James R. Prochnow![](media/image1.png){width="1.823611111111111in"
height="0.9208333333333333in"}

\(303\) 572-6546

November 12, 2003

VIA E-MAIL http: //www.fda.gov/dockets/ecomments

Dockets Management Branch (HFA---305)

Food and Drug Administration

5630 Fishers Lane, Rm. 1061

Rockville, MD 20852

> Re: Comments of Jarrow Formulas, Inc. and Jarrow Industries, Inc. for
> Docket No.: 2003N-0346 -- Food Labeling: Ingredient Labeling of
> Dietary Supplements That Contain Botanicals

To Whom It May Concern:

Our law firm represents Jarrow Formulas, Inc. ("JFI"), 1824 S. Robertson
Blvd., Los Angeles, CA 90035-4317, and Jarrow Industries, Inc., 12246
Hawkins Street, Santa Fe Springs, CA. 90670-3365 ("JII") . Throughout
this document, these two companies shall be referred to, collectively,
as "Jarrow." JII manufactures and packages dietary supplements for JFI,
formulates dietary supplements and does contract manufacturing for other
dietary supplement companies. JFI markets and distributes dietary
supplements throughout the United States.

These Comments concern the proposal by FDA to restrict the use of the
common name "ginseng" to Asian and American ginseng and to prevent the
continued labeling of a related plant *Eleutherococcus senticosus* by
what most people consider its common and usual name, "Siberian ginseng."
These Comments present both non-constitution and constitution reasons as
to why the FDA proposal is flawed and should not become a final rule.
Additionally, we ask that the FDA not enforce the Farm Bill provision,
which is contrary to its own "common and usual name" policy.

Part 1. Non-Constitutional Issues

**Rule is a Significant Regulatory Action**

The FDA determined the rule is not a significant regulatory action. We
disagree. According to the American Herbal Products Association,
Siberian ginseng sales may account for half of reported ginseng
sales.[^1] We disagree with the FDA's assertian that this is not a
significant regulatory action for the following reasons:

The impact of the law is considerable.

It does "adversely affect a sector of the economy in a material way."

It does adversely affect competition.

It does adversely affect jobs.

It does raise novel legal or policy issues, as it appears to be the
first attempt to regulate common names, and especially regulating such
names according to a document produced by the regulated industry and
subject to undue influence from its members.

**Siberian Ginseng is the Common and Usual Name**

The name "eleuthero" is unknown to the herb-consuming public as a
"common name" of *Eleutherococcus senticosus.* This herb is known to
consumers as Siberian ginseng, a term by which it has been *commonly
known as and referred to* by the consuming public, since the 1960s[^2].
Hence, the Farm Bill seeks to prevent the "common and usual name" of
this plant from being used to describe it. The American Herbal Products
Association, possibly acting on behalf of its sponsors in the panax
ginseng industry is complicit in creating a marketing obstacle for a
long-established herbal tea and dietary supplement ingredient by
changing its name to an obscure and unknown fragment of its Latin
botanical name.

**Reference is an Industry Document**

The industry-produced reference book, *Herbs of Commerce (HOC)*, is
lacking in the scientific and legal/regulatory research and validation
that would make it truly authoritative. The listings in *HOC* may have
been influenced by commercial interests of members of the American
Herbal Products Association. Whether or not this is so, there appears to
be no legitimate record of the use of "eleuthero" as a common and usual
name in the history of this plant, which has been in continuous use for
over 4,000 years. During the entire history of its use, the plant has
never been known in any language by the common name "eleuthero". In
redefining the common name "Siberian ginseng" to "eleuthero", *Herbs of
Commerce* supports the agenda of sellers of *Panax* species, a wealthy
part of the industry, to the detriment of the less-influential marketers
of *Eleutherococcus senticosus*. Similarly, the provision in the Farm
Bill concerning ginseng nomenclature was inserted to aid a particular
group of producers (Wisconsin ginseng growers) to the detriment of other
producers (of Siberian ginseng products). We are not convinced that
avoiding confusion was the goal of either attempt to prevent the use of
"Siberian ginseng" a long-used common name. Indeed, the change will
create confusion among consumers who have been buying and using Siberian
ginseng and wish to continue using it. Both the *HOC* and Farm Bill
provisions may simply be an effort to prevent competition from a plant
which has been marketed legally in the US under the name Siberian
ginseng and is known to its consumers by that name. The term Siberian
ginseng has been in use since at least the 1960s.

**No Rationale for Equating *Panax* with Ginseng**

There is no valid rationale for including all species of the genus
*Panax* as ginseng. *Panax ginseng* is ginseng. *Panax pseudoginseng* is
Tienchi. *Panax quinquefolius* ("American ginseng") is not the same
plant as *Panax ginseng*, and should perhaps be called "quinqufol"
(following the "eleuthero" example of using a fragment of the Latin
name) or some other common name distinguishing it from true panax
ginseng. These two plants−Asian ginseng and American ginseng−do *not*
have a long history of use as equivalent products in any of the
countries in which they have substantial history. They are not
considered interchangeable in China or by reputable practitioners of
Traditional Chinese Medicine. In fact, in many Asian countries, selling
American ginseng as "ginseng" is considered fraud. The proposed rule
implies that all species of *Panax* can now be called "ginseng." This
will create further confusion in the marketplace. See **Table One.**

**[TABLE ONE -- Species of Genus *Panax*]{.underline}**

**[Panax]{.underline}** 

**[Panax assamicus]{.underline}**

**[Panax ginseng]{.underline}** (Korean ginseng)

**[Panax japonicus]{.underline}** (chikusetu-ninjin)

**[Panax japonicus var. major]{.underline}**

**[Panax notoginseng]{.underline}** (tienchi)

**[Panax omeiensis]{.underline}**

**[Panax pseudoginseng]{.underline}**

**[Panax pseudoginseng subsp. himalaicus]{.underline}**

**[Panax pseudoginseng subsp. pseudoginseng]{.underline}**

**[Panax pseudoginseng var. angustifolius]{.underline}**

**[Panax pseudoginseng var. bipinnatifidus]{.underline}**

**[Panax pseudoginseng var. elegantior]{.underline}**

**[Panax quinquefolius]{.underline}**

**[Panax shangianus]{.underline}**

**[Panax sinensis]{.underline}**

**[Panax stipuleanatus]{.underline}**

**[Panax trifolius]{.underline}**

**[Panax variabilis]{.underline}**

**[Panax vietnamensis]{.underline}**

**[Panax vietnamensis var. fuscidiscus]{.underline}**

**[Panax wangianus]{.underline}**

**[Panax zingiberensis]{.underline}**

**Assigning a common name to all members of a genus is not botanically
valid.**

**Brassica example:** The genus *Brassica* includes rapeseed, mustard,
turnips, broccoli, cauliflower, kale, cabbage and brussels sprouts (see
table two). The latter five are subspecies of *the same specie*. The
Latin binomial, if expressed as genus and specie, is identical for
broccoli, cabbage, cauliflower and brussels sprouts. Consumers know them
by their common names and are not confused by their botanical
classification in the same genus or specie. If by regulation all foods
in the genus *Brassica* could be called broccoli, consumer confusion
would result. Botanical classification does not justify dictating a
common name, nor preventing an excepted common name from being used.
This is unprecedented. See **Table Two**.

**[Table Two]{.underline}**

**Brassica** **species**

-   **[Brassica amplexicaulis]{.underline}**

```{=html}
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```
-   **[Brassica balearica]{.underline}**

-   **[Brassica barrelieri]{.underline}**

-   **[Brassica carinata]{.underline}** (Ethiopian mustard)

-   **[Brassica cretica]{.underline}**

-   **[Brassica deflexa]{.underline}**

-   **[Brassica erucastrum]{.underline}**

-   **[Brassica hilarionis]{.underline}**

-   **[Brassica incana]{.underline}**

```{=html}
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```
-   **[Brassica insularis]{.underline}**

    -   **[Brassica insularis subsp. insularis]{.underline}**

```{=html}
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```
-   **[Brassica juncea]{.underline}** (Indian mustard)

```{=html}
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```
-   **[Brassica macrocarpa]{.underline}**

```{=html}
<!-- -->
```
-   **[Brassica maurorum]{.underline}**

```{=html}
<!-- -->
```
-   **[Brassica montana]{.underline}**

```{=html}
<!-- -->
```
-   **[Brassica napus]{.underline}** (rape)

    -   **[Brassica napus var. napobrassica]{.underline}** (Swedish
        turnip)

    -   **[Brassica napus var. napus]{.underline}** (annual rape)

```{=html}
<!-- -->
```
-   **[Brassica nigra]{.underline}** (black mustard)

```{=html}
<!-- -->
```
-   **[Brassica oleracea]{.underline}**

    -   **[Brassica oleracea var. acephala]{.underline}** (kale)

    -   **[Brassica oleracea var. alboglabra]{.underline}** (Chinese
        kale)

    -   **[Brassica oleracea var. botrytis]{.underline}** (cauliflower)

    -   **[Brassica oleracea var. capitata]{.underline}** (cabbage)

    -   **[Brassica oleracea var. gemmifera]{.underline}** (brussel
        sprouts)

    -   **[Brassica oleracea var. gongylodes]{.underline}** (kohlrabi)

    -   **[Brassica oleracea var. italica]{.underline}** (asparagus
        broccoli)

    -   **[Brassica oleracea var. medullosa]{.underline}** (marrow-stem
        kale)

    -   **[Brassica oleracea var. oleracea]{.underline}**

    -   **[Brassica oleracea var. ramosa]{.underline}** (perennial kale)

```{=html}
<!-- -->
```
-   **[Brassica oxyrrhina]{.underline}**

```{=html}
<!-- -->
```
-   **[Brassica rapa]{.underline}** (field mustard)

    -   **[Brassica rapa subsp. chinensis]{.underline}** (bok-choy)

    -   **[Brassica rapa subsp. oleifera]{.underline}** (biennial turnip
        rape)

    -   **[Brassica rapa subsp. pekinensis]{.underline}** (Chinese
        cabbage)

    -   **[Brassica rapa subsp. rapa]{.underline}** (turnip)

```{=html}
<!-- -->
```
-   **[Brassica rupestris]{.underline}**

**[Brassica tournefortii]{.underline}**

**[Brassica villosa]{.underline}**

**Regulatory designation of common name can create confusion**

Jerusalem artichoke is *Helianthus tuberosus*, a sunflower*.* Artichoke
is *Cynara scolymus*, a thistle. Following the same logic as in the
proposed rule, FDA could undertake to protect artichoke interests by
preventing plants outside the genus *Cynara* from using the common name
"artichoke" in any part of the name. This would not serve the industry
nor the consumer. The common name "Jerusalem artichoke" describes a
plant long sold, and bought, under that name. Consumers do not confuse
it with artichokes. The addition of "Jerusalem" as a modifier of
artichoke is sufficient to consumers to differentiate between the two.
Similarly, consumers of Siberian ginseng are not confused by this
designation and know it is different from Panax ginseng or American
ginseng.

**Origin of the term "ginseng"**

The Chinese term from which "ginseng" is derived, renshen or jenshen,
means "man" referring to the humanoid shape of certain ginseng roots and
"shen" which is a general type of tonic plant; hence a "man-shaped tonic
plant". This designation does not accurately describe all *Panax
ginseng* roots, many of which are not man-shaped. Cultivated *Panax
quinquefolius* roots are not "man-shaped" (they are carrot-shaped),
hence do not fit the translated common name. Furthermore, Siberian
ginseng roots sometimes *are* "man-shaped" hence some Siberian ginseng
roots are "man-shaped tonic plants" while most cultivated American
ginseng roots are not. There are many "shen" (tonic) plants that are not
in the genus *Panax* or even the family *Araliaceae*. See **Table
Three**.

**Table Three**

**Chinese Tonic Herbs**

Ginseng and other "shen" plants

**Ginseng - Ren Shen**

Tonifies the base qi, the lungs, the spleen and stomach, generates
fluids, benefits the heart and calms the spirit.

**Kinds of Ginseng:**

Wild mountain root - ye shan shen - shan shen - ji lin shan shen.

Cultivated ginseng.

White root - bai shen - tang shen - sugar root - qi and yin deficiency.

Fresh dried root - sheng shai shen - nourishes the yin.

Red root - cured by steaming - hong shen - warmer.

Korean red - gao li shen - stronger, more warming than Chinese.

Panacis quinquefoli - American ginseng - xi yang shen - benefits the qi,
nourishes the yin, lung yin.

Acanthopanacis - Siberian ginseng - wu jia pi - adaptogen, dispels
wind-dampness, relieves qi-blood obstruction, motor development in
infants.

Codonopsitis - dang shen - poor man\`s ginseng - tonifies digestion -
spleen, lungs, nourishes fluids.

Pseudostellariae - tai zi shen - prince ginseng - strengthens
digestion - spleen, generates fluids.

**Consumer Confusion is a Potential Safety Issue**

Some sources have cautioned about the use of Siberian Ginseng by certain
populations, for example pregnant women or those with high blood
pressure. Additionally, there is information about potential drug
interactions between Siberian Ginseng and digoxin. While we do not
believe there is any safety issue with this plant, and while the AHPA
classifies it as Class 1 (safe when used as directed), some consumers
may choose to apply the most conservative stance and avoid this herb.

The proposed rule, by preventing the use of the common and usual name
for Siberian Ginseng, which has been in use for nearly 40 years,
actually prevents consumers from avoiding the herb, as it the name
"eleuthero" is not widely known. Hence FDA, through this rule, *may be
creating a public safety hazard* by preventing sensitive consumers from
recognizing a plant that is already very well known by its common and
usual name.

**The Common and Usual Name**

Siberian Ginseng is the common and usual name of *Eleutherococcus
senticosus*. There is no doubt about this. The name appears on over
68,000 websites, dozens of popular reference books and hundreds of
popular articles. The name is deeply rooted in the vernacular of herbal
supplement consumers and herbal tea consumers. The common name was
apparently not created by marketers of this herb, but by a popular
health author, Richard Lucas, who used it in *Nature's Medicines* in
1966s. FDA regulations require companies to label their products with
the common and usual name of foods sold. "Eleuthero" is clearly not the
accepted common name of this ingredient, nor is it the subject of a
federally-mandated statement of identity. This is a name made up by
individuals in the herb industry to protect American ginseng, *Panax
quinquefolius,* (and true ginseng, *Panax ginseng*) from competition.
There is little doubt that the proposed rule will reduce sales of
Siberian ginseng, since existing Siberian ginseng consumers do not know
it by the industry-invented name "eleuthero". However, the change may
not achieve the goal of protecting American ginseng from competition
either, since consumers of Siberian ginseng do not *choose* to buy
American ginseng and may not buy it even if they are unable to find
Siberian ginseng. These two botanicals are not considered substitutes
for each other and there are consumers who buy each as a matter of
choice, not because they are confused.

**Additional comments:**

Key members of the Wisconsin Congressional delegation quietly
incorporated this provision into the Farm Bill based on what appears to
be a disinformation campaign by the Wisconsin ginseng producers claiming
that Siberian ginseng was a worthless weed and its sale fraudulent.

This proposed rule sets up a conflict between the FDA's public safety
and protection mandate and protectionism for a special interest within
the botanicals industry. Even within industry there is no consensus on
this issue, and the Congress and the FDA appear to have been manipulated
by a small segment of the industry. The Agency must not abandon consumer
protection for the benefit of those companies who now feel threatened by
an herb that is sold, and has been sold for over 30 years under the name
Siberian ginseng.

