© 2012 Dr. Dale Peterson & drdalepeterson.com

As a physician I strive to help others restore and maintain their health as safely and effectively as possible. In doing so I utilize and recommend the strategies I believe will bring the greatest improvement in the shortest amount of time without harming the individual in the process. There are times when the person consulting me has a challenge for which there is no innocuous solution. I then recommend what I believe to be the safest course, the one least likely to have an undesirable outcome.

Many people who come to me do so because they have heard that I understand and utilize a wider variety of therapies than most physicians. They come from different vantage points. Some are individuals who prefer to manage their health challenges with diet, activity, and nutritional supplements, but value my ability to prescribe medications if they are needed. Others have been aggressively pursuing standard medical approaches and are often taking many medications. They are seeking alternatives only because those treatments have not resolved the challenges they are facing.

The people who have been using “natural” approaches are often leery of surgery or prescription drugs while those who have been through operations and are on multiple drugs are afraid to try nutritional supplements because they view them as untested, unregulated, and poorly understood.

In reality, the two sides have much more in common than they realize. In practice I view many “dietary supplements” as medications and some of the “drugs” I prescribe as natural supports. Since foods, supplements, and drugs are all marketed for sale in capsules, tablets, liquids, lotions, creams, and ointments it is important to know how to tell what you are purchasing.

There are practical definitions of foods, dietary supplements, and drugs. Merriam-Webster defines food as “material consisting essentially of protein, carbohydrate, and fat used in the body of an organism to sustain growth, repair, and vital processes and to furnish energy; also: such food together with supplementary substances (as minerals, vitamins, and condiments).” It defines a dietary supplement as “a product taken orally that contains one or more ingredients (as vitamins or amino acids) that are intended to supplement one's diet and are not considered food.” In pharmacology, a drug is "a chemical substance used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being.”

There are also legal definitions. According to the Food, Drug, and Cosmetic act Section 201(g)(1) a drug is (a) an article that is recognized in the official United States Pharmacopeia, official Homeopathic Pharmacopeia of the United States, or official National Formulary, or any supplement to them; (b) an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or an article (other than food) intended to affect the structure or any function of the body of humans or other animals.

A dietary supplement is defined under the Dietary Supplement Health and Education Act of 1994 (DSHEA) as a product that is intended to supplement the diet and contains any of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical (excluding tobacco), an amino acid, a concentrate, metabolite, constituent, extract, or combination of any of the above, a substance historically used by humans to supplement the diet. The hormones DHEA, pregnenolone, progesterone, and melatonin are marketed as dietary supplements in the United States.

These legal definitions account for the FDA’s bizarre regulatory rules and the strange games that must be played by distributors of dietary supplements. Every time I recommend a dietary supplement it is with the intention of treating, curing, or preventing disease. Unfortunately, if a company suggests that one of its products is helpful in that regard it comes under fire from the FDA, as did the Diamond Walnut Company for truthfully stating that the omega 3 fatty acids within their walnuts help to prevent heart disease. Because of that simple statement, Diamond’s walnuts were declared a “new and unapproved drug” and the company received a warning letter from the FDA.

While the legal definitions of foods, supplements, and drugs determine how each group is regulated by governmental agencies, they are not particularly helpful in determining their relative safety or their impact on the body. In dealing with my personal health challenges and when making recommendations to others I am not concerned about the legal or regulatory status of a substance. I consider how the substance affects body processes, what benefits it can provide, and the risks involved in consuming or using it. I encourage you to take a similar approach.

When evaluating a substance I first attempt to determine whether it will support or undermine the body’s ability to do what it is designed to do. I then consider any known benefits or risks associated with its consumption. Finally I ask whether ingesting the substance is expected to result in improvement in the quality or length of life. Only by considering these factors can a sound decision regarding the use of a food, supplement, or drug be made.

Whole foods are almost always support the body’s ability to function properly. They provide varying amounts of macronutrients (carbohydrate, protein, and fat) and micronutrients such as vitamins, minerals, amino acids, and fatty acids. With the exception of those that are genetically modified, whole foods provide benefits with little or no risk. Consuming whole foods is expected to improve the quality of life and result in a longer life span.

Refined foods, while a rich source of carbohydrates, have been stripped of micronutrients. They are known to increase the risk of obesity, diabetes, degenerative diseases, and they can shorten life expectancy.

Dietary supplements are the most difficult to categorize. Some are simply whole foods such as barley or wheat grass and fruit or vegetable concentrates. These can provide significant benefits with no risks, provided that the plants from which they are obtained are grown in rich, organic soil.

