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:4/28/2016)... -- First quarter 2016:   , Revenues ... first quarter of 2015 The gross margin was 49% ... and the operating margin was 40% (-13) Earnings per ... from operations was SEK 249.9 M (21.2) , Outlook ... 7,000-8,500 M. The operating margin for 2016 is estimated ...
(Date:4/15/2016)... CHICAGO , April 15, 2016  A ... companies make more accurate underwriting decisions in a ... offering timely, competitively priced and high-value life insurance ... health screenings. With Force Diagnostics, rapid ... and lifestyle data readings (blood pressure, weight, pulse, ...
(Date:3/31/2016)... 31, 2016   ... the "Company") LegacyXChange is excited to release ... soon to be launched online site for trading 100% ... ) will also provide potential shareholders a sense of ... to an industry that is notorious for fraud. The ...
Breaking Biology News(10 mins):
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... While ... machines such as the Cary 5000 and the 6000i models are higher end machines ... is the height of the spectrophotometer’s light beam from the bottom of the cuvette ...
(Date:6/23/2016)... ... 23, 2016 , ... Mosio, a leader in clinical research ... Recruitment and Retention Tips.” Partnering with experienced clinical research professionals, Mosio revisits the ... tools, and strategies for clinical researchers. , “The landscape of how patients receive ...
(Date:6/23/2016)... 2016   Boston Biomedical , an industry ... to target cancer stemness pathways, announced that its ... Drug Designation from the U.S. Food and Drug ... including gastroesophageal junction (GEJ) cancer. Napabucasin is an ... cancer stemness pathways by targeting STAT3, and is ...
(Date:6/23/2016)... A person commits a crime, and the detective ... the criminal down. An outbreak of foodborne illness ... (FDA) uses DNA evidence to track down the bacteria that ... It,s not. The FDA has increasingly used a complex, cutting-edge ... illnesses. Put as simply as possible, whole genome sequencing is ...
Breaking Biology Technology: