May 2003
by Steven Novella, MD

Recently a patient of mine with a serious neurological disorder inquired as to whether or not there were any natural supplements that could treat her condition. The patient was filled with earnest, but cautious, hope. She cited information she had gained from friends, on the internet, and from dietary supplement advertising. Natural supplements, she had been lead to believe, were of no possible risk to her because they were not drugs, they were just supplements. Also, she was encouraged that they would be both safe and effective because they were natural. Finally, she was very impressed with the reports from friends that their medical condition was improved after taking the supplement.
Increasingly the American public is relying upon self-treatment with substances which are marketed as natural supplements to treat minor symptoms, prevent or treat illness, enhance performance, and generally promote health and long life. Utilization of guidance by qualified healthcare professionals is sporadic at best, and complicated by a proliferation of pseudoprofessionals whose advise is questionable. Most people I talk to erroneously believe that the Food and Drug Administration (FDA) or other government regulations protect the public from harmful substances or fraudulent claims, but sadly this is not true.

The supplement industry in recent years has benefited from a loosening of regulations, allowing them to market a wide range of products with quasi-health claims. At the same time the public has been subjected, with very little critical analysis, to the idea that there has been a change in medical thinking, adopting a new respect for natural treatments and nutritional supplements. As a result the public is spending billions of dollars ($17.1 billion in 20001) on treatments for which there is little rationale or evidence, with unclear risks, based upon poorly conceived ideas that amount to little more than supplement industry propaganda.

Current Regulations

The FDA website gives a good summary of the current status of regulation regarding supplements:

“FDA regulates dietary supplements under a different set of regulations than those covering ‘conventional’ foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.

FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.”2

DSHEA opened the floodgates for store shelves to be packed with “supplements” for every ailment and human condition. Essentially, DSHEA created a new category of health claims, referred to as “structure or function” claims. Under DSHEA products could be labeled with claims that they either enhance, improve, or support a biological structure or function without any FDA oversight. For example, a company could claim that their product “boosts the immune system” without first having to meet any burden of evidence. The FDA has no power to regulate such a claim.

The line was drawn at treating specific diseases. Therefore, a company could not claim that a supplement cures cancer. However, they can claim that their product enhances the immune system’s ability to fight cancer. This may seem like a subtle distinction, and it is, which was the whole point. Supplement manufacturers quickly found ways to use DSHEA to make health claims under the “structure or function” clause, without actually making any specific claims. In practice, DSHEA granted free reign to commit fraud as long as you are careful about the wording.

In addition, DSHEA declared that herbal remedies would be regulated as dietary supplements as long as they were not marketed with any of the type of claims that are reserved for pharmaceuticals – disease specific claims. As long as companies restrict themselves to structure or function claims, their product is legally a supplement, and is therefore free of FDA regulations. Therefore, in essence, a company could decide for themselves whether or not their product would be classified legally as a nutritional supplement simply by restricting themselves to certain kinds of claims and avoiding certain others.

The FDA handles post-marketing safety, which simply means that after there are complaints or reports that harm has already occurred (such as happened with the dietary supplement ephedra) then the FDA can step in and investigate. Regarding the honesty of claims, the Federal Trade Commission regulates supplements like they would any product – if companies commit actual fraud in their marketing (which is hard to do given the leeway they are provided) then they can be fined. The fines usually amount to a slap on the wrist compared to the millions most supplements earn their companies – the cost of doing business.

What is a Nutritional Supplement?

The first misconception I would like to explore is the definition of a dietary supplement. There are now two definitions – a scientific definition, and a legal definition. As stated above, the legal definition of a supplement is any substance marketed with supplement–like claims, including many herbs and also homeopathic remedies. A more reasonable and scientifically accurate definition, however, is a substance which is taken for its nutritional value.

Nutrients can be divided into several categories. Some nutrients provide energy in the form of calories. The only substances which provide calories are protein, fat, sugars, and alcohol. Our bodies are not able to extract energy from any other substance. So we must consume a certain amount of calories from one or more of the above substances in order to survive.

Proteins and fatty acids are used not only as a source of calories but also as a source of structural elements or as key components of biochemical processes. In addition, there are certain “essential” fatty acids and amino acids (the building blocks of proteins). The definition of “essential” is a specific substance that our bodies need but that they cannot make from other substances. Some fatty acids we can manufacture by chemically altering other fatty acids, but some we cannot and therefore we must get them directly from our food.

