Study Compares Regulation of Conventional, Homeopathic Drugs; Finds Strong Similarities

Los Angeles, California (January 18, 2006) ­ A new study comparing the standards by which homeopathic medicines are regulated to conventional drugs and dietary supplements shows that homeopathic medicines undergo extensive Food and Drug Administration (FDA) pre-market evaluation that more resembles traditional pharma than dietary supplements. "Regulation of homeopathic drug products" in the January American Journal of Health-System Pharmacy also suggests that the published monographs, peer review and pre-market oversight of homeopathic medicines may provide a model for the regulation of dietary supplements. Homeopathic medicines are among the top 10 best-selling over-the-counter products in the cough, cold, flu and oral analgesics for children categories.

"This is the first peer reviewed article that objectively assesses the regulatory strengths of conventional drugs, homeopathic medicines and dietary supplements," says J.P. 'Jay' Borneman, article co-author, Homeopathic Pharmacopoeia Convention of the United States board member and president of Hyland¹s, Inc., the nation's largest manufacturer of homeopathic medicines.

The article counters a misconception among health experts, which assumes homeopathic products receive less-stringent pre-market oversight similar to that of dietary supplements. The post-market standard for introducing dietary supplements into the market was the subject of much controversy last year. Instead, homeopathic drugs are subject to FDA prescription and Federal Trade Commission (FTC) nonprescription drug review and compliance rules that apply to manufacturing, labeling, advertising, marketing and sales. With the exception of expiration dates, rules such as tablet imprinting and finished product testing are functionally identical to conventional over-the-counter drugs.

Sales of homeopathic drugs in the United States are estimated at between $300 and $450 million a year (2003 figure), with sales at major drug and big box retailers growing at 8 percent a year and purchased by 3.6 percent of the population, says the study. Dietary supplements ­ most often high-dose vitamins ­ are consumed by 15 million Americans (5.1 percent of the
population) and are regulated separately by the Dietary Supplemental Health and Education Act (DSHEA).

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