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Farm Bill Bans Use of Name
ISSUE:
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54

Legal and Regulatory

Farm Bill Bans Use of Name "Ginseng" on Non-Panax Species: "Siberian Ginseng" no longer allowed as commercial term

The new Farm Security and Rural Investment Act of 2002 ("Farm Bill") has a provision that effectively bans the use of the name "Siberian Ginseng" and any other use of the term "ginseng" in a commercial herbal product unless it is used for an herb in the genus Panax. The new law, signed by President George W. Bush on May 13, 2002, makes the term "Siberian ginseng" for Eleutherococcus senticosus illegal in commerce on herb product labels, as well as in promotion literature and advertising.1

The term "Siberian Ginseng" has been used in the United States since Eleutherococcus senticosus (Rupr. & Maxim.) Maxim., Araliaceae was introduced as a commercial herbal product in the 1970s and since the publication of Richard Lucas' booklet Eleuthero (Siberian Ginseng).2 In the late 1970s there was considerable debate within the herb industry about the name. Ginseng purists did not want to see it sold with the common name ginseng as they did not consider it a true ginseng (i.e., in the genus Panax, which includes Asian ginseng, P. ginseng, and American ginseng, P. quinquefolius). Others with commercial interest in the importation of eleuthero argued, successfully at the time, that both genera are members of the family Araliaceae, both are used as adaptogens or tonics, and they are somewhat interchangeable in their use. The new Farm Bill now settles that old argument in favor of the purists, particularly those with an economic interest in the term "ginseng" here in the United States: ginseng farmers in Wisconsin.

A press release from the Ginseng Board of Wisconsin called for the immediate removal of "false products" from the U.S. market, stating, erroneously, that American and Asian ginseng are the "only two kinds of ginseng in the world."3 Other species in commerce that qualify as ginseng include Japanese ginseng (P. japonicus C.A. Mey.) and Vietnamese ginseng (P. vietnamensis Ha & Grushv.).

The trend toward using the common name eleuthero for E. senticosus began as a movement within the herb industry itself, and was codified in the first edition of Herbs of Commerce.4 In that 1992 publication, which lists approximately 550 herbs sold in the U.S. market, the name eleuthero was given as preferred over Siberian ginseng ("Other Common Name"). In 1997 the U.S. Food and Drug Administration (FDA) adopted Herbs of Commerce as an official list for common names of herb products sold in the United States. Subsequent federal regulations require that common names used on products be consistent with the names standardized in that edition of Herbs of Commerce.5 Thus, eleuthero has been the preferred commercial name since 1997.

The second edition of Herbs of Commerce, published in 2000, also lists eleuthero as the "Standard Common Name;" Siberian ginseng is listed as an "Other Common Name" along with "Ussurian thorny pepperbush," a name proposed by Russian researchers that never received appreciable acceptance in commerce.6

The introduction to Herbs of Commerce states, "In no case is the listing of a common name in this ["Other Common Names"] field meant to imply that such a name is an acceptable option in identifying plants in labeling, and, in fact, only the Standardized Common Name is acceptable for this purpose."6 The book's editors and AHPA officials anticipate that FDA will eventually adopt this second edition as its listing of standardized common names for herbs sold in the United States, but the FDA has not announced its acceptance.

The American Botanical Council reinforces this nomenclature in its publications. Eleuthero is the common name used in HerbalGram and the listings for E. senticosus in ABC's three books* have used this term.

Specific language

The Farm Bill provision contains the following language under Subtitle I -- General Provisions:

Section 10806. Market Names for Catfish and Ginseng:

(b) Ginseng Labeling --

(1) IN GENERAL -- Notwithstanding any other provision of law, for purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)

(A) 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; and

(B) only labeling or advertising for herbs or herbal ingredients classified within that genus may include the term 'ginseng'.

(2) AMENDMENT -- Section 403 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343) (as amended by subsection (a)(2)) is amended by adding at the end the following):

'(u) If it 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'.

The ginseng provision was introduced into the Farm Bill by U.S. Sen. Russell Feingold (D-WI), presumably representing the interests of the fairly influential Wisconsin American ginseng growers lobby, including the Ginseng Board of Wisconsin, Inc. (GBW). According to a release from AHPA, the organization worked closely with Feingold's office "in developing this law in a manner that is consistent with current FDA regulations and AHPA's Herbs of Commerce. We were able to successfully show that their original approach, based on the chemistry of ginsenosides, was problematic. We were also persuasive in requesting that this legislation not attempt to amend DSHEA [the Dietary Supplement Health and Education Act of 1994]. Ultimately, however, it has been a principle cause of the Ginseng Board of Wisconsin to reserve the name 'ginseng' for plants of the genus Panax, and this legislation is the Ginseng Board's coup de grace on this issue."7

