The Ongoing Debate on Regulating or Not Regulating the Dietary Supplements
Artist Statement
I have always been intrigued with overwhelming health
news associated with the dietary supplements because most of the time, the
accuracy and authenticity of the news seem doubtful when I try to validate the
proof of the claims. As a matter of fact, billions of dollars are spent on
supplements in the United States each year, yet we know little to no about
their health effects and safety concerns. Hundreds and thousands of dietary
supplements have become part of our food menus for the sole reason that they
are marketed well by the companies. It is not uncommon that supplement
producing companies launch their new products into the marketplace without
informing the FDA. Unlike the drug control mechanism, the safety decisions for
these dietary supplements are left to the producers alone who specifically aim
to maximize their profits without investing much time and effort to ensure the
safety standards of their products.
Upon
digging a little deeper into this situation, I came across the very fact that
there are two schools of thought i.e. for and against the regulation of these
dietary supplements. One side takes a stance that the supplements industry
should not be brought under strict regulations because it is already being
supervised by the FDA. Furthermore, the purpose of these dietary supplements is
to fulfill various requirements of the human body, thus they are meant to provide
benefits to us and nothing else. I am not with this side because when I leaf
through the literature stuff such as Sanchez et al. (2006), Dara et al. (2008),
and Krishnan et al. (2009), I see a reasonably valid and justified side of the
picture which resonates about the health concerns due to low safety standards associated
with these supplements. Despite the bleak side of these supplements, these
products can enter into the marketplace without any testing by the FDA, without
any quality, purity, or safety.
When
I read about the Dietary Supplements Health and Education Act of 1994, known as
DSHEA, I came across the very fact that the said law does not restrict these
supplements to enter into the marketplace. On the other hand, FDA only takes
the burden when it finds some adulteration or misbranding of the product. This
implies that FDA does not act proactively as in the case of drug control, it
only takes the burden of action when there is a problem with the product. Given
this situation, I do believe that it is extremely hard to figure out what is
going on with the supplements, what is in them precisely, and who would
guarantee the safety and quality of these supplements? These questions beg
serious concerns and call into question the validity of the proclaimed benefits
of these supplements. It is crystal clear that the capacity and the role of FDA
are limited because product manufacturers are free to make the claims, and
suppose if FDA encounters any issue with the claim, FDA needs to take the
responsibility to come forward and provide evidence that the claim is
misleading or false. In my opinion, this does not make sense for the reason
that the mushroom growth of the supplements industry has outpaced the FDA’s
capacity to properly regulate it. This is what this essay is all about as it
emphasizes that toughest regulations should be imposed on the supplements to
ensure consumer’s safety all along the line. (
Thesis Statement
“The risks associated with the intake of dietary
supplements are more than the benefits claimed by the companies, therefore,
strict regulations should be imposed on all types of dietary supplements so
that only those supplements are allowed to enter in the marketplace that are
marked 100% safe”.
Introduction
According to Valavandinis
(2016), botanic or herbal products, vitamins, minerals, and chemicals
substances that are added to the diet for the purpose of improving people’s
health are known as dietary supplements. The providers of these dietary
supplements claim there should not be any stiff regulatory standards upon these
supplements because various needs of the human body are met and fulfilled by
these supplements. For example, sports persons require more energy and the
sports energy drink supplements which boost the carbohydrates to the body
provide them with the desired energy. Indeed, hundreds and thousands of
supplements are being sold in the marketplace, thereby making it a multibillion-dollar
industry on the score that the consumer demand is fueling the supply from
strength to strength, the consumer perceives them as healthcare prevention
products which could be consumed to elevate health, and the consumer has an easy access to the information as well as the
purchase of these supplements through the internet highway. Despite that FDA
points to the potential health hazards in addition to the benefits associated
with these dietary supplements, and FDA does not allow these products to be
marketed as health-related drugs, still, the consumer mostly ignores the cons
and gives them a go based on the proclaimed health benefits tagged with these
supplements. Given the facts stated above, this essay takes a stance that the
risks of these dietary supplements are more than the proclaimed benefits, and
the government’s regulations for these supplements are not enough when compared
with the potential risks associated with these supplements. Hence, these
dietary supplements should be brought under strict regulations before they
enter into the marketplace so that the consumer does not fall prey to their
devastating effects.
Body
The regulations upon these
supplements imposed by the US government give credence to the view that they
are not taking into consideration the very fact that the general consumer who
is consuming these supplements is not knowledgeable nor professional. He is not
aware of the potential hazardous side-effects of these supplements, and it is
highly likely that due to his ignorance, he might fall prey to the
disadvantages associated with the intake of the supplements. Valavandinis
(2016) underlines that due to the rapid growth of these supplements and the
related false therapeutic marketing, it becomes extremely hard to
experimentally test these supplements. Secondly, the access to these
supplements is just a click away because ordering them through the internet
highway means quickly receiving them at your doorstep. Third, the United States
alone is not affected by the lack of safety concerns, but Europe is also affected
by the weak regulations (BEUC, 2016). A study conducted in England by Geller et
al. (2015) provides an insight into this matter that every year, there are
around 23,005 visits of emergency departments related to dietary supplements.
As a matter of fact, the EU’s Rapid Alert System for Food & Feed (RASFF)
recorded 55 red alerts that the weight loss supplements were subjected to the
addition of an industrial chemical. The red alerts show that there is no
professional and common harmonized regularity system which perfectly regulates the
standard and safety of these supplements.
