So What is a Drug Anyway?

Most people would say a drug is a product you take when you’re sick. Or maybe one that prevents you from getting sick. To law enforcement, it’s an illegal substance. But of course it’s not that simple. Since the US and Canadian governments enacted their Food and Drugs acts decades ago, much has changed because of scientific innovation.

Today we are faced with some substantial challenges in considering the regulation of new innovative products. What is a pill made from herbs proven to shrink a man’s prostate? What is a topical cream to improve the appearance of the skin that actually turns off melanocyte production allowing the skin to appear whiter? What is a simple sunscreen preventing burning of the skin and reducing the risk of skin cancer? Depending on where you live, these products can be foods, drugs, cosmetics or categories invented by local governments to try to find a place where they belong.

Realistically, it is impossible for governments to stay ahead of innovation. Products land in the market and then governments scramble to understand what to do. An excellent recent example is the electronic cigarette. Are these just another addictive vice? Or are they a helpful new form of nicotine replacement  reducing the hazards of smoking?

Governments feel it is their duty to protect their citizens, so they try to create regulations that are proportional to risk. The only realistic solution for them trying to regulate products is to stop worrying about the names of product categories, such as drug, nutritional supplement or cosmetic. What matters is risk. Is a 30% acid facial peel (a “cosmetic”) more or less risky than taking an 81 mg aspirin tablet? How about the concentrated energy shot that’s found favor amongst students trying to stay awake during exams? Here the classification of cosmetic, drug, food or nutraceutical is irrelevant. All that matters is the risk they pose versus the benefits they provide.

Fortunately, the risks of these kinds of products can be estimated. Those experienced in this area know that there are a number of fundamental measures to assess a product’s risk. These include:

1. Clinical safety assessment. There are lots of established protocols that can give you a pretty good idea of the risk of products.

2. Actual in-market experience. How many adverse reactions have taken place since products were marketed? While after the fact, these give real world experience among large populations of people.

Based on measures of risk, appropriate regulations should kick in. Should products be preapproved before they enter the market? Should they be imported under strict licenses? Should they include mandatory warnings or be used under professional supervision? Should they be manufactured to specific quality requirements?

Consumer products should simply be classed based on a risk assessment scheme. While this is a very different approach than that used currently around the world, the perfect parallel exists in the world of medical devices. Bandages and toothbrushes have different requirements than implantable cardiac pacemakers. Globally, governments have found amazing commonality on how to regulate these kinds of products. It is a smart and practical regulatory regime that doesn’t rely on an arbitrary classification of products. While this would be a dramatic departure and no doubt create all kinds of challenges to our current global schemes of regulation, it would solve the ongoing issue that governments face in how they regulate new innovative consumer products. And the situation is only going to get worse because the pace of innovation is greater than ever in recorded history.