In April 2014, we’ll be coming up on the tenth anniversary of the FDA’s ban of ephedra based nutraceuticals. What does the ephedra ban have to do with today’s nutraceutical industry or with the role of an independent nutraceutical product liability insurance broker? Read on.
Ephedra alkaloids, extracted from Ephedra sinica, have been used medicinally by humans going back into prehistory. One would think that if any plant derivative had stood the test of time for safe and efficacious use by humans it was ephedra, which acts as a central nervous system stimulant. Called ma huang in traditional Chinese medicine, this herb had not proven itself to be a problem. In North America, where ephedra bearing plants were also common, native and settler alike concocted “teas” noted for their “pick me up effect.”
Move ahead to the 1960s and 70s. In this country and others in the west, many of these traditional remedies were tapped for isolation and concentration of their desired properties for use as a treatment. In effect, a nutraceutical industry was born around the concentration and packaging of many substances that people necessarily once took in less concentrated forms.
To make a very long tale much shorter, where people are involved there is both variation and excess when one is discussing how they react to taking supplements. There were bound to be problems of some sort, and in the pioneering days of the nutraceutical industry, there were really no effective trade groups, governmental regulators, or other frameworks in place to ensure that ephedra was safe from abuse, incorrect dosage, or other issues, like negative interactions with other substances.
The 90s saw all things ephedra come to a head. Reports of adverse reactions, up to and including death, were making the rounds of both the nutraceutical industry as well the establishment medical community. Eventually, state and federal politicians and regulatory authorities involved themselves.
Battles over claims, efficacy, advertising, adverse reporting, warnings, you name it, erupted over ephedra. Ephedra came under increasing scrutiny from the FDA. One alkaloid changed the entire face of the industry. As an independent nutraceutical product liability insurance broker, I watched this all play out step by step while keeping my clients informed.
It took the death of a Major League Baseball pitcher in 2003 for the FDA to move to ban ephedra. As many of these regulatory cases go in court, a seesaw battle took place, but eventually the ban on ephedra based supplements was final in 2004.
No one knows which nutraceutical will be the next ephedra. What you can count on in this country is that some enterprising lawyer, either seeking a fortune, or Ralph Nader style fame, will find or create the next industry crisis over some product or substance, perhaps one made or marketed by your business.
As surely as insurance is created to protect commerce from inherent risk—and attorneys are just such a hazard—your insurance will inevitably be tested. Why not be ahead of the next “ephedra style” regulatory battle by utilizing the services of an independent nutraceutical product liability insurance broker? Your company needs someone who keeps abreast not only of insurance company offerings, but also of developments industry wide.[author-box-2]