Help
Subscribe


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

 25 April 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

 25 April 2018 
Primary sclerosing cholangitis in the USA
 25 April 2018 
Central mediators of irinotecan-induced steatohepatitis
 25 April 2018 
Neuroimaging in Hep C
 24 April 2018 
PPI and risk of stroke
 24 April 2018 
Scoring system identifies cancer risk in Barrett's
 24 April 2018 
Microbiome in athletes vs sedentary subjects
 23 April 2018 
Sleep deprivation and NAFLD in the USA
 23 April 2018 
Genome-wide study on HBV-related acute-on-chronic liver failure
 23 April 2018 
Antibody suitable for further clinical development to complement existing therapeutic strategies for HCV
 20 April 2018 
Two annexin A11 epitopes targeted by IgG1 and IgG4 autoantibodies were shared between patients with IAC/AIP and IgG4 antibodies blocked binding of IgG1 antibodies to the shared annexin A11 epitopes
 20 April 2018 
Obesity and physical activity in diverticulosis
 20 April 2018 
Adalimumab with azathioprine in Crohn's
 20 April 2018 
Worldwide H.pylori prevalence
 19 April 2018 
Fibrosis in patients with chronic hepatitis B
 19 April 2018 
c-Myc expression and pancreatic cancer
 19 April 2018 
Olmesartan prescription in the USA
 18 April 2018 
Online tool predicts bowel dysfunction severity prior to anterior resection
 18 April 2018 
Hep C treatment for sustained virologic response
 18 April 2018 
Endoscopic necrosectomy reduces risk of death 
 17 April 2018 
Colorectal cancer screening and ethnic inequities
 17 April 2018 
Training programs should consider radiation education for advanced endoscopy fellows
 17 April 2018 
Aspirin and pancreatic cancer
 16 April 2018 
Surgery for colorectal polyps has increased 
 16 April 2018 
Advanced fibrosis can be ruled out in primary health care patients
 16 April 2018 
Antibiotic use and colorectal adenoma
 13 April 2018 
Colorectal cancer cell lines
 13 April 2018 
Infliximab and corticosteroid-free clinical remission in Crohn's
 13 April 2018 
Teduglutide for children with short bowel syndrome
 12 April 2018 
Prescriptions for opiate drugs amongst primary care patients with IBD
 12 April 2018 
Lower GI bleeding related to comorbidity
 12 April 2018 
non–Clostridium difficile bacterial infections in IBD
 11 April 2018 
Bile acid deficiency in IBS 
 11 April 2018 
Stem cell therapy for fistulas in Crohn's
 11 April 2018 
Physician perception of IBD trial results
 10 April 2018 
Overweight in childhood and type 2 diabetes
 10 April 2018 
immunoglobulin G associates with clinical features of IBD
 10 April 2018 
T-cells repertoires in celiac disease
 09 April 2018 
Biomarker tests for colorectal cancer screening
 09 April 2018 
Fecal transplantation in C. difficile infection and treatment outcome 
 09 April 2018 
No weigh-loss drug improved all cardiometabolic risk factors
 06 April 2018 
Colonoscopy and colorectal cancer mortality
 06 April 2018 
Eosinophilic esophagitis and health-related quality of life
 05 April 2018 
Laparoscopic Nissen fundoplication for GERD treatment
 05 April 2018 
Random biopsies for neoplasia in IBD
 04 April 2018 
Alpha‐1 antitrypsin deficiency and liver disease
 04 April 2018 
Adjuvant chemotherapy for advanced colon cancer
 29 March 2018 
Prevention of metachronous gastric cancer
 29 March 2018 
Acute lower GI bleeding
 28 March 2018 
Decision aid used by IBD patients
 28 March 2018 
Transition for young adults with IBD
 28 March 2018 
Amitriptyline in functional dyspepsia
 27 March 2018 
Emergency department utilization for IBD 
 27 March 2018 
Management of hemorrhoids in the USA
 27 March 2018 
Adult ulcerative colitis
 26 March 2018 
Biological therapy response in IBD 
 26 March 2018 
Obesity and diverticulosis
 26 March 2018 
Practice guidelines for chronic constipation
 23 March 2018 
Health-related quality of life in eosinophilic esophagitis
 23 March 2018 
Genetics and chronic liver disease
 23 March 2018 
Global prevalence of H.pylori

Blackwell Publishing


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