The Safety of Botanicals Argument

Some have made the argument that the vast majority of raw materials used in dietary supplements are, for the most part, inherently safe, and the regulations and their requirements are overkill. Why should small businesses making tinctures or supplements made from “old” herbs be subject to so much documentation, testing, etc.?

Yes, we’re talking about botanicals, and the fact is the majority of the ingredients—particularly those more traditional ones like echinacea, ginkgo, etc.—used in dietary supplements are, for the most part, essentially safe.

Sure, there are some plants that if there were to be a mix-up or if you ingested too much of it could cause a serious adverse event, but a responsible manufacturer making quality products isn’t going to willy-nilly source ingredients or formulate products that harm the consumer. If anything, it’s far more likely that sourcing a powder with limited consideration to anything but cost, would get a manufacturer something that was mostly maltodextrin or similar before something potentially harmful—because let’s face it, maltodextrin is cheap. Not to mention it looks in powder form like pretty much most everything else in powder form. Therefore, from a safety standpoint, it’s probably not too much of an issue with the majority of herbal supplement ingredients—with a few exceptions.

A small number of product categories have been regularly targeted for adulteration with active pharmaceutical ingredients (API’s)—or drugs—those being sexual enhancement, sports nutrition, and weight loss. The American Herbal Products Association (AHPA) maintains a website listing of those products in which the U.S. FDA and international agencies have taken action—keepsupplementsclean.org. It’s not a small list and after looking it over, the problem of adulterating supplements with drugs is a significant global issue.

Though products in these arenas are strictly compliant and contain no APIs, there have been more than a small number of those that have been intentionally spiked with drugs. These products are blatantly illegal, and are masquerading as dietary supplements. Several high-profile cases in recent years included people who took products in these categories that were spiked with drugs and died, and when that kind of tragedy happens, the collateral damage can have a negative effect on the entire dietary supplement category. Consider Kava kava, which was essentially forced out of the market due to case study reports of liver toxicity in 2003. It wasn’t necessarily the reports that did the job of effectively killing off the ingredient—but the insurance companies who excluded coverage for insuring those products so that most businesses stopped manufacturing/carrying products with the ingredient.

The rules are the rules and are there for a reason. And since it’s true some are more than OK with potentially harming, if not simply fleecing, consumers by putting products in the marketplace that are made with ingredients not listed on the label, or with ingredients listed on the label that aren’t actually in the product. Compliance can go a long way to support and protect what is a healthy overall category, and growing, at an estimated $30 billion per year.  So, the burden is real, and there isn’t an easy out.

Devon Powell was formerly the chief operations officer at the American Herbal Products Association and executive director at the International Aloe Science Council. He is currently a consultant to the dietary supplement industry, assisting manufacturers and brand marketers with regulatory initiatives including GMP compliance, QA, QC, auditing, and related elements. He can be reached at [email protected].