Navigation Links
Dietary supplements manufacturers gain new tool to help ensure quality products

Rockville, Md., July 7, 2009 A first-of-its kind collection of standards designed to assist dietary supplements manufacturers in providing quality products to consumers is being released today by the U.S. Pharmacopeial (USP) Convention. The USP Dietary Supplements Compendium (DSC) will also help manufacturers in complying with Food and Drug Administration (FDA)-issued current Good Manufacturing Practices (cGMPs). Under these practices, manufacturers are responsible for the quality of the ingredients they use in manufacturing their finished dietary supplements.

The DSC is a comprehensive resource containing quality specifications for dietary supplements and their ingredients. These quality specifications include standards for identity, strength, purity and performance characteristics (e.g., dissolution, disintegration) of more than 500 dietary supplements and ingredients. In addition to these standards, the DSC includes general and regulatory information, guidance documents, appendices, and macro/microscopy, thin layer chromatography (TLC) and high performance liquid chromatography (HPLC) full-color images that greatly simplify the analysis of ingredients of botanical originmaking it a central repository of necessary information for dietary supplements manufacturers.

"With the release of this new Dietary Supplements Compendium, USP is seeking to partner with ingredient suppliers, dietary supplements manufacturers, contract laboratories, regulatory bodies and independent consultants to raise the quality of supplements and to fulfill the need for public standards in the dietary supplement community," said James Griffiths, Ph.D., vice president of food, dietary supplement and excipient standards for USP. "With the current cGMPs from FDA stipulating that dietary supplements manufacturers determine the quality of ingredients they buy from suppliers by setting their own specifications, the DSC can significantly assist manufacturers by providing guidance on suitable specifications, including scientifically valid analytical methods and acceptance criteria. Consumers expect and deserve this kind of added protection."

The DSC serves as a tool for manufactures in:

  • Developing, manufacturing and testing new products;
  • Qualifying raw materials;
  • Preparing for international quality control and cGMP audits;
  • Setting and validating standard operating procedures;
  • Collecting in-process and batch-release tests; and
  • Accurately packaging, labeling and storing products.

The DSC draws its quality specifications from the United States PharmacopeiaNational Formulary (USPNF) and the Food Chemicals Codex (FCC), USP's publications of standards for the identity, strength, purity and consistency of medicines and food ingredients, respectively. These specifications include items that may be considered dietary supplements or ingredients, including amino acids, vitamins, minerals, articles of botanical origin and their dosage forms. USPNF is considered an official compendium under the Federal Food, Drug, and Cosmetic Act (FDCA), with the FDCA food misbranding provisions applying to any dietary supplement product represented as conforming to compendial specifications (and such products being deemed misbranded by FDA if they fail to so conform). USP has been setting quality standards for medicines for nearly 200 years.


Contact: Francine Pierson
US Pharmacopeia

Related biology news :

1. UF scientists reveal how dietary restriction cleans cells
2. Dietary calcium could possibly prevent the spread of breast cancer to bone
3. Changing the global dietary environment
4. Market testing of dietary supplements and drugs underscores value of USPs public health programs
5. Researchers uncover details about how dietary restriction slows down aging
6. The dietary supplement genistein can undermine breast cancer treatment
7. Annual Bibliography of Significant Advances in Dietary Supplement Research 2007
8. Results of the third school nutrition dietary assessment study published
9. Desert woodrats switch one dietary poison for another
10. Desert woodrats switch one dietary poison for another
11. Following the dietary guidelines may slow heart disease in women
Post Your Comments:
(Date:11/12/2015)... golden retriever that stayed healthy despite having the gene ... new lead for treating this muscle-wasting disorder, report scientists ... and Harvard and the University of São Paolo in ... pinpoints a protective gene that boosts muscle regeneration, ... Children,s lab of Lou Kunkel , PhD, is ...
(Date:11/12/2015)... 2015   Growing need for low-cost, easy ... been paving the way for use of biochemical ... analytes in clinical, agricultural, environmental, food and defense ... in medical applications, however, their adoption is increasing ... continuous emphasis on improving product quality and growing ...
(Date:11/10/2015)... , Nov. 10, 2015  In this ... the basis of product, type, application, disease ... in this report are consumables, services, software. ... are safety biomarkers, efficacy biomarkers, and validation ... report are diagnostics development, drug discovery and ...
Breaking Biology News(10 mins):
(Date:11/24/2015)... , Nov. 24, 2015  Twist Bioscience, a ... Emily Leproust, Ph.D., Twist Bioscience chief executive officer, ... Conference on December 1, 2015 at 3:10 p.m. ... York City. --> ... . Twist Bioscience is on Twitter. Sign up ...
(Date:11/24/2015)... , ... November 24, 2015 , ... ... OrthoAccel® Technologies, Inc., on being named to Deloitte's 2015 Technology Fast 500 list ... facility, OrthoAccel manufactures AcceleDent®, a FDA-cleared, Class II medical device that speeds up ...
(Date:11/24/2015)... CHARLOTTESVILLE, Va. , Nov. 24, 2015 /PRNewswire/ ... company focused on discovering drugs for metabolic disorders, ... Watkins to its Board of Directors (BOD). ... executive officer of Human Genome Sciences (HGS), and ... Industry Organization. Jim Powers , Chairman ...
(Date:11/24/2015)... ... November 24, 2015 , ... Whitehouse Laboratories is pleased ... The new stand-alone facility will be strictly dedicated to basic USP 61, USP 62 ... clients the chance to have complete chemistry and micro testing performed by one supplier. ...
Breaking Biology Technology: