Don’t supplement users deserve consumer protection, too?

By Scott Gavura

 

One of the most pervasive yet appealing health myths is the idea that natural equals safe. It’s a statement that’s repeated constantly by manufacturers of supplements and “natural” health products. It’s been the primary argument used, with considerable success, to give these products completely different regulatory structures than exist for drug products. Weaker regulation of supplements and natural health products has been a boon to manufacturers, but the same can’t be said for consumer protection. It’s effectively a buyer-beware marketplace in most parts of the world, with little accurate information available to consumers. But supplement manufacturers aren’t content with the minimal regulation that’s currently in place – they want health “freedom”. In this case, “freedom” means the right to sell any product, while being exempted from safety and regulatory requirements. New Canadian legislation is poised to raise safety standards for drugs and enhance the ability of regulators to recall dangerous products, yet consumers of natural health products are left behind. The legislation proposes to exempt anything considered a “natural health product”. This is not only bad public policy, but it has the potential to cause avoidable harm. After all, shouldn’t users of supplements and natural health products be entitled to the same safety and quality standards as those that use prescription drugs? If the supplement industry gets its way, the answer will be “no”.

In late 2013 the Canadian government introduced Bill C-17, the Protecting Canadians from Unsafe Drugs Act. Also called “Vanessa’s Law”, the bill is named after the daughter of Terence Young, a Canadian Member of Parliament whose daughter died of an adverse drug reaction. The Act has been written to enhance and strengthen Canadian food and drug regulations, and is expected to bring Canadian regulations in line with international best practices for drug regulation. The Act will do the following:

  • give government the authority to recall drugs from the market (it currently must ask the manufacturer’s permission, and the decision is at the manufacturer’s discretion)
  • increase fines to manufacturers from $5,000 to $5,000,000 per day for companies that do not comply with the Food and Drugs Act
  • the ability to require companies to undertake post-marketing (real-world) research
  • the ability to force a manufacturer to change a drug’s label because of new harms or risks to health
  • make adverse event reporting mandatory for hospitals.

These changes are overdue in Canada, and welcome. There is an interesting exemption. The act applies to “therapeutic products” which is defined as:

a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations

Even the preamble makes it clear – there are apparently no issues with natural health products:

And whereas new measures are required to further protect Canadians from the risks related to drugs and medical devices, other than natural health products

What are the consequences of excluding natural health products? Tainted drugs can be recalled, but not contaminated or mislabelled supplements (which have been documented with Canadian products). Adverse event reporting becomes mandatory for drugs and even “medical devices” (e.g., bandages) but reporting on herbal products and other supplements is not. And oddly, even some drug products are considered “natural health products” (e.g., some decongestants). The result of this legislation, if passed intact, will mean the extent to which consumers will be protected from unsafe products will vary.

Drug safety disasters like thalidomide led to the pharmaceutical regulatory framework that is generally in place around the world today. Amazingly, manufacturers of supplements and other “alternative” medicine products have been largely successful in circumventing these safety rules, convincing regulators that “natural” equals “safe”, and therefore, should be exempted from regulation. In the USA, the framework is DSHEA, which removed the onus of demonstrating safety and efficacy from the manufacturer and put the requirement to demonstrate harm on the FDA – exactly the same scenario as drugs in the early 1900′s. In Canada, the Natural Health Product regulations had a similar effect, and implemented a lowered bar for non-drug supplements. Today even homeopathic remedies in Canada are deemed safe and effective and approved with unique recommended uses.

Is there any rationale that would exempt natural health products from stronger regulatory oversight? Some (particularly the industry) point to the lack of evidence of harms. And from one perspective, that is true. Despite their widespread use, surveillance of supplements (the limited amount that occurs) reveals generally few adverse events. It could be that many products lack meaningful pharmacologic activity — either positive or negative. An adverse event is probably less likely in placebos that have no beneficial effects. But beyond efficacy, there are several other factors, unique to supplement use, that may contribute to the perception (and under-reporting) of harms from supplements. I’ve mentioned several reasons before, which include:

  • Consumers believing natural products are safe may be less likely to associate adverse events with supplement use.
  • Supplements don’t require a prescription. No health professional may be involved in measuring the response to therapy, who might be able to identify adverse events as part of a monitoring plan.
  • Side effects and harms may not be reported, as some are reluctant to share concerns with health professionals.
  • Consumers may not know how to manage an adverse event, and to whom they should report an adverse event. They may be unwilling to describe health consequences to the vendor of a product, or report in a setting like a natural foods store.
  • Users may have a distrust of “conventional” medicine which drove their initial use of the product. When adverse events were identified, they may be reluctant to consult “conventional” health care providers for assistance.
  • Some fear of losing access to supplements, which may drive a reluctance to report adverse events.
  • Supplements are commonly used for short intervals for self-limiting conditions, and long-term harms may not appear (or be detectable).

