How to evaluate product claims? Regulation of nutritional products
PRINCIPLE: The micronutrients cited for discussion with a physician at this site are selected on an abundance of peer-reviewed scientific and medical publications of studies clearly documenting that the specific dosage and period of consumption are safe and proven to be likely to reduce the risk of disease.
FOR SUPPLEMENTS AND PHARMACEUTICALS IN GENERAL, THERE IS LITTLE FEDERAL REGULATION.
HEALTH CLAIMS, AND LONG-TERM SAFETY: Most people do not realize that companies can sell almost any natural product, even those which may be unsafe, and make almost any claim about its benefits, as long as the claim is not directly attached to the product container. Federal regulations have entirely different standards for natural products, including herbs and vitamin supplements , than for medicine and drugs. This essay explains the different standards by which you can judge claims, and how to decide whether to buy and use a product.
The Federal Government does not regulate health claims about nutriceuticals unless they are directly attached to the product. “According to the Dietary Supplement Health and Education Act, almost any product that contains vitamins, minerals, herbs or other botanicals, amino acids, or even metabolites of these things might be a dietary supplement. And although manufacturers of these products aren’t allowed to claim [on the label] they will cure or prevent diseases, they can make what are called ‘function’ claims- that the product will make you feel better…” (R. Rawls, C&EN pg 27 (Dec 23, 1996). Anyone can mail you an advertisement stating “Buy our product and you will definitely lose weight” or “Buy our product which careful studies have shown will reduce your risk of cancer”, and there is no regulation of those claims. It is thus very difficult to determine whether a product is effective, or even safe, or not. Unless harm is caused to a sufficient number of people who file complaints with the Food and Drug Administration to demonstrate that a natural product is hazardous, there is no requirement for a company to demonstrate that their product is safe.
An example may help. DHEA (dihydroepiandrosterone) has become a very popular supplement recently, which companies claim will help you feel young again. It is a natural product, and thus not regulated by the Food and Drug Administration. DHEA is produced in the adrenal gland and converted into human hormones, estrogen and testosterone. On the positive side, it may lead to such benefits as energy, mood and memory improvement. On the downside, long term supplementation could lead to cancer, liver damage, and other unknown side effects. When it first was sold commercially, the FDA and DEA tried to find some basis for regulation, but there existed no credible negative data. Unfortunately, that does not mean DHEA is safe, only that no one has studied it sufficiently to determine what harm it might cause. Those marketing the product are unlikely to invest in the kind of long-term clinical studies necessary to show the product effective, or hazardous, because generally such natural products cannot be patented, so any study would help competitor’s sales as well as their own.
STANDARDS OF CREDIBILITY: Practically, there are three different standards by which nutritional products can be judged: 1) the media including health and nutrition ads and books, 2) the German Commission E Monographs, and 3) U.S.-accepted, peer-reviewed literature, especially double-blind clinical trials.
THE MEDIA AND NATURAL REMEDY BOOKS AND PRODUCTS: The media, health, and nutrition books and advertising have a clear goal – to sell product. As almost any claim can be made for nutritional products, with almost no justification, you cannot place any credibility in what you read. My mother told me honey will cure baldness – I can write a book claiming honey will cure baldness! Note that inside the flyleaf of such books is a disclaimer that nothing in the book should be taken as medical advice! I surveyed 10 major health and nutrition books, and found that the “natural remedies” for various illnesses were different in each book, that most had no scientific evidence to support the claims made in the book, and that I could not find any justification for the claims in the medical and scientific literature. Time Magazine recently ran an article on the good and bad news related to health, citing 3 positive studies and 3 negative ones related to health. The Berkeley Wellness Newsletter reviewed those 6 studies and found each of them to have major flaws, contradictory studies not mentioned, or lack of confirming studies. The media are concerned with sales – not necessarily with accurate information.
PubMed: is a service which indexes the most distinguished medical publications in the world. This is an excellent source used by most researchers and physicians to find information about studies most likely to be valid. Click on Medline to go to this site and perform your own keyword searchers – but realize that it can be a lengthy and frustrating process unless you have a strong scientific or medical background. There are more than 5,000 articles each year on MEDLINE about vitamin C – finding the useful ones can be a challenge. And remember, a single study rarely proves anything. Imagine if you flipped a coin once, and concluded from that that it always comes up heads! For medical information to be accepted by most experts, the study must be repeated, other variables must be explored, independent researchers must test the hypothesis – it can be a long and arduous process. Consider vitamin C. Perhaps no other micronutrient has been studied in more detail, tried by more people, tested in more studies. Yet there is still considerable debate among experts whether one should take a vitamin C supplement, what possible benefits it might have to take one, and even what the Daily Value should be. This is why the standard set by Personal Health Corporation is SAFE and PROVEN – a micronutrient should be shown consistently to be safe for your present and future health, and should be proven likely to reduce your risk of disease, in numerous peer-reviewed clinical trials. Any herb or micronutrient meeting these standards is probably reviewed at this web site under Health and Nutrition Information. If not, please send a message and an effort will be made to add information on the topic.
