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EXECUTIVE SUMMARY
The FDA has been instructed by the Dietary Supplement Health and Education Act (DSHEA) on how the Federal Government requires it to react to the marketing of herbal dietary supplements. Most of these products are safe when taken in low dosages and not combined with other herbal dietary supplements or prescription medications. However, research indicates that there are significant areas where more understanding is needed and that there needs to be more education available to the public.
Introduction
Our planet is rich with biologically produced compounds and molecules naturally produced in plants across the world. These chemicals interact with our physiology in a variety of ways, and throughout history, cultures have identified different, naturally-produced substances that can have beneficial effects on our wellness. These herbal remedies are entering into the marketplace as more individuals are seeking to maintain their health and wellness through more ‘natural’ means. These herbal dietary supplements are not controlled or regulated by the Federal Drug Administration (FDA), and as such, they may pose a risk when combined with other herbal dietary supplements or with over the counter drugs.
On the one hand, ancient Greeks prescribed the bark and leaves of the willow tree to relieve pain and fever. Later research and experimentation by Friedrich Bayer with the compounds found in the willow tree led to the discovery of what would become aspirin. As remote parts of the world come into contact with modern markets, their products will begin introduced to U.S. markets under the pretense of having properties to increase health and wellness.
On the other hand, Peruvians in South American chewed the leaves of the coca leaf for strength and stimulation before modern science revealed the extremely addictive nature that the alkaloids (cocaine) extracted from the leaves could become. In this situation, regardless of the health and wellness benefits of these compounds, the government was compelled to regulate the substance to ensure the overall health of the population.
The research conducted in this paper does not work to prove that herbal dietary supplements in the U.S. marketplace present a danger to health and safety; but instead is intended to explore the opinions, confidences, and thoughts that the public has on these products.
How do we define Herbal Dietary Supplements?
The Dietary Supplement Health and Education Act (DSHEA) of 1994 defined a ‘Botanical Dietary Supplement’ as a plant or plant part (a botanical) that is:
• it is intended to supplement the diet
• contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
• is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
• is labeled on the front panel as being a dietary supplement.
For our discussion, an herbal dietary supplement does not need to be labeled as such. Many of the products are not marketed as dietary supplements in that manner. They have an implication to their benefit, but do not state as such. Examples include, “Bigelow Chamomile Tea”, (see Figure 1) which show a statement claiming to be “calming”, and have a reputation for aiding in relaxation; but this product has no statement as being an herbal dietary supplement on its front label.
Figure 1
The Office of Dietary Supplements (ODS, a branch of the National Institutes of Health) provides a listing of these common forms of herbal dietary supplements. To consider the vast quantities of substances and their common forms of production would be beyond the scope of this research. For our purposes, we will use the ODS’s list:
• A tea, also known as an infusion, is made by adding boiling water to fresh or dried botanicals and steeping them. The tea may be drunk either hot or cold.
• Some roots, bark, and berries require more forceful treatment to extract their desired ingredients. They are simmered in boiling water for longer periods than teas, making a decoction, which also may be drunk hot or cold.
• A tincture is made by soaking a botanical in a solution of alcohol and water. Tinctures are sold as liquids and are used for concentrating and preserving a botanical. They are made in different strengths that are expressed as botanical-to-extract ratios (i.e., ratios of the weight of the dried botanical to the volume or weight of the finished product).
• An extract is made by soaking the botanical in a liquid that removes specific types of chemicals. The liquid can be used as is or evaporated to make a dry extract for use in capsules or tablets.
The final definition of what an herbal dietary supplement is, we look to the definition provided by the World Health Organization: “In medicine, it refers to any substance with the potential to prevent or cure disease or enhance physical or mental welfare, and in pharmacology to any chemical agent that alters the biochemical physiological processes of tissues or organisms. Hence, a drug is a substance that is, or could be, listed in a pharmacopoeia.” (WHO) The term ‘drug’ is applicable to these substances, as they have the potential to enhance physical or mental welfare. When discussing herbal dietary supplement in this research, we will also be placing herbal dietary supplements under the context of being a drug.
What is the role of the FDA?
In relation to herbal dietary supplements, the role of the FDA has an uncertain role. In the FDA mission statement we see that it addresses two specific components to our society; our food supply and the drugs available. The herbal dietary supplements, however, fall in a narrow niche between these two components. They are not defined exactly as “food”, nor are they “drugs”. They are components of food products that are intended to add to, replace, or instead of medicinal drugs.
“The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.” (Emphasis added.)(FDA)
The statement that the FDA considers itself responsible to ensure that the pubic receives adequate, science-based information about the medicines and foods to improve health is an important statement, and the foundation on which this research project is built. Two questions immediately arises when considering this statement; first, is the FDA doing enough to ensure the public receives the information that they need, and second, does the FDA do enough to regulate these products.
The U.S. Government outlined the regulation of herbal dietary supplements in the 1994 Dietary Supplement Health and Education Act (DSHEA). This act interferes with the FDAs mission because in regards to herbal dietary supplements the FDA is a reactionary agency; it reacts to complaints. The FDA does not require manufactures to test the products, but instead investigates after the product has entered the market. As Marion Nestles, a Professor of Nutrition, Food Studies, and Public Health at New York University explains, “Congress passed DSHEA on the basis of two quite questionable assumptions: that supplements are basically harmless, and that supplement-makers are basically honest. The law does not require supplement manufacturers to demonstrate the safety or effectiveness of their products to the FDA before selling them. Instead, the FDA must prove a supplement harmful by providing documentation from clinical trials or multiple case reports in court - a tedious process.” (Nestles)
The FDA explains its understanding of the DSHEA on its website, as follows:
“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 their products 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)
Dangers of Herbal Dietary Supplements
The assumption that the FDA makes, via the DSHEA act, is that herbal dietary supplements are safe; and that any the manufacturers of these products have adequate knowledge to prevent any illness or injury may occur. Studies indicate that the rate of incidents,(injury, illness, or death), caused by herbal dietary supplements demonstrates their mostly benign reaction.
Observation of a Poison Control Call Center, as documented in Dietary Supplement Adverse Events (Wallace), recorded only 275 calls out of 75 thousand (0. 4%) which involved herbal dietary supplements. Of these 275 calls over half, 163 (59.3%), were calls regarding individuals who had no symptoms and/or were requesting information regarding supplements. Of the 112 calls, only 8 required hospital admission, including 3 requiring intensive care. Of the 75 thousand calls, only one death was possibly linked to herbal dietary supplements. In the case study, the patient was a body builder who had taken five herbal dietary supplements, most of which included central nervous system stimulants, (caffeine and yohimbe), designed to ‘burn-fat’.
When compared to the 30,000 hospital visits and 200 deaths related to food allergies in our normal diet, we can conclude that in most case the herbal dietary supplements are reasonably safe. (AAFA)
St. John’s Wort
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St. John’s Wort most noticeably increases the breakthrough bleeding in women taking oral contraceptives, and lead to unplanned pregnancy. “Women using oral contraceptives should be warned against using St John’s Wort.” St. John’s Wort also interacted negatively an antihistamine, fexofenadine, complicated interactions leading to organ rejection following surgery, and complicated interactions with other antidepressants. (Zhou 11)
Ephedra
Ephedra is also a very interesting herbal dietary ingredient which requires discussion. Ephedra is the common name for Ephedra sinica, an herbal stimulant which has been used in China since ancient times. Ephedra gained national attention in the early 2000s when the medical examiner performing the autopsy stated that “toxicity of ephedra played a significant role” in the deaths of Baltimore Orioles pitcher Steve Bechler during the spring on 2003. (Bodley) Another professional athlete, Korey Stringer of the Minnesota Vikings, was also using supplements including ephedra when he died of heat stroke during the summer of 2001. (AP, Sports Illustrated)
Following these events FDA Commissioner Mark B. McClellan testified before a House Sub-Committee that “the RAND (Research and Development Corporation) study concluded that ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when it is taken with other stimulants.” Early in 2004, the FDA banned outright the sale of ephredra. (FDA) However, subsequent legal action occurred in 2005 when a Federal Judge, Tena Campbell, overturned the ban of ephedra in the state of Utah. In 2006, the 10th Appeals Court in Denver, CO upheld the ban, overturning the ruling made in Utah.
