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Different types of standards
January 1999

Many different types of standards apply to the evaluation, production, testing, and monitoring of dietary supplements. Below is a summary of the different types that exist and some examples of each:

Type of Standard

Description

Examples

terminology

definition of dietary supplement names used on product labels.

Herbs of Commerce

potency

active ingredients or marker compounds and ratios thereof that make up a particular type of dietary supplement

USP

 

dissolution rates

the rate that a substance dissolves, and thus is available for absorption in the blood stream

USP

test methods

methods considered valid for testing products for ingredients, potency, and purity

INA MVP

health benefit claims

criteria for statements made about a product's capacity to provide a particular health benefit

FDA and FTC regulations

manufacturing standards

manufacturing practices used to ensure purity and reliability

NNFA GMP

FDA GMP

HACCP

Botanical Safety Handbook

dosage recommendations

the amount of a nutrient recommended for daily consumption

RDA

U.S. RDA

RDI

DV

allowable dosage variances

the degree to which a product's potency may differ from labeled amounts

USP

labeling requirements

includes many of the above measures plus things like expiration date and lot numbers

FDA and FTC regulations

NNFA GMP

FDA GMP

policies and programs established by trade associations, publishers, and trade show sponsors

requires a variety of procedures, such as product registration and testing

NNFA TruLabel ComPLI

Natural Foods Expo

adverse event or consumer complaint reporting systems

policies and procedures for reporting consumer complaints

AHPA chaparral AER

FDA SN/AEMS

 

Developing any one of these types of standards presents challenges. Practices vary widely throughout the industry. Different types of dietary supplements and different types of manufacturing operations call for different manufacturing standards.

Efforts are further complicated by the fact that the dietary supplements industry is evolving rapidly, so that standards developed today may soon become obsolete. Also, it is difficult to establish a standard in some areas because too little is known to form an accurate one. In botanicals especially, we are only beginning to learn which parts of a plant provide the most benefit. Despite these difficulties, many attempts have been made to implement standards with some recent notable successes.


 

   
 

More about standards & regulations:

Industry standards

Creating a quality model for dietary supplements

Different types of standards

Pros and cons of standards

Competing standards

Testing products for quality

Dosage recommendations

Good manufacturing practices (GMPs)

Self-regulatory quality standards

Government regulations

FDA safety monitoring

Federal Trade Commision (FTC)

State laws

Health benefit claims

RDA, DV, and other recommended intake values

Funding of research at the National Institutes of Health (NIH)

Possible future FDA regulations

Possible future Codex regulations

 

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(c) Copyright 1999-2003 Dietary Supplement Quality Initiative. For permission to reprint, please contact our editor.