Quinine In Homeopathic Medications: The Facts

Recent news has reported the FDA's action to remove quinine as an ingredient in certain prescription drugs and any new drug used without FDA approved indications. However, the FDA quinine regulation does not apply to homeopathic medications, such as non-prescription Hyland's Leg Cramps with Quinine.

Hyland's Leg Cramps with Quinine is classified as a "homeopathic drug" within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA). It is manufactured, marketed and sold in compliance with relevant sections of the Homoeopathic Pharmacopoeia of the United States (HPUS) and the Federal Food, Drug, and Cosmetic Act (FDCA) and its attendant regulations as set forth by the Food and Drug Administration (FDA). Hyland's Leg Cramps with Quinine contains the homeopathic medicine Cinchona OfficinalisHPUS, which is made from the bark of the Cinchona tree. This bark is a natural source of quinine and the source of quinine in the homeopathic medicine.

It is interesting to note that quinine in carbonated beverages has been deemed safe by the FDA at a level of 2.45 milligrams per fluid ounce (www.fda.gov). By comparison, since homeopathic medicines use very low doses of active ingredients, Hyland's Leg Cramps with Quinine Tablets, contain 0.005 milligrams of quinine per tablet, and Hyland's Leg Cramps with Quinine Caplets, contains 0.009 milligrams of quinine per caplet. By contrast, Whole Foods Market, one major marketer of tonic water, says their brand contains about 20 milligrams of quinine per six ounce serving - 4,000 times the amount of quinine found in one Hyland's Leg Cramps with Quinine tablet, and more than 2,000 times the amount of quinine found in one Leg Cramps caplet. The safety of Hyland's Leg Cramps with Quinine, has never been challenged.

The following Quinine Facts may be helpful:

• In 1972, the FDA initiated Over-The-Counter Drug Review (OTC Review), but specifically excluded homeopathic drugs from its coverage. "Because of the uniqueness of homeopathic medicine, the Commissioner has decided to exclude homeopathic drugs from this OTC drug review and to review them as a separate category at a later time . . . ." 37 Fed. Reg. 9464 (May 11, 1972). Included in that review were non-homeopathic medicines including quinine.


• In 1988, FDA published Sec. 400.400 (also known as Compliance Policy
  Guide 7132.15), Conditions Under Which Homeopathic Drugs May be Marketed, which "provides guidance on the regulation of OTC and prescription homeopathic drugs and delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S." (May 31, 1988). This document re-affirmed FDA's 1972 position on the OTC review.


• In 1994, citing numerous safety concerns associated with use of quinine
  and concluding that the data were not adequate to establish that quinine is
  effective for prevention and/or treatment of nocturnal leg muscle cramps,
  FDA declared that these products could not continue to be sold OTC for leg
  cramps without approved applications. Drug Products for the Treatment and/or Prevention of Nocturnal Leg Muscle Cramps for Over-The-Counter Human Use, 59 Fed. Reg. 43234, (August 22, 1994). Since this portion of the OTC review did not include homeopathic drugs, homeopathic products containing Cinchona Officinalis HPUS and its natural quinine are unaffected.


• FDA issued revised guidance in 2006, Compliance Policy Guide Sec.
  440.100, Marketed New Drugs Without Approved NDAs or ANDAs (June, 2006). In this document, FDA stated that the guidance applied to any drug required to have FDA approval for marketing, including new drugs covered by the Over-the-Counter (OTC) Drug Review. Since FDA had previously announced that it would review homeopathic OTC drugs after the conclusion of its review of allopathic OTC drugs, this guidance did not supersede FDA's Compliance Policy Guide 400.400, Conditions Under Which Homeopathic Drugs May Be Marketed.


• FDA ordered all firms to cease manufacturing unapproved products
  containing quinine, including quinine sulfate and any other salt of quinine
  on or after February 13, 2007, and to cease shipping such products
  interstate on or after June 13, 2007. After these dates only FDA approved
  quinine products may be manufactured and shipped interstate. (71 Fed. Reg.
  75557 (Dec. 15, 2006)). This action was aimed at prescription quinine
  products because (1) quinine products subject to the OTC Review have been
  illegal since 1994, and (2) FDA explained that it had "reviewed the labeling
  of many unapproved quinine products and found that they did not provide the most up-to-date information physicians need to use quinine drugs as safely and effectively as possible . . . ." It is this action by FDA that has
  caused confusion about medicines containing naturally occurring homeopathic quinine from Cinchona Officianalis, HPUS.

• Homeopathic quinine is safe. In most cases a daily dose of homeopathic
  quinine is less than that from a glass of tonic water.


• Homeopathic quinine is legal. Cinchona officinalis (naturally occurring
  source of homeopathic quinine) is an official homeopathic drug monographed in the Homoeopathic Pharmacopoeia of the United States, and recognized within the meaning of the Federal Food, Drug and Cosmetic Act.


• Homeopathic quinine is effective. Hyland's Leg Cramps with Quinine is
  among the top-selling analgesic medicines in the United States.

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