Docket No. 01N-0319

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

PROPOSED COLLECTION OF INFORMATION IN A HEALTH AND DIET SURVEY

> October 9, 2001

The American Herbal Products Association (\"AHPA\") is the national
trade association and voice of the herbal products industry, comprised
of companies doing business as growers, processors, manufacturers, and
marketers of herbs and herbal products. AHPA serves its members by
promoting the responsible commerce of products that contain herbs.

In a *Federal Register* notice dated August 7, 2001, ("the August 7
Notice" or "the Notice") the Food and Drug Administration (FDA)
published a proposal to collect certain information in the form of a
Health and Diet Survey ("the Survey"). The agency stated that the Survey
would provide information related to dietary supplements and food. The
majority of AHPA's members sell herbal dietary supplements or herbal
ingredients for dietary supplements. AHPA's members therefore have an
interest in the proposed Survey.

The August 7 Notice specifically asked for comment in four areas
including whether the proposed collection of information is necessary
for the proper performance of FDA's functions. In addition, the Notice
identified ten questions to be asked in the Survey, seven of which are
related to dietary supplements. The other three questions are related to
the overall diet and food, and the agency stated that these three
replicate questions from an earlier survey. The agency stated that the
Survey would provide FDA with information about consumers' knowledge,
perceptions, attitudes, and practices related to dietary supplements and
foods.

AHPA's comments here are offered only for the agency's request for
comments as to whether the collection of information described in the
docket is necessary for the proper performance of FDA's functions, and
only in relation to that part of the Survey that is proposed for dietary
supplements.

## 

## **collection of Information is not necessary**

AHPA believes that the collection of data related to dietary supplements
envisioned in the Survey is not necessary for the proper enforcement of
FDA's functions. AHPA further believes that the collection of
information as described in this scheme would be wasteful of the
agency's resources. These beliefs are based on two primary factors.

To begin with, much of the information described in the Notice is
already available. Many of the same questions that are identified in the
Notice have already been asked of these same consumers by a variety of
service businesses in the dietary supplement industry that have special
expertise in collecting and evaluating consumer data, as well as by
health and academic researchers and trade organizations.

Secondly, FDA is a regulatory agency. It's primary function at this time
*vis-à-vis* dietary supplements should be focused on enforcement of the
current regulations that govern these products and the completion of
those regulations that are still necessary to finalize the
implementation of the Dietary Supplement Health and Education Act
(DSHEA), passed seven years ago this week. Until such time as FDA is
fully enforcing the current regulations and has completed the
implementation of other necessary regulations, the agency should avoid
any other activities that would distract its resources.

## **FDA SHOULD CONSIDER EXISTING DATA**

AHPA appreciates FDA's interest in the knowledge, perceptions, attitudes
and practices of consumers of dietary supplements. As stated above,
however, much of the information that is described in the Notice is
already available, so that this interest can be satisfied much more
efficiently by assessing existing data that has already been gathered
from consumers.

While the following list is not intended to be exhaustive, AHPA is aware
of several publications and documents that provide meaningful data that
is directly related to the information that is identified in the Notice:

-   Eisenberg *et al.* Unconventional medicine in the United States:
    prevalence, costs, and patterns of use. New England Journal of
    Medicine 1993; 328:246-252, and Trends in alternative medicine use
    in the United States, 1990-1997: results of a follow-up national
    survey. JAMA 1998 Nov 11; 280(18):1569-75. Eisenberg's work provides
    useful information about the prevalence of use of dietary
    supplements generally as well as about specific supplement
    categories, such as herbal products. These publications also report
    on other of the factors described in the Notice, such as the
    purposes for which consumers use supplements.

-   Prevention Magazine, Emmaus, PA, *Consumer Use of Dietary
    Supplements*, Spring 2000. This national survey of 2000 adult
    Americans was \"developed with technical assistance from\" FDA\'s
    Office of Nutritional Products, Labeling and Dietary Supplements at
    the Center for Food Safety and Applied Nutrition. The earlier effort
    was designed with many of the same objectives that are evident from
    the questions proposed in the Notice, including: measurement of
    consumer use of supplements (number of users; total amount spent per
    year; use of various subclasses of supplements), determination as to
    whether dosing recommendations are followed and whether supplements
    are used with or instead of drugs, understanding of consumers
    information sources and purchasing decision factors, and assessment
    of public confidence in supplements and public opinion regarding the
    federal government\'s role in ensuring product safety and efficacy.
    It appears from these descriptions that FDA has already expended at
    least the resource of \"technical assistance\" by supporting this
    effort to answer the same types of questions that are now proposed
    in the Survey.

-   Natural Marketing Institute (NMI), Harleysville, PA, annual *Natural
    Marketplace Trends Report*. NMI describes this work as a trended,
    annual, nationally projectable consumer research study of 2000-plus
    households that records many of the same topics that FDA has
    identified in its proposed survey, such as consumer motivations,
    behaviors, attitudes and influences. NMI's interest goes beyond
    supplement users but these consumers are included in and are an
    important part of their ongoing survey. NMI is generally regarded as
    one of the finest professional researchers and analysts of the
    natural market consumer and AHPA has cooperated closely with NMI
    over the past year to make certain that their report is specifically
    attentive to consumers of herbal supplements.

