Editorial: Who Patrols the Sandbox?

By Len Monheit

Whether we’re talking ingredients or finished products, a healthy marketplace requires some barriers to entry. There has to be at least a minimal rite of passage that entitles someone to play in the sandbox. In some industries, it’s having adequate money to develop both a pipeline and a channel, in others there are intellectual property barriers, and in yet others it’s a costly registration process that prevents short-term thinkers or those not equipped to be compliant (for whatever reasons including general ignorance) from participating.

Technically, these barriers exist in almost any jurisdiction in the world, were the barriers adequately defined and enforced. And it doesn’t matter whether we are talking food, supplements or natural health products, drugs, or many other product categories. Two related factors have made an ‘entry commitment’ an obstacle easily avoided in our case, a fact compounded by the lack of enforcement will or resources on the part of regulatory authorities. These factors are 1) the Internet and 2) the pace at which news travels.

It’s obvious that the two are intertwined. The Internet is obviously a key media that facilitates the dissemination of news and information – and at speeds almost unheard of not too many years ago. It has given rise to online chat rooms where viral marketing either by design, or by net effect, can cause a product to go from nowhere to street corner buzz, literally in a matter of hours. And with companies using key word advertising and other tools such as un-policed wires and press release distribution vehicles, ingredients and products can readily be introduced and gain interest and traction almost overnight..

It’s against this backdrop that industry seeks to defend itself and attempt to post some boundaries, actually mostly just those inherent in the laws, whether in Canada, the United States or anywhere else in the world for that matter. The reality of the situation is that if you try hard enough, you can get just about any product, legal or not. To compound this, you can find people willing to say just about anything, making it harder and harder for industry to illustrate that it is regulated and that there are things happening in the business environment that just plain shouldn’t.

I’d venture to guess that most of us don’t want to consider ourselves in the same ‘sandbox’ as certain players , yet here we are, positioned that way by media and other detractors.

This past week the US supplements industry took a black eye when MSNBC ran an expose on Florida-based Hi-Tech Pharmaceuticals. In amongst the allegations was the contention that the supplements industry is unregulated (as it surely must be if someone was selling ephedra long after FDA’s ban went into effect etc.).

I didn’t want to specifically speak about the ‘belief’ that industry is unregulated. – at least in what is said in the media. I actually wanted to focus on the reality instead, that for practical purposes, there are numerous venues, where despite laws, industry is unregulated. If someone were to blast out a message on PRweb or another service, who would stop them or take them to task? If an ingredient were launched to cure cancer and that ad ran on one of the main search engines, who’d catch it? If a company wanted to post ads on a chat site offering steroids and steroid precursors, who’d really do anything about it? If someone wished to write a patent describing the uses of a particular material or process for food or supplement, affecting or influencing a disease state, couldn’t they effectively get that message out and begin to drum up interest and sales? And then couldn’t they take the money and run, if in fact, they ever hit the radar screen of the regulators?

True, we do get the FDA or Health Canada warning about unlabelled drug ingredients in various products, but what fraction of the offences are really being caught? I know many of you will say that there have been enforcement actions brought by FDA, Health Canada and other agencies, some with significant penalties – and I don’t disagree.

Something’s got to give though, and I think it has to start with a company’s first entry onto the stage, be it Internet, TV, radio or through any other communications and sales vehicle. Maybe it’s a first alert system, designed to at least educate the simply ignorant or those not seeking to take deliberate advantage of an enforcement vacuum for quick commercial return. Maybe it’s a new company ‘guidance manual’ that automatically gets shipped out explaining GRAS and NDIs, GMPs, structure function and qualified health claims. Maybe it explains the roles of NHPD, FDA, FTC, CFIA and other agencies in a simple easy to read ‘do and don’t’ based document. Maybe it’s all of the above rolled into a baseline enhancing education system that requires a percentage of a company’s staff be trained or certified in various categories in order to be part of identified trade associations.

The trigger for this week’s rant, in case you’re wondering are several releases and patent notices received or viewed over recent months. We’ve all seen them, shaken our heads, and probably even recognized them as the first notice they really are, of a company’s intentions and approach. When they are grossly illegal, shouldn’t something be said? When they are misleading or obviously misrepresenting, should it trigger some action? Could there be an anonymous blacklist covering ingredients and finished products and the nature of their infraction /violation / deficiency / tactic / misrepresentation / abuse / borrowing of another’s science or IP? Is there a direct line to FTC? (Who, by the way have not responded to my notes and messages as it seems they would rather hear from only US citizens.)

Anyway, enough ranting for now. Back at you next week.

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