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Herb Safety

Little Hover Commission 2004

Regulation of Acupuncture: A Complementary Therapy Framework

Much greater attention also needs to be placed on the portion of the scope of practice related to prescribing herbs. These substances are not regulated for purity, potency or effectiveness by the federal Food and Drug Administration nor California authorities.126 Yet there are growing concerns about herb-drug interactions, mislabeling and impurities.

This issue extends beyond the purview of California regulators, and beyond the regulation of this profession.127 However, since California includes herbs in the scope of practice for acupuncturists, regulators are obligated to take actions that are within their purview to protect the public. If California wants to be a leader in regulating this profession it would explore the public policy issues that have the potential to harm consumers or discourage consumers from pursuing the potential benefits of herbs.

Herb-drug interactions pose an increasing risk to the public that was not present when ancient herbal practices were developed. Further, in California, herbs from around the globe are used, posing further risk of herb combinations that were unknown in ancient Asian practice, but can result from the intermingling of healing practices.

A significant concern is impurities found in processed herbs, including pesticides, pharmaceuticals and heavy metals. The Department of Health Services in 1998 studied "Asian patent medicines," the term it uses to describe herbs, plants, animal parts and minerals. In the 260 products tested, significant numbers contained dangerous contaminants: 17 included undeclared pharmaceutical components, 24 included lead, and 36 included arsenic. In addition, of the products tested, 32 percent contained undeclared pharmaceuticals or heavy metals and 9 percent had more than one adulterant.128

According to the lead scientist of that study, the situation appears to be improving. However, no follow-up study has been conducted due to budget constraints. He estimates that he receives calls regarding problems with herbs from the California poison control center or a coroner's office approximately once per month.129

This issue has recently been gaining national attention. The Institute of Medicine in 2002 published a framework for improving federal rules on the safety of dietary supplements, including herbs. It identified some problems with the federal Dietary Supplement Health Education Act of 1995. Chief among them:

  • Consumers have assumptions and expectations about safety (believing products would be screened by government to ensure that they are as safe as over-the-counter medications, when in fact they are not tested for safety, purity or efficacy).
  • The act limits the authority of the Food and Drug Administration to oversee these products as it does pharmaceuticals.
  • Safety controls are less rigorous than those used in many other countries.130

In May 2004, Consumer Reports magazine reported that dangerous supplements are readily available due to lack of controls.131 The magazine profiled several patients who experienced organ failures as a result of consuming Chinese herbal potions.

Those specific cases did not occur in California and problems with herbs extend beyond those that are used in traditional Oriental medicine. But California has a duty to ensure that it is employing the policy mechanisms that protect the public. Policy-makers could explore the following mechanisms:

  • Require mandatory centralized reporting of adverse events. This is a recommendation from the medical director of the state poison control center.132 Because reporting is voluntary and not made to a central location, there is not enough information to analyze patterns so steps could be taken to prevent problems. The concept is supported by the American Herbal Products Association and the American Medical Association.133
  • Certify and label for purity and strength. Until federal rules are updated, California could require that herbs sold in California are certified by private sector laboratories that are capable of providing reliable "certificates of analysis" that many herbal companies already use to verify purity and strength.134
  • Improve labeling. Ingredients should be listed in English according to internationally recognized plant classifications and standards recognized by medical professionals globally.135 In addition to the labeling concerns raised in the DHS study, herbs distributed by individual herbalists and acupuncturists can carry handwritten, unspecific labels. Without clear labeling using universally understood terms, it is difficult or impossible for other medical professionals to know the actual contents of herbal formulas ¬≠creating particular difficulty in determining the potential of herb-drug reactions.136
  • Improve public notice. Retailers should be required to post warning signs near displays of herbs and dietary supplements regarding the lack of regulation for safety and efficacy.137
  • License all distributors. The State could license or certify non-acupuncturists who distribute herbs -similar to the standards required of acupuncturists -to ensure that herbalists have the skills, knowledge and abilities necessary to protect consumers. Training should include responding to allergic reactions, herb-drug interactions and procedures to follow in medical emergencies. This training should encompass herbs from all regions of the world and may be connected to degrees in pharmacy.
  • Require consumer cautions. In the absence of standards for herbalist training and licensure, individuals who recommend the use of herbs could be required to prove they follow the "buyer beware" disclosures established in SB 577 (Burton), Chapter 820, Statutes of 2002. This statute applies to unlicensed elements of complementary and alternative medicine, and requires written disclosure including practitioner education and a statement that the activity is not licensed by the State.

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