Nearly 20 years ago the FDA compiled and published a list of"Unsafe Herbs."(1) Included with such obviously toxic plants as belladonna (Atropa belladonna L., Solanaceae), poison hemlock (Conium maculatum L., Apiaceae), and jimson weed (Datura stramonium L., Solanaceae) were some that certainly did not merit inclusion in that category. Horse chestnut (Aesculus hippocastanum L., Hippocastanaceae), a widely used treatment for varicose veins in Europe, was listed as was bloodroot (Sanguinaria canadensis L., Papaveraceae), a popular ingredient in toothpaste and mouthwash. But perhaps the crowning insult to herbal medicine was the categorization of St. John's wort (Hypericum perforatum L., Clusiaceae) as unsafe. That herb is currently the best selling prescription drug in Germany for mild to moderate depression. It has recently enjoyed a huge wave of popularity as an herbal dietary supplement in the United States.
In November 1988, the FDA instructed a U.S. marshal to seize two barrels of black currant oil (Ribes nigrum L., Grossulariaceae) on the grounds that because it was to be placed in gelatin capsules, it was a "component" of food and therefore an unapproved food additive.(2) The case was summarily dismissed in U.S. District Court, but in 1992, the FDA appealed to the U.S. Seventh Circuit Court of Appeals. In finding for the defendant, Judge Cudahy of that body noted that under the FDA's definition, any food to which water was added could become a food additive. He called their contention an "Alice-in-Wonderland approach" that would allow the FDA to make "an end-run around the statutory scheme."
During the early 1990's, there was considerable interest in this country in obtaining approved food additive status (GRAS listing, generally recognized as safe) for stevia.(3) The leaves of this plant, Stevia rebaudiana (Bertoni), Asteraceae, and its principal constituent, stevioside, are now widely used in Asian rim nations as non-caloric sweeteners. The safety of both products is unquestioned there. Years of use in multi-ton quantities have not resulted in any significant toxicity being reported. Nevertheless, in May 1991, the FDA embargoed the importation of stevia leaves, stevioside, and food containing them on the grounds that the herb was an unapproved food additive and not GRAS listed.
I have personal knowledge of two excellent petitions, both comprehensive, detailing the widespread use of stevia and the safety of its constituents that were submitted to the FDA in the early 1990's. Both were rejected on the grounds of questionable safety, citing references in foreign scientific journals of questionable quality that dealt with purported toxic effects of the plant. If these same references had supported the safety of stevia, they would never have been considered by the Agency because of their questionable quality.
The rejection of GRAS status for stevia became moot with the passage of DSHEA in 1994. The FDA import embargo was lifted in 1995, so long as the herb was intended to be sold as a dietary supplement.(4) Stevia is now readily available in health food stores and pharmacies and is widely used. Interestingly, no adverse effects have been reported from its use in this country, supporting the contention that the FDA erred in refusing to grant the herb approved food additive status. In fact, the original position of the herb industry was that stevia was a safe food, not a food additive -- a position FDA was unwilling to accept.
Passage of DSHEA also caused the agency to lift a number of previously imposed import alerts and import bulletins affecting herbal products. These included an import ban imposed on evening primrose oil (Oenothera biennis L., Onagraceae) in 1990, as well as long-standing restrictions on ginseng and ephedra (Ephedra sinica Stapf., Ephedraceae).(5)
In 1977 FDA questioned the inherent safety of ginseng products when it issued Import Alert 66-02. This action challenged the GRAS status of ginseng products by suggesting that ginseng was only safe as a water infusion (i.e., as an herbal tea) and that ginseng in any other form was considered unsafe a priori. "The import alert was intended primarily to preclude ingestion of ginseng other than as a water infusion."(6) For several years after this alert was issued, importers of Chinese or Korean ginseng (Panax ginseng C. A. Mey., Araliaceae) products had them relabeled in the country of origin as "ginseng tea capsules" for products containing dried ginseng powder in gelatin capsules or "ginseng tea extract" for liquid or semi-liquid concentrated extracts. The inherent absurdity of this policy was patently obvious to most observers of the scene during that time and appears to be all the more ludicrous and irrational in retrospect 20 years later. Of course, there were few if any subs tantiated reports of adverse reactions to ginseng products at that time to justify this policy.
DSHEA resulted from a public and legislative revolt against the agency's proposed restriction on the availability of herbs and other dietary products. The new legislation does not prevent the FDA from acting against unsafe products; it simply requires them to provide evidence of lack of safety before taking action. It also permits structure/function statements to be made on the label of herbal products, providing such information is followed by a disclaimer noting that the claim had not been approved by the FDA. Nevertheless, the desire of the agency to exert restrictive control over herbs continues. In 1997, they adopted a new approach.