Supplements that contain supportive amounts of micronutrients are also safe and can be very beneficial in maintaining a high quality of life and in extending life span. On the other hand, taking high amounts of some micronutrients can cause significant damage and increase the risk of premature death.

An example is niacin, which is also called vitamin B3. Deficiencies of niacin result in pellagra, a condition characterized by what are called the “four Ds” - diarrhea, dermatitis (skin disease), dementia, and death. Pellagra can be prevented or reversed by supplementing niacin. In amounts up to 100 mg. niacin supplements rarely cause any adverse reactions. Higher amounts commonly cause uncomfortable flushing of the skin. When taken in doses of three grams or higher, which have been prescribed to lower cholesterol and triglyerides, serious side effects can occur including liver damage, gout, peptic ulcers, loss of vision, high blood sugar, and an irregular heartbeat.

Many substances sold as dietary supplements in the United States are neither whole food concentrates nor standard micronutrients. They fall into the broad categories of herbs and other botanicals, metabolites, constituents, extracts, and hormones.

Herbs vary widely in safety and efficacy. When used medicinally they can be divided into three classes: superior herbs, inferior herbs, and messenger herbs. Superior herbs are substances that have little or no potential to cause adverse effects and that are safe for long-term consumption. Garlic is an example of a superior herb. It is often used as a seasoning, can be used daily over the course of one’s lifetime, and, outside of causing a distinctive body odor, does not cause any undesirable effects. Traditional Chinese herbal formulations are dominated by superior herbs.

Inferior herbs, on the other hand, are substances that are capable of conferring specific benefits, but which also have the potential to cause harm. St. John’s wort is an example of an inferior herb. While St. John’s wort has been used for centuries to treat depression and has been demonstrated to be beneficial in helping the body overcome viral infections it can cause side effects such as dry mouth, dizziness, diarrhea, nausea, increased sensitivity to sunlight, and fatigue. Skilled practitioners use inferior herbs sparingly. They generally use combinations of herbs that are formulated to work synergistically to obtain the desired result.

Messenger herbs are substances that tell the body how to respond to a particular blend. A knowledgeable herbalist can change the action of a formulation simply by changing the messenger herb while the blend of superior and inferior herbs remains the same.

Consumption of non-herbal botanicals can also have unintended consequences. Aloe vera is used topically to relieve a wide variety of skin conditions, but it is also used internally to ease heartburn, boost the body’s immune response, and to relieve constipation. While it is generally safe, I have seen individuals who have developed a dark staining of their large intestine called melanosis coli from prolonged use.

A metabolite is a substance that results from the breakdown of a larger molecule. Metabolites can have far different effects on the body than their parent compounds. I was recently asked about 7-keto-DHEA, a dietary supplement that is being promoted for weight loss, memory enhancement, and prevention of age-related decline of the immune system.

7-keto-DHEA is formed when dehydroepiandosterone (DHEA), a hormone produced primarily in the adrenal glands, is metabolized. DHEA functions primarily as a precursor of testosterone, but it can also be used to manufacture estrogen. It is frequently recommended for mood enhancement, increased sex drive, and to promote muscle and bone strength.

Due to the increased production of other hormones, DHEA supplements can cause breast enlargement, hair loss, and increase the oiliness of the skin. Women can experience growth of facial hair, lowering of the voice, and other masculinizing effects.

Hoping to find substances that would provide greater benefits with fewer undesirable effects, researchers at the University of Wisconsin evaluated the activity of 150 DHEA metabolites. Of these, 7-keto-DHEA was found to be the most promising. It boosts the activity of two enzymes that increase the body’s metabolic rate. A 2007 study showed that supplementation during a calorie-restricted diet prevented the decrease in metabolic rate usually associated with dieting. It did so without causing changes in heart rate and rhythm or nervous excitability typically seen with stimulants.

Hormones are interrelated, and changes in one hormone level commonly affect the levels of others. One study looked at the topical administration of 7-keto DHEA in healthy men between the ages of 21 and 70. While no significant changes were noted during the eight days that 7-keto DHEA was given, levels of testosterone, estradiol, and sex-binding hormone were decreased for up to three months after the 7-keto DHEA was discontinued. This suggests that supplementing a metabolite can have lasting effects on the body’s production of other hormones. It also demonstrates that products sold as dietary supplements can have far reaching effects in the body and should not be viewed as harmless simply because they do not fall under the legal definition of a drug.

A constituent is a substance that is typically part of a whole food, but which has been packaged separately. Some are major components of whole foods. For example, fish oil containing omega-3 fatty acids is sold as a dietary supplement. Small amounts of omega-3 fatty acids are obtained when certain fish are eaten, but much more can be consumed when the oil is separated from the flesh of the fish and placed in capsules. Fiber is a major constituent of many foods. When separated from the whole food it can be sold as a dietary supplement such as wheat bran or psyllium husk. Major food constituents are generally safe as they are substances that are normally present in the diet, but are simply being consumed in greater amounts.

