Last week’s victory by FDA in the Court of Appeals was a pretty definite one. In the judgment, the court ruled essentially that the intent of DSHEA allowed FDA to use risk-benefit analysis in evaluating the safety of an ingredient, and that at no dose was ephedra safe. The judgment goes far beyond ephedra, and so too must industry’s calculated, not panicked, response.
The impact of the decision, while largely unknown, could be far reaching. Those predicting catastrophe envision ingredient after ingredient nipped off eligible lists as safety gets called into question (implied risk) and benefits and attributes fail to be realized, creating negative equations for many, if not most, of the ingredients currently on the marketplace. (One imagines black cohosh, arginine and potentially vitamin E and others right at the top of the ‘hit’ list.) Industry has contended (and statements and approaches from the FDA appear to confirm) that the agency realizes absolutely no benefits from supplements. The challenges of science in the long term and of a preventative healthcare model means it is frequently different to assess and even more significantly, to quantitate supplement benefits. And with mounting scrutiny on those supplements where the scientific support was thought to have been rather solid (vitamins and minerals), one must ask whether there are many products at all where FDA would accept that there are any benefits. Skeptics (perhaps they’re actually realists) suggest not. One other questions stemming from the decision is the risk definition. The zero tolerance (unsafe at any dose) suggests that any type of risk is unacceptable, including apparently, the risk of potential abuse leading to safety issues.
It’s all quite worrying and it will be of significant importance to track where this goes. Of course, underlying the entire argument is that safety and efficacy must be substantiated (they should be anyway) in order to have an argument to head off a potential confrontation with the FDA. We know that these efforts are underway. There must also be an effective means to put in perspective, discredit or at least provide transparency when faulty science or reporting leads to misinformation about product safety, or even product efficacy for that matter. We know that any controversial findings not immediately argued or contested become part of the accepted record.
Arguing this judgment and its impact, on the basis of ephedra, in my opinion, would be a mistake. Public goodwill and the future of DSHEA would quite likely be sacrificed if this were to be about ephedra. The distance from that specific ingredient must be huge if the impact of this decision is to be challenged effectively. Any other approach would get caught up in the legislative and consumer backlash associated with this product, rather than the issue of benefit, personal freedom, personal responsibility, and ‘safety when used appropriately’.
So is the situation all gloom? At this stage the outlook is not bright, although obviously this court has effectively determined, with the judgment in its current form, that FDA has the power under DSHEA to remove what it believes is an unsafe ingredient, from the market. The court also attempted to interpret the intent of DSHEA determining that the risk benefit analysis was contemplated by the law. Several sources, intimately involved in the development of DSHEA, have stated that this is untrue the issue was never discussed, let alone contemplated under the law.
So it appears as though mid to long term, aspects of the decision and its implications can be challenged. This will likely be in the form of broad consideration and implications, and for industry to succeed, must be done in a mature, well-constructed approach, using reason rather than fear.
It is unfortunate and bewildering that the decision is so forceful. However, as I commented last week, had the decision gone against the FDA, the headlines would have read, FDA can’t even keep ephedra of the market – current law inadequate. And at a time when too many in the industry are having trouble grasping the potential ramifications of not supporting and quickly resolving the pending AER legislation, this double dose of powerlessness and perceived irresponsibility would make previous negative media coverage look friendly by comparison.
As the adage goes “May we live in interesting times” – but not too interesting.