The NZ government is currently writing a new law (Natural Health Products Bill) aimed to regulate natural health products (NHPs). What is happening in New Zealand is not unique: the push for tighter controls on NHPs is occurring all over the world, including Europe, Canada and South Africa. However, if it wasn’t evident before, these newer regulations make it crystal clear that prescription drugs have a monopoly over the terms “medicine” and “therapeutic benefit,” and that it is very difficult for anything that isn’t a Big Pharma drug to make a therapeutic claim. It is the regulations of medicines, not the regulations of NHPs, that result in vague labels on products. Let us explain, using New Zealand’s current proposed bill as an example.
The new bill will permit health claims to be made for NHPs. Now a health claim is quite different from a therapeutic claim. A therapeutic claim, as defined in the NZ Medicines Act but similar definitions will exist in other countries as well, is quite far reaching and refers to preventing, alleviating, curing and treating diseases, ailments, defects and injuries. In contrast, a health claim can mean a number of things but is generally limited to the maintenance or promotion of health or wellness. So a health claim cannot assert a cure for an ailment. For example, a health claim could be: “Relieves the symptoms of arthritis” versus a therapeutic claim which would be “treats or cures arthritis”.
The bill contains a list of conditions for which a health claim is allowed. No mental disorder is on the list. However, some symptoms that occur within the context of having a psychiatric illness are allowed. For example, Major Depressive Disorder isn’t on the list, but dysphoria, apathy, and demoralization are. Nevertheless, the word “treat” cannot be part of the health claim as an NHP can’t treat or cure, only medicines can do that. Therefore, an NHP could have on the label: “alleviates the symptoms of irritability” “supports demoralization” but the law prevents labels such as “treats irritability” or “treats depression”. This is how labels end up being so vague. It isn’t the manufacturers who are vague, it is the regulation of medicines that prevents clear labelling that reflects scientific evidence because only medicines can claim a therapeutic benefit and some conditions aren’t allowed to have health claims associated with them.
Let’s take an example of an NHP: St John’s Wort. There is solid empirical evidence showing that St John’s Wort can be used to treat mild to moderate depression(1) and is as good as antidepressants with fewer side effects. However, if one goes into a health food store to look at how it is labelled, in NZ it is sold as a mood enhancer, or a mood supporter. The label cannot be accurate about the extent of scientific studies supporting its use because that would make it a medicine and then it could not be sold over-the-counter. The companies presumably have a choice from one country to another to register SJW as a medicine and restrict it to medical prescriptions or sell it over-the-counter for assisting with dysphoria. However, registration of medicines will often require animal safety data as well, data that are frequently not available for products that have been used for thousands of years, like botanicals. This example helps illustrate why labels end up being so confusing to the public.
But it gets even worse: the new bill makes it challenging for health claims to actually be made. Within the proposed bill is the creation of a white list, that is a permitted ingredients list (PIL) that specifically outlines what ingredients are allowed to be contained within an NHP as well as a dose restriction on those ingredients identifying the highest dose allowed for daily intake. Again, this system is not unique and has already been adopted in Canada, Europe and Australia.
The regulators claim that this level of restriction is necessary because when something is being used for medicinal purposes, there is inherent risk associated with consuming that product. However, the dose restrictions are not actually based on safety data. The level restrictions are actually way below any identifiable toxic dose even when compared to the North American tolerable Upper Levels that are declared safe for chronic (i.e. long term) consumption. And NHPs simply don’t carry the same level of risk as pharmaceutical medicines. For example, in the US alone, it has been estimated that 128,000 hospitalized patients die annually from serious adverse reactions to drugs which had been responsibly prescribed by a doctor.(2) Including deaths from outside hospitals would significantly increase these numbers. In contrast, based on the 2014 Annual Report of the American Association of Poison Control, no man, woman or child died from any nutritional supplement.(3) So does it make sense to regulate NHPs as drugs and claim that safety is the primary driver of this regulation?
Now let’s explore some further ramifications of this legislation and put two and two together. The bill allows for vague health claims on NHP labels. But the bill also limits the doses and ingredients allowed in the NHP for the stated reason of ensuring safety of the public. Our studies and those of others have shown that dose is important and that a certain dose is required in order to show a health benefit. For example, the VITACOG study(4) from the University of Oxford in the UK showed that combining folic acid (0.8mg), B6 (20mg) and B12 (0.5mg) improves mild cognitive decline, a proposed health claim allowable under the new NZ bill. However, the proposed PIL limits folic acid to 0.5mg and B12 to 0.05mg. (Note: This is particularly egregious because B12 is one of the nutrients for which no risk has been identified at any dose.) We have similar examples from our own research. This means that while health claims will be allowed, the dose required to achieve that health benefit and make the health claim will not be allowed.
There are further implications for the restrictions on doses and ingredients. By requiring an NHP to be registered as a Medicine if used above the dose limits or if containing a nutrient not listed on the permitted ingredient list, the NHP Bill will place the responsibility of prescribing and monitoring the nutrients onto physicians, the ones who generally prescribe a restricted medicine. Research shows that physicians receive, on average, fewer than 24 contact hours of nutrition teaching during five years of medical school.(5) So when the government states that the restriction is placed there for the safety of the public, ironically, they are placing patients at risk of being prescribed nutrients by a profession whose knowledge base in the area is severely limited.
This legislation makes it clear that only products registered under the Medicines Act can make therapeutic claims and be called medicines and the NZ government has no intention of changing this situation. At what point did our society essentially hand over the rights to make a therapeutic claim to the drug companies and limit access to using products that impact positively on health? Here is an opportunity to set the record straight and acknowledge through legislation that there are verifiable health and therapeutic benefits from taking nutrients without having to regulate them like medicines. If the data substantiate it, then allow the claim to be made, not only in New Zealand, but across the world.
These are just some of the reasons why labels are so vague.
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1. Sarris J. St. John’s wort for the treatment of psychiatric disorders. Psychiatr Clin North Am. 2013; 36(1): 65-72.
2. Light DW, Lexchin J, Darrow JJ. Institutional corruption of pharmaceuticals and the myth of safe and effective drugs. J Law Med Ethics. 2013; 41(3): 590-600.
3. Mowry JB, Spyker DA, Brooks DE, McMillan N, Schauben JL. 2014 Annual Report of the American Association of Poison Control Centers’ National Poison Data System (NPDS): 32nd Annual Report. Clin Toxicol. 2015; 53(10): 962-1147.
4. de Jager CA, Oulhaj A, Jacoby R, Refsum H, Smith AD. Cognitive and clinical outcomes of homocysteine-lowering B-vitamin treatment in mild cognitive impairment: A randomized controlled trial. Int J Geriatr Psychiatry. 2012; 27(6): 592-600.
5. Adams KM, Lindell KC, Kohlmeier M, Zeisel SH. Status of nutrition education in medical schools. The American Journal of Clinical Nutrition. 2006; 83(4): 941S-4S.
Mad in America hosts blogs by a diverse group of writers. These posts are designed to serve as a public forum for a discussion—broadly speaking—of psychiatry and its treatments. The opinions expressed are the writers’ own.
This is why medical libraries, if they have publications like the Journal of Orthomolecular Medicine, keep them hidden away like pornographic books- they’re seditious literature, because they can permit ordinary educated chumps to successfully prevent and treat diseases from anxiety to the Zika virus without bankrupting themselves or getting iatrogenic “joneses” from psychiatric “medicines”.
In the US they bombard us with these advertisements for Prevagen, and when I say bombard with advertising I mean it its like WWII carpet bombing. Prevagen Healthy Brain Function, Extra Strength, Capsules (30 ea) $59.99
Look what I found,
“This is not our original Prevagen review.
The company behind Prevagen — Quincy Bioscience — demanded we take down our unfavorable review of this brain supplement.
According to the National Council Against Health Fraud, here are the complaints charged against Quincy BioScience:
The product cannot work as advertised because its only purported active ingredient, apoaequorin (a protein), is completely destroyed by the digestive system and transformed into common amino acids no different than those derived from other common food products.
The amount of amino acids Prevagen adds to the user’s intake are trivial in comparison to normal dietary intake.
Claims that clinical tests demonstrate that Prevagen will improve memory and support healthy brain function, sharper mind, and clearer thinking are false.
Studies touted in Prevagen’s marketing campaign “if they exist at all, are, on their face, so seriously flawed that they demonstrate nothing regarding Prevagen.”
If you wish to see the original complaint, you can download it as a PDF here” http://bebrainfit.com/why-alpha-brain-focus-factor-and-prevagen-miss-the-mark/
I guess what this all means that with enough money and lawyers you can sell all the snake oil you want and use lawyers to silence your critics. I blame attacks on the supplement industry on the big time abusers like the makers of Prevogen. I would be angry if someone I cared about was wasting over $60 a month, $720 a year on this stuff after seeing that stupid repetitive ad with trickery showing brain cells lighting up and the tiny little disclaimer that says the brain cell show is only a “dramatization”
Here is the Prevogen ad on YouTube for people outside the United States who may have not been subjected to the carpet bombing ad campaign like us who see it 5000 times a year. https://www.youtube.com/watch?v=KitLCvo6blI
3,944 views, comments all deleted. I wonder why that is, lol. Did 3,944 people forgot to comment ? Double lol.
