Important Product Description Content Changes

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Important Product Description Content Changes

January 25, 2011

Please Read Notice

Dear Mayway Customer,

You will notice in our online product detail pages that our herbal product descriptions now include only the list of ingredients, Traditional Chinese Medicine functions, standard dosage and Cautions and Contraindications. This change is part of our ongoing efforts towards total compliance with FDA guidelines.

In the United States, herbal products have been determined to be a food supplement and not a medicine. While both categories are regulated by the Food and Drug Administration (FDA), they are treated very differently. While claims can be made regarding the curative effect of medicines, before medicines can be sold at all they are subject to a very rigorous and expensive testing and approval process. Food supplements on the other hand can be easily brought to market without a pre–approval process by the FDA, but medical claims cannot be made based on historical use or traditional Chinese medicine texts. While the FDA has allowed limited claims regarding the effect of a food supplement on “structure and function”, even those limited claims are subject to being based on evidence on hand, notice to the FDA of the use of such claims and an FDA disclaimer (*“These statements have not been evaluated by the Food and Drug Administration. These products and statements are not intended to diagnose, treat, cure or prevent disease.”) There is discussion to further restrict or even eliminate structure and function claims. We have come to the conclusion that the best way to ensure that we and our customers are marketing Mayway herbal products in compliance with FDA requirements is to be highly selective about the information we display on our website now and in the future.

We believe that licensed practitioners of Chinese medicine are best suited to make the determination of what herbal formulas best meet the requirements of their patients. Of course, FDA restrictions on claims apply not only to companies like Mayway but also apply to practitioners of Chinese medicine who dispense (sell) products to their patients. Additionally, we will no longer be distributing, supporting or using the printed A Practitioner's Formula Guide and ask that you not use it to order products or distribute copies of pages to patients or customers. Most importantly, we insist that no “medical” claims be made about our products.

Mayway will of course continue to market the highest quality herbal products and our herbal consultants will continue to provide appropriate support as needed. We urge you to look into this matter, and join us in being FDA compliant. Thank you.


Yvonne Signature

Yvonne Lau

We suggest you do your own research on the subject and come to your own conclusions regarding what is and is not allowed when describing herbal products to patients and customers. For your reference, here are links to the DSHEA law and the FDA’s guidelines about what claims can be made for nutritional supplements:

Significant Amendments to the F, D & C Act; Dietary Supplement Health and Education Act of 1994 (DSHEA)
From FDA Website

Claims That Can Be Made for Conventional Foods and Dietary Supplements
FDA Website, September 2003

The following are some recent examples of an FTC settlement order and an FDA warning letter concerning medical claims for nutritional supplements:

FTC Approves Final Order Settling Charges That Nestlé Subsidiary Made Deceptive Health Claims for BOOST Kid Essentials
FTC website, January 18, 2011

FDA warning letter to a Chinese herb web retailer
FDA Website, November 26, 2010

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