On June 25, 2008, an herb company filed suit against the Federal Trade Commission (FTC), claiming it has the right to inform customers about the historical use of herbs in treating disease. Houston attorney Richard Jaffe, Esq., filed the suit on behalf of New Mexico-based Native Essence Herb Company and its owners, Mark and Marianne Hershiser.

"Herb sellers should be able to tell consumers that an herb has a long historical use to treat a disease," said Jaffe, a health care litigator and author of Galileo's Lawyer, an inside look at the battles between government and complementary and alternative medicine. "The FTC's prohibition of this kind of truthful information is unreasonable and unconstitutional."

According to the suit, "The FTC's dietary supplement advertising guidelines with respect to claims concerning the historical use of herbs violate the First Amendment. ... Plaintiffs can accurately and completely quote or provide a link to information contained on any informational federal government website concerning herbs or herbal remedies."

In April, the FTC informed Native Essence that its Web site "contained false, leading or unsubstantiated claims," including claims that Native Americans and other cultures have used some of the listed herbs for hundreds or thousands of years. The FTC, which had received no consumer complaints, threatened to file an injunction against the company. The commission also sent a stipulated consent agreement requesting all proceeds from the sale of specific herbs unless Native Essence could demonstrate it lacked adequate funds to do so.

The Hershisers removed the historical information from the company Web site but chose to file suit against the FTC rather than acquiesce to the commission's demands. They hope the courts will decide herbal companies can provide consumers with information taken from government Web sites and other recognized legitimate sources.

"This is a precedent-setting case," Jaffe said. "The issue has never been litigated; it not only affects the Hershisers, but all companies which sell herbal products."

The FTC guidelines, Dietary Supplements: An Advertising Guide for Industry, address historical claims in section II C (2), "Claims Based on Traditional Uses":

In assessing claims based on traditional use, the FTC will look closely at consumer perceptions and specifically at whether consumers expect such claims to be backed by supporting scientific evidence. Advertising claims based solely on traditional use should be presented carefully to avoid the implication that the product has been scientifically evaluated for efficacy. The degree of qualification necessary to communicate the absence of scientific substantiation for a traditional use claim will depend in large part on consumer understanding of this category of products. As consumer awareness of and experience with "traditional use" supplements evolve, the extent and type of qualification necessary is also likely to change.

There are some situations, however, where traditional use evidence alone will be inadequate to substantiate a claim, even if that claim is carefully qualified to convey the limited nature of the support. In determining the level of substantiation necessary to substantiate a claim, the FTC assesses, among other things, the consequences of a false claim. Claims that, if unfounded, could present a substantial risk of injury to consumer health or safety will be held to a higher level of scientific proof. For that reason, an advertiser should not suggest, either directly or indirectly, that a supplement product will provide a disease benefit unless there is competent and reliable scientific evidence to substantiate that benefit. The FTC will closely scrutinize the scientific support for such claims, particularly where the claim could lead consumers to forego other treatments that have been validated by scientific evidence, or to self-medicate for potentially serious conditions without medical supervision.

Resources

1. Law Offices of Richard A. Jaffe, June 25, 2008.
2. "Native Essence Herb Company Sues FTC." Associated Press, June 28, 2008.

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