Yes, the supplement industry is full of guys selling alleged miracle products. Going without miracle products is one of the ABC’s of supplement use, because the miracle is how fast your money vanishes into some knave’s bank account. Fortunately, the real ABC’s are pretty cheap, should you take the time to educate yourself on the subject. I pay no more for certain supplements (particularly B3 and C) than I did 40 years ago. The real cheapskate buys his/her supplements in bulk, whenever possible.
I’m wondering if you know who the National Council of Health Fraud is. It’s run by Stephen Barrett, MD, actually a psychiatrist, who has never said anything good about “alternative” medicine including of course, supplements. I think it changed it’s name into quackwatch for whatever reason but it’s reason for existence is clear, that anything outside of conventional medicine is useless, fraudulent or dangerous.
It’s interesting that you focused on one product out of the roughly 85,000 different supplements. Maybe because, as you said, it is heavily advertised. By the way, I am not a fan of prevagen and don’t take it or wouldn’t recommend anyone take it either. I agree it’s a very expensive supplement with little science to back it up. On the other hand that still leaves roughly 85,000 different ones to choose from and I guarantee there are many that are more effective and safer than many of our drugs.
I don’t like to argue with such individuals, because they ensure that the supplements I use most will remain inexpensive, thanks to low or no demand. I’ve had one episode of flu in 20 years while using megascorbate and that was because of my own carelessness.
(Sorry for the delay in our replies)
Yes, we certainly do know who Stephen Barrett is, as well as his Canadian buddy Terry Polevoy. They think they are God’s gift to the public, and that their mission is to ‘protect’ the public from health scams and frauds. I would like to avoid scams as much as the next person, but they have blocked legitimate scientific research in academic settings — why? because they are already made up their minds that it was impossible that the natural product could be beneficial. Does that make sense to anyone?
Julia and Bonnie, Thanks for the great article. Are you familiar with the work of William Walsh? He seems to be doing great things with nutrients. Please comment.
Yes, I am very familiar with his work and his book. He has certainly become very famous. However, he hasn’t published his work very much so it is hard to know exactly what he has found. This is a travesty! I understand he does very well with his patients but it would be to the benefit of everyone if he could systematically share it.
Perhaps, being Albertans, you’d be more familiar with the late Abram Hoffer’s work, as he was pretty straightforward about what he found. He also used the story about Daniel and his comparative dietary trial of pulse vs. the Babylonian King’s rich diet in a journal article about 20 years ago.
Yes, I did know Abram — but honestly, I did not know he ever used the story from the book of Daniel! Thanks for that news.
I guess I don’t understand your comment, Julia. Walsh has a website, FB page/feed, and many Youtube videos explaining the science in detail. He also has trained about 500 doctors. How is that not sharing what he has found? To me it seems he is talking and that the problem is no one wants to listen.
I think what Julia means is that there is very little peer-reviewed research in the scientific literature that supports his approach, and none that I know of that validates his categorization system. However, he might be on to something important — as I said, I have some very smart clinician friends who have found his training to be helpful.
Yes, very familiar with the little bit of scientific research that led to his clinical work. And I have clinician friends who think his guidance has been very helpful.
I always wondered when it said, “Brain support.” Did that mean you’d get a stiff neck? Or was that “thyroid support”? Hmm…men’s support, eh? Why don’t they just put those in the condom section?
Maybe your entire spine would become rigid with proper brain support, giving you impressive posture as compensation for being unable to tie your shoes yourself.
I’m still waiting for the cure for Idiot Who Sneezes All Over Me On the Bus. Hmmm. If I were truly the dangerous nutcase they claimed I was, I’d punch him out, but unfortunately, I can’t seem to get up the nerve to purchase a fly swatter. I know, throw bottles of Vitamin C at him, but that’ll get me 20 years in the loony bin slammer.
After I got sneezed on and caught a cold, I found it went away in a day and a half by upping the vitamin C and zinc, especially since years ago I stopped the flu shot. Gosh that sure made me sick. I sure wish being broke would pass as quickly as the common cold. Any vitamin cures for that?
Not for being broke. A palliative is buying needed supplements in bulk or when there are “twofers” to slow down the rate of financial decline.
My general rule of thumb is that if it costs a fortune I am suspicious. If it’s free or very cheap for sure it’s in every grandma’s medicine cabinet, passed down from generation to generation for a very good reason. Vitamin C, I hear, can be purchased in the dollar store for a dollar. Hugs, caring, listening, all these are free. Except I got it in my head to patent doggie kisses and sell them for hundreds a piece. Miracle cure!
I’m sure doggie kisses help many!