Natural Health Product Regulations

Canada currently has a system of harsher regulations of natural health products, that country s classification for dietary supplements. In 2004, the government formally began regulating natural health products under the Natural Health Products Directorate (NHPD). The NHPD maintains certain safety and quality levels that manufacturers of dietary supplements must meet. Many in the United States would like the FDA to adopt a similar practice. 

Echinacea is sold as a dietary supplement in the United States and as natural health products in Canada, while in Germany and many European countries, Echinacea products are sold as drugs in pharmacies (Bauer, 2000). There are a number of products on the market, which include dried herbal and root, alcohol tinctures and extracts, and expressed juice products, thus, standardization would be a difficult task. However, regulation would be less difficult because all of these products would fall under a dietary supplements category. 

Biomedical research continues to broaden our understanding of the molecular mechanisms underlining both health and disease. Research undertaken since the 1950s has pinpointed a host of proteins produced naturally in the body that have obvious therapeutic applications. Examples include the interferons and interleukins (which regulate the immune response), growth factors, such as erythropoietin (EPO which stimulates red blood cell production), and neurotrophic factors (which regulate the development and maintenance of neural tissue). 

The last known naturally occurring case of smallpox occurred in Somalia in 1977. In May 1980, the World Health Assembly certified that the world was free of naturally occurring smallpox. By the 1960s, because of vaccination programs and quarantine regulations, the risk for importation of smallpox into the United States had been reduced. As a result, recommendations for routine smallpox vaccination were rescinded in 1971. In 1976, the recommendation for routine smallpox vaccination of health-care workers was also discontinued. In 1982, the only active licensed producer of vaccinia vaccine in the United States discontinued production for general use, and in 1983, distribution to the civilian population was discontinued. All military personnel continued to be vaccinated, but that practice ceased in 1990. Since January 1982, smallpox vaccination has not been required for international travelers, and International Certificates of Vaccination forms no longer include a space to record smallpox vaccination. 

The kind of natural products listed in the table above, however, are not defined in the United States today as drugs hut as dietary supplements, nutritional supplements, natural foods, or some similar nondrug product. Such products are not subject to the same standards of testing as are synthetic drugs. They are regulated by the Dietary Supplement Health and Education Act (DSHEA) of 1994 (Public Law 103-417). According to that law, the makers of natural products used... 

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