4 COMMENTS

  1. For the “natural” supplements:
    - certainly requirements for accurate contents labelling would be good,
    - perhaps require a prominent notice in the “health” supplement stores stating that the industry is unregulated and buyer beware,
    … but other than that, I prefer having the right to experiment on myself with these products if I want to.

    Presently, I am lucky enough that I don’t take anything in pill form (well, except TUMS), but in the future, if my doctor hasn’t a clue about some problem (the normal situation for digestive problems, in my experience), and someone says product X worked for them, I’ll want to be able to give it a try.

    Rather than wait 20 years for a product to be rigorously tested, then to be told that it causes a 60% improvement in 71% of cases, I can test it right now on 100% of the sample I am interested in! If I want to.

  2. The article is replete with mights and maybes- not a particularly scientific foundation for a significant and costly proposal in my opinion. If there is concrete evidence that some natural products are dangerous, either in content or in manufacturing process, then by all means go after the organizations that manufacture them. To suggest that additional regulation will do much to help is unproven. Drugs are constantly being recalled, and repurposed., yet remain questionable in effectiveness and in the overall numbers of people dying from adverse reactions. Knowledge about adverse interactions and safe dosages of supplements will help in those situations where a health risk is proven or at least strongly suspected. Linking this information to drug interaction databases available to pharmacists would be valuable. Regulation on it’s own, however, is questionable. Perhaps If the regulatory bodies were truly independent from Pharmaceutical company influence, then this article and it’s proposal might have merit. As it stands, there is a huge trust issue and concern that additional regulation will only harm genuine competition and growth in an emerging market. I fully concur with Dr. Dawkins when he says “”there is no alternative medicine. There is only medicine that works and medicine that doesn’t work.” However, you first have to find out what does and does not work. As a referee in this matter regulatory bodies are not seen as unbiased. First fix the regulatory process. Chances are that the crowd sourcing impact will be much faster at identifying and weeding out bad products and interactions than the slow cumbersome, financially and politically influenced approach suggested.

    • Andrew, by the looks of the accompanying photograph the article seems to be from the same country where a recent study of supplements showed that 3 of 4 did not even have any of the contents mentioned on the label. Worse some actually had the opposite ingredient that may have made the condition worse!

      As someone living in the above country I very much want to know what is in the bottles I buy.

      If there is a less appropriate place to bring up the problems with regulated medicine an article on unregulated medicine requesting it is regulated is it. Saying there is an imperfect system is the first step not a reason to give up.

      Anything would be better than letting the snake oil salesmen peddle ineffective or dangerous goods.

  3. I agree with RD re: his proclamation about medicine either working or not working. And so therein lies the rub. The Chinese herb ma huang can be standardized into the amines ephedrine hydrochloride (as well as pseudoephedrine). These are then used in regulated products such as decongestants and coupled with other ingredients to be used as a bronchodilator (among others). They are then known colloquially as “medicine”.

    These products are then regulated by the FDA and subject to all of the regulatory conditions we’ve come to expect. But the parent ingredient, ma huang, is not privy to such regulation. It is considered a “natural” or “alternative” health product. And by current definition it is not scrutinized in the same manner as the related compounds even though it can be used in the same way. Clearly this is a problem. Health “freedom” as cited above by supplement manufacturers is a misnomer. Freedom in this context clearly suggests a willful ignorance regarding consumer concerns.

    Yes, the regulatory process is a mess. I am acutely aware of this because the industry I’m in creates Blood Establishment Computer Software which is regulated by the FDA per their 510(k) directive. The inspections are always a miasma of confusion, misdirection, occasional incompetence and far too little straightforward proficiency. In other words our government at work. But however broken or inefficient the system is, it’s better than nothing. And the current “system” for the supplement industry is nothing (much). Reform is needed.

Leave a Reply