What’s in that herbal supplement? Caveat parentis! It may be that nobody knows for certain

October 10, 2006

Parents of your patients probably aren’t aware that vitamins, herbal preparations, and nutritional supplements are not regulated by the US Food and Drug Administration the way pharmaceuticals are, and that this lack of standards and enforcement can have dangerous consequences under certain circumstances. They need to be cautioned about what they give to their child-and you are in the best position to raise a red flag and provide education.

Oct. 10-Atlanta-Parents of your patients probably aren’t aware that vitamins, herbal preparations, and nutritional supplements are not regulated by the US Food and Drug Administration the way pharmaceuticals are, and that this lack of standards and enforcement can have dangerous consequences under certain circumstances. They need to be cautioned about what they give to their child-and you are in the best position to raise a red flag and provide education.

With the booming popularity of complementary and alternative medicine, herbals and other supplements have become big business. Estimates are that at least 20% of adults taking an herbal product are also taking a prescription medication-a potential problem because some herbs interfere with the metabolism of certain drugs in the gastrointestinal tract and liver. For this and other reasons, you need to advise parents that they should give herbals to their child only under your, or another practitioner’s, supervision.

Presenting yesterday at the AAP’s National Conference and Exhibition here, Cheston M. Berlin, Jr., MD, of The Pennsylvania State University College of Medicine in Hershey, highlighted the consequences of the 1994 Dietary Supplement Act to an audience of pediatric clinicians. “Manufacturers can make health claims with respect to these products without proof that they are efficacious,” Dr. Berlin said. The companies are required only to add the phrase “… not intended to diagnose, treat, cure or prevent any disease” to the label of their product.

A prime example of the fallout from this situation, said Dr. Berlin, is the case of a product called “Mother’s Milk Tea,” sold to breastfeeding mothers without any list of its ingredients on the package-even though one Web site that markets the product lists a mix of several herbal constituents in the tea: sweet fennel seed, anise seed, coriander seed, spearmint leaf, lemongrass leaf, lemon verbena leaf, althea root, so-called blessed thistle herb, and fenugreek seed.

Dr. Berlin explained that the active ingredients of herbals and nutritional supplements are, at best, often unknown and the purity of the formulations uncertain. Most importantly, any attempt to regulate their purity and safety is severely restricted by the 1994 act, and manufacturers are not required to report any adverse effects attributed to their product.

To illustrate his point, Dr. Berlin presented data from a 2003 study by Draves and Walker that analyzed the concentration of the active ingredients of St. John’s wort, hypericin and pseudohypericin, in 54 commercially available formulations of this herbal in the US and Canada. The researchers found a large variation in total content of active ingredient, with only two products observed to be formulated within 10% of their labeled claim.

A bonus tip when speaking about herbals with parents: Aloe vera, garlic, ginseng, kava, St. John’s wort, valerian, and Echinacea taken with a prescription drug can increase the plasma concentration of the pharmaceutical. Share that advice in reviewing what they are giving to their child during illnesses and at other times.