Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -230

Accepted - Volume 298

Comment Record
Commentor Mr. Sherman Morton Date/Time 2003-03-11 21:16:06
Organization Hickory Hill Home Industries LLC
Category Health Professional

Comments for FDA General
1. General Comments Docket No. 95N-0304 Comment on the proposed rule entitled “Dietary Supplements Containing Ephedrine Alkaloids” (62 FR 30678) Concerning the medicinal use of Ephedra: The herb Ephedra has been safely used for many years in herbal medicine for the treatment of respiratory ailments, colds, influenza and allergies. It is used in small quantities and normally in conjunction with other herbs that are also recommended for the respiratory system. When recommended by a responsible herbalist or nutritionist, one will not find among the uses weight loss. Additionally, the responsible herbalist or nutritionist will take into account whether the client has any sort of cardiovascular disease or weakness, high blood pressure, glaucoma, tachycardia or urinary problems for example. In the face of cardiovascular or other problems, Ephedra would be contraindicated because of the potential for elevated blood pressure and other complications. As we consider the potential of removing Ephedra from the general market or restricting use of the herb, we must proceed with great caution. Even as Ephedra has safe valid uses it also has been misused and abused, but so also can other substances such as antibiotics, tranquilizers and pain relievers. In order to mitigate the dangers of misuse of substances like Ephedra, the public must be better educated. They must also be encouraged to seek out trained Herbalists, Nutritionists, Naturopaths or others trained in the use of herbs and other natural modalities of disease prevention. It would also be wise for the FDA to consult the research done by the German Commission E on the use of herbs in medicine. The following is the information from the page of the Commission E monographs ( on Ephedra: Name of Drug Ephedrae herba, ephedra, ma huang. Composition of Drug Ephedra consists of the dried, young branchlets, harvested in the fall, of Ephedra sinica Stapf, E. shennungiana Tang [Fam. Ephedraceae], or other equivalent Ephedra species, as well as their equivalent preparations in effective dosage. The herb contains alkaloids; main alkaloids are ephedrine and pseudoephedrine. Uses Diseases of the respiratory tract with mild bronchospasms in adults and children over the age of six. Contraindications Anxiety and restlessness, high blood pressure, glaucoma, impaired circulation of the cerebrum, adenoma of prostate with residual urine accumulation, pheochromo-cytoma, thyrotoxicosis. Side Effects Insomnia, motor restlessness, irritability, headaches, nausea, vomiting, disturbances of urination, tachycardia. In higher dosage: drastic increase in blood pressure, cardiac arrhythmia, development of dependency. Interactions with Other Drugs In combination with: Cardiac glycosides or halothane: disturbance of heart rhythm. Guanethidine: enhancement of the sympathomimetic effect. MAO-inhibitors: Greatly raising the sympathomimetic action of ephedrine. Secale alkaloid derivatives or oxytocin: development of hypertension. Dosage Unless otherwise prescribed: Single dosage: Adults: Herb preparations corresponding to 15 - 30 mg total alkaloid, calculated as ephedrine. Children: Herb preparations corresponding to 0.5 mg total alkaloid per kg of body weight. Maximum Daily Dosage Adults: Herb preparations corresponding to 300 mg total alkaloid, calculated as ephedrine. Children: 2 mg total alkaloid per kg of body weight. Mode of Administration Comminuted herb, as well as other galenical preparations for internal use. Duration of Administration Ephedra preparations should only be used on a short-term duration because of tachyphylaxis and danger of addiction. Note: Ephedrine-containing preparations are listed as addictive by the International Olympic Committee and the German Sports Association. Actions In animal experiments: antitussive Ephedrine acts by indirectly stimulating the sympathomimetic and central nervous system. Bacteriostatic As can be seen in the information above, there are valid uses of the herb Ephedra. As people attempt to use it for weight loss, they move into the higher dose region and then begin to experience adverse health problems. Even so, deaths may occur with the introduction of any foreign substance into the body, including prescription medications. While warning labels are at times effective, if they are too long people will ignore them and they will be rendered ineffective. Keeping any warning labels very simple concise will encourage compliance. If we allow the public options, such as the use of natural remedies (Ephedra and other herbs), for the treatment of respiratory ailments and colds, we may be able to move people away from the overuse of antibiotics and thus mitigate or reduce the problem of drug resistant bacteria. Again, with proper education Ephedra can be and is used very effectively for treating various maladies safely. Thank you for your attention to this matter. Sherman A. Morton, Jr., CN, Certified Nutritionist, American Health Sciences University License # 000806

EC -230