Help
Subscribe


GastroHep.com - the global online resource for all aspects of gastroenterology, hepatology and endoscopy

 19 February 2018

Advanced search
GastroHep.com - the global online resource for all aspects of gastroenterology, hepatology and endoscopy Profile of Roy Pounder

Home

News  
Journals
Review Articles
Slide Atlas
Video Clips
Online Books
Advanced Digestive Endoscopy
Classical Cases
Conference Diary
PubMed
International GH Links
USA GH Links
National GH Links
National GI Societies
Other Useful Links




Emails on Gastroenterology and Hepatology
the National AIDS Treatment Advocacy Project
Visit the gastroenterology section of the EUMS

News

FDA science-based plan for dietary supplement enforcement

The FDA has outlined its science-based approach to protecting consumers from unsafe dietary supplements.

News image

fiogf49gjkf04

Dr Lester Crawford, Acting Commissioner of the FDA, has outlined the agency's science-based approach to protecting American consumers from unsafe dietary supplements.

Dr Crawford said the agency would soon provide further details about its plan to ensure that the consumer protection provisions of the 1994 Dietary Supplement Health and Education Act (DSHEA) are used effectively and appropriately.

The DSHEA sets up a distinct regulatory framework for dietary supplement products. It gives the FDA regulatory authority to act against supplements or supplement ingredients that present safety problems, are marketed with false or misleading claims, or are otherwise adulterated or misbranded.
There are approximately 29,000 products currently available.
FDA

"FDA is absolutely committed to protecting consumers from misleading claims and unsafe products," said Dr Crawford.

"Unlike most foods, some dietary supplements are pharmacologically active".

"And we have seen over the last 10 years a huge growth in the dietary supplements industry, including the introduction of products that seem far removed from the vitamins and minerals of the pre-DSHEA days".

"We have become increasingly aware of the potential health problems some of these products pose."

In the last 6 months, FDA has inspected 180 supplement manufacturers, sent warning letters to distributors, and refused entry to 1171 foreign shipments of dietary supplements. It has also seized or supervised voluntary destruction of almost $18 million worth of mislabeled or adulterated products.

"We will continue to aggressively enforce DSHEA against unsafe or mislabeled products," Dr Crawford said.

In March the FDA requested that 23 companies cease distributing dietary supplements containing androstenedione. These are marketed to stimulate testosterone and muscle growth but have anabolic steroid effects in the body.

Over the next several months FDA will provide additional information to explain and implement the tools available to the agency under DSHEA to act against unsafe supplements and false or misleading supplement labeling claims.

The FDA is also developing regulations for industry on good manufacturing practices (GMPs). When finalized, this rule, proposed last spring, will help protect consumers from dietary supplements that contain impurities or contaminants as a result of how they are manufactured or handled.

FDA is, in addition, putting dietary supplement labeling under closer scrutiny. Dietary supplement labels cannot claim the supplement will treat or cure a disease, and since December 2002 FDA has worked with the Federal Trade Commission to challenge false claims of supplement effectiveness for treating a range of diseases.

To support its consumer protection actions, the agency is developing approaches to systematically review the evidence about the safety of individual dietary supplements. The FDA expects to evaluate the available pharmacology, published literature, evidence-based reviews, and adverse event information.

When DSHEA was passed a decade ago, there were about 4000 supplements on the market, including vitamins, minerals, amino acids, and herbs and other botanicals. Congress determined that these products were more like foods than drugs, and that like foods dietary supplements should in general be given the benefit of the doubt as to safety.

A recent Institute of Medicine report, sponsored by FDA, estimated that American consumers spend $18 billion annually on dietary supplements. There are approximately 29,000 products currently avialable; another 1000 new products are introduced each year.

FDA
22 April 2004

Go to top of page Email this page Email this page to a colleague

 19 February 2018 
The effectiveness of screening colonoscopy in the right colon was not significantly different from that in the left colon/rectum
 19 February 2018 
No significant differences, among racial or ethnic groups, found in patients with significant fibrosis
 19 February 2018 
Hydrogen production greater in patients on a fructan-containing diet, than those following a maltodextrin-containing diet

 16 February 2018 
Undetected celiac in the elderly
 16 February 2018 
Inflammatory bowel diseases are global diseases
 16 February 2018 
Fructans induce non-celiac gluten sensitivity
 15 February 2018 
Oral direct-acting antiviral treatment for Hep C virus genotype 1
 15 February 2018 
NSAIDS and GI damage
 15 February 2018 
Primary vs secondary surgery for the presence of lymph node metastasis
 14 February 2018 
Management of hemorrhoids in the USA
 14 February 2018 
Predicting adenoma detection rate
 14 February 2018 
Normal bowel frequency characterization in the USA 
 13 February 2018 
Prebiotics improve endothelial dysfunction
 13 February 2018 
Personalising treatment options for IBS
 13 February 2018 
Diagnostic criteria for a Rome IV functional gastrointestinal disorders
 12 February 2018 
Visceral hypersensitivity and functional GI disorders
 12 February 2018 
Depression and aggressive IBD
 12 February 2018 
Variability in interpretation of endoscopic findings impacts patient management
 09 February 2018 
Treatment of choice for anastomotic stricture in IBD
 09 February 2018 
PRO measurement information system 
 09 February 2018 
Overall disease severity indices for IBD
 08 February 2018 
Prediction of endoscopically active disease

 08 February 2018 
Steroid-refractory acute severe ulcerative colitis
 08 February 2018 
Decision aid used by IBD patients
 07 February 2018 
Ursodeoxycholic acid combined with bezafibrate for itching
 07 February 2018 
Change in microbiome in gastritis vs gastric carcinoma
 07 February 2018 
Colorectal cancer and primary sclerosing cholangitis-IBD
 06 February 2018 
Risk of death after liver transplantation
 06 February 2018 
Crohn’s disease vs refractory pouchitis
 06 February 2018 
Support for functional dyspepsia symptom diary
 05 February 2018 
Helicobacter spp influence on GI tract 
 05 February 2018 
No link found between severe reflux and all-cause mortality 
 05 February 2018 
Psychological distress in PPI non-responders
 02 February 2018 
Assessing psychosexual impact of IBD
 02 February 2018 
Decrease in overall mortality with cholera vaccination
 02 February 2018 
Diagnostic performance of fecal immunochemical tests
 01 February 2018 
Screening frequency with family histories of colorectal cancer
 01 February 2018 
IBD and sport participation
 01 February 2018 
Life with a stoma 
 31 January 2018 
Aprepitant and gastroparesis 
 31 January 2018 
Anesthesia risk in colonoscopy
 31 January 2018 
GED-0301 for Crohn's Disease
 30 January 2018 
Intestinal dysbiosis and allergic diseases in infants
 30 January 2018 
Fructans and IBS symptoms in children
 29 January 2018 
Dosing calculator for therapy optimization in IBD
 29 January 2018 
Glecaprevir–pibrentasvir for in HCV
 29 January 2018 
Food allergen injections in eosinophilic esophagitis
 29 January 2018 
Reliability of the IBD index
 26 January 2018 
Tofacitinib vs biological therapies for ulcerative colitis
 26 January 2018 
Optimizing selection of biologics in IBD
 26 January 2018 
Nutritional risk and laparoscopic-assisted gastrectomy outcomes
 25 January 2018 
Patient-reported outcome measure for functional dyspepsia
 25 January 2018 
Predicting intra-abdominal infections after colorectal surgery
 25 January 2018 
Predictors of gastric cancer risk
 24 January 2018 
Risk factors underlying previously undiagnosed cirrhosis
 24 January 2018 
Ethnicity influences phenotype in IBD
 24 January 2018 
Bariatric surgery vs medical obesity treatment
 23 January 2018 
Atrophic gastritis after H. pylori eradication
 23 January 2018 
Ectopic pregnancy in women with IBD
 23 January 2018 
Celiac disease in IBS in the USA

Blackwell Publishing


GastroHep.com is a Blackwell Publishing registered trademark
© 2018 Wiley-Blackwell and GastroHep.com and contributors
Privacy Statement
Disclaimer
About Us