Another category of nutrient is vitamins. Vitamins, by definition, are substances which our bodies need in order to carry out their biochemical functions but that our bodies cannot manufacture from other substances. Therefore, we must consume vitamins in our food. Minerals are similar to vitamins but they are mineral elements, such as iron, rather than chemical substances.

Therefore, a substance is a nutrient if it provides calories, essential proteins or fatty acids, vitamins, or minerals. A nutritional supplement would then by definition provide a nutrient or nutrients to supplement what we get from food.

A drug, however, is not a nutrient. Rather, drugs exert a pharmacological effect on the body. They alter the biochemical function of the body, usually by binding to receptors on or inside cells to alter the balance of biochemical reactions and produce a physiological effect. Drugs may also be targeted against microbes invading one’s body.

So are herbs nutritional supplements or drugs?

Typically, herbs contain dozens or hundreds of chemical substances, most of which with little or no nutritional value. Herbs are primarily used for their pharmacological effects. In other words, herbs are drugs. DSHEA, however, allows them to be marketed as supplements not based upon how they are used or the kinds of effects they have in the body, but solely on the type of claims that are made for them by the manufacturer.

All Natural

Another important component of the marketing of nutritional supplements, herbs, and other products is the claim that they are natural. In today’s culture the word natural comes with it an almost mystical aura of wholesomeness, which translates into both safety and effectiveness when applied to healthcare products. There are many problems, however, with this belief. The first is that the word natural does not have a clear, and specifically a legal, definition. So companies can label almost any product as natural without regulation.

If we attempt to come up with a working scientific definition of “natural” the fuzziness of this term becomes clear. At first glance, it seems like a simple concept. Something is natural if it occurs in nature. An apple, for example, is natural. However, what if I make apple sauce out of a bunch of apples? Is the apple sauce natural? What if I bake an apple pie, or dehydrate the apple to make apple chips, or what if I separate out some of the components of the apple and purify them? We quickly wander into the gray zone of how much processing of a naturally occurring substance is required for a substance to no longer be considered natural.

We could take a maximally restrictive definition, which is that in order to be considered natural a substance must occur in nature and not be processed or altered in any way. A maximally liberal definition could be, however, any substance which occurs in nature regardless of how much processing, purification, or other alterations it has been subjected to. Most people would choose something in between these extremes, but in between there is a smooth spectrum of gray without a clear place to draw the line, hence ambiguity in the definition and the total lack of any regulation of how the term is used in marketing.

Beyond the definition of natural is the assumption that there is any inherent advantage in safety or efficacy of substances which occur in nature. This belief appears to be largely based in a vague fear of the toxins and chemicals produced by a modern industrial society. Such a fear is occasionally well-placed, but it has also led to misplaced trust in all things natural.

What substances happen to occur in nature at this time in the world’s evolutionary history does not have any particular correlation to the needs or desires of any one species, particularly not one egocentric primate. Plants and animals evolve chemicals that serve their immediate needs. Animals, in turn, evolve the ability to consume plants and/or animals in their environment so that they have access to nutrition. Animals may evolve the enzymes to digest or to detoxify their food. However, many plants evolve toxins specifically to discourage animals from eating them.

So, in nature we see the full spectrum of chemicals from those that have little or no pharmacology activity for humans, have various nutritional components, and also have pharmacological and toxic effects. Sometimes we can use these pharmacological effects for medical purposes. Some naturally occurring substances are just deadly and have no practical purpose. Therefore, from both a logical and empirical point of view there appears to be no specific relationship between whether or not a substance occurs in nature and whether or not it has a harmful or potentially useful effect on human physiology.

A particular naturally occurring substance may be useful, but this has nothing to do with the fact that it occurs naturally. Also, if the chemical structure is altered the properties of that substance are likely to change, but there is no reason to suspect that changing it will necessarily make it more or less harmful or beneficial. In other words, substances which do not occur in nature may also be benign, deadly, useful, or anything in between.

The bottom line is that being natural means absolutely nothing in and of itself to the safety or effectiveness of any product.

The Misuse of Research Claims

Increasingly companies are claiming that their products’ benefits are backed by scientific research. However, on closer inspection they are misusing and abusing such research to promote their product, rather than investigate its true safety and effectiveness.

The most common error made by such companies is to base clinical claims (safety and effectiveness for a specific health benefit) on pre-clinical or basic science studies (looking at cells and chemicals in test tubes and petri dishes – which is called in vitro). In other words, they may cite a study which shows that their “supplement” increases the activity of T-cells (a type of cell in the immune system) in vitro. They then use this data to support the claim that their product “enhances the immune system,” or even cures cancer. The problem here is that the precise relationship between basic science in vitro observations and the ultimate clinical implications in a human are not clear. There are hundreds of substances which look promising in the test tube for every one that eventually is found to be safe and effective in people. For example, increasing the activity of certain T-cells may have no benefit to the functioning of the immune system, or it may be harmful by causing auto-immune destructive effects on the body.

Making clinical claims based upon pre-clinical research is just another type of deception used to market supplements. Companies do not fund useful clinical research into their products for two good reasons. The first is that they don’t have to, so why take on the expense of research if it is not demanded. The second is that well-designed meaningful clinical research just might demonstrate that their product has no benefit – that their amazing health claims are not true. So under DSHEA, clinical research for supplements is a lose-lose proposition for the industry.

The Marketing of Supplements

The strategies which are currently employed by the growing supplement industry to market their products reflects the inadequate state of regulation brought about by DSHEA. Companies typically use a combination of strategies, each of which may be legal (although deceptive) in and of themselves, but the combination is designed to create the impression of specific health claims.
For example, companies will often have MD’s or other health professionals endorse their products. These hired guns are careful not to make any specific health claims, and often all they say is that the product is “healthy” and they recommend its use. The purpose of such endorsements, however, is easy to see.

Another component of the marketing strategy is to make precisely those claims which are allowed by DSHEA. A skeptical individual might think it an amazing coincidence that all supplements have exactly the kinds of health benefits that their manufacturers are allowed to claim without regulation. Websites and company advertising material are therefore full of claims that their products boost the immune system, detoxify the body, enhance energy, improve mental function, or other “structure/function” claims.

The third component is the liberal use of testimonials. Testimonials are very useful to companies because they are simply relating what others are claiming about their products – they are not making the claim themselves. Also, it is not difficult to find positive testimonials for any product. Further, personal stories and recommendations are particularly compelling to the public.
Finally, as discussed above, companies will often cite basic research that shows their product contains certain components or has certain effects in vitro to substantiate their health claims.

Therefore, supplement companies may combine on their promotional material doctor recommendations, vague structure/function health claims carefully worded to seem as if they are specific health claims, misinterpreted research allegedly supporting the supplement’s health benefits, and finally amazing testimonials claiming the supplement cures everything from fatigue to cancer. The consumer is left with the definite impression that the product is supported by mainstream physicians and backed by research. Further, consumers are likely to believe that the health claims have been reviewed in some way, and at least companies would not be allowed to directly lie about their products safety and effectiveness.

It is therefore not surprising that American consumers are spending billions on an exploding supplement industry. Companies can essentially market any combination of substances, make any health claims they wish using the formula above, and be completely free of any FDA oversight. Companies can decide for themselves that their products are “supplements” simply by avoiding in their marketing certain word choices which make direct curative claims (but indirect claims and testimonials are OK).

Noni Juice

In order to illustrate the marketing strategy I have outlined above, I will use as an example the marketing of tahitian noni juice. Noni is the fruit of a tropical tree common in Polynesian islands. It has been used by some islanders as a native folk remedy, which is not unusual since every culture has their folk remedies. Noni juice is now being mass produced and marketed internationally as a dietary supplement.

The home page for the Morinda corporation, a major marketer of noni, has the following claims:

“TAHITIAN NONI® Juice supports the immune system, which strengthens the body’s natural ability to fight disease and infection.
It supports proper digestion, which means you absorb more nutrients at the cellular level.
It is good for so many systems of the body, it help give your hair a healthy shine and lets your skin glow.
You may notice increased mental clarity, increase attention span, and greater physical performance levels.”3

These same claims could be taken off any of thousands of websites for different substance, again because they follow the format of claiming support for body structure and function, precisely those claims allowed by DSHEA.

If you click on the “Doctors Speak” button you will read endorsements by physicians such as:

“Out of all the food supplements I have studied and written about, TAHITIAN NONI® Juice has piqued my interest the most. I plan to continue studying it and writing about it because I believe it can help so many people in so many ways.”
—Neil Solomon, M.D., PhD., Physiology

“Noni helps improve the entire spectrum of your health, not just a single problem. Noni helps your body generate life force… and revives your body’s natural ability to heal itself.”
—Dr. Sam Kolodney

“The Morinda Citrifolia that grows in French Polynesia is about 20% higher in nutrients than is noni fruit from any other part of the world. TAHITIAN NONI® Juice is the only one I use in my practice and the only one I endorse.”
—Scott Gerson, M.D.

As stated, we see no specific health claims, just a clear endorsement, not only for noni but for a specific brand of noni.

If we click on the “Research studies” we are first met with a disclaimer which says, “The site linked hereby is not endorsed nor operated by Morinda. The testimonials are on an independent site and we have no control on any testimonials submitted.” How convenient – an extra layer of legal protection for Morinda. On this linked site there are many testimonials, with 68 specific diseases listed, each containing claims of noni cures. The diseases range from acid reflux to yeast infections, and include several types of cancer, common problems like weight loss, and often imaginary problems such as chronic fatigue.

The page on research discusses a number of studies, almost all of which are in vitro and simply relate to interesting compounds found in noni.4 Like many plant products, noni does contain many substances and I’m sure some of them will be found to have pharmacological effects on the body. Perhaps through standard research there are potential new drugs that can be developed from noni compounds. But this research tells us nothing about the safety or overall health effects of consuming raw noni juice regularly.

The site also lists one human trial, the first, which is ongoing. The trial will not look at health outcomes, but rather biochemical changes that are believed to relate to health outcomes, specifically “chemopreventive” markers in smokers. It is always a good trick to list ongoing research or future research – it tends to lend legitimacy in the minds of consumers without producing peer reviewed positive results.

Conclusion

Simply put, DSHEA is pro-industry, anti-consumer regulation. It has established a system in which companies are functionally not held accountable for the safety of their products or the claims that they make for them, and there is no incentive to fund meaningful research. DSHEA should be repealed. The concept of structure and function claims should be abolished. Also, the idea of allowing companies to decide for themselves whether or not their product is a drug or a supplement must be eliminated.

In its place new regulation should ensure that all drugs are treated like drugs, even if they are “natural” or herbal. This means that they will fall under FDA regulation and require adequate evidence of safety and effectiveness before they can be marketed to the public.

True supplements, like vitamins and minerals, should not be regulated like drugs. They are more similar to food, so they should still be regulated for purity and accuracy is labeling. However, no health claims of any type should be allowed in the marketing of any supplements (or food for that matter) unless the claims are first subjected to FDA review. This review process would not necessarily require that any new research be done, but it would ensure that any health claims are honest and adequately supported by existing research. This common sense measure would go a long way to protecting the public from misinformation in the vital area of personal health.

Fortunately, there is mounting criticism of DSHEA and the supplement industry. The December 19th issue of the New England Journal of Medicine, for example, contained three sharply critical articles echoing many of the points I have made here.5, 6, 7 The FDA is also doing the best they can under the hamstringing of DSHEA. The Consumer Health Information for Better Nutrition initiative announced in December of 2002 is designed to “encourage” the supplement industry to provide more honest and science based information in their labeling and claims.8 But still, the FDA lacks teeth to effectively enforce this initiative.

Hopefully the American public will learn that they are being sold a bill of goods and this will lead to improved regulation designed to protect the consumer and spawn meaningful research.

References

1)Dietary Supplement Enforcement Report, www.fda.gov/oc/nutritioninitiative/report.html
2) U. S. Department of Health and Human Services, U.S. Food & Drug Administration, Center for Food Safety & Applied Nutrition: Dietary Supplements; http://vm.cfsan.fda.gov/~dms/supplmnt.html
3) http://www.nonijuice.us/
4) http://www.incc.org/research.htm
5) DeSmet ASM, Herbal Remedies, NEJM 347, 25:2046-56, 2002
6) Stephen Straus, M.D., of the National Center for Complementary and Alternative Medicine (NCCAM), Herbal Medicines: What’s in the Bottle?, NEJM 347, 25:1997-8, 2002
7) Marcus D, Grollman A, Botanical Medicines: The Need for New Regulations, NEJM 347, 25:2073-6, 2002
8) FDA Announces Initiative To Provide Better Health Information For Consumers, www.fda.gov/bbs/topics/NEWS/
2002/NEW00859.html

Filed under: Science and Medicine, DSHEA, Noni, supplements