Additionally, there is no sound reason to enforce the ginseng provision
immediately, while other provisions of the proposed rule will take
effect according to the familiar timetable of proposed rule, a
reasonable comment period and a period before the rule is enforced.
Indeed this timetable is designed to allow companies to come into
compliance with the new rules.

Part 2. The Constitutional Issue

Public Law 107-171, upon which the proposed regulation is based,
violates the First Amendment right of free commercial speech, a right
that the United States Supreme Court repeatedly has recognized and
reaffirmed. *E.g., Thompson v. Western States Med. Ctr.,* 535 U.S. 357
(2002); *Central Hudson Gas & Elec. Corp. v. Public Serv. Comm'n of New
York,* 447 U.S. 557 (1980). By electing totally to suppress commercial
speech that is not inherently misleading in the first instance *and*
that has never been found to pose *any* risk to the public, the Congress
has overstepped the constitutional restrictions on limiting commercial
speech.

The Supreme Court's precedent requires a four-step analysis of
commercial speech regulations. First, it must be determined whether "the
speech concerns lawful activity and is not misleading," *Thompson,* 535
U.S. at 367, because a total ban on commercial speech is constitutional
only when "the expression itself \[is\] flawed in some way, either
because it was deceptive or related to unlawful activity." *Central
Hudson,* 447 U.S. at 566 n.9. Second, once it is found that the speech
is lawful, the court must determine "whether the asserted governmental
interest is substantial." *Thompson,* 535 U.S. at 367 (citation and
internal quotations omitted).

Third, if the government interest is found to be substantial, it must
then be determined whether the regulation advances the government's
interests "in a direct and material way," a burden that the government
cannot satisfy "by mere speculation or conjecture; rather, a
governmental body seeking to sustain a restriction on commercial speech
must demonstrate that the harms it recites are real and that its
restriction will in fact alleviate them to a material degree."
*Edenfield v. Fane,* 507 U.S. 761, 770-71 (1993) (citations omitted).
That is, the regulation must "*directly* advance\[\] the governmental
interest." *Pearson v. Shalala,* 164 F.3d 650, 656 (D.C. Cir. 1999)
(quoting *Central Hudson*) (original emphasis). Finally, it must be
determined whether the regulation "is not more extensive than is
necessary to serve that interest," *Thompson,* 535 U.S. at 367 (citation
omitted), *i.e.,* "whether the fit between the government's ends and the
means chosen to accomplish those ends is \... reasonable." *Pearson,*
164 F.3d at 656 (internal quotations and citations omitted).

The application of this established constitutional test establishes the
invalidity of the law that the Department seeks to enforce through the
proposed regulations. First, there is nothing "inherently misleading" in
labeling as "ginseng" a product that has historically been known as a
variety of ginseng. The government cannot, of course, ban commercial
speech that is merely "potentially misleading." *Pearson,* 164 F.3d at
655; *see* *Central Hudson,* 447 U.S. at 562*.* When there is, for
example, *no* evidence (or only qualitatively weak and outdated
evidence) to support a seller's health claim, the government may ban the
claim. *Pearson,* 164 F.3d at 659-60 & n.10; *Whitaker v. Thompson,* 248
F. Supp. 2d 1, 10 (D.D.C. 2002). The government will not be able to show
that consumers will necessarily be misled into believing that a product
labeled "ginseng" is *Panax* ginseng -- particularly because a potential
purchaser can readily determine from the description of the contents
that the product is Siberian ginseng*.*

The government may nonetheless have an interest in "ensuring the
accuracy of commercial information," *Edenfield,* 507 U.S. at 769, even
when the speech is not inherently misleading. Of course, "truthful,
nonmisleading commercial information" cannot be suppressed. *44
Liquormart, Inc. v. Rhode Island,* 517 U.S. 484, 497 (1996). But "the
more significant questions under *Central Hudson*" are the last two
steps of the inquiry: whether the regulation directly advances the
government interest and whether the government has chosen reasonable
means to accomplish its ends. *Pearson,* 164 F.3d at 656 (citation
omitted). Even if the government has *some* interest in regulating the
description of ginseng, it cannot possibly satisfy these requirements.

