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Important Product Description Content Changes - updated April 2011

Important Product Description Content Changes - updated April 2011

April 2, 2011

Dear Mayway Customer,

Mayway’s decision to ensure our full compliance with FDA regulations pertaining to the marketing of herbal products by removing all bio-medical information from our website has stirred an interesting and important debate, much support and some concern.

Many of the stakeholders in this industry, including Mayway, believe that Chinese herbal products with their long history of recognized, effective use, should have its own separate category of regulatory requirements. However, that is not the law in the United States where herbs are regulated as dietary supplements, and, in fact, selling medicinal herbs in some other countries is subject to even stricter regulation. At the risk of over–simplifying very complex issues, in the United States, Chinese herbal products may not be marketed with bio–medical healing properties unless they are “drugs” and subject to prior extensive and expensive testing and pre–approval by the FDA. So long as the law remains as it now is, we believe that it is necessary and appropriate for us to comply with the FDA regulations concerning the sale of dietary supplements.

Also, because these regulations pertain to the marketing of herbal remedies, others who are not involved directly or indirectly in the marketing of herbal products may choose to publish information on the bio-medical effects of herbs and not be limited by those regulations. However, we believe it is clear that under current law, that we and others selling herbal products may not use bio–medical information published by ourselves or others, directly, indirectly or even remotely in conjunction with the sale of products. For example, Mayway, in our marketing material including our website, is not allowed to link to an article in a respected acupuncture journal describing the bio-medical benefits of a particular herb.

Mayway is very concerned that the consequences of non-compliance with FDA regulations will be far worse than the inconvenience of looking elsewhere for bio–medical information. If the industry persists in marketing products by reference to disease curing bio-medical effects, it is altogether possible that the FDA will determine that these products will not be allowed to be sold at all, as they will be treated as a "drug" with strict and expensive pre-approval requirements.

Mayway is only speaking to what marketing information we believe is permissible for us and others who sell herbal products. We understand that licensed practitioners may not have such limitations when communicating to their patients as part of diagnosing, treating conditions and prescribing remedies. It is not our intention to advise practitioners on what they should or should not say to their patients about herbal remedies as part of treatment.

We feel it would be beneficial for licensed practitioners to have a comprehensive resource of Chinese herbal products bio–medical information which is not connected directly or indirectly to any manufacturer or distributor or in any way to the sale of products, and instead serves as an educational resource. Mayway supports the concept of an independent not–for–profit entity providing such a resource, perhaps organized by the various schools for Chinese medicine or by professional organizations. This entity could create an independent, perhaps non–profit, Herbal Physician’s Desk Reference that would provide a web–based database for all herbal medicinal products.

Other ideas being considered include changing the statutory status of natural medicines. This March, Mayway attended the American Herbal Products Association meeting of the Chinese Herbal Products Committee. This committee includes representatives of 34 Chinese herb companies. We announced our decision to remove all Western medical claims from our marketing materials and web site and explained the importance of the situation to the other members. After discussion, a working group within the committee was formed to investigate this idea of statutory change further.

What can you do? Of course, these initiatives are only in their beginning stages. We believe that because a comprehensive alternative has not yet been articulated by the Chinese herbal medicine community, that it is much too early to contact legislatures or the FDA. We do encourage contacting the herbal committees of the American Association of Acupuncture and Oriental Medicine, the Council of Colleges of Acupuncture and Oriental Medicine, your state practitioner association (in California, there are several, e.g. the California State Oriental Medicine Association, and voicing your opinion.

We welcome your input on this always complex and sometimes controversial subject. Thank you.


Yvonne Signature President


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

Read original January article