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By Erika Bartholomew

Erika Bartholomew-finalAncient Chinese healers have been touting the all-inclusive benefits of natural, herbal concoctions since they began producing them, as early as 3000 B.C. Fast-forward 5,000 years and a majority of populations in the West are also taking herbal supplements or natural hormones to improve their health—to cure an illness, reduce pain, ward off ill-effects of aging, etc. These supplements, or nutraceuticals, have become increasingly popular in western cultures as they are gravitating to a wellness-based health care strategy rather than the diseased-based approach that has classically prevailed. This trend has also been linked to a more positive psychological connotation of health versus disease in general.

While many people consume these nutraceuticals in addition to medications prescribed by their physicians, some choose herbal supplements, vegan diets, and “natural healing” in place of standard-of-care therapies suggested and prescribed by doctors. Steve Jobs famously delayed chemotherapy for his pancreatic cancer, opting for acupuncture and herbal remedies instead. The passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) allowed for dietary supplements to enter the market space without being held to the same rigorous health and safety studies, or efficacy studies as prescription drugs. Prior to the passage of DSHEA, vitamins, minerals, and nutritional supplements were allowed on the market but were regulated as foods rather than non-prescription drugs. Botanical remedies were regulated as drugs but often referred to as “(unapproved) food additives.”

With the lack of safety or efficacy studies required, very little evidence is required for effect claims on these products. There are, however, restrictions on disease claims (claims to prevent, cure, treat, or diagnose), which are not allowed. While claims made for effects on the basis of structure and function must be truthful and not misleading, the Food and Drug Administration (PDF) does not evaluate claims made by manufacturers on the basis of scientific evidence, as required for drugs (prescription or non-prescription). Although nutraceuticals may not be held to the same rigorous safety and efficacy standards of drugs, there are requirements for quality in manufacturing, distribution, and storage channels. Independent testing labs, such as the U.S. Pharmacopeial Convention, NSF International the National Pharmacy Association, and ConsumerLab, to name a few, often review some, but not all, products for ingredient content and dissolution characteristics.

In addition, some nutraceuticals are quite potent and have the potential to interact with other prescribed medicines. There are a number of potential problems including physicochemical interactions in the gastrointestinal tract (e.g., divalent cations interacting with tetracycline antibiotics and fluoroquinolone antibacterials) or enzyme and transporter interactions (e.g., Cytochrome P450s, p-Glycoprotein) as seen between certain antivirals and St. John’s wort. Warnings of drug-dietary supplement interactions have started making it onto drug labels, but these additional agents are sometimes taken to support one’s health without the physician’s knowledge.

What is the bottom line? Do nutraceuticals genuinely offer alternative options for health and healing? Please join us at the 2015 AAPS Annual Meeting and Exposition, where we will hold a symposium on this interesting and polarizing topic: Health Wave Meets Disease Treatment. This symposium will consist of engaging talks from John Markowitz, Pharm.D., from the University of Florida; Chris Gorski, Ph.D., from Mylan Labs; and Mark Menoloscino, M.D., to share their expertise and perspective on this fascinating subject!

Erika Bartholomew received her Ph.D. from Cornell University in 2013, and has since been a member of a preformulation group within Merck. She is supporting early discovery efforts through Lead Optimization, and transitioning new chemical entities into Early Development