There seems to be confusion as to how the FDA views Kava in its various forms. FDA has been known to tell bars, restaurants, and health bars that they consider kava to be a dietary supplement and therefore it is subject to the regulations set forth in the Dietary Health and Education Act of 1994. The FDA argues that since it is not a traditional part of the American diet prior to 1994, that it falls under the DHSEA regulations which classify Kava as a Dietary Supplement rather than a traditional food (beverage).
There are several issues with the FDA’s position. First, Kava has a 3,000 year history of use in Polynesian culture. There are over 1.5 Million people of Polynesian heritage living within the United States a large population of who have been drinking Kava since their major migration in the 1950’s. In fact, the last state to be added to the union was Hawaii in 1959; an island with nearly ½ million Polynesians who regularly drank, and continue to drink Kava as part of their diet and culture. Hawaii was added to the Union in 1959, and as such, if there was any doubt about Kava being a regular part of the American diet as a food or beverage, a few hundred thousand Kava drinkers became Americans that year. Thus, Kava is clearly grandfathered in under the 1994 DHSEA as a traditional beverage (food) and is therefore not a dietary supplement or a new dietary ingredient and thus not subject to Dietary Supplement regulations such as the FDA’s maximum recommended daily dose of Kavalactones.
Kava was recognized not only as a food long before 1994, but also as a medicine in the most prominent medical compendium of its time, the King’s American Dispensatory, published in 1898 by Harvey Wickes Felter, M.D., and John Uri Lloyd, Phr. M., Ph. D. If the FDA does not wish to recognize the Kings American Dispensatory as an official medical authority, then it can surely find Kava in part 2 of the 1950 official American Dispensatory under Ganosan and Neurocardin.
The FDA’s attempt to classify the traditionally prepared beverage Kava Kava as a dietary supplement is an attempt to impose Kavalactone limitations and labeling requirements in a similar manner to dietary supplements in order to negatively impact the establishments revenue generating ability. For the following reasons, traditionally prepared Kava as it is served in this establishment does not meet the FDA’s own criteria to classify it as a Dietary Supplement.
From the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(ff) The term “dietary supplement”—
(1) means a product (other than tobacco) intended to supplement the diet that bears or
contains one or more of the following dietary ingredients:
(A) a vitamin;
(B) a mineral;
(C) an herb or other botanical;
(D) an amino acid;
(E) a dietary substance for use by man to supplement the diet by increasing the total dietary
(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described
in clause (A), (B), (C), (D), or (E);
(2) means a product that—
(A)(i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or
(ii) complies with section 411(c)(1)(B)(ii);
(B) is not represented for use as a conventional food or as a sole item of a meal or the diet;
(C) is labeled as a dietary supplement; and
(A) include an article that is approved as a new drug under section 505 or licensed as a
biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to
such approval, certification, or license, marketed as a dietary supplement or as a food unless
the Secretary has issued a regulation, after notice and comment, finding that the article, when
used as or in a dietary supplement under the conditions of use and dosages set forth in the
labeling for such dietary supplement, is unlawful under section 402(f); and
(B) not include—
(i) an article that is approved as a new drug under section 505, certified as an antibiotic under
section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42
U.S.C. 262), or
(ii) an article authorized for investigation as a new drug, antibiotic, or biological for which
substantial clinical investigations have been instituted and for which the existence of such
investigations has been made public, which was not before such approval, certification,
licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary,
in the Secretary’s discretion, has issued would be lawful under this Act.
Except for purposes of section 201(g), a dietary supplement shall be deemed to be a food
within the meaning of this Act.
For traditionally prepared Kava to fall under the FDA’s dietary supplement regulations, including labeling requirements and Kavalactone limits, it must first clearly meet the FDA’s definition of a dietary supplement. To meet the FDA’s definition it must meet all three sections. The following analyzes the traditionally prepared form of Kava as it pertains to these three sections.
Kava is a botanical and therefore meets the criteria for section 1c.
Kava does not meet the criteria for section 2b if it is represented for use as a conventional food, such as a traditional Polynesian tea served in an open (unsealed) container such as a cup or bowl. Kava’s on-site preparation, its representation as a “tea” and its open and unsealed container servings, meets the definition of a conventional food, rather than a dietary supplement. Furthermore, Kava has the following nutritional value: The majority of dried kava root is comprised of carbohydrates of which 40% is starch, 20% fiber, 3% simple sugars, 3.5% protein and 3.5% minerals. The remaining 30% of dried Kava root is comprised of fats and resins, which include the active constituents, Kavalactones. Therefore, it is clear that Kava roots have significant caloric and nutritional value as a conventional food item and if served as such, it does not meet the FDA definition of a dietary supplement under this section.
While the traditionally prepared Kava beverage has already been shown exempt under section 2, Section 3 will be analyzed for thoroughness below.
Section 3(ii) states that the definition of a dietary supplement does not include “…an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted…”. There have been many pharmaceutical preparations of Kava over the years which include LI 150®, WS1490®, that have been patented for use in clinical applications as listed below. Furthermore, these substantial clinical investigations have been made public under the following prestigious journals, thereby fulfilling the definition of Section 3bii in its entirety:
Effect of a special kava extract in patients with anxiety-, tension-, and excitation states of non-psychotic genesis. Double blind study with placebos over 4 weeks (PMID:1930344)
Journal of Phytomedicine -Volume 10, Supplement 4, 2003, Pages 38–49
Kava-Kava extract LI 150 is as effective as Opipramol and Buspirone in Generalised Anxiety Disorder – An 8-week randomized, double-blind multi-centre clinical trial in 129 out-patients. Journal of Phytomedicine – Volume 10, Supplement 4, 2003, Pages 38–49
Corrigendum to “Clinical efficacy of kava extract WS® 1490 in sleep disturbances associated with anxiety disorders. Results of a multicenter, randomized, placebo-controlled, double-blind clinical trial” [J. Affect. Disord. 78 (2004) 101–110]
Journal of Affective Disorders, Volume 83, Issues 2–3, December 2004, Page 287
For the purpose of this analysis, Kava’s application as an investigational drug under section 3 is irrelevant, though it is important to note an alternate classification for Kava such that it may be represented in a manner that exempts it from the FDA’s definition of a dietary supplement.
The FDA’s definition of a dietary supplement under the Federal Food, Drug, and Cosmetic Act (FD&C Act) Section 321 SS 2B is clear and traditionally prepared Kava beverages clearly do not meet the FDA’s definition. The representation of Kava as a traditional Polynesian Tea qualifies it as a conventional food item rather than a dietary supplement Therefore, when Kava is served in its traditionally prepared beverage form in an open container, it is not subject to the FDA’s labeling and proposed Kavalactone limitations that are imposed upon Kava Kava containing dietary supplements.
Copyright Tyler Blythe 2011