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.
(Note: Once again, please do not forget our two related Action Alerts—one on the FDA’s new NDI guidance, the other on the Durbin bill—in the last paragraph of this article. We are emphasizing these Action Alerts so strongly because the guidance and the bill could have a devastating effect on your natural health freedoms.)
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. This is especially the case given that they are almost never associated with nasty pathogenic bacteria in food, which cause millions of Americans to be hospitalized and thousands to die each year.
Actually, deaths associated with dietary supplements are extremely rare. For example, in the most recent 2009 NPDS dataset, there is only one death reported. As we noted last week, it was concurrent with an “unknown dietary supplement or homeopathic agent.” So there was an alleged supplement or homeopathic agent, but they don’t know what it was! There was another death attributed to ephedrine, but the report indicates that this was in the “Miscellaneous Stimulants and Street Drugs” category—not a dietary supplement. Not a single death by vitamins or any other category of nutritional supplements. What’s especially revealing is that ingredients which might be classified as NDIs don’t enter the picture.
Like all guidelines, the devil is in the details. The Dietary Supplement Health & Education Act of 1994 (DSHEA) fully envisaged pre-market notification (though not approval) of NDIs, that is, dietary ingredients not marketed prior to October 15, 1994. But it didn’t set any hard-and-fast rules over what was required to show their safety. And now, seventeen years on, we see where the FDA is taking this. And what we see is an unashamed attempt to blueprint one of the most lethal weapons presently being used in Europe to decimate its natural products industry.
What the NDI guidelines force companies to do, once an ingredient is deemed to fit the NDI classification, is prove its safety before it can be sold. This notion is fundamental, because it moves us away from the long-cherished notion of presumption of safety for natural dietary ingredients, and places the burden of proof on the manufacturer. It actually may sound quite reasonable to some, but the reality is that proving safety is a very complex process—and one that is simply out of reach of most of the smaller companies that have been at the forefront of pioneering the natural health foods revolution since the 1960s.
This article serves as a distress call to practitioners and citizens who rely on diverse natural ingredients for healthcare. In Europe, there are two main ways that regulators are forcing products off the market. Either they get declared unlicensed drugs, or they get classified as unauthorized “novel foods.” In our experience of these problems in the EU, the novel food bans are proving at least as important a tool for the regulators as unlicensed drug classifications. Well, now it’s the FDA’s turn to use this same weapon on its people!
The FDA reckons there are around 55,600 dietary supplements on the US market, and the Institute of Medicine estimates that around 1,000 new products are brought to market each year. The FDA says that over the last sixteen years or so, it has processed around 700 NDIs. With these guidelines, expect to see many more being forced through this tortuous route. Ingredients that can’t jump the new hurdle will simply fall by the wayside—and cost is going to be one of the biggest barriers.
An obvious challenge is the effect of the guidelines on new products. They might be botanicals for which evidence of bulk use pre-1994 is hard to demonstrate (many have discarded their sales records), or nutrients that are delivered in a different molecular form (even if it’s one that is more natural). But an even bigger challenge—and this is central to the issues we now face in the EU—is retrospective effect of the guidelines. There may be very large number of products on the market that are structurally and chemically different to those that were on the market pre-1994, the era before the massive expansion of the US natural products industry.
In short, we see the NDI guidelines, modeled on the EU’s Novel Food Regulation, as being nothing less than a mechanism to freeze-frame the US natural products industry, and haul it back to its pre-1994, pre-revolutionary state.
Technically, there are a huge number of issues with it, the most fundamental of which is how to classify a particular nutrient, and especially its chemical structure, as an NDI. This includes a manufacturer’s need to demonstrate how much of it was used, since the FDA says that the ingredient must have been used “in bulk” in dietary supplements to not fall afoul of the NDI classification. Secondly, how one is to go about demonstrating safety of an NDI needs radical review. We think the requirements should be graded according to the nature of the substance in question.
We urge the US industry to immediately consult with European supplement manufacturers who have had experience with the Novel Food Regulation, because accepting these guidelines blindly will, in our opinion, sound the death knell for the vibrant and innovative natural products sector that has done so much in the last seventeen years to help people to manage their health naturally.
If you have not done so already, please send your message to Congress through our Action Alert on the FDA’s NDI guidance and our Action Alert on the Durbin bill. Both these issues are monumentally important if you want to maintain your access to natural supplements.