Substances found in smaller quantities in whole foods are also available as dietary supplements. An example is quercetin, which is found in a number of fruits and vegetables as well as in black and green teas. Quercetin is an effective antioxidant. It is also promoted as an immune system support and an aid to controlling allergy symptoms.

Food constituents as dietary supplements would seem to be a simple matter of separating and concentrating a substance to more effectively obtain the benefits it conveys. The use of constituents as dietary supplements can be carried to extremes, however. An example is methylhexanamine, which is commonly known as DMAA. In 1944 Eli Lilly and Company, a major pharmaceutical company, patented methylhexanamine for use as a nasal decongestant and sold it under the trade name Forthane. More effective decongestants have since been discovered, so DMAA is no longer being used medically.

When the FDA banned the sale of ephedrine as a dietary supplement in 2005 companies promoting products for enhanced energy and weight loss began to look for alternatives. One company, Proviant Technologies, reintroduced the former drug, DMAA, as a dietary supplement. They were able to do so by claiming that methylhexanamine is found in geranium oil. Geranium oil is used topically in aromatherapy, and geranium leaves are occasionally used to make tea. The claim is suspect, however, since independent researchers have been unable to confirm DMAA as a constituent of geraniums.

Body building supplements containing DMAA were removed from U.S. military base stores after two soldiers taking them collapsed and died during physical training. Although the role of DMAA in the deaths is unknown, sale of DMAA products as dietary supplements has been banned in Canada, New Zealand, Sweden, and Australia. The FDA has challenged the marketing of DMAA products in the United States.

Extracts are very similar to constituents, differing primarily by the difficulty of separating and concentrating the substance from a food or plant. Extracts often have more specific effects than constituents. One example is grape seed extract, which acts as an antioxidant, strengthens capillaries and veins, helps maintain tissue flexibility, and slows the release of histamine in the body. Another is grapefruit seed extract, which has antifungal properties.

Identifying an extract product should be straightforward, but unfortunately this is not always the case. Sambucol is the trade name of an extract of substances from black elderberry. It is highly effective in shortening the severity and duration of influenza and other viruses. Unfortunately, the company that markets Sambucol is unable to mention this in any of its U.S. materials. While the product is clearly labeled “Black Elderberry Extract” in Europe, the same product in the U.S. is simply called “Black Elderberry Syrup” making it indistinguishable from elderberry products that do not have the potential to stop viruses in their tracks.

Surprisingly, a number of hormones are sold as dietary supplements in the United States. DHEA, from which 7-keto DHEA is obtained, is one of them. Others are melatonin, pregnenolone, and progesterone. Hormones are potent substances that produce multiple effects throughout the body. They interact with each other and play a critical role in maintaining and balancing major body functions. Relatively small changes in hormone levels can produce dramatic changes. Both sexes produce testosterone and estrogen. Testosterone, which is dominant in males, produces the lower voice and expanded hair growth common to men. Estrogen, which is dominant in females, is responsible for breast development and other sexual characteristics that are common to women.

It is amazing to me that hormonal substances are allowed to be sold as dietary supplements in amounts far beyond those normally produced by the body. Between 0.005 and 0.025 mg. of melatonin is normally released daily. In contrast, melatonin is available in amounts up to 5 mg. per capsule as a dietary supplement. That is 200 - 1000 percent more than that normally present in the body! Since melatonin not only sets the body’s internal clock and signals the onset of sleep, but also influences the activity of the immune and reproductive systems supplementing such massive amounts may well result in adverse consequences that are not yet fully understood.

Dietary supplementation can be extremely beneficial in restoring and maintaining health. Do not, however, accept the illusion that a product is safe to use because it is available as a dietary supplement rather than as an over-the-counter or prescription drug. Food supplements such as barley grass or vegetable concentrates carry no greater risk than consuming the actual food. Basic vitamin, mineral, amino acid, and fatty acid supplements are very safe when taken in optimal amounts, but can pose dangers if taken in therapeutic amounts. The more concentrated a constituent becomes the greater the risk of it causing adverse effects. Extracts should be selected for the specific benefits they provide. Hormonal supplementation can be safe and beneficial if done appropriately, but can be fraught with challenges if taken unnecessarily or in high amounts. When possible, consult with someone who understands the intricacies of herbs, constituents, metabolites, extracts, and hormones before deciding to add a product to your personal health regimen.

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