The regulatory safety
concerns become more critical when it is observed that there is little to no
consensus on defining the boundaries whether a particular dietary supplement is
included in the natural health products category, contemporary medicine, or in
the category of food supplement. It is not uncommon that a dietary supplement
which is marked and regulated as a food supplement in the United States might
be marked and regulated as a controlled substance or a complementary medicine
(Dwayer et al., 2018). Even the regulatory concerns in the United States become
manifold because sellers of dietary supplements can market their products even
if FDA has low satisfaction regarding their safety (Orhan et al., 2016). This
makes the consumer vulnerable to the low safety standards of these dietary
supplements because without confirming its safety, the seller company can put
it into the hands of the consumer. This could be the reason that 85,000+
supplements have been floated into the US in the current decade with great
concerns over ingredient misidentification, safety, and quality standards of
these products (Mudge et al., 2016; Orhan et al., 2016).
This situation furthers a
serious debate that why not FDA uses the same regulatory standards on these
dietary supplements that are strictly imposed to control drugs? As a matter of
fact, the FDA regulatory restrictions exist on dietary supplements, yet with
broad loopholes. For instance, FDA does not proactively check a supplement
before that supplement enters the marketplace, it only starts its checking once
the product reaches into the hands of the consumer. Only those products that
are adulterated or misbranded come under the scrutiny of FDA (FDA, 2018). On
the flip side, when it comes to scrutinizing medical drugs, FDA acts
proactively because until the drug is proven safe, it cannot enter into the
market ("FDA
regulation of drugs versus dietary supplements", 2015). Given the cons of
these dietary supplements, why not FDA enforces similar rules of drug control
to the supplements? Obviously, any medical drug cannot be marked as sellable
until it is proven safe for the consumer. The drug producer needs to provide
sufficient evidence that the drug is free from all types of health hazards and
it fully conforms to the acceptable safety standards. Why FDA does not apply
the same rules to the regulation of dietary supplements when there is enough
evidence regarding the safety concerns with these supplements? Unfortunately,
it is easier said than done and trickier to implement than it sounds. It seems
like FDA nullifies the safety concerns when it comes to properly regulating
these dietary supplements. FDA must not ignore the very facts presented by
Valavanidis (2016) that alone in the year 2013, one hundred thousand calls were
received by the US poison control centers due to the exposure of consumers to
supplement related poisoning. Hence, there is a great need for an increased and
strict governmental regulation on these supplements so as to ensure the safety
of the consumer all along the line.
Conclusion
The current essay acknowledges that there are hundreds and thousands of dietary supplements being marketed and sold in the consumer market based on the proclaimed health benefits associated with these supplements. But the current essay deems that the potential risks of these supplements outweigh the proposed benefits. The reasons are numerous, such as these supplements could be hazardous to health, the consumer is ignorant about the side effects of these supplements, the red alerts and safety concerns are alarming, and most of all, devoid of any safety regulatory mechanism, these supplements are easily accessible through the internet. The essay concludes that beyond doubt, the safety of these products needs additional oversight and strict regulations should be imposed on all types of dietary supplements so that the consumer does not fall prey to low-standard and harmful dietary supplements.
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References
BEUC. (2016). Food Supplements Challenges & risks for consumers.
Retrieved from https://www.beuc.eu/publications/beuc-x-2016-092_ipa_beuc_position_on_food_supplements.pdf
Dara, L., Hewett, J., & Lim, J. K. (2008). Hydroxycut hepatotoxicity:
a case series and review of liver toxicity from herbal weight loss
supplements. World journal of gastroenterology: WJG, 14(45),
6999.
Dwyer, J. T., Coates, P. M., & Smith, M. J. (2018). Dietary
supplements: regulatory challenges and research resources. Nutrients, 10(1),
41.
FDA regulation of drugs versus dietary supplements. (2015). Retrieved
from https://www.cancer.org/treatment/treatments-and-side-effects/complementary-and-alternative-medicine/dietary-supplements/fda-regulations.html
FDA. (2018). Dietary Supplements. Retrieved from https://www.fda.gov/food/dietarysupplements/
Krishnan, P. V., Feng, Z. Z., & Gordon, S. C. (2009). Prolonged
intrahepatic cholestasis and renal failure secondary to anabolic androgenic
steroid-enriched dietary supplements. Journal of clinical
gastroenterology, 43(7), 672-675.
Mudge, E. M., Betz, J. M., & Brown, P. N. (2016). The importance of
method selection in determining product integrity for nutrition research. Advances
in Nutrition, 7(2), 390-398.
Orhan, I. E., Senol, F. S., Skalicka-Wozniak, K., Georgiev, M., &
Sener, B. (2016). Adulteration and safety issues in nutraceuticals and dietary
supplements: Innocent or risky. Nutraceuticals, Nanotechnology in the
Agri-Food Industry; Grumezescu, AM, Ed, 153-182.
Sanchez, W., Maple, J. T., Burgart, L. J., & Kamath, P. S. (2006,
April). Severe hepatotoxicity associated with use of a dietary supplement
containing usnic acid. In Mayo Clinic Proceedings (Vol. 81,
No. 4, pp. 541-544). Elsevier.
Valavanidis, A. (2016). Dietary Supplements: Beneficial to Human Health
or Just Peace of Mind? A Critical Review on the Issue of Benefit/Risk of
Dietary Supplements.
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