A survey conducted in the United States in 2002 revealed that approximately 38 million people were using herbal and dietary supplements, citing them as important for their health, yet only about one third of them had reported the usage of these herbal products to a qualified medical practitioner. Estimates from other reports suggested that approximately 25% of those seeking medical treatment for serious medical conditions were also using ‘unconventional’ treatment which they rarely reported to their doctors. Herbal and dietary supplements have become readily available and can be purchased in almost all retail outlets.
This makes it easy for patients to use them without supervision from a qualified medical practitioner (Medscape Today, 2007). Most people tend to think that since herbs have been obtained from nature, they are automatically safe. But is this really the case? True, some of these products may be consumed without occasioning any harm to the body but some may contain contaminants that may lead to medical complications and even death. For this reason, it is important that the US Food and Drug Administration regulate these herbal supplements for safety and efficacy (Finkel & Pray, 2004).
Concerns arising from use of Herbal supplements The use of herbal and dietary supplements is not under regulation by the US Food and Drug administration. This is very dangerous since it means that these products have not been tested for purity and potency yet they are being consumed by humans in large quantities every day (Medscape Today, 2007). Many plants are quite toxic depending on the climate as well as the condition of the soil where they were grown. The FDA warns that most of the herbal products which are marketed have not been tested and do not contain any information on their toxic content.
Thus, while most users may escape injury, there have been some isolated reports of some people dying or incurring grave injuries as a result of using herbs (Finkel & Pray, 2004). Other than the natural toxicity which may be present in plants, it has also been reported that the preparation of these herbs is questionable. Medscape today reports that some of the prepared herbs have been found to actually contain prescription drugs and worse still, heavy metals. These products are never labeled as part of the ingredients and this poses a risk to those who consume them.
The danger here lies not only in the fact that these contaminants may cause toxic poisoning to the patients but also in the fact that some patients are allergic to certain products and may consume them without knowing, thus endangering their lives (Medscape Today, 2007). Currently, the labeling of products from herbs is under the regulation of the Dietary Supplement Health and Education Act. Manufactures of herbal products are required to make general statements on the safety and efficacy of the product. This includes a compulsory statement that disclaims the product from diagnosis, prevention or cure of any disease.
Unfortunately, these labels have been designed to promote the use of the product but do not really give the consumer any concrete information on the nature and content of the product. If the FDA is mandated to regulate these products, they will be able to place more necessary information such as side effects and contraindications so that the users know what to expect. This will also put herbal products in the same category as prescription drugs which might probably make the users more inclined to report the usage of these products to their physicians (Medscape Today, 2007).
Another issue that raises concerns on the efficacy and safety of the herbal supplements is the fact that no testing or quality control is performed on them prior to being sold in the market. As such, a consumer cannot really be sure if the supposed ingredients that the manufacturer claims to be the contents are actually there or if the product can actually perform the healing wonders that it is purported to. Other than the obvious rip-off, this issue presents concerns over the overall safety of the product (Finkel & Pray, 2004).
In deed, the effects of no FDA regulation on herbal products have been seen in the ban on some of the herbal supplements such as those containing ephedra whose usage had resulted in adverse effects on the cardiovascular system in patients. Another product, Kava, was also prohibited due to worries on hepatotoxicity (Medscape Today, 2007). It is rather unfortunate that the FDA can only act against the use of herbal supplements as they evaluate them case by case. In the event that a product has brought about serious injury, investigations will not occur unless there are many other similar reports.
This is rather dangerous because by the time the FDA reacts; many people could have been permanently injured or killed as a result of using the product, a situation which could have been easily avoided if the products had been suggested to quality control and analysis. Prevention is always better than cure and mandating the FDA to regulate herbal products will not only go a long way in improving the quality of these products but is also bound to save many lives (Finkel & Pray, 2004). Evidence supporting lack of Safety and Efficacy in Herbal Products
There are very many herbal supplements which are available in the market and which are purported to heal a variety of ailments ranging from the common cold to more serious illnesses such as cancer. Some have been successful in healing these ailments but there are those which have failed in achieving this goal. Other than the above mentioned herbal products, Ephedra and kava whose usage was banned due to the danger posed to the users, there are other products which also exhibit the same concerns. Serious reactions to some herbal supplements purchased over the counter have also been recorded with permanent injuries and even death.
A case study by Marks (2007), researches on the effects of Tricana which was sold as a herbal supplement to the user and had been hailed for promoting good effects to one’s metabolism which included, loss of weight and the enhancement of energy. Mark focuses on a patient who developed dilated cardiomyopathy after ingesting this supplement, a potentially fatal condition. In deed, the use of this product did not promote the much hailed beneficial effects but instead caused insomnia, nervous conditions and diarrhea.
The FDA withdrew Tricana from the market in the year 2000 as a result of these safety concerns (Marks, 2007). Other products include Chaparral which was purported to be a blood purifier as well as a cure for cancer and has also resulted in adverse reactions. It has caused very many cases of liver and kidney related conditions and actually left one patient in need of a liver transplant. Apparently the research on this product has found that the use of chaparral has no benefit whatsoever on the body and pharmacist were advised to inform consumers against using this product (Finkel & Pray, 2004).
These are just a few examples of the dangerous effects that over the counter herbal supplements have posed to their users. Thus, one cannot help but feel that some form of regulation by the FDA will have prevented such occurrences. Granted, some herbal products have a record of success. But it is precisely due to the other dangers posed by the other supplements that the US Food and Drug Administration should regulate the use of these products.
Right now, the reaction of the FDA is more reactive than proactive; removing herbal supplements from the market only after they have occasioned some serious harm to the user. America cannot afford to have knee jerk reactions to matters that concern the safety of the public. Conclusion While we advocate for the FDA to regulate the use of these products so as to promote their safety and efficacy, it will also be in order to engage in some form of public awareness so that the consumers can know ways in which to check for the safety of the herbal supplements.
If they have to buy these products, they should be encouraged to purchase them from pharmacists who are more inclined to give them correct information on the product efficacy. Other sales agents are more inclined to make misleading statements on the product so as to make a quick sale. Above all, it is essential for consumers to be encouraged to report the usage of any of these herbal supplements to their physicians especially if they are taking other medication to prevent any adverse reactions as some of these drugs may not interact well (Finkel & Pray, 2004). ]