AHPA Tells Children's Hospital About Supplement Regulations

PHILADELPHIAThe American Herbal Products Association (AHPA) told the Childrens Hospital of Philadelphia (CHOP) that removing most dietary supplements from its formulary is based on a lack of accurate information.

CHOP said it was removing supplements because they are essentially unregulated" and there is no sound information about adverse side effects, drug interactions or even standard dosing." However, AHPA president Michael McGuffin wrote, "I assure you that supplements are well-regulated by several federal agencies," in a letter to Sarah Erush, PharmD, BCPS, pharmacy clinical manager and a member of the hospital's Therapeutic Standards Committee.

McGuffin noted supplement company must register with FDA, and that the agency routinely inspects supplement firms for good manufacturing practice (GMP) compliance, which McGuffin called a "a much more stringent standard than for conventional foods." Plus, he said supplement companies must submit serious adverse event reports (AERs) to FDA.

FTC and FDA also regulate product claims and advertising, McGuffin wrote.

 McGuffin informed Erush of existing safety information available for commonly used herbs and botanicals. He pointed AHPAs Botanical Safety Handbook as an authoritative compilation of safety information from clinical trials, pharmacological and toxicological studies, medical case reports and historical texts on more than 500 species of commonly used herbs.

McGuffin concluded, "Simply removing these popular vitamins and supplements from the CHOP formulary is unlikely to eliminate unintended drug interactions with dietary supplements. A more effective approach would be to educate staff and patients about the benefits and risks of drugs and supplements so patients have informed and safe access to the broadest selection of health care options."

John Shaw, executive director and CEO, and Cara Welch, Ph.D., senior vice president of scientific and regulatory affairs for the Natural Products Association (NPA) also sent a letter to Erush explaining that dietary supplements are regulated.