Dietary Supplement Analysis
The Dietary Supplement Health and Education Act of 1994 (DSHEA) defines dietary supplements as a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, mineral, amino acid, herb or other botanical; a dietary substance for use to supplement the diet by increasing the total dietary intake; a concentrate, metabolite, constituent, extract, or combination of any ingredient described in the first two definitions; and it is intended for ingestion in the form of a capsule, powder, softgel, or gelcap, and not represented as a conventional food or as a sole item of a meal or the diet.
The Food and Drug Administration regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under DSHEA, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. However, FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.
Generally, manufacturers do not need to register with FDA or get FDA approval before producing or selling dietary supplements. They do need to make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g., voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.
The rapid expansion of the dietary supplement marketplace has resulted in a proliferation of ingredients and products that has outstripped the pace of development of reliable analytical methods for verifying ingredient identity and measuring the amounts of declared ingredients in raw materials and finished products. The development of reliable analytical methods is needed to verify ingredient identity and measure the amounts of declared ingredients in raw materials and finished products.
Analytical methods are used for quantitative and qualitative analysis of raw materials and finished products. The objective of such methods is to generate reliable, accurate data for use by manufacturers or regulators for quality control or enforcement actions. Manufacturers generally need methods applicable throughout the manufacturing process, while regulators require versatile methods that can be used for the same analyte in a number of dissimilar finished products.
In contrast to single-chemical-entity products such as those in the pharmaceuticals industry, natural products are complex mixtures that originate from biological sources. Such test articles pose particular analytical challenges for a number of reasons. Raw materials are invariably “irregular” because their chemical composition depends on factors such as geographical origin, weather, harvesting, etc. Irregularity of finished products is the result of this variability in raw materials coupled with the complexity added by use of multiple ingredients in finished formulations. This complexity means that a new method may be needed for each raw material and for each finished product that uses that material. Official methods generally apply only across a narrow range of materials, so new methods must be validated across the range of uses to which it will be put. Analysis of an entity that falls outside this range generally requires revalidation of the method.
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To accelerate the rate of methods development and validation, Congress appropriated funds to speed up an ongoing collaborative effort to develop and disseminate validated analytical methods and reference materials for the most commonly used botanicals and other dietary supplements.
FDA’s Office of Dietary Supplements has developed the Dietary Supplements Methods and Reference Materials Program. The program is a broad-based approach supporting the technical and scientific aspects of analytical methods development through critical laboratory research, as well as building the infrastructure necessary for scientific evaluation and wide dissemination of new methods and reference materials. The information collection and collation component will ensure that vital techniques and knowledge accumulated over the past century are readily accessible to the public.
The AOAC International Dietary Supplement Task Group, representing government, trade organizations, and other key stakeholders, was formed in 2001 to identify dietary supplements, identify methods that currently exist for these ingredients, and assist AOAC in validating these methods. The Task Group has identified the top 18 dietary supplements where rugged analytical methods are needed and is continuing to expand the list of dietary supplement materials. In October 2001, FDA and the National Institutes of Health’s Office of Dietary Supplements awarded AOAC a grant to validate methods for ephedrine-type alkaloids and aristolochic acid through AOAC’s Official Methods program. The validation involves collaborative studies using HPLC and HPLC-MS methods (see sidebar).
Given the increased production of functional foods, processors should be aware that there are regulatory differences between functional foods and dietary supplements, but that there are some overlapping regulations. Even though the law does not specifically define “functional foods” or “nutraceuticals”—terms widely used in the marketplace—FDA regulates such products as conventional foods under the authority of the Federal Food, Drug, and Cosmetic Act (FDCA). FDA regulates dietary supplements under a different set of regulations than those covering conventional foods and drug products (prescription and over-the-counter).
On January 30, 2001, FDA issued a letter to manufacturers restating the requirements of FDCA regarding the marketing of conventional foods containing novel ingredients, including botanicals. FDA issued this letter because of the significant growth in the marketing of foods containing these ingredients. Of particular concern to FDA was the use of these ingredients and claims made on the label or in labeling. Botanicals and other novel ingredients added to conventional foods must be either pre-approved food additives or generally recognized as safe (GRAS) for these uses. Substances added to food that are neither approved food additives nor GRAS for their intended use causes the food to be adulterated and unable to be legally imported or marketed in the United States.
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PRODUCTS & LITERATURE
Top-Loading Electronic Balances in the UW/UX Series feature backlit display, automated calibration, built-in ports for remote displays, and choice of units. A data-capture function sends weighting data and calibration reports to printers or computers. The balances have a communication function, which is said to allow easy integration with existing lab or business software. For more information, contact Shimadzu Scientific Instruments, Inc., 7102 Riverwood Dr., Columbia, MD 21046-2502 (phone 800-477-1227).
Environmental Monitoring Software can collect, document, and trend environmental monitoring data for audits and inspections and provide critical information on the quality of the aseptic processing environment during manufacturing. This is beneficial for industries charged with meeting more stringent regulatory requirements. For more information, contact BD Diagnostic Systems and Compliance Software Solutions Corp., 7 Loveton Cl., Sparks, MD 21152 (phone 410-316-4468).
Automated Clean-Up System, the AutoPrep 2000, automates the separation of interfering coextractives from target analytes in environmental and food samples prior to GC or GC/MS analysis, reducing downtime and extending the life of analytical columns. The new design integrates an autosampler, allowing up to 60 samples to be cleaned and collected in flasks. For more information, contact O.I. Analytical, P.O. Box 9010, College Station. TX 77842-9010 (phone 979-690-1711).
Viscometer, the Visconic, is designed to eliminate the need for a sample loop. It is a long-stemmed, inline, vibrating-fork meter that can be installed directly into large-bore pipes and tanks. This allows for the use of the meter in process applications. It may be used for measuring dynamic viscosity, kinematic viscosity, and density. For more information, contact Solartron Mobrey, Inc., 19408 Park Row, Ste. 320, Houston TX 77084 (phone 281-398-7890).
The dietary supplements addressed in the first call for methods, selected by the AOAC Task Force on Dietary Supplements, Ingredients Ranking Sub-Group (IRS), included chondroitin sulfate, glucosamine, St. John’s wort, ginkgo, SAMe, beta-carotene, and saw palmetto.
AOAC is now looking for analytical methods for the following ingredients in dietary supplements, applicable to the raw botanical as well as the processed product: saw palmetto, SAMe, chondroitin sulfate, vitamin E, coenzyme Q10 , Panax ginseng (Asian) and Quinquefolius ginseng (American). AOAC is asking anyone who is using a method which is applicable to any of these dietary supplement ingredients to contact Senior Scientific Advisor Al Pohland or Program Coordinator Mai Nguyen at AOAC International, 481 N. Frederick Ave., Suite 500, Gaithersburg, MD 20878 (phone 301-924-7077, fax 301-924-7089, E-mail [email protected] or [email protected]). For more information, see www.aoac.org/dietsupp/Call_5-2-2003.pdf.
by JAMES GIESE