Self-regulatory quality standards in effect

Self-regulatory quality standards in effect
January 1999

Several self-regulatory standards for producing dietary supplements are in place. These standards serve to ensure consistently high-quality products. Here is a summary of current initiatives listed in alphabetical order:

AHPA Botanical Safety Handbook

This handbook -- developed by the American Herbal Products Association (AHPA) -- provides information about practices affecting safety, such as cleanliness and contamination. It also gives guidelines for serving size and other labeling issues. The handbook serves as a guide for health care practitioners and consumers.

The Botanical Safety Handbook provides readily accessible safety data in an easy-to-use classification system for more than 600 commonly sold herbs.The handbook also features additional information regarding international regulatory status, standard dosage, and certain common toxicity concerns.The editors of this book are among the most respected leaders in the herbal products industry. Their experience includes years of clinical practice, manufacturing and industry governance, and significant writhing and lecturing about herbs.

Index includes a thorough listing and classification of herbs sold in the United States.

Appendix includes technical information on important chemical constituents.

Contains more than 500 botanical entries.

Provides accurate data on the safe use of herbal products.

Includes specific information relevant to prior health conditions, pregnancy, and nursing.

Presents guidelines on the information to be included on labels for herbal products.

AHPA Herbs for Commerce

This reference developed by the American Herbal Products Association (AHPA) provides a compilation of common names "standardized" to botanical names for herbs. It is used in FDA labeling regulations that went into effect in March 1999. The second edition will be issued in the first quarter of 1999.

INA Methods Validation Progam (MVP)

Methods are being developed as part of the Methods Validation Program (MVP) currently under development by the Institute for Nutraceutical Advancement (INA). MVP is the industry's most concerted effort to standardize test procedures for botanical products. INA is a consortium formed in 1998 by Industrial Labs, an independent testing laboratory in Denver, Colorado. INA includes thirty manufacturers, suppliers, and distributors; and seven industry trade associations. Methods have been published for three raw materials so far: Kavalactones in Piper Methysticum, Flavonol Glycosides in Ginkgo Biloba, and Ginsenosides in Panax Ginseng and American Ginseng.

New Hope Communications exhibitor standards for Natural Products Expo

New Hope Communications sets exhibitor quality standards for suppliers who participate in Natural Products Expo East and Expo West, the industry's largest trade shows. Participants must sign an agreement to abide by these standards. They include requirements and guidelines for:

product safety

product ingredients

product claims

product labeling

product literature

show floor activity

NNFA GMP Compliance Program

The National Nutritional Foods Association (NNFA) began its Good Manufacturing Practices (GMPs) compliance program in 1999, designed to be implemented over a three-year period. Member manufacturing facilities are inspected by a third party to determine whether NNFA specified performance standards are being met. Practices involving personnel, plant and grounds, sanitation, equipment, quality operations, production and process controls, warehousing, distribution, and post-distribution are audited under the program. Manufacturers who pass the inspection are certified and allowed the use of the NNFA GMP seal of approval on their products. Participation in the GMP program is optional for NNFA supplier members.

NNFA TruLabel Program

The TruLabel program of the National Nutritional Foods Association (NNFA) is a dietary supplement label registration and random-testing program required of all NNFA supplier members who manufacture under their own label. Products must be registered in order to be displayed at the annual NNFA Marketplace trade show. Unregistered products are removed from display shelves. The TruLabel is an NNFA-internal program overseen by NNFA's Science and Quality Assurance department, and does not authorize use of the TruLabel name or logo in product advertising. TruLabel policies are governed by the NNFA's Committee for Product and Label Integrity (ComPLI) and the board of directors.

Registered products are subject to random testing conducted by independent laboratories for consistency between contents and labels. Products that pass testing are published as compliant. Should a test reveal a product or ingredient deficiency, the member company is contacted and given a brief period to correct the product or label. A company that fails to comply is expelled from membership, and is thus unable to exhibit at NNFA's annual convention and trade show. NNFA plans to publish products that fail in their newsletter.

USP Standards

The US Pharmacopoeia (USP) is a nonprofit corporation that functions as a quasi-public institution whose standards are enforceable by the US Food and Drug Administration. The USP establishes and disseminates quality standards for the use of medicines and dietary supplements. These standards are published in the United States Pharmacopoeia and the National Formulary (USP-NF). Proposed revisions are published for public review and comment in Pharmacopeial Forum (PF).

Dietary supplements products may be labeled with the USP or NF insignia if they meet associated standards established by USP.

USP insignia

A "USP" insignia indicates that the manufacturer claims that certain vitamin and mineral ingredients contained in the product have an FDA-approved or USP-accepted use, have been used extensively without a significant safety risk, and that they meet the compendial quality standards published in the United States Pharmacopoeia. These standards specify allowable rates of disintegration and dissolution, strength (accuracy of dosage units), range of acceptable impurities, and existence of an expiration date.

USP's NF insignia

An "NF" insignia indicates that the manufacturer claims that herbal ingredients contained in the product have been used extensively without a significant safety risk and meet the compendial quality standards published in the United States Pharmacopoeia National Formulary (USP-NF). These standards specify allowable rates of disintegration and dissolution, strength (accuracy of dosage units), range of acceptable impurities, and existence of an expiration date. Unlike the USP insignia, NF products are not required to have an FDA-approved or USP-accepted use.