Botanical supplements

Chandra, A., Rana, J., and Li, Y., Separation, identification, quantification, and method validation of anthocyanins in botanical supplement raw materials by HPLC and HPLC-MS, J. Agric. Food Chem., 49, 3515, 2001. 

In 1997, Landmark Healthcare Inc. commissioned a report entitled The Landmark Report on Public Perceptions of Alternative Care. They conducted 1500 telephone interviews in November 1997, using random digit selection. The survey included a representative sample of minority patients—85%o Caucasian, 8%o African-Americans, and 3% Hispanic. The survey found that 17%o of the U.S. population used botanical dietary supplements in the past year and even more striking, 75 /o of the U.S. population was most likely to use botanical products. Eighty-five percent of those reported to have taken a botanical supplement self-prescribed and self-administered the products. Three-fourths of patients who used alternative forms of care did so in conjunction with conventional medicine, yet 15% of patients replaced their conventional treatment with alternative care (16). 

The NMI surveyed by mail 2002 households, July through August 2001. Only 53%i of botanical supplement users were satisfied with botanical supplements. Despite the low satisfaction for botanical products, supplement users accounted for most of the increase in the previous year 46%i of botanical users increased utilization while only 10%i of the general population... 

There are other risks of contamination to botanical and botanical supplements. Due to stress on the supply of cultivars for botanical supplements, products may vary greatly in their active content. In the era of limited resources, with increasing utilization and decreasing wild production, there is pressure to produce a product. Raw material costs may override the... 

As a result of DSHEA, botanical supplements are presumed safe by virtue of being grandfathered by the FDA if the product was marketed before October 15, 1994. Products brought to market after that date only require 75-day premarket notification to the FDA with information that substantiates that the ingredients will reasonably be expected to be safe (65). FDA cannot take action until patients are injured but it is increasingly clear relatively rare adverse events may not be detected until a significant number of patients are killed or injured. 

Gurley BJ, Gardner SF, Hubbard MA, et al. Assessment of botanical supplementation on human cytochrome P450 phenotype Citrus aurantium, Echinacea, milk thistle, saw palmetto. Clin Pharmacol Therapeut 2004 75(2) P35. 

Table 65-1. Botanical Supplements and Some Associated Risks. ...

Gurley B, Hubbard MA, Williams DK, Thaden J, T ig Y, Gentiy WB, Breen P, Carrier DJ, Cheboyina S. Assessing the clinical significance of botanical supplementation on human cytochrome P450 3A activity compariscm of a milk thistle and bla cohosh product to rifampin and clarithromycin. JCfiwP amiaco/(2006) 46,201-13. 

Gange, C.A., C. Madias, E.M. PeUx-Getzik, A.R. Weintraub, and N.A. Estes, 3rd. 2006. Variant angina associated with bitter orange in a dietary supplement. Mayo Clin. Proc. 81(4) 545-548. Gurley, B.J., S.F. Gardner, M.A. Hubbard, et al. 2004. In vivo assessment of botanical supplementation on human cytochrome P450 phenotypes Citrus aurantium. Echinacea purpurea, milk thistle, and saw palmetto. Clin. Pharmacol. Ther. 76(5) 428-440. 

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