HOMEOPATHIC DRUGS SUPPLYING ALCOHOL DOSES BASED ON DELIVERED ALCOHOL

HOMEOPATHIC DRUGS SUPPLYING ALCOHOL DOSES BASED ON DELIVERED ALCOHOL in monograph-allowed dosage regimens for OTC drugs should be exempt from FDA regulations limiting alcohol levels in systemic OTCs, the American Homeopathic Pharmaceutical Association urged in Nov. 23 comments to FDA. The comments revised earlier recommendations by AHPhA for a "blanket exemption" for homeopathic products and were submitted as a follow-up to an October meeting with the agency.

Several homeopathic organizations including AHPhA and the American Association of Homeopathic Pharmacists previously petitioned FDA to request exemptions for homeopathic drugs from the FDA proposal to limit the alcohol levels in systemic OTCs ("The Tan Sheet" Feb. 21, In Brief).

"Instead of a blanket exemption for homeopathic drugs," the association said, "we propose that the agency exempt...any homeopathic drug which, when used according to its labeled directions, provides a delivered dose of alcohol that is no greater than the delivered alcohol in a dose of an allopathic drug that complies with the proposed rule."

Published in October 1993, FDA's proposal would limit the alcohol content of systemic OTCs to 10% for adults and children 12 and older, 5% for children aged six to 12 and .5% for children aged two to six. AHPhA maintained that such a restriction "would impose dramatic and unnecessary hardships on the homeopathic drug industry by applying...standards developed exclusively based on allopathic considerations."

FDA's proposal "nowhere limits the recommended dosage" of a drug, only a drug's "alcohol content," AHPhA noted. Acknowledging that "homeopathic drugs which contain alcohol do so at substantially higher levels than is common in allopathic drugs," the association remarked that focusing "on content rather than delivered dosage is especially important to homeopathic drug manufacturers" because doses "are measured in drops rather than teaspoons."

In a survey of the marketplace conducted by AHPhA on dosage levels in medications, the association said that the "most common dosing directions" in children's medications were one teaspoon for children ages six to 12 and a half teaspoon for children ages two to six. "Considerably greater variation" existed in allopathic products' dosing recommendations for adults and children 12 and older. AHPhA reported that while two teaspoons was a common dose, "there are a number of products which recommended four teaspoons."

"We believe that for our purposes, a delivered alcohol dose of 2 ml is an appropriate limit for adults and children 12 and older," AHPhA suggested. The association added that "the maximum delivered doses we are proposing would largely solve the problems created for adult homeopathic medicines by FDA's proposed rule."

If FDA's "proposed maximum content was present in doses" of typical children's medications, AHPhA pointed out that the delivered dose of alcohol would be .25 ml in children ages six to 12 and .0125 ml in children ages two to six. AHPhA concluded that "it is unlikely" that a product containing high levels of alcohol would be acceptable as a children's medication.

"We believe that the ingested alcohol limit proposed for children aged two to six effectively bars the use of any alcohol- containing product, even most homeopathic products," the association said. "Accordingly," AHPhA stated that "members of the association will not label products for use by children below the age of six."

AHPhA nevertheless insisted that FDA's proposed limit of alcohol for children ages two to six "is not supported by the data developed by the American Academy of Pediatrics Committee on Drugs." AAP recommended "that a child's blood-alcohol level should not exceed 25 mg per dl following a single dose of alcohol medication," AHPhA pointed out. AHPhA noted that based on the common dose of a half teaspoon in children ages two to six, "under FDA's proposal," a child in that age group could ingest only .0125 ml of alcohol. "FDA has thus reduced by a factor of 200 the dose which the AAP found acceptable" in that age group, AHPhA said.