Ginseng Labeling On Over 100 Firms’ Products Challenged In Calif. Lawsuit

A California group is seeking to preliminarily and permanently enjoin 107 companies from manufacturing, distributing or selling dietary supplements labeled or advertised as "ginseng" or "Siberian ginseng" that contain herbs not associated with the Panax genus.

Citizens for Responsible Business, which is described as a non-profit California corporation, seeks, "on behalf of the general public...an injunction preventing defendants from falsely labeling and branding certain food products as 'Siberian ginseng' or 'ginseng,'" according to a complaint filed in San Francisco state court Nov. 19.

The suit alleges that 107 defendants, which include manufacturers, marketers and retailers, have "falsely applied the terms 'ginseng' or 'Siberian ginseng'" to a product called eleuthero, of the genus Eleutherococcus scenticosis, which is "a weed or a bush [that is] unrelated to ginseng plants and roots."

"The differentiating active ingredient present in eleuthero...is comprised of chemicals known as 'eleutherosides,' while the active chemicals contained in ginseng are known as 'ginsenosides,' which are believed to be responsible for the beneficial effects attributed to ginseng," the lawsuit notes.

"The defendants, thus, unfairly exploit the high price that ginseng demands by misbranding eleuthero products as 'ginseng' or 'Siberian ginseng' and thereby charging for them the high price that only ginseng commands in the marketplace," the suit contends.

It further alleges "this unfair and deceptive business practice is and has been a betrayal of the consumers' trust and reasonable expectations" and "significantly undermines the market for ginseng and damages the reputation of America's ginseng products."

The allegations stem from a federal law passed in May that stipulates supplement labeling may not refer to a product as ginseng "unless it is an herb or herbal ingredient derived from a plant classified within the genus Panax" (¹ (Also see "FDA Ginseng Labeling Enforcement Stressed In House Ag Approps Bill" - Pink Sheet, 15 Jul, 2002.), p. 15).

The provision, which was included in the Farm bill (HR 2646), took effect immediately. However, the California lawsuit maintains that defendants, which still are marketing ginseng or Siberian ginseng products, have violated the FD&C Act and continue "to engage in unlawful business practices" under California law.

When the legislation was passed, the American Herbal Products Association sent a letter requesting FDA and the Federal Trade Commission grant affected ginseng marketers more time to implement the necessary labeling changes.

AHPA said it has not heard back from either agency and re-sent the communication to FDA Dec. 3 in light of the pending lawsuit. The trade association pointed out that FDA typically allows a reasonable amount of time for firms to implement new labeling requirements.

Defendants named in the lawsuit include supplement manufacturers and marketers GNC, Rexall Sundown, Twinlab, Chattem and Pharmavite, as well as food and drug retailers such as Rite Aid, Wal-Mart and Safeway.

In addition to prohibiting firms from selling products falsely labeled as ginseng, the complaint seeks "restitution and disgorgement of all money obtained by defendants from the sale of food products labeled or advertised as 'ginseng' or 'Siberian ginseng' which were not derived from plants classified within the genus Panax." This amount "is yet to be ascertained," the complaint notes.

In a Nov. 25 AHPA update, the trade group suggests that "any member company...named in this action consider joint legal representation as a means of minimizing expenses in this matter." AHPA noted that defendants with common interests, such as retailers or brand marketers, might consider hiring a single attorney.

The group said many of its member companies already have complied with the labeling provisions of the Farm bill. An AHPA update in May advised manufacturers "to consider revising labels the next time" products that do not conform are manufactured and labeled.

Although Rexall said it always changes supplement labeling to comply with new laws, the firm's ² Web site still notes the availability of Siberian Ginseng. Pharmavite said its attorneys currently are assessing the lawsuit and working to develop a response, and Chattem said it does not comment on litigation.

FDA said it has not taken any action against ginseng-labeled products based upon the Farm bill provision.