May 17 2021

Regulation of Supplements Lacking

A recent audit of natural products manufacturers in Canada reveals how lacking regulations are in this industry. Scott Gavura does a good review of this over at SBM. I want to amplify some of what he says and add further context.

For background, so that everyone knows where I am coming from, I tend to take a nuanced approach to regulation. I believe in the power of capitalism and a free market to allocate resources in an organic way that will reflect, at least in part, actual merit. But free markets do not exist in a vacuum, they need to be crafted by an agreed upon set of rules. Further, there are always going to be people who try to work the system, bend the rules, and exploit others. Further, the evolutionary forces at work within a free market do not always favor acceptable outcomes. We know from history what happens in unregulated markets (we don’t have to guess) – they lead to fraud, exploitation, and monopoly. People will use wealth and power to rig the system so they gain more wealth and power at the expense of everyone else. The people who do this best will tend to succeed over time. While 1% of the population displays psychopathic traits, the figure is 4-12% among corporate CEOs.

If we look at the supplement and medicine industry, we have a very clear historical picture of what things were like prior to the FDA in the US. This was the era of patent medicine. Corporations created products that had mostly random ingredients but generally included something that was a stimulant and/or addictive. They then used a prominent doctor to promote the product, claiming it was good for a long list of common ailments. There was no evidence of safety or efficacy, the entire industry was one giant scam. Market forces did not favor quality, they favored the superficial appearance of quality. That is the risk of any product with subjective qualities, the market can devolve into products with all sizzle and no steak.

This is perhaps especially true in the over-the-counter medicine market. Most of the symptoms and ailments that people will self-treat are self-limiting – they will go away on their own, like a cold or flu. Many others are chronic, where symptoms will wax and wane. So anything can seem to work. Much of the market is also for “health maintenance” with even more vague claims. Products can be sold to provide more energy, boost the immune system, provide greater mental clarity, or just promote wellness (claims that are essentially impossible to subjectively evaluate). Throw in a little placebo effect, the power of hope and wishful thinking, and you have a recipe for selling worthless products with bold claims that many people will come to believe. In such an arena market forces will favor slick claims, not actual product quality or effectiveness. The evidence for this is overwhelming, with countless dramatic examples.

We are now living through a second era of patent medicine, a post-regulation era when the supplement industry has successfully lobbied many governments to relax regulations. They then proceed to exploit those lax regulations to deceive the public with an endless stream and mostly worthless snake oil.

There are two basic ways that regulation can be too loose. The first is in the laws themselves, which may not require, for example, any evidence of safety or efficacy for products. The second is in lax enforcement, essentially leaving it to industry to self-regulate. I think you can imagine how that might turn out.

The recent audit in Canada was essentially to see how supplement producing were complying with rules for self-monitoring. The answer is – about as bad as you would predict.

As Scott reports

  • The auditors pulled a sample of 25 site licenses. In 13/25 licenses, Health Canada relied on inspections from other countries. In 10/13, there was no assurance these inspections included natural health product manufacturing processes.
  • For the remaining 12 sites, Health Canada failed to verify one or more components that would demonstrate GMP.
  • 88% of products were advertised with misleading information.
  • 56% has severe problems with labeling information, such as ingredients, dosages, and side effects or warnings.

This audit is not an isolated piece of information. I wrote previously about studies showing that most supplement product suffer from adulteration, substitution, or contamination. So the chances are better than even that for any given supplement product, you are not even getting what’s on the label.

This is basic manufacturing quality, transparency, and honesty. Forget about products that have reasonable evidence for efficacy to back up their claims. That would require a legislative change, changing laws that current serve manufacturers to ones that actually protect consumers.

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