CONTACTS:
AHPA— Robin Gellman (301) 588-1171, ext. 107
CRN— Judy Blatman (202) 204-7962
NNFA— Tracy Taylor (949) 622-6272 ext. 245
UNPA— Loren Israelsen (801) 474-2570

Dietary Supplement Associations Undertake Scientific Evaluation of Kava

Washington, D.C., December 20— A coalition of dietary supplement industry associations endorsed the Food and Drug Administration’s (FDA) effort to gather information from healthcare practitioners about possible cases of liver toxicity caused by the popular botanical kava (Piper methysticum).

In a letter issued December 18, FDA stated that it is investigating whether the use of kava products marketed in the United States poses a public health concern. The agency noted that approximately 25 cases of sometimes serious liver toxicity reportedly associated with kava consumption have been identified by German and Swiss health authorities. In a conference call with trade representatives on December 18, the FDA informed the associations that its letter to health care practitioners is meant to serve as a data gathering tool and is not issued as a warning or alert.

"Safety is our first concern. We are taking the German and Swiss situation very seriously and as such, the industry coalition has initiated an expert scientific evaluation of all of the adverse event reports," said Michael McGuffin, President of the American Herbal Products Association. "Despite the fact that the kava products under scrutiny are ones manufactured and sold in Europe, we believe that it is critical that kava’s long history of safe use be re-affirmed by a review of the information."

The FDA letter requested that any adverse events associated with the use of kava products be promptly communicated to FDA’s "MedWatch Program." The letter also noted several incidents of "serious injury allegedly associated with the use of kava-containing supplements."

"We are actively proceeding with a number of initiatives on this issue, both within and outside the industry, working jointly with regulators and the scientific community to learn as much as we can about these adverse events and the safety of kava," said John Cardellina, Ph.D., Vice President for Botanical Sciences, Council for Responsible Nutrition.

Kava has become a best-selling herb in the United States for stress, anxiety and tension, ranking ninth in retail sales in mainstream markets in the Unites States in 2000.

The Dietary Supplement Industry Coalition is comprised of the following associations:

The American Herbal Products Association (AHPA) is comprised of growers, processors, manufacturers, and marketers of herbs and herbal products. AHPA serves its members by promoting the responsible commerce of products that contain herbs. Media contact: Robin Gellman, AHPA, (301) 588-1171, ext. 107

Council for Responsible Nutrition (CRN), Council for Responsible Nutrition (CRN) -- Founded in 1973, the CRN is a science-based trade association representing more than 100 companies in the dietary supplement industry, including ingredient suppliers and manufacturers. CRN members adhere to a strong code of good ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices. To find out more, visit www.crnusa.org. Media contact: Judy Blatman, CRN, 202-263-1005

National Nutritional Foods Association (NNFA), founded in 1936, represents the interests of some 3,000 retailers and 1,000 manufacturers, suppliers and distributors of health foods, dietary supplements, natural ingredient cosmetics and other natural products.
Media contact: Tracy Taylor, NNFA, (949) 622-6272, ext. 245

Utah Natural Products Alliance (UNPA) was organized in 1991 and represents the interests of the $3 billion dietary supplement industry based in Utah.
Media contact: Loren Israelsen, UNPA, (801) 474-2572