“Natural” Does Not Mean “Better”

At least, not always.

But that’s what purveyors of Natural Health Products (NHPs) say. Synthetic is bad. Natural is good.

Unfortunately, things are not that simple. Some things that occur naturally on Earth are very good for you. But some of them are very bad.

Some things that are synthetic are very good for you. But some of them are very bad.

And some things, natural and synthetic, do nothing at all.

Along with the Green revolution came the Natural Health revolution. We’ve begun to hear more and more about how many chemicals permeate through our food chain, how many pills we take and how many food additives we eat.

As a corollary, we have begun to see Natural Health and Food stores cropping up on street corners. Supermarkets have "all organic" sections. Pharmacies have a whole aisle dedicated to herbal supplements.

Companies respond to customer demand. Customers have begun demanding natural and "organic" foods. So companies have committed resources acknowledging this demand.

But are these products as good as the companies say? Do the hippies down at the natural food store know, without a doubt, that taking certain supplements will boost your immune system, or help prevent cancer, or increase your energy level? Or are they simply reading the label and regurgitating it to their customers?

It is a question that has gotten some international attention recently. Most notably perhaps, is the company POM Wonderful, which has

…been banned from endorsing any product without competent and reliable scientific information to back up the claim. [The Globe and Mail]

POM Wonderful has shown up in the news a couple of times this year. In March, POM was one of 17 companies given a warning letter from the Food and Drug Administration for making misleading statements about their POM Juice and POMx pills.

In the case of POM pomegranate juice, the agency said that the company’s Web site, which is listed on its bottles, carried misleading claims that the juice could prevent or cure diseases like hypertension, diabetes and cancer.Such claims are not allowed on food products and would require that the juice be treated, in regulatory terms, as a drug, according to the letter sent to the company. [The New York Times]

In September of 2010, the Federal Trade Commission released a statement concerning the advertisements of POM. David Vladeck, Director of the FTC’s Bureau of Consumer Protection said

When a company touts scientific research in its advertising, the research must squarely support the claims made.  Contrary to POM Wonderful’s advertising, the available scientific information does not prove that POM Juice or POMx effectively treats or prevents these illnesses.

POM disputes the FTC’s claims, and has filed suit against them. This battle will go on for a while.

But this situation raises a big question: how are NHPs regulated? How are the health benefits they claim to provide substantiated? Let’s investigate…

Perhaps unsurprisingly, NHPs are not regulated in the same way as drugs. Up until the 1990’s, Canada did not have a non-drug supplement regulation framework in place. Products were either drugs or they were food products.

After several years in development, the Natural Health Product Regulations (NHPR) were put into effect on January 1, 2004. So what products fall under these regulations?

Products that fall within these Regulations include herbal remedies, homeopathic medicines, vitamins, minerals, traditional medicines, probiotics, amino acids and essential fatty acids. In addition, many everyday consumer products, such as certain toothpastes, antiperspirants, shampoos, facial products and mouthwashes are also classified as NHPs in Canada because of their medicinal ingredients and intended uses. [Health Canada Website] (emphasis mine)

I emphasize ‘homeopathic medicines’ because I am not a big fan of homeopathy and I am thoroughly disgusted that Canada allows such products to be sold.

So the NHPR does require that these products meet certain standards of safety and efficacy. Unfortunately, these standards are set extremely low.

In the case of homeopathic medicines, for example, Health Canada will accept references to the Homeopathic Pharmacopeia or Homeopathic Materia Medica. These documents are essentially a collection of anecdotal evidence, and have no scientific basis.

For other NHPs, Health Canada will accept "references to a traditional use". This means that if a product has been used for over 50 years to treat a certain ailment, it is deemed "effective" by Health Canada standards. No scientific evidence or medical studies are necessary in this case. If sufficient documentation is not available to prove that a product has been used for 50 years, the word of "three or more herbalists or aboriginal elders may serve as the source of information".

What pops into my mind in this case is bloodletting, which was used for well over 50 years and, by these standards, it would have sufficient evidence to prove its efficacy.

The topic of efficacy becomes the primary issue here. I would never take a prescription medication, or even an over-the-counter medication, without knowing that it has been sufficiently tested. Why then, do we take NHPs without demanding the same high standards of testing?

It seems as though we should. Looking at Health Canada’s Advisories, Warnings and Recalls for the Public – 2009, we see that more than half of the warnings were issued for NHPs.

Natural, it seems, does not mean better.

It is a very polarizing issue. A post written by Barry Green on Ottawa Skeptics a couple of years ago summarizes the position of the two sides extremely well.

When skeptics look at NHPs, they see a broad spectrum of products ranging from those proven effective under certain circumstances (vitamins) to those with possible pharmacological properties yet unproven (naturopathy) to those which are the very essence of quackery (homeopathy).  Skeptics see efficacy regulations as necessary to prevent wasting healthcare spending on nonsense and to protect the public from fraud and the dangerous distraction of ineffective treatments.

When CAM advocates look at NHPs, they see a rich pharmacopoeia of natural remedies whose curative powers, tapped through ancient wisdom, can be experienced firsthand without the need for scientific sanction, the dangers of "allopathic" medicine or the enrichment of "Big Pharma."  NHP supporters see efficacy regulations as unethical restriction and unnecessary expense.

My personal opinion is that NHPs should be required to undergo a higher standard of efficacy and safety testing. I don’t think all NHPs are bad. However I do feel that any product which is intended to alter the function of your body, even if the intent is to improve function, should be rigorously tested.

This will not go over well. It was announced recently in the European Union that all herbal supplements must be classified as either food or drugs by April 2011. This puts the supplements under the same guidelines of testing as pharmaceutical drugs. However, many NHP proponents see this as a big problem, since many small-time manufacturers of NHPs will not be able to afford to get the regulatory approval and be driven out of business.

This seems a bit hypocritical to me. If you are so concerned about the health of people, don’t you want to guarantee that what you are selling them is not only safe, but also that it truly is making them healthier?

Another big problem is that the current system of regulation makes it far too easy for peddlers of pseudoscience and quackery to make a profit off the general public, whose choices about products and treatments for maintaining a healthy lifestyle have gotten much more complicated in recent years. The recent acai berry scam comes to mind, not to mention the large number of sham diet drugs on the market today. All of these products were able to flourish because of the lack of strong regulation on NHPs.

So sometimes "natural" is better. Sometimes it’s not. But in order to be sure the products need to be tested. We can’t take tradition, word of mouth, or anecdotes as evidence anymore. We need something more concrete. Because after all, we are all trying to be healthy. So let’s do the legwork and find the best way to make that happen.