Help the Dietary Supplement
Community Create a Reliable Compendium of Collaboratively Studied
Methods
Industry representatives know that each year an ever-increasing variety of dietary supplement products enter the marketplace, but the efficacy and safety of many of these products are simply not supported in terms of analytical science. Moreover, it is not possible to conduct adequate clinical studies on the products’ active ingredients because there are very few reliable analytical methods. Today, AOAC is aggressively undertaking the development and validation of these methods and is expediting its signature collaborative study process. Representatives from the dietary supplement industry are urgently needed to help in this process.
Who Is AOAC?
- AOAC INTERNATIONAL is a
not-for-profit organization cited in the U.S. Code of Federal Regulations
under Title 21: “It is the policy of FDA in its enforcement program to use
methods of analysis of AOAC INTERNATIONAL when available and applicable.” AOAC
is also cited under Title 9 within this context by the U.S. Department of
Agriculture. AOAC is internationally recognized by CODEX, ISO, and IUPAC as
a provider of fully validated, reference methods and has been the leader in analytical methods validation for 120 years.
What Is AOAC’s Role in Creating a Compendium of Dietary Supplement Methods?
- AOAC itself maintains no laboratories, conducts no research, performs no tests. The actual work of devising and testing methods of dietary supplements will be done by AOAC’s government and industry stakeholders. AOAC coordinates these scientific studies, receives and evaluates the results, gives official sanction to acceptable methods, and publishes and distributes the methods and performance data.
Who Gives AOAC Infrastructure Support in This Effort?
- Stemming from the success of an ongoing dietary supplement project, AOAC was awarded a contract from FDA-NIH/ODS to find and validate methods leading to a total of 20 AOAC Official Methods for selected ingredients in dietary supplements in 5 years. In order to fulfill this goal, AOAC Dietary Supplement Task Force determines method needs for select ingredients, with top priority going to those ingredients with the most urgent public health concerns and largest market size. Most importantly, the group gathers together a network of experts to aid in the process of identifying the best methods (through data obtained from the rigors of laboratory validation).
How Will the Methods Be Distributed
and Used?
- The methods will be entered into e-AOAC, an electronic compilation of analytical methods, and will be used as reference methods by all members of the dietary supplement industry as well as the government. Leila Saldanha of NIH, chair of the AOAC group that prioritizes industry’s and governments' methods needs, explained the appeal of e-AOACSM, “The overall goal is to have a central reference point [e-AOACSM] to access dietary supplement methods that industry and other key stakeholders can use,” she said. “Once these methods are validated, it will give rise to the availability of readily accessible reference methods.”
How Will Stakeholders Learn AOAC
Validation Criteria?
- Comprehensive training courses will provide AOAC stakeholders with the basic information and guidelines required to optimize the probability that a given method can be validated to the technical and practical standards required to meet AOAC’s criteria for methods approval. For more information on these training course, visit the AOAC Website at www.aoac.org.
What Will This Project Do for
Me?
- Companies chosen by the expert review committee and NIH to have their methods validated through the AOAC method validation process will receive the guidance and support required to perform the collaborative testing and validation and, if the method is chosen, receive the credit of contributing to a much-needed, collaboratively studied compendium of dietary supplement methods.
What Organizations Does the AOAC
Task Group Represent?
- Chair Darryl Sullivan of Covance Laboratories; U.S. Food and Drug Administration; National Institutes of Health/Office of Dietary Supplements (a non-voting member); Council for Responsible Nutrition; American Herbal Products Association; American Herbal Pharmacopoeia; National Food Processors Association; Utah Natural Products Alliance; Inspectorate for Health Protection and Veterinary Public Health Research & Development, Section Food; U.S. Treasury; ConsumerLabs.com; Center for Science in the Public Interest; National Nutritional Foods Association; National Institute of Standards and Technology; United States Pharmacopeial Convention, Inc.; National Research Council of Canada; National Laboratories of Foods and Drugs Department of Health, Taiwan; NSF International; and Health Canada.
Who Do We Contact at AOAC for More Information?
Robert Rathbone.........................................................301-924-7077 ext 105
Director of Publications and Official Methods........rrathbone@aoac.org
Al Pohland....................................................................301-924-7077 ext 123
Chief Scientific Officer...............................................apohland@aoac.org