The sequence of events here demonstrates the difficulty which the FDA faces in regulating herbal dietary supplements under DSHEA. In response to the ban of ephedra, supplement manufacturers have turned to using the biological compounds found in bitter orange (Citrus aurantium). The National Center for Complementary and Alternative Medicine (NCCAM) issued the following statement:
“Many herbal weight-loss products now use concentrated extracts of bitter orange peel in place of ephedra. However, bitter orange contains the chemical synephrine, which is similar to the main chemical in ephedra. The U.S. Food and Drug Administration banned ephedra because it raises blood pressure and is linked to heart attacks and strokes; it is unclear whether bitter orange has similar effects. There is currently little evidence that bitter orange is safer to use than ephedra.” (Emphasis added.) (NCAAM)
The role of the FDA, dictated by the DSEA, is that bitter orange is allowed to be marketed in herbal dietary supplements, manufacturers do not have to perform testing, and that after an incident occurs, then it can react to complaints by performing an investigation, and ultimately issue a ban or warning about the bitter orange-containing products.
Among the Elderly
Research conducted on the elderly border population near El Paso found that 31% were in risk of having a drug-herb interaction, as reported by the Prevalence of Polypharmacy, Polyherbacy, Nutritional Supplement Use and Potential Product Interactions among Older Adults Living on the United States-Mexico Border. The study presents that the older population have a greater degree of health problems, and are likely to be on taking one or more prescription medication while at the same time taking herbal dietary supplements concurrently. The study reported that patients aged >60 years visiting an emergency department (ED) reported that 25% of patients had pre-existing potential drug interactions when they visited the ED. Another study in a similar population (older adults aged >50 years visiting an ED) found that 47% of patients surveyed had potential adverse drug interactions, with 50% of these being related to ED treatment.
The conclusion of that report is that “it should be a priority to educate older adults living on the US-Mexico border about the proper use of medications, herbal products, and nutritional supplements so as to minimize the risk of adverse affects.” However, these same warning are no less meaningful to all age and regional demographics.
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Discussion
The role of the FDA in relation to herbal dietary supplements is not fully understood by the public. The DSHEA outlines, by the Federal Government, what the role the FDA is to play in relationship to dietary supplements. This fact is little understood by many people; as they either expect the FDA to play a more prominent role through either greater regulation or by doing research on their own. The FDA does not perform research for prescription medication; there is no reason to ask a government agency to do it on herbal dietary supplements.
Our society is based upon the freedom of choice; freedom to drink excessive quantities of alcohol, smoke cartons of cigarettes in the confines of our own home, and eat an exclusive diet of Twinkies and Big Macs. Each of these choices carry with it numerous health consequences; alcoholism, lung cancer, obesity and diabetes; however, they are ultimately our choice to make. Herbal dietary supplements are protected by the government because, ultimately, it is our choice to take these products.
The difference however, is that these products are taken, sometimes under the misconception, that they will provide health and wellness benefits, even when they do not, or may contribute to illness, disease, or discomfort.
The research conducted indicates that there is room for further understanding of herbal dietary supplements, and all signs point to the fact that the public wants more information regarding these products. In the research survey, the majority of respondents thought that the FDA was doing a poor job, but none of them mentioned DSHEA. The research conducted on one herbal supplement, St. John’s Wort, showed that it interacted with a many other prescription and OTC drugs. Research among the elderly concluded that these patients required additional education about the dietary supplements they were taking; but that same message could be said about any demographic age group. As Amber Novak stated, “It is up to us (naturapathic doctors and practicioners of TCM) to teach people how to properly use these supplements.”
Conclusion
Unfortunately, the role for the FDA to play in the marketing of herbal dietary supplements has been decided by Congress. As such, to change the current state of these supplements in our market must be directed towards politicians to rewrite the Dietary Supplement Health and Education Act. It took the death of two professional athletes for ephedra to be banned from the markets, which shows how powerful the supplement industry lobbyists have become.
The manufacturers of herbal dietary supplements are protected by Congress, and as such, they should be held to a higher standard for their products. Congress should rewrite the DSHEA so that significant penalties are placed upon these manufacturers if their products are not safe. Unlike Twinkies, Big Macs, and beer, people are taking these products with the belief that it will make them healthier. Manufacturers who do not adequately understand their products or market them deceptively should be held accountable to a greater degree.