Kava Labeling Revisions Adopted By Trade Groups; FDA Issues Advisory

Various dietary supplement trade associations adopted revised kava labeling requirements for their member companies following the release of an ¹ FDA consumer advisory on the botanical.

After meeting the morning of March 26, the American Herbal Products Association's executive committee agreed to revise AHPA's trade recommendation for kava.

"Not more than six months from the date of this executive committee action," the labeling of AHPA member companies' kava products must carry statements urging consumers to consult a healthcare professional before use if they have liver problems, are taking any medication or frequently drink alcohol.

Labeling also must tell consumers to stop using kava and see a doctor if they experience symptoms that could indicate a liver problem, such as "unexplained fatigue, abdominal pain, loss of appetite, fever, vomiting, dark urine, pale stools, yellow eyes or skin." Pregnant women and individuals under age 18 should be advised not to use kava, AHPA adds.

The trade group's advisory also requires that "products containing kava...be formulated and labeled to limit consumption of total kavalactones to 300 mg per day." Any formulation changes also must be completed within six months, the association says.

AHPA originally floated some of the labeling proposals in a Dec. 19 letter to members (² (Also see "Kava Removed From UK Market; FDA Contacts Healthcare Community" - Pink Sheet, 24 Dec, 2001.), p. 14). However, the March 26 update represents the trade association's first official position on kava labeling and formulation.

The Council for Responsible Nutrition issued voluntary recommendations on March 28. For the most part, CRN's suggested labeling language mirrors that required for AHPA members. CRN additionally notes, however, that firms may want to alert consumers that "excessive use [of kava], or use with products that cause drowsiness, may impair...ability to operate a vehicle or heavy equipment."

The National Nutritional Foods Association said it plans to release comments the week of April 1, while the Consumer Healthcare Products Association noted it adopted voluntary codes regarding kava labeling in March 2001. Although the codes already are similar to the recommendations being made by other trade groups, CHPA said it plans to revisit its guidelines in light of the recent FDA action.

The trade associations' initiatives come in response to a consumer advisory issued by FDA March 25 warning that supplements containing kava (Piper methysticum) "may be associated with severe liver injury."

"Although liver damage appears to be rare, FDA believes consumers should be informed of this potential risk," the advisory states, noting the agency "will continue to investigate the relationship, if any, between the use of dietary supplements containing kava and liver injury." FDA, however, appears careful not to imply a causal relationship between the two.

The advisory further encourages consumers and health-care practitioners to report adverse events that may be related to kava to the agency's MedWatch program.

The same day, FDA issued a ³ letter to healthcare professionals informing them of the consumer advisory so that, "in the event [they] are contacted," they are "aware of our advice to consumers."

The letter is the second one FDA has issued to healthcare practitioners in recent months; in a ⁴ Dec. 19 letter, FDA requested medical professionals investigate cases of liver toxicity to determine if they were related to kava products.

The focus on kava was prompted by regulatory actions taken by several European countries due to adverse event reports linking the botanical to various liver injuries. After 28 AEs were reported in Switzerland and Germany, the German government announced its decision to ban sales of the herbal (⁵ (Also see "Kava Safety Reconsidered In Germany, FDA/Trade Associations Take Note" - Pink Sheet, 3 Dec, 2001.), p. 8).

The UK's Medicines Control Agency and the French health agency, L'Afssaps, took similar steps soon thereafter (⁶ 'The Tan Sheet' Jan. 14, 2002, In Brief).

In the U.S., AHPA, CRN, NNFA and the Utah Natural Products Alliance jointly hired a private toxicologist, who determined there was no causal relationship between the liver injuries cited in the AERs and kava consumption (⁷ (Also see "Kava/Hepatotoxicity Link Not Demonstrated By AERs, Toxicologist Says" - Pink Sheet, 25 Feb, 2002.), p. 3).

Among industry members, Nutraceutical International Corp. said it does not plan to suspend sales of its kava products, but company execs are in talks to revise labeling to notify consumers of potential risks.