PHYSIOLOGICAL MECHANISMS AND PEER-REVIEWED, PLACEBO-CONTROLLED, DOUBLE-BLIND CLINICAL TRIALS:
The gold standard of nutritional research involves two steps. First, there must be a reasonable physiological mechanism by which a beneficial process occurs. In biochemistry, there is a clear cause and effect relationship in well-understood processes. For micronutrients, we generally know the processes in which they are involved. It makes sense that the vitamin folate reduces the level of the harmful substance homocysteine in the blood, because we understand the exact chemical reaction which occurs and requires folate. On the other hand, if someone told me that eating sweets will help me lose weight, I would be very suspicious, because extra sugar is generally converted to fat and stored as extra weight – there is no clear reason why sweets will help me lose weight.
But even when there is a plausible mechanism, that does not mean the substance will be useful. I went to a lecture by a “distinguished nutritional expert” at a natural foods convention, who went down a laundry list of chemicals found in the body, and explained why they were useful, and why they should all be purchased and used as supplements. What he failed to mention is that those substances are all made naturally by our own bodies, their levels are carefully regulated by our bodies, and thus if I take them as supplements, my body will probably absorb only some of them, and even those will probably be immediately converted to fat and stored like any other excess calories. The only thing that will benefit is his company’s bottom line.
So the second step is to run a proper test of the micronutrient – the best being a peer-reviewed, placebo-controlled, double-blind clinical trial. A clinical trial is a test using people. Placebo- controlled means that some of the people get the real substance being tested, others get “placebos”, that is exactly the same treatment but without the active ingredient. You see, our brains have tremendous control over our health, an area of active scientific research called psychoneuroimmunology – your psyche controls your brain (neuro) which controls your immune system. So if a doctor or salesperson tells you that a pill will cause you to lose weight, as much as 70% of the time it will work – for a while. If they give you the same sugar pill and tell you it will cure your cold symptoms, it will work up to 70% of the time. So to see if a substance really works, a test must be designed to compare the real substance with the placebo effect. Another problem is that if the doctor or researcher doing the evaluation knows who has gotten the real tablets, they might even unconsciously misinterpret the data. They might decide those taking the real tablet feel better, and those on the placebo don’t. In a double-blind trial, the researcher evaluating the data does not know who is getting the real tablets and who is getting the placebo – thus the patients and the researcher are both “blind” to who is getting the real test substance – double-blind. Finally, when the study is completed and submitted for publication, the best scientific journals submit the article for review by independent experts, “peers”, who review the study carefully to determine if it is well-designed and accurate. Unlike many trade and marketing magazines which try to look like real scientific studies, and then advertise the product on the next page, peer-reviewed studies are independently judged to be valid. Note this still does not mean that the conclusions of these studies is correct – only that it appears well-designed.
When do we know for sure? Sadly, there is no truth in science, only the best available answer based on the knowledge we have at this point. For instance, beta-carotene was thought to be a wonderful antioxidant, potentially reducing the risk of cancer, heart disease, and other conditions just as vitamins C and E appear to. There were numerous epidemiological studies showing those people who ate diets rich in beta-carotene were healthier than others who did not. These epidemiological studies show a correlation – but not proof! Perhaps there are other substances in the fruits and vegetables containing beta-carotene that provide the beneficial effects, while beta- carotene does not. So double-blind, placebo-controlled studies were done, and these also appeared very promising. But even these numerous trials were done on very limited numbers of people. This tide of evidence encouraged major studies to examine the effects of beta-carotene. These studies, involving tens of thousands of people over years of study, showed that beta- carotene at best was not beneficial, and might even be harmful!! Beta-carotene was removed from major clinical trials. It is wonderful and beneficial to eat fruits and vegetables rich in beta- carotene (and other micronutrients which may be the actual beneficial factors), but supplements of beta-carotene are no longer being tested in major clinical studies – because they appear more likely to cause harm than benefit.
Thus, one can purchase and take a variety of supplements, but recognize that in most cases, the product is as likely to harm you as to provide any benefit, except the “placebo effect” – which you can get for free. A New Yorker article explained that placebo is as effective as any antidepressant, except for SAMe.