AHPA's reference to ginsenoside chemistry refers to the position taken by the Ginseng Board of Wisconsin, Inc. (GBW) that the chemistry of both P. ginseng and P. quinquefolius is characteristically different from the chemical structures in eleuthero. A GBW press release states that eleuthero "does not contain any ginsenosides (the [primary] active ingredients in ginseng) but contains Eleutherosides E and B. Some of the eleutherosides are glycosides, but they don't include the 'saponin glycosides that characterize Panax ginseng.'"3

On June 18, 2002, AHPA's President Michael McGuffin wrote to the FDA and the Federal Trade Commission (FTC), noting that AHPA nomenclatural policy was already codified as an industry standard by both editions of Herbs of Commerce, that the term ginseng was reserved for species in the genus Panax, and that eleuthero was already the standardized common name for E. senticosus.7

"AHPA fully understands and accepts the purpose and rationale of the Farm Bill's ginseng section and AHPA does not oppose this law," he wrote. However, McGuffin noted that many of AHPA's members need ample time to sell already manufactured products labeled Siberian ginseng, that some members still use the name Siberian ginseng, and he requested a moratorium to allow members to re-label future eleuthero products.

The AHPA letter requested the following:7

¥ Products labeled Siberian ginseng: 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."

¥ Products labeled eleuthero: a period of two years from May 13, 2002, within which to manufacture and ship products containing eleuthero that are 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").

¥ Advertising eleuthero: 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."

McGuffin stated that AHPA was in contact with Feingold's staff and the Wisconsin Ginseng Board of Trade on this matter and requested from FDA and FTC their agreement and assent to the AHPA proposal and a compliance timetable. As of the time of this writing (July 23), there was no word from either agency of their agreement to the proposal.

A report from the U.S. House Committee on Appropriations dated July 26, 2002, includes language introduced by U.S. Rep. David Obey (D-WI) that states an expectation that FDA will "take all appropriate action to expeditiously enforce" the new limits to the use of "ginseng" on product labeling or in advertising. Obey is the ranking minority member of the House Appropriations Committee, which includes the Subcommittee on Agriculture, Rural Development, Food and Drug Administration and Related Agencies.

AHPA reports that it has received a response to its requests from FTC, in which they stated, "While the FTC will coordinate with FDA and provide whatever assistance they may require in their enforcement of this new measure, we anticipate that FDA will take the primary role in implementing this amendment to their statute." The FDA had not yet responded.8

AHPA said they learned from Obey's office that the word "expeditiously" is not meant to instruct FDA to make this their most immediate priority, it is also clear that he will not support a full year of non-enforcement.

The U.S. Senate Agriculture Appropriations Subcommittee, chaired by Sen. Herb Kohl (D-WI), also has jurisdiction over the FDA budget, among other agencies. Like Obey, Kohl reportedly would like to see the law on this issue enforced expeditiously.

Although a relatively popular herb, eleuthero usually lags behind Asian ginseng in retail sales in most channels of trade and ahead of American ginseng. Market surveys are often unspecific about the type of ginseng being measured, so it is probable that such survey statistics can include sales for both American and Asian ginsengs as well as eleuthero. The AHPA letter cites a survey from Nutrition Business Journal stating that sales of "ginseng" were reported in 2000 to be $173 million, or 7.5 percent of all "single herbal category" sales.

The new legal provision also impacts the use of the word "ginseng" in relation to other species not in the genus Panax including so-called "Indian" or "Ayurvedic ginseng" for ashwagandha (Withania somnifera (L.) Dunal, Solanaceae), "Brazilian ginseng" for suma (Hebanthe eriantha (Poir.) Pederson, Amaranthaceae, syn. Pfaffia paniculata (Mart.) Kuntze, Amaranthaceae), and other terms that have exploited the term ginseng in commerce. 

References

1.     107th Congress. Farm Security and Rural Investment Act of 2002. Public Law 107-171 <http://www.ers.usda.gov/Features/farmbill/>.

2.     Lucas R. Eleuthero (Siberian Ginseng): Health Herb of Russia. R&M; Books: Spokane (WA); 1973.

3.     Ginseng Board of Wisconsin. Farm bill bans use of name "ginseng" on non-Panax species: Siberian ginseng, Indian ginseng, Brazilian ginseng, and others no longer allowed as commercial term (press release). Wausau, WI. 2002.

4.     Foster S. Herbs of Commerce. Austin (TX): American Herbal Products Association; 1992.

5.     21 Code of Federal Regulations. Sec. 101.4(h)(1)-(2).

6.     McGuffin M, Kartesz JT, Leung AY, Tucker AO. Herbs of Commerce. 2nd edition. Silver Spring (MD): American Herbal Products Association; 2000.

7.     McGuffin M. Letter to JA Levitt, C Taylor, MK Engle, M Rusk. 2002, Jun 18.

8.     Gellman R. Eleuthero/Ginseng. AHPA Report. 2002 September.

*    ABC's three books are The Complete German Commission E Monographs: Therapeutic Guide to Herbal Medicines (1998), Herbal Medicine: Expanded Commission E Monographs (2000), and The ABC Clinical Guide to Herbs (in press).