-   Dietary Supplement Education Alliance, Chatsworth, CA, *Dietary
    Supplement Barometer Survey*. Conducted from June 28 through July 1,
    2001 by Harris Interactive, this national poll of 1,027 Americans
    aged 18 and older examined the extent to which consumers use dietary
    supplements, their reasons for use, and their level of knowledge.
    Again, these are some of the same points that FDA has identified in
    its proposed Survey.

-   National Nutritional Foods Association, Newport Beach, CA, *A Study
    of Supplement Use*, May 2000. This random digit dialing survey of
    1016 Americans aged 18 and over was conducted by Yankelovich
    Partners. Similar to some of the information identified by FDA, the
    survey reported on consumers' use by product category, their reasons
    for use and on their sources of information, among other
    information.

In addition, AHPA is aware that the Council for Responsible Nutrition,
Washington, DC, prepared a consumer survey within the last year, and
that health researchers such as Dr. Allen Mitchell of Slone Epidemiology
Unit at Boston University and industry consultants including the Hartman
Group, Bellevue, WA, are engaged in ongoing data collection activities
that are designed to provide the same kind of information about
supplement consumers as has been described in the Notice.

In summary, AHPA believes that the agency would make better use of its
own resources by identifying, obtaining and analyzing information that
already exists. AHPA is prepared to assist in such activities in any way
possible.

## 

## **FDA SHOULD PRIORITIZE ENFORCEMENT**

AHPA has been consistent in its communication with FDA and in its public
statements in advocating for the agency to be much more active in
enforcing the existing federal regulations that govern dietary
supplements. Nevertheless, the supplement industry has been tagged as
"unregulated" by newspapers, television and radio reporters, such that
it is almost inevitable that one of the perceptions of supplement users
is, in fact, the misperception that this class of goods is unregulated.

The reality is, as FDA knows, that the entire dietary supplement
industry IS regulated. Current federal law empowers both FDA and the
Federal Trade Commission to police the supplement industry and to
enforce their separate regulations. AHPA is concerned that this
misreporting and probable misperception of the true nature of the
regulation of supplements is due in part to insufficient enforcement by
FDA.

AHPA's President recently published an article in an industry journal
which discussed the concerns articulated here. In the article a modest
proposal was offered to put the supplement industry and FDA back on a
congruent regulatory track: FDA should declare from today through
December 31, 2001 an amnesty period for manufactures who currently make
unlawful drug claims on their products. During this period, FDA should
communicate in writing with these companies indicating how the company
is in breach of the law. If these companies fail to comply, FDA should
use their authority to seize the illegal products and lodge court
actions against the manufacturers who were duly forewarned.

In the area of establishing further regulations for supplements, AHPA
has also consistently advocated for the prompt publication of a proposed
final rule for good manufacturing practices for dietary supplements. We
reiterate that position here.

What do these suggestions have to do with the Notice that is the subject
of these comments? Arguably they are at best peripherally related, and
are offered to provide examples of the kinds of enforcement actions and
regulatory implementation that AHPA believes should take priority over
most other of FDA's activities in relation to dietary supplements, and
certainly over the Survey proposed in the August 7 Notice. Inadequate
enforcement of the existing regulations that govern dietary supplements
is negatively impacting consumer perceptions and attitudes and should be
addressed by an activist enforcement policy at FDA.

## 

## **SUMMARY**

The American Herbal Products Association believes that the collection of
data related to dietary supplements envisioned in the Survey that is the
subject of the August 7 Notice is not necessary for the proper
enforcement of FDA's functions. AHPA further believes that the
collection of information as described in this scheme would be wasteful
of the agency's resources. Rather, AHPA believes that the agency should
identify, obtain and analyze the highest quality data that already
exists on the knowledge, perceptions, attitudes and practices of
consumers of dietary supplements, and invest the resources thus saved in
enforcing the regulations that currently exist for dietary supplements
and in completing the implementation of this important law, especially
in the area of good manufacturing practices.

AHPA stands ready to support FDA in any of the efforts described above,
either by assisting in the identification of professional consumer
survey resources, by communicating regulatory and enforcement messages
to our members or by cooperating in crafting appropriate messages to
consumers. Should FDA determine that their best course of action is to
proceed with the Survey that is the subject of the Notice, AHPA stands
willing to assist in any way it can to insure the fairness, accuracy and
objectivity of the survey and its results.

> Respectfully submitted,
>
> Michael McGuffin
>
> President,
>
> American Herbal Products Association
>
> 8484 Georgia Avenue
>
> Suite 370
>
> Silver Spring, MD 20910
>
> James Lassiter
>
> The Lassiter Group
>
> Chair, AHPA Government Relations Committee
>
> 219 Broadway, #255
>
> Laguna Beach, CA 92651
>
> Anthony L. Young
>
> General Counsel
>
> American Herbal Products Association
>
> Piper, Marbury, Rudnick & Wolfe LLP
>
> 1200 19^th^ Street, N.W.
>
> Washington, D.C. 20036