Mislabeling of Herbal Products in the US and Lack of FDA Regulation
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Mislabeling of Herbal Products in the US and Lack of FDA Regulation
The use of herbal products has increased significantly in the United States, with many people relying on medicinal herbal products as some part of primary care. The switch to the use of herbal products has been driven by the need to embrace a healthy lifestyle, particularly in commodities that easily accessible to the consumer market. In turn, this has opened a new market, attracting companies to capitalize on the growing demand for herbal products in North America. This boom has put pressure on the Food and Drug Administration Agency (FDA), which does not have adequate resources required to monitor the dietary supplement manufacturers. The impact of this is the increasing threat to the safety of the consumers because of the possible contamination and substitute products. There is, therefore, a growing concern calling for attention to the issue of mislabeled products and the inadequacy of FDA regulation. This research paper will present an argument regarding the integrity of the herbal product substitution, contamination, and use of fillers along with the possible health risks for the consumer.
The Growing Use of Herbal Products
North America has witnessed a growth in the number of people in the population seeking to use dietary supplements and herbal products in recent years. According to Tucker et al. (2018), over 50% of the adult population in the United States consume herbal dietary products, and this is the fuel behind the $35 billion industry. However, this is not a practice that started recently in the United States but has always been there since the last decade. Abebe (2002) recorded that in a survey conducted in 1999 revealed that approximately 49% of American adults were using some form of herbal products in the previous year. It then reflects that the use of herbal products is not new in this age of information, as many people have always regarded the significant use of herbal products on their general health. Navarro et al. (2019) also supported these findings by including in their studies that the use of herbal products has increased in the United States and is responsible for over $36 billion in commerce om the nation. All these figures show the relevance and need to analyze the industry practices along with the impact of the products on American consumers.
The growing use of herbal products in North America can be attributed to consumer awareness regarding their health and wellbeing. Different studies have shown that people seek to use herbal products for various reasons but with the primary objective being pursuing better health and wellbeing. A study by Rashrash et al. (2017) on the prevalence use of herbal medicine among adults in the US revealed that a higher percentage of people using the herbal medicine are individuals already diagnosed with chronic illnesses like cancer, diabetes, breathing issues, and people with a history of stroke among others. It then gives a clear picture that the consumer market is driven by the need to improve their health. Ceballos R (2013) mentioned that the increase of the use of herbal products in America could be attributed to the preference of the population for natural therapies, concern for the undesirable side effects of modern medicine, and preference for preventive medicine. Though honest needs drive consumers, integrity in the market remains the biggest threat to the consumer population.
Mislabeling of Herbal Products in the US
The growing demand for herbal products has one crucial impact on the integrity of the industry, and this is mislabeling of the products, which ends up threatening the health of the consumers. Navarro et al. (2019) defined mislabel of herbal products as when the chemical analysis of the products cannot verify every ingredient listed on the label. In other terms, mislabeling refers to the situation where the production companies offer false information regarding the ingredients of the herbal products made available for the public’s consumption. Previous research recorded that most of the herbal products made available to the consumer market are always incorrectly. The findings from the study performed by Navarro et al. (2019) revealed that of the 272 products tested, only 132 had accurate information on the labels regarding the ingredients while the remaining 140, which makes 51%, were mislabeled. Mislabeling occurs when the production companies fail to use at least one of the used compounds or contain compounds that have not been included in the label. In turn, this misleads the consumers regarding what they are purchasing and putting them at risk of affecting their health and wellbeing.
Impact of Mislabeling Herbal Products
Mislabeling of herbal products creates an increasing threat to the healthcare industry only in North America but also around the world. The issue can be traced to the administrative protocols put in place to protect the consumers. DaSilva and Hoareau (2009) mentioned that the effectiveness of the herbal product industry is determined by the availability of the facilities and information regarding the bioprocessing and production of the products. It shows that a greater number of Americans are at risk of developing health issues, given the fact that there is a high number of herbal products that are not labeled correctly in the market. It is from this perspective that Abebe (2019) mentioned that it is highly likely that US healthcare practitioners will witness an increasing number of patients that have been using herbal products. It is essential to realize that the consumer population is not familiar with the research process involved in making the products. However, they rely on the information on the labels and approval of the FDA with the hopes that the products will provide the desired results. Abebe (2019) also stated that approximately 70% of the patients using herbal supplements are unaware of the possible adverse effects and barely informs care providers on the usage of these products. It is this that shows the lethality of mislabeling herbal products in the US and the lack of effective FDA regulations.
Using mislabeled products can cause various health risks. A study by Newmaster et al. (2013) found that several products use plants that have toxic side effects along with others that negatively interact with other herbal products, medications, or supplements. An excellent example of mislabeling associated with substitution from the study by Newmaster et al. (2013) was the substitution of Hypericum perforatum with Senna alexandrina, which is known for its adverse effects like chronic diarrhea, liver damage, and epidermal breakdown. Abebe (2002) also indicated that some of the herbal products contain coumarin derivatives with coagulate activities, and taking such products increases clotting time, which then puts an individual at the risk of developing heart diseases such as hypertension. In another study, Abebe (2019) mentioned that most of the herbal supplements have plat components like aloe, feverfew, cranberry, and garlic, and when these are taken without direction from a medical practitioner can increase the risk of blood clotting. A study performed by Ekar and Kreft (2019) showed that the mislabeling of products especially associated with diabetes is the leading risk factor behind the increasing number of people who have diabetes. Sarris (2018) also mentioned that though herbal medicine has been used in managing psychiatric disorder for years, misinformation of the herbal products can aggravate mental disorders. Therefore, it shows that the mislabeling of herbal products plays a crucial role in the development of various health disorders affecting the consumer population in North America.
Challenges Relating to Monitoring the Safety of Herbal Products
The leading challenge that results in the mislabeling of the herbal products in the United States is attributed to the lack of adequate FDA regulations. According to Avigan et al. (2016), the safety of the herbal products is often approved by the FDA, where they are evaluated both in vitro and in vivo studies. Avigan et al. (2016) further explained that regardless of the efforts put in place to reduce the risk of harmful products in the market, the FDA does not have adequate resources to determine some of the compounds missing or substituted in the herbal products. Ekor (2014) also added that one of the challenges often encountered by the quality control agencies is the difficulty in determining the inclusion of every plant or even the compounds extracted from different plants. Ekor (2014) explained that regulatory bodies like the FDA often find it challenging to determine factors like the processing techniques and compatibility with other medicines. It is because of this that Newmaster et al. (2013) suggested the use of barcoding to detect compounds that threaten the safety of the consumer population along with the issue of substitution in herbal products. It, therefore, indicates that lack of clear regulation policies by the FDA or the need to go the extra mile and ascertain the production process encourages the mislabeling problem.
Conclusion
Mislabeling of the herbal products is a serious issue affecting the consumer population and burdening the American healthcare system. The problem arises when companies involved in the production of the herbal product offer misleading details to the uninformed consumers who consume the products without realizing the associated risks to their health. FDA must enforce rules and regulations that monitor the production process of every herbal product made available in the market to ensure integrity. At the same time, the FDA should encourage the purchase of the herbal products from healthcare practitioners who can guide the consumers on the right herbal supplements to take that will not threaten their health and wellbeing. Therefore, it is vital to promote integrity in the herbal products industry as a means of creating an atmosphere of trust, and that will facilitate sharing of the right information with the consumers to reduce associated adversities.