NSF Announces New Stability Testing Guideline for Nutritional Supplements Bearing Expiration Dates
Regulatory, industry and consumer groups helped develop the new guideline
ANN ARBOR, Mich. — Consumers often look for expiration dates on products but federal regulations do not currently require expiration dating for nutritional supplements. To help nutritional supplement companies make sure they have the necessary data to support expiration dating on product labels. NSF International, developer of the U.S. national standard for dietary supplements, helped create a new voluntary Stability Testing Guideline.
NSF-DBA, an NSF International Company that provides dietary supplement training, consulting and testing services, worked in conjunction with regulators and industry trade groups to coordinate the development of the new guideline. The guideline outlines the science-based criteria necessary to support expiration dating in order to comply with the current Good Manufacturing Practices (GMP) for dietary supplements.
“If expiration dates or voluntary claims such as “best by” or “use before” appear on a nutritional supplement label, FDA officials expect supporting stability test data to be available and they will look for this information during GMP inspections,” said Casey Coy, NSF-DBA Group Leader. “Dietary supplement companies can be proactive and use this guideline to ensure their expiration dates are backed by sound science.”
The guideline suggests that nutritional supplement companies identify the physical, chemical and microbiological characteristics under long-term storage. It specifies that companies understand the impact of manufacturing, packaging, labeling, distribution and holding/warehouse processes may have on a product’s stability. The guideline also proposes that stability testing be conducted in the same container used for marketing the nutritional supplement product. Factors involved in stability testing include: dietary ingredient strength, chemical fingerprints, microbial growth, preservative content, moisture content, pH, viscosity and oxidation, among other parameters such as the product’s container-closure system.
In addition to conducting stability studies, NSF-DBA provides analytical method development and validation services and a wide array of consulting, training and regulatory support services to the dietary supplement industry. As the developer of the U.S. national standard for dietary supplements and provider of accredited third-party testing and certification of dietary supplements, NSF has in-depth knowledge of the supplement manufacturing and retailing industries and possesses a strong reputation for protection of public health.
About NSF-DBA: A leading provider of pharmaceutical training, NSF-DBA has an outstanding international reputation not only for training but also in the fields of pharmaceutical quality management and regulatory compliance for 25 years (www.nsf-dba.com).
In 2007, NSF International acquired DBA to expand its range of health science services on a global scale and in 2010 more than 60 training sessions were delivered to the pharmaceutical, biotech and dietary supplement industries. NSF-DBA provides training and expert services that address the increasing global demand for assistance in these areas.
About NSF International: NSF International, an independent, not-for-profit organization, certifies products and writes standards for food, water and consumer goods to minimize adverse health effects and protect the environment (www.nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment.
NSF also tests and certifies supplements and other nutritional products to verify that the contents match what is printed on the label and that the product is free of undeclared substances and unacceptable levels of contaminants such as lead.
Additional NSF services include NSF Education and Training programs, safety audits for the food and water industries, and management systems registrations delivered through NSF International Strategic Registrations (NSF-ISR).
CONTACT: Greta Houlahan