylactic Reaction ◽  
Medication History ◽  
Herbal Products ◽  
Initial Symptoms ◽  
History Of ◽  
Willow Bark

OBJECTIVE: To report a case of anaphylaxis resulting from the use of a willow bark–containing dietary supplement in a patient with a history of an aspirin allergy. CASE SUMMARY: A 25-year-old white woman presented to the emergency department of a community teaching hospital with anaphylaxis requiring epinephrine, diphenhydramine, methylprednisolone, and volume resuscitation to which she responded favorably. Medication history revealed that she had ingested 2 capsules of Stacker 2 (NVE Pharmaceuticals, Newton, NJ), a dietary supplement promoted for weight loss, prior to experiencing her initial symptoms. Among other active ingredients, this product contains willow bark. Of significance is that this patient also reported a history of allergy to acetylsalicylic acid. No other causes for anaphylaxis were identified. She continued to receive routine supportive care and the remaining hospital course was uncomplicated. DISCUSSION: Dietary supplements, including herbal products, are used by many individuals who consider them to be inherently safe despite limited regulatory oversight by the Food and Drug Administration. While there may be value to specific botanical ingredients, a potential for adverse effects also exists. The popular product consumed by our patient is used for weight loss and contains willow bark, a source of salicylates. Based on the Naranjo probability scale, it is probable that this case of anaphylaxis was due to this dietary supplement. CONCLUSIONS: The use of any willow bark–containing dietary supplement may present a risk of anaphylactic reaction to patients with a history of allergy to salicylates. Clinicians need to recognize the potential for adverse effects from dietary supplements.

Dietary Supplements: A Definition That is Black, White, and Gray

2005 ◽  
Vol 31 (2-3) ◽  
pp. 341-348 ◽  
Author(s):  
Suzan Onel
Keyword(s):  
Dietary Supplements ◽  
Dietary Supplement ◽  
Food Additives ◽  
Food Ingredients ◽  
Drug Products ◽  
Drug Law ◽  
The World ◽  
Education Act ◽  
Food And Drug Law ◽  
Product Claims

The Dietary Supplement Health and Education Act of 1994 (“DSHEA” or “the Act”) was a seminal event in the world of food and drug law. The Act took a controversial category of product traditionally regulated by FDA as either a food or a drug, depending upon the product claims and formulation, and created a new regulatory category called “dietary supplement” that was placed within the “food” definition. As such, products meeting the “dietary supplement” definition benefited in two significant ways, (1) dietary supplements could make “structure/function” claims traditionally within the realm of drug products; and (2) unlike food ingredients, dietary ingredients could be used in dietary supplements without being either approved food additives or generally recognized as safe (“GRAS”) ingredients. These legislative provisions significantly changed the legal, corporate, and consumer landscape, allowing products to enter the marketplace with broadbased claims without FDA premarket review or approval of the ingredients, formulation, or product claims.

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