WASHINGTON, March 28 /PRNewswire/ -- The Council for Responsible Nutrition (CRN) today recommended voluntary cautionary labels for the popular botanical kava (Piper methysticum) following the recent consumer advisory (http://www.cfsan.fda.gov ) on kava issued by the Food and Drug Administration (FDA). The recommended language is consistent with the FDA consumer advisory.
"CRN has been engaged in an ongoing dialogue with FDA, other associations, and outside experts to assess the scientific information and adverse event reports (AERs) on kava," said John Cordaro, president and chief executive officer, CRN. "We agree with the agency's conclusion that even though no causal relationship has been found between kava and liver problems, a consumer advisory is an appropriate and cautionary way for FDA to inform consumers of a potential, but rare, risk. CRN is taking FDA's advice further by recommending voluntary cautionary label elements for the product."
CRN expects that member companies who adopt label recommendations will act swiftly to implement marketplace changes in a responsible and reasonable time frame.
The elements of the voluntary cautionary label are as follows:
- *Council for Responsible Nutrition Proposed Elements of Voluntary Cautionary Label for Kava Products
- *Ask a health care professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication.
- *Stop use and see a doctor if you develop symptoms that may signal liver problems, including jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other nonspecific symptoms can include nausea, vomiting, light- colored stools, unusual tiredness, weakness, stomach or abdominal pain, and loss of appetite.
- *Not for use by persons under 18 years of age, or by pregnant or breastfeeding women.
- *Not for use with alcoholic beverages.
- *Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.
CRN also pointed out that most of the adverse event reports (AERs) appear to have included confounding factors, such as use of drugs known or suspected to cause liver injury, or alcoholic beverages.
Prior to recent reports from Europe, there was no reason for concern about kava products. The eight clinical studies that have been conducted on kava supplements do not suggest liver toxicity. A panel of independent experts assembled by CRN recently reviewed the available medical literature on kava and concluded that the product is safe as a dietary supplement.
CRN reminded consumers that FDA has not taken any regulatory or other action regarding kava products, nor has the agency advised against use of kava products.
CRN will continue to maintain a dialogue with FDA and offer to assist in this continuing scientific assessment.