The ban on using ginseng to describe any variety other than *Panax*
ginseng cannot pass muster under the third *Central Hudson* factor
because there is no basis for claiming that there is any public health
justification for its limitation on the use of the word "ginseng."
*Pearson,* 164 F.3d at 656. And even if the government could show --
which, in light of the historic evidence that all three varieties of
ginseng are known as "ginseng," it cannot do -- that it has an interest
in protecting against the fraudulent use of the description, the statute
would founder on the fourth *Central Hudson* factor, *i.e.,* the
reasonableness of the regulation.

This is so because the government has not shown, and cannot show, that
any legitimate goals of the statute or the proposed regulation cannot be
satisfied with something less than outright suppression of Jarrow's
commercial speech. The District of Columbia Circuit's *Pearson* decision
addressed precisely that issue, rejecting the government's argument that
the plaintiff should not be allowed to make health claims on its
products. The court held that disclaimers are "constitutionally
preferable to outright suppression," 164 F.3d at 657 (citations
omitted), and that:

> \[W\]hen government chooses a policy of suppression over disclosure --
> at least where there is no showing that disclosure would not suffice
> to cure misleadingness -- government disregards a "far less
> restrictive" means.

*Id.* at 658.

There is no showing that disclaimers and disclosures in ginseng labeling
would not suffice to cure anything that might be misleading to the
consuming public in continuing to describe a ginseng product as
"ginseng." That being so, the government's ban on Jarrow's commercial
speech fails the *Central Hudson* standard.

CONCLUSION:

The provision of the proposed rule (Docket No 2003N-0346) concerning
labeling of the botanical *Eleutherococcus senticosus* appears to fail
both on constitutional and non-constitutional grounds. The enforcement
of this provision would violate FDA policy governing the use common and
usual names for food ingredients. It also creates a potential public
safety hazard by preventing sensitive consumers, and those under
medication with digoxin, from recognizing an ingredient that some
experts advise them to avoid. We urge the FDA not to enforce this
provision and to seek the repeal of the provision in the Farm Bill
(Public Law 107-171) concerning this ingredient.

![](media/image2.wmf){width="6.944444444444445e-4in"
height="6.944444444444445e-4in"}

Respectfully submitted,

Greenberg Traurig LLP

By: James R. Prochnow

Claude C. Wild III

Robert S. McCaleb - Consultant

Appendix A: Industry Comments

AHPA Comment on the regulation:

**AHPA has described above in its response to FDA question 3 how FDA
nutrient content claims regulations (21 C.F.R. §§101.13 and 101.65),
improperly circumscribe commercial speech regarding food and dietary
supplement product content. In addition to the nutrient content claim
regulations, Section 10806 of the Farm Security and Rural Investment Act
of 2002 (Farm Bill), signed into law on May 13, 2002, amended the
Federal Food, Drug, and Cosmetic Act to state that the term ginseng may
only be considered to be a common or usual name (or part thereof) for
any herb or herbal ingredient derived from a plant classified within the
genus Panax. In addition, this amendment states that only labeling or
advertising for herbs or herbal ingredients classified with that genus
may include the term ginseng. Finally, the amendment makes it a crime if
a product purports to be or is represented as ginseng, unless it is an
herb or herbal ingredient derived from a plant classified within the
genus Panax. This section of the Farm Bill was supported by Senators
Feingold and Kohl of Wisconsin and by Representative Obey of the same
state. The amendment was requested by the Ginseng Board of Wisconsin, a
state sponsored trade group of Wisconsin growers and marketers of
American ginseng (Panax quinquefolius) and the intent of the law is
clear, to make other herbs that are sometimes known as ginseng less
competitive with American ginseng by making it a crime to use the name
ginseng for any other herb. While AHPA worked with Senator Feingold\'s
staff to assure that this language in the Farm Bill was carefully drawn
to accomplish only the limited purpose of assuring that the common name
ginseng was reserved to the genus Panax, AHPA did not endorse this
legislation. Instead, AHPA has addressed this issue in its publication,
Herbs of Commerce, 2nd edition (2000). That reference is consistent with
Section 10806 of the Farm Bill, namely that only plants in the genus
Panax use the term ginseng in their Standardized Common Names. Herbs of
Commerce, 2nd edition is presently being considered for incorporation by
reference by the Food and Drug Administration under 21 C.F.R. Sec.
101.4(h). The use of the term ginseng as part of the common name of
plants of genera other than Panax is observed in trade from time to
time. In most cases, these names are marginally used, either for herbs
that are of limited market distribution or by only a minority of product
vendors. The one exception to this is the common practice of identifying
eleuthero (Eleutherococcus senticosus) as Siberian ginseng. Although
some manufacturers now label their products containing eleuthero with
the name eleuthero, it is a much more common industry practice to use
the name Siberian ginseng. It is therefore that plant and marketers of
that plant that will be most widely affected by the new law. Eleuthero
is an important botanical in the United States market, as are the two
principle species of Panax, specifically American ginseng (Panax
quinquefolius) and Asian ginseng (Panax ginseng). According to data
published by Nutrition Business Journal (NBJ), sales of ginseng were
reported in 2000 to be \$173 million, or 7.5% of all single herbal
category sales of \$2.3 billion. Because NBJ did not specify separately
their estimate of sales for eleuthero products, it is not possible to
know from the NBJ report what portion of this amount was actually
reporting sales of eleuthero as opposed to sales of ginseng, that is, of
products from the genus Panax. However, AHPA has contacted several of
its members that sell products containing one or the other or both of
these herbs. While we have not conducted a detailed market review of the
relative sales of the ginsengs and eleuthero, it is certain that sales
of eleuthero represent a significant portion, and perhaps half of all
sales that have been historically recorded for ginseng. Shortly after
this section became law, AHPA notified its members of the legislation
and urged members to change product labels at the next printing.
Nonetheless, AHPA must take the view that this legislation does not pass
muster under the Supreme Court\'s decision in Thompson v. Western States
Medical Center. The affect of the legislation is to deem, without
inquiry, that the name Siberian ginseng is unlawful and misleading. But
Congress made no reasoned determination in this regard. There is no
substantial governmental interest barring the use of the name Siberian
ginseng, a name that has been in use for almost 40 years, for this herb.
And the statute is more extensive than necessary because if does not
give companies a reasonable time to come into compliance. AHPA has
therefore requested a moratorium on enforcement of the Farm Bill\'s
ginseng section and the opportunity for AHPA and the herbal products
industry to educate customers as to the fact that eleuthero is what has
previously been marketed as Siberian ginseng as follows: A. Siberian
ginseng labeled product - a period of one year from May 13, 2002, within
which to run out inventories of products containing eleuthero that are
presently labeled as Siberian ginseng. B. Eleuthero labeled product - a
period of two years from May 13, 2002, within which to manufacture and
ship products containing eleuthero that is labeled as eleuthero with
parenthetical information that references the former name of Siberian
ginseng (e.g., formerly known as Siberian ginseng, or formerly, Siberian
ginseng). C. Eleuthero advertising - a period of two years from May 13,
2002, for manufacturers, distributors and retailers to advise consumers
in advertising that eleuthero was formerly known as Siberian ginseng.
While it is not shocking that narrow special interest legislation
appears in a Farm Bill, it is surprising that it is found as an
amendment to the Federal Food, Drug, and Cosmetic Act without hearing or
discussion. AHPA respectfully suggest that enforcement of this provision
must be tempered because of its failure to address the issues discussed
above.**

[^1]: AHPA Comments on the proposed rule. See Appendix A

[^2]: Lucas R. 1966 *Nature's Medicines.* Parker Publishing Co. West
    Nyack, NY