Author + information
- M. Hafeez Chaudhry, MD⁎ ()
- ↵⁎The Heart Center, 7610 Carroll Avenue, Suite 300, Takoma Park, Maryland 20912
Tachjian et al. (1) fail to present a meaningful review of the challenges of herbal supplement use in patients with cardiovascular disease. Instead, they present outdated and incorrect information and make sweeping generalizations about herbal products and dietary supplements in general. As a result, the reader is no better equipped to manage patient care. This is unfortunate, because the potential for drug–herb interactions is a critical topic and is clinically relevant for practicing cardiologists, as 24% of consumers have reported using herbal supplements (2), with few patients discussing this supplementation with their health care professionals. Those patients willing to discuss herbal use with their physicians often project distrust of medicine when natural products are too eagerly dismissed.
One apparent purpose of the review was to highlight what are perceived by the investigators as regulatory shortfalls of the dietary supplement industry. However, they lack a fundamental understanding of the regulatory requirements. Herbal supplements are considered dietary supplements as defined in the Dietary Supplement Health and Education Act of 1994 (DSHEA) (3), which provides a regulatory framework distinct from that for conventional foods or drugs. In their review, the investigators make numerous references to products that are not herbal dietary supplements or are not commonly available. It is unclear, for example, why a review on herbal supplements would highlight drug interactions with grapefruit juice, a food. In claiming a lack of government oversight, the investigators state that “the only requirement is for the manufacturer to send a copy of the product label to the U.S. Food and Drug Administration (FDA)” (1). Although there are numerous requirements in place for herbal dietary supplements, submitting a label to the FDA is not among them. The investigators continue, “A new dietary supplement … can be introduced and marketed overnight … despite containing new, experimental, and unregulated herbal ingredients” (1). Again, this statement is false. If a manufacturer wishes to market a product that contains a new herbal ingredient, there is a new dietary ingredient 75-day pre-market notification process in which safety data are supplied to the FDA for review (4). Similarly, the investigators claim that manufacturers are “exempt … from any post-marketing surveillance” (1), while in reality, this responsibility is assigned to both the FDA and the Federal Trade Commission. Furthermore, the investigators suggest that manufacturers do not comply with adverse event reporting law, noting that “between 1990–94, fewer than 10 of more than 2,500 reports of adverse effects made to the FDA came from herbal product manufacturers” (1). These data, which predate both the law requiring the reporting of serious adverse events (2006) and DSHEA (1994), present a skewed view of industry compliance.
The investigators suggest a lack of regulation whereby an herbal ingredient can be introduced to the market without restriction, no post-market surveillance is conducted, and herbals present a disproportional risk to patients. DSHEA, serious adverse event reporting, and good manufacturing practices for dietary supplements, introduced by the FDA in 2007 but mandated by DSHEA in 1994, provide a strong and appropriate regulatory framework for the dietary supplement industry in the U.S. Despite these advances, potential drug-herb interactions will continue to present challenges to practicing clinicians. Thus, to meet patients' expectations, clinicians need a clear and factual presentation of the regulatory background of herbal supplement products and a thoughtful evaluation of defined and theoretical contraindications and drug interactions affecting patients being treated for cardiovascular diseases. This review is a step backward in opening up a dialogue between clinicians and patients on the topic of herbal products.
- American College of Cardiology Foundation
- Tachjian A.,
- Maria V.,
- Jahangir A.
- Council for Responsible Nutrition
- U.S. Food and Drug Administration
- U.S. Food and Drug Administration