A Complicated Pill to Swallow: An Ethical Analysis of Dietary Supplement Regulation in the US
- Ella Kerins
- 1 day ago
- 28 min read
When you take a vitamin or supplement throughout your daily routine, do you ever wonder how effective it is, the meaning behind certain marketing claims, or, most importantly, who approved it? Dietary supplement regulation in the United States was vastly transformed by the passing of the Dietary Supplement Health and Education Act (DSHEA) in 1994, yet, in a time marked by creatine craze, “GLP-1” supplements, and an overwhelming interest in wellness, it is imperative to ethically review regulations through the lens of public health. However, it becomes difficult to gauge ethicality when considering that the US government has a duty to both dietary supplement consumers and corporations. Do current regulations prioritize either stakeholder? What responsibilities does the US government have to them? How is corporate autonomy balanced with consumer health in dietary supplement public policy?
Table of Contents
Introduction
Background Information
Current Regulations
Role of the FDA
Consumer Safety
Ingredient Regulations
Product Advertising and Labeling Oversight
Enforcement
Role of the FTC
Summary
Ethical Analysis
Defining Key Terms
Responsibilities of the US Government
To the Consumer
To Dietary Supplement Companies
Balancing of Responsibilities
Application to Current Industry
Areas of Balance
Areas for Improvement
FDA Post-Market Surveillance System
Alternate Suggestions
General Consensus
Conclusion
Overview of Ethical Opinion
Recommendations
Final Thoughts
Main Image by wirestock from Magnific https://www.magnific.com/free-photo/closeup-shot-
Introduction
A young athlete named Amanda is trying to supplement her workout regime with glutamine, an amino acid known to preserve muscle tissue. Her choice of product is a pill from Vitamin Shoppe called “BodyTech,” which is marketed for sports nutrition and claims to support muscle recovery. After a few weeks of taking the product, Amanda sees no difference in the way her muscles look or feel. Turning to Instagram, Amanda discovers a group of athletes who have had similar experiences with the product. Upon reaching out to them, the group decides to sue Vitamin Shoppe for false and misleading marketing.
Throughout litigation, Amanda comes to understand that because BodyTech is a dietary supplement, it did not receive pre-market approval. In the end, the court rules against Amanda and other plaintiffs on the basis that Vitamin Shoppe’s claims properly complied with federal dietary supplement regulation, which permits “structure/function” claims. This type of marketing describes how an ingredient generally impacts a bodily system (“Structure/Function Claims”). For Vitamin Shoppe, the favorable result allows them to maintain product marketing; however, Amanda and other plaintiffs feel dismissed. The product may not have caused them physical harm, but its lack of effectiveness—in their experience and potentially for other people—is disappointing. How should the US government balance the economic interests of companies like Vitamin Shoppe with the health interests of consumers like Amanda?
In the United States, dietary supplement manufacturers are required to comply with the federal Dietary Supplement Health and Education Act (known as DSHEA, pronounced de-SHEY) of 1994. DSHEA is a set of amendments made to the federal Food, Drug, and Cosmetic Act (the Act) that allocates oversight responsibility to the Food and Drug Administration (FDA) and to the Federal Trade Commission (FTC). In general, the FDA is responsible for product standards and labeling, while the FTC handles product advertising (“Dietary Supplement”). Still in many ways, the industry could be considered underregulated.
Starting with multivitamins and cod liver oil, to now including GLP-1 and stress-reducing gummies, over the past three decades, the dietary supplement industry has transformed into an enterprise worth an estimated $54 billion (Antonio et al. 2). However, toggling in the gray area between food and drug, production and marketing regulations have not simultaneously evolved (Richardson et al.). As seen in the opening case study, products may not meet consumer expectations, and, more importantly, supplements do not go through FDA pre-screening or need governmental marketing approval. Yet, the US government does not have sole obligation to consumers, but it must also consider the interests and autonomy of dietary supplement companies. This paper will ethically examine DSHEA and other regulatory standards to ultimately answer the question: To what extent do current regulations on the US dietary supplement industry balance governmental responsibilities to the consumer with responsibilities to corporations?
Background Information
2.1 Current Regulations
DSHEA was signed into law in 1994, permanently changing the landscape of the dietary supplement industry. In section two of the law, the US Congress detailed their intentions, most notably explaining the importance of protecting American consumers, the necessity to decrease medical expenditures in the US, and the integral role this industry plays in the American economy. They believed DSHEA could act as a preventative health measure in a society that has a proven increased interest in wellness (“Dietary Supplement”).
Before understanding the mechanics of dietary supplement public policy, it is important to understand that legally and functionally, dietary supplements and prescription drugs are very different. DSHEA defines a dietary supplement as “a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: (A) a vitamin; (B) a mineral; (C) an herb or other botanical; (D) an amino acid; (E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E)” (“Dietary Supplement” sec. 3). In contrast, drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” (United States, Congress, House, sec. 321). This distinction is reflective in dietary supplement and drug regulations. While drugs go through an extensive pre-screening process, are tested in clinical trials, and must receive FDA approval, dietary supplements are not evaluated before entering the market. Instead, dietary supplement companies are expected to independently follow regulations, and action is only taken once products are launched.
The agencies taking these actions are the FDA and FTC, who share responsibility for regulating the dietary supplement industry (“Memorandum of Understanding”). The FDA monitors the safety, quality, and labeling of supplements, whereas the FTC handles other advertising, such as posters, slogans, and commercials (Fajardo). However, as previously noted, dietary supplements do not receive pre-market approval from either agency. As the FDA explains, “Under the FD&C Act, it is the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law” (“FDA 101”). This message is reinforced by the mandatory disclosure required on all dietary supplements: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease” (“Dietary Supplement” sec. 6). The pre-market approval process is reserved for drugs, biologics, and medical devices, as is depicted in the chart below. Other aspects of this diagram will be further discussed in coming sections.
Separation of Regulations | |||||||
FDA-regulated products | Pre-market Approval (FDA) | Pre-market Notification (FDA) | Labeling (FDA) | Mandatory Adverse Event Reporting (FDA) | GMPs (FDA) | Facility Registration (FDA) | Advertising (Primarily FTC) |
Foods | ✓ | ✓ | ✓ | ✓ FTC | |||
Dietary Supplements | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ FTC | |
Drugs | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ FTC | |
Biologics | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ FDA | |
Medical Devices | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ FTC | |
Role of the FDA
Consumer Safety
A major aspect of the FDA’s role in dietary supplement regulation is their efforts to uphold consumer safety. There are multiple ways this is accomplished, with the two main areas being setting and enforcing current good manufacturing practice (cGMP) standards and the oversight of adverse event reporting.
The FDA’s set of federal cGMP guidelines were last established in June, 2007. They encompass sanitation standards for manufacturing facilities, the prevention of adulterated products, and methods to increase the quality, purity, and strength of supplements. These standards do not codify what type of supplement potency testing is mandatory though, mainly due to the limited methods of testing available (Wallace). This ambiguity, combined with the FDA’s difficulty in having a clear picture of all dietary supplements on the market, makes it difficult to successfully enforce cGMP standards, raising questions about whether or not reform is needed (Richardson et al.).
Under the Act, dietary supplement adverse events (AEs) are defined as “any health-related event associated with the use of a dietary supplement that is adverse” (United States, Congress, House, sec. 379). Adverse events are often understood to be negative side effects of dietary supplements, though it is important to clarify that they may not be caused by the supplement, but rather occur in temporal proximity to consumption. Dietary supplement adverse events can be caused by a variety of reasons, including inappropriate consumption (e.g., by someone who should not take that supplement because of a health condition), incorrect consumption (e.g., overdosing), and adulterated supplements (“FDA 101”).
Adverse experiences range from common, such as rashes, diarrhea, and joint pain, to serious. The Act defines a serious adverse event (SAE) as “an adverse event that-(A) results in (i) death; (ii) a life-threatening experience; (iii) inpatient hospitalization; (iv) a persistent or significant disability or incapacity; or (v) a congenital anomaly or birth defect; or (B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A)” (United States, Congress, House, sec. 379). Distinguishing between these two categories is important for understanding how dietary supplement adverse events are reported.
Consumers and health care professionals are responsible for reporting non-serious adverse events to the FDA; however, as of 2013, manufacturers are expected to report serious adverse events, which they are aware of, within 15 days (Wallace and Koturbash). Over the last decade, the FDA has used two different dietary supplement adverse event reporting systems: first, the Center for Adverse Event Reporting
System (CAERS), and more recently, the Human Foods Complaint System (HFCS) (“Human Foods”). In an effort to streamline the process though, the FDA is transitioning into using the Adverse Event Monitoring System (AEMS), which will encompass adverse event reporting for all fields into one database (“FDA Launches”).
Before exploring the ethical considerations of reporting systems and responsibilities, it is important to consider the prevalence of these reactions and their rate of reporting. In the opening justifications section of DSHEA, the law states: “safety problems with the supplements are relatively rare” (“Dietary Supplement” sec. 2). On the other hand, an article published in 2022 by the American Medical Association Journal of Ethics explains, “Adverse Events (AEs) associated with dietary supplements are not uncommon. One study found that between 2004 and 2013, the FDA’s central reporting system (CFSAN Adverse Event Reporting System, or CAERS) received more than 15 000 reports of health problems linked to supplements, including 339 deaths and nearly 4000 hospitalizations” (Richardson et al.). The same article references another statistic from CAERS, which estimates that only 2% of all dietary supplement-related adverse events get reported (Richardson et al.). While the statistics they cite, along with the clause from DSHEA, are out of date, it becomes difficult to gauge how large of an issue adverse events present and whether or not current regulations are ethically functioning.
Ingredient Regulations
While dietary supplement companies have relative freedom with what types of products they choose to manufacture, they do have restrictions on which ingredients they can use. Ingredients that may not be included in dietary supplements fall into two main categories: new dietary ingredients and banned ingredients.
Under DSHEA, new dietary ingredients (NDIs) are defined as “a dietary ingredient that was not marketed in the United States before October 15, 1994, and does not include any dietary ingredient which was marketed in the United States before October 15, 1994” (“Dietary Supplement” sec. 8). NDIs may not be used in dietary supplements unless the dietary supplement company has evidence that the ingredient is generally regarded as safe (GRAS) and submits this evidence to the FDA 75 days prior to the product entering the marketplace. This process is known as the “NDI Pathway”. In essence, GRAS ingredients are not subject to pre-market approval on the basis that they have been used in products before, unlike NDIs (“Generally Recognized”).
Furthermore, since the passing of DSHEA, the FDA has explicitly banned the usage of ephedrine alkaloids (also known as ephedra or Ma huang) and 1,3 dimethylamylamine (also known as 1,3-DMAA and geranium extract) in dietary supplements. It is notable that the banning of ephedra and 1,3-DMAA, both known to cause cardiovascular issues, each took seven years.
Product Advertising and Labeling Oversight
While the FTC handles product advertising, in particular, the FDA regulates dietary supplement product labeling claims. Under DSHEA, the FDA prohibits the usage of claims that promise to prevent, mitigate, or cure any disease in dietary supplement advertising (“Dietary Supplement” sec. 6). Instead, permitted dietary supplement product claims include four different categories: nutrient content, structure/function, health, and qualified health (“Dietary Supplements”).
“Nutrient content” claims promote benefits that are directly related to a classic or well-researched nutrient deficiency. When these claims are made, the prevalence of that nutrient deficiency must also be included in labeling (“Dietary Supplement” sec. 6). These claims often include the words or synonyms for high and low, to depict the presence of beneficial ingredients and the absence of undesirable ones. An example of this type of claim is: “Good source of omega-3 fatty acids” (“Label Claims”).
“Structure/function” claims describe how a product can increase general well-being with regard to specific organs or bodily systems. They may also explain how a product will maintain bodily structures and functions. Examples of these claims include: “fiber maintains bowel regularity” or “antioxidants help maintain cell integrity” (“Structure/Function Claims”). This was the type of claim seen in the case study. Both nutrient content and structure/function claims are expected to be truthful and not misleading, as is customary for all dietary supplement advertising, but they do not require pre-market approval. Rather, dietary supplement companies must submit the text of their claims to the FDA no later than 30 days prior to product release (“Structure/Function Claims”).
Contrastingly, “health claims” must be approved by the FDA before the product can be marketed. This is because health claims assert that a supplement can reduce the risk of a disease. FDA approval verifies a claim’s substantiation, which needs to meet significant scientific agreement (SSA) standards. To satisfy these requirements, a group of experts must support the scientific basis for the claim and the nature of the actual advertisement text. This is one of the few times the FDA approves a dietary supplement before commercialization (“Authorized Health”). One instance where health claims could be used is linking the usage of calcium to a reduced risk of osteoporosis (“Label Claims”).
On the other hand, “qualified health claims” do not receive pre-market approval, nor do they have to meet the more rigorous SSA standards. These claims suggest that a product may reduce the risk of a disease and must be accompanied by disclaimers, explaining that they don’t allege to cure, mitigate, or prevent disease (“Qualified Health”). An example of a qualified health claim given FDA discretion is: “Consuming 500 mg each day of cranberry dietary supplement may help reduce the risk of recurrent urinary tract infection (UTI) in healthy women. FDA has concluded that there is limited scientific evidence supporting this claim” (Kavanaugh 22).
In addition to its responsibility for product labeling, the FDA also ensures that ingredient listings and supplement facts panels are safe and accurate. One important aspect of DSHEA, with regard to this facet of marketing, is its proprietary blends policy. Proprietary blends are dietary supplement companies’ signature compounds, and under DSHEA, manufacturers can choose to list out their ingredients on packaging or sub in the phrase "proprietary blend.” In a similar way that the recipe of Coca-Cola is highly guarded, dietary supplement companies want to protect their special formulations. Still, the FDA has the right to know what is in proprietary blends for matters of cGMP monitoring and prioritizing consumer safety during adverse reactions (“Proprietary blends”). Proprietary blends are an excellent example of the competing interests within this industry. Dietary supplement companies want to make competitive products, but consumers want to know what they are ingesting into their bodies.
Enforcement
In terms of enforcing industry