Alliance for Natural Health, July 26, 2011
Are the NDI guidelines the ultimate FDA tool to freeze dietary supplement innovation? A special report by Robert Verkerk, PhD, ANH-USA Scientific Director and ANH-Europe Executive and Scientific Director.
If the US natural products industry values its ability to keep a diverse range of products available for the benefit of the American public, and believes in not exposing the public to unnecessary costs, we strongly suggest that it look very closely at the latest guidelines from the FDA—with eyes wide open. We refer to the FDA guidelines on so-called “new dietary ingredients” (NDIs) that we’ve been telling you about over the past several weeks. These guidelines preempt a crackdown on ingredients used in natural products, one that appears to be coordinated closely with a similar clampdown happening currently in Europe. The guidelines bear an uncanny likeness to the European Union’s Novel Food Regulation.
The justification given for the new guidelines is—as is always the case when facing a tighter regulatory noose around dietary supplements—consumer safety. This of course brings about a predictable response from the natural health sector: “But where are the dead bodies?” It’s actually quite a pertinent question, and one that is rarely taken seriously by the FDA or other regulators.
A careful examination of the most recent two years of US National Poison Data System (NPDS) figures reveals that, of all products to which we are exposed that might cause harm, pharmaceutical drugs caused 80% and 81% of fatalities, respectively. The majority of these were from unintentional poisoning. Are you surprised? It makes it even more of a wonder that regulators continue to try to convince the public that pharmaceutical-like regulation will be the best way of guaranteeing their safety!
The NPDS data, combined with other data from the Centers for Disease Control and Prevention (CDC), shows emphatically that botanicals and dietary supplements are the safest products that we put in our mouths.