Marketers making seemingly reasonable structure/function claims for their products began to receive letters from the FDA noting that these statements -- permitted under DSHEA -- were really drug (therapeutic) claims which are not allowed. That menopause is a natural process often accompanied by some unpleasant symptoms is a universal truth. Menstruation is also a well-recognized condition to which all healthy females of appropriate age are subject. Some degree of prostatic enlargement is experienced by almost all males over 40 years of age. Cholesterol is a normal component of all human blood. Claims to modify these conditions are obviously structure/function claims to everyone except FDA officials. They have apparently begun to consider as drug claims any recommendations for the alleviation of conditions that also may be treated by approved drugs.(8)
Most recent in the long series of inappropriate actions by the agency was the temporary import detention on June 11, 1997, of a 5,450 pound shipment of red yeast (Monascus purpureus Went) because it "appears to be an unapproved new drug."(9) This product serves as the basis of Cholestin(TM), a popular proprietary product that reduces serum cholesterol levels. Red yeast is a traditional Chinese health food, widely consumed in that country for more than 2,000 years. It has been used in the United States for at least 60 years. The detention order was subsequently withdrawn.
The safety and efficacy of red yeast have been repeatedly confirmed by numerous clinical trials. The nature of its active principles -- mevinolin and several chemically related HMG-CoA reductase inhibitors -- is well-known. It obviously qualifies as a legal dietary supplement, but because it has a cholesterol-reducing effect -- a condition often treated by approved drugs -- the FDA has seen fit to consider it a drug.
If this attitude were to prevail and if the agency wished to act in a consistent manner, the importation of garlic would also have to be prohibited. Garlic is another dietary supplement widely advertised and appropriately labeled for its cholesterol-reducing effects. Its mechanism of action is, at least in part, the same as red yeast's, namely inhibition of HMG-CoA reductase.(10) Fiber is another natural product, widely known for its ability to reduce cholesterol.(11) Although it probably acts by a different mechanism, the end result is similar, so logically and for the sake of consistency, an import ban should be placed by the FDA on all dietary fiber-containing products. And what about all those low-fat health foods widely recommended to reduce blood lipids? Will they, too, be banned in this country because they mimic, to some degree, the beneficial effects of synthetic drugs?
The illogical nature of the FDA's position in this entire field is evident. Those of us who work daily with herbal medicine tend to become cynical about the agency's actions. But how else can one interpret the activities of an organization that has found (by default) prune juice to be an unsafe and/or ineffective laxative and peppermint an unsafe and/or ineffective digestive aid?
I have personal knowledge of attorneys in Washington, D.C., many of whom have themselves worked at one time for the FDA, who openly characterize the agency's position on herbs as, "If it's green and comes from abroad, the FDA is against it." This is truly a sad commentary on an organization that should be trying to assist millions of Americans who now use herbs to obtain quality products together with sufficient information to use them safely and effectively.
This would not be difficult to accomplish. The FDA could initially adopt the German Commission E herbal findings and then subject them to review by a panel of American experts to determine any modifications that might be required for the U.S. market. Logical, inexpensive sensible regulations could thus be implemented in a very short period. What is needed is an agency and policy-making officials within the agency willing to listen and to learn about a field that is extremely important to the American public and that is expanding at a rapid rate. Also, and this may come as a shock to some persons there, it is a field in which the safety and efficacy of a substantial number of the products are supported by reasonable amounts of sound scientific and clinical research.
In Friedrich von Schiller's William Tell, the fisherman Ruodi comments on the sad state of affairs in Switzerland under the tyrant Gessler. He cries out, "Good heavens, when will there come a savior for this land?" Some of the arbitrary herbal actions of the United States Food and Drug Administration in recent years have been compared even by staid federal judges to a children's fantasy. These actions continue in the FDA's attempt to define obvious structure/function statements as drug claims. All of which causes those of us involved in the scientific aspects of herbal medicine to join Ruodi in his plaintive plea -- "When will there come a savior...?"
(1.) Larken, T. 1983. Herbs are often more toxic than magical. FDA Consumer, 17(8): 510.
(2.) Blumenthal, M. 1993. Firm wins appeal in black currant oil case. HerbalGram No. 29: 38-39.
(3.) Blumenthal, M. 1992. AHPA petitions FDA for approval of stevia leaf sweetener. HerbalGram No. 26: 22, 55.
(4.) Blumenthal, M. 1995. FDA lifts import alert on stevia. HerbalGram No. 35: 17-18.
(5.) Blumenthal, M. 1995. FDA drops import alert on evening primrose oil. HerbalGram No. 34: 18-19.
(6.) Leger, E.R. nd. Personal communication from E.R. Leger, Assistant to the Director, Division of Regulatory Guidance, Bureau of Foods, FDA to Jay H. Geller.
(7.) Anon. 1995. Dietary supplements: Recent chronology and legislation. Nutrition Reviews 53(2): 31-36.
(8.) Young, A.L. 1993. Personal communication, May 5.
(9.) Anon. 1997. FDA takes import detention approach to Cholestin regulatory status. F-D-C Reports - "The Tan Sheet." 5(28): 1-3.
(10.) Schulz, V. and Hänsel R. 1997. Rationale Phytotherapie, Springer-Verlag, Berlin, pp. 122-123.
(11.) Tyler, V.E. 1993. The Honest Herbal, 3rd ed., Pharmaceutical Products Press, Binghamton, NY, pp. 55-57.
Article copyright American Botanical Council.
By Varro E. Tyler