Docket No. 00P-1355

BEFORE

THE UNITED STATES OF AMERICA

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

COMMENTS OF THE

AMERICAN HERBAL PRODUCTS ASSOCIATION

ON THE

CITIZEN PETITION OF THE CONSUMER HEALTHCARE PRODUCTS ASSOCIATION
REGARDING STRUCTURE/FUNCTION CLAIMS FOR CONDITIONS ASSOCIATED WITH
PREGNANCY OR NURSING

> March 5, 2000

The American Herbal Products Association (AHPA) is the national trade
association and voice of the herbal products industry. AHPA is comprised
of domestic and foreign companies doing business as importers, growers,
processors, manufacturers, marketers, and distributors of herbs and
herbal products. AHPA serves its members by promoting the responsible
commerce of products that contain herbs and that are used to enhance
health and quality of life.

On March 11, 2000 the Consumer Healthcare Products Association (CHPA)
submitted a petition to have the Commissioner of Food and Drugs
establish a requirement that many dietary supplements bear certain
cautions with respect to their use in pregnancy or while nursing a baby.
At the same time, CHPA proposes that other dietary supplements be
exempted from any such requirement. AHPA disagrees with the CHPA
petition and, with this comment, suggests that the Food and Drug
Administration reject the petition and the positions set forth in the
petition.

**AHPA'S POSITION REGARDING PREGNANCY LABELING FOR HERBAL SUPPLEMENTS**

In July of 1998, AHPA's Board of Trustees adopted a trade recommendation
for its members with respect to herbs that have been identified as not
for use in pregnancy or when nursing an infant. In 1997, AHPA published
the *Botanical Safety Handbook*. This book was authored by various
herbalists and AHPA's current president Michael McGuffin. The authors
utilized the rich history of use and reporting of information regarding
the safe use of herbs to present a conservative and cautionary view to
the use of herbs in dietary supplements. In this book, herbs classified
in Class 2b or 2c are defined as not for use in pregnancy or nursing,
respectively, unless otherwise directed by a qualified expert. AHPA's
trade recommendation is that products containing any Class 2b or 2c
herbs be labeled in accordance with this recommendation.

AHPA is opposed to the CHPA petition because it disregards current
existing data and information regarding the use of botanicals while
pregnant or nursing. Moreover, AHPA is concerned that the general
statement that CHPA proposes to be included on the labels of most
dietary supplements presents a message that is so common as to be
ignored. AHPA's view is that more thought and attention must be given to
the message delivered to pregnant women and mothers and its form and
substance.

At the Spring 2000 hearing convened by the Administration to discuss
this subject, AHPA made its views known and contributed substantially to
the debate on this issue. AHPA encourages the Administration carefully
to consider the views expressed at that hearing by AHPA and those AHPA
members who provided testimony.

> Respectfully submitted,
>
> Mr. Michael McGuffin
>
> President
>
> American Herbal Products Association
>
> 8484 Georgia Avenue
>
> Suite 370
>
> Silver Spring, MD 20910
>
> \(301\) 588-1171
>
> Anthony L. Young
>
> Piper Marbury, Rudnick & Wolfe LLP
>
> 1200 Nineteenth Street, N.W.
>
> Washington, D.C. 20036
>
> \(202\) 861-3900
>
> Counsel for the American Herbal Products Association