Herbal and botanical supplements

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Information about Herbal and botanical supplements

Herbal and dietary supplements (HDS) are commonly used by many people, both healthy and with specific ailments. The “well” HDS user often seeks to preserve health or promote a healthier lifestyle. The ailing HDS user seeks to supplement conventional therapies, hoping to achieve better health, or even to substitute for prescribed medications, with the perception that HDS are safe and as effective.

40% of the US population use them

It is estimated that over 40% of the U.S. population uses alternative therapies of some kind, most commonly HDS. Up to 40% of patients attending liver clinics also use supplements. Alarmingly, however, most patients who use HDS do not reveal this to their primary care provider. Moreover, it is not uncommon for providers to fail to ascertain a history of HDS use from their patients. Users of HDS tend to be Asians, younger, highly educated, and more health conscious than nonusers. The most common reasons for their use include obesity/weight loss, body building, menopausal symptoms, gastrointestinal disorders such as indigestion or constipation, liver disease, and neurological complaints such as headache and migraines.

Mechanism of action of Herbal and botanical supplements

Herbal and dietary supplements are considered foods, and are defined as products taken by mouth that contain a dietary ingredient intended to supplement the diet. These ingredients include vitamins, minerals, herbs and other botanicals, amino acids, enzymes, organ tissues, and metabolites. However, since HDS are not drugs, they are regulated differently than conventional pharmaceuticals.

FDA approval information for Herbal and botanical supplements

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA) (http://www.fda.gov/Food/DietarySupplements/default.htm), manufacturers of HDS are responsible for the safety of their products, but need not have FDA approval before marketing. More recently, the Current Good Manufacturing Practices–Dietary Supplement Act (2007)–establishes the minimum standards for manufacturing, packaging, labeling, and holding, and is intended to ensure the identify, purity, quality, strength, and composition. Manufacturers are not required to conduct preclinical safety and efficacy assessments prior to marketing. The FDA’s specific responsibility is to determine if an HDS is unsafe, after which it can take action to recommend withdrawal from the market. Concern over a specific HDS or ingredient usually is triggered from reports of adverse events which may come from MEDWATCH or the manufacturer, which is statutorily compelled to alert the FDA of such events about which it becomes aware.

Herbal and dietary supplements

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