Is the issue of adulteration of products marketed as supplements really an industry issue, or simply the outlier event many would have us believe? Frankly, that depends on whom you ask.
Deliberate, economically motivated adulteration is a simple case to categorize (some of those companies operate in our marketplace rather freely), but when it comes to the spiking of what would otherwise be supplements with active pharmaceutical products (approved or unapproved) one either gets 'let's do everything we can to call out and eliminate this horrible behaviour' , or more frequently, 'not our problem'.
While not a new issue, over recent months, adulteration or contamination of products marketed as supplements has become a more persistent and dangerous problem, so much so that FDA has begun maintaining a website detailing Recalls, Market Withdrawals & Safety Alerts. Of particular note are the products contaminated with sibutramine, an appetite suppressant, recently recalled by FDA (Meridia) and other regulatory authorities, as representing a serious risk. From an industry liability perspective, if the health risk is so severe that Meridia itself has been recalled, what is the risk of a product adulterated at two to three times a previously approved prescription dose?
On several occasions, the Food and Drug Administration (FDA) has initiated dialogue with industry on this subject, clearly asking for help. In September, Dr Joshua Sharfstein, Principal Deputy Commissioner of the FDA spoke at the annual CRN conference, and just last week, he spoke again, this time to all the major industry trade association heads. Three categories of significant concern are: weight loss, erectile dysfunction and sports / performance enhancing products, and, from an industry standpoint, serious dollars (multi-billions) are at stake.
In industry circles though, many wonder why Sharfstein is coming to industry for what they believe is not an industry problem. Some are at a loss as to what legitimate industry can really do. Others are frustrated at the traditional ‘broad brush’ being used to describe supplements when this is clearly an illegal activity.
So is this an industry issue? Are there things we really can do?
There are some actions or at least some awareness that we, as a sector should consider. As to this being an industry issue (or not), I personally find it disconcerting when those who should know better persist in describing the entire industry as one made up of only 'good guys', when we know that to be a false statement. Those operating in the world of spiked products are not solely outliers and this is not the only area where opportunists put us at risk, exposing a very vulnerable underbelly - to regulators, consumers, and the media. In fact, just a few weeks ago, Novacare LLC, member of one of the major industry trade associations and operating under a third party GMP certification, was the subject of an FDA recall ("products appear to contain sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction").
Is this perhaps one of the reasons FDA is engaging industry directly? Do they know that not everyone in the room is a 'good guy'? I would expect so.
Unfortunately, just as true is the fact that there are few things legitimate industry can really do, although a subject likely to come up in future coverage is the testing for suspected adulterants. Whether voluntary or mandatory, many would argue that good industry should not pay more when it is already making higher quality products. This same argument has been used to champion against third party certification. In the absence of such activity though, how can you really tell who is doing the right thing? Shouldn't risk management show that testing lowers risk and presumably liability?
We are entering a time in industry that I think will be really defining. With GMP enforcement still in early stages, and issues such as deliberate adulteration on the radar, companies will increasignly be known by the company they keep, the standards they adhere to and the voluntary measures they take to stay on top. Stay tuned...
FDA, industry partner to tackle tainted supplements issue