Herbal medicinal products in the European Union - AESGP

[CAN 5] Policy Issues: Indications for Use – Multi-ingredient Low Dilution Homeopathic
Preparations, Bureau of
Programme, March 1997.
Pharmaceutical Assessment, Therapeutic Products
[CAN 6] Guideline for Low Dilution Multi-ingredient – Homeopathic Products with
Indications for Use, Bureau of Pharmaceutical Assessment, Therapeutic Products
Programme, March 1997.
[CAN 7] Good Manufacturing Practices, Supplementary Guidelines for the Manufacture
of Herbal Medicinal Products, Final Version, Drugs Directorate, Canada, 1996.
(1998 version to be available in the near future.)
[CAN 8] Policy Issues: Herbs Used as Non-medicinal Ingredients in Nonprescription
Drugs for Human Use, Bureau of Nonprescription Drugs, The Drugs Directorate,
Health Canada, September 1995.
[MEX 1] Bylaws of the General Health Law, 4 February 1998.
[MEX 2] Labeling Norm for Medicinal Products.
[USA 1] Dietary Supplement Health and Education Act. 1994. Public Law 103-417.
[USA 2] Office the Federal Register. 1997. Code of Federal Regulations. Procedures for
classifying OTC drugs as generally recognized as safe and effective and not
misbranded, and for establishing monographs. Title 21: Food and drugs, part
330.10 rev. Washington, DC: U.S. Government Printing Office.
[USA 3] Office of the Federal Register. 1997. Code of Federal Regulations. Adequate and
well-controlled studies. Title 21: Food and drugs, part 314.126 rev. Washington,
DC: U.S. Government Printing Office.
[USA 4] Federal Register. May 11, 1972. 37:9464.
[USA 5] Commission on Dietary Supplement Labels. 1997. Report on the Commission on
Dietary Supplement Labels.
[USA 6] Quote from Prevention Magazine survey. 1997. In: HerbalGram 40.
[USA 7] Tom Simone citing data from Information Resources Inc., Chicago. In:
[USA 8]
Drugstores largest mass-market channel for supplement sales, Natural Business,
March 1998.
Richman, A. and J.P. Witkowski. 1997. Whole Foods, October. In: Herbalgram
41:53.
[USA 9] Office of the Federal Register. 1997. Code of Federal Regulations. Current good
manufacturing practice in manufacturing, packing or holding human food. Title
21: Food and drugs, part 110 rev. Washington, DC: U.S. Government Printing
Office.
[USA 10] Keller, K. 1992. Results of the revision of herbal drugs in the Federal Republic of
Germany with a special focus on risk aspects. Zeitschrift für Phytotherapie
116:118.
[USA 11] Henry A. Waxman in Hearing of the Subcommittee on Health and
[USA 12]
Environment, Committee on Energy and Commerce, House of Representatives,
29 July 1993.
Tyler, Varro. 1997. When will there come a savior? HerbalGram 41:27-28.
[USA 13] Nutrition Labeling and Education Act. 1990. Public Law 101-535.
[USA 14] Food and Drug Administration Modernization Act of 1997. Public Law 105-115.
[USA 15] Foster, S. ed. 1992. Herbs of Commerce. American Herbal Products Association,
Bethesda, MD.
[USA 16] Federal Trade Commission Act, 5 U.S.C. 45.
[USA 17] Federal Trade Commission. 1994. Enforcement policy statement on food
advertising. Federal Register 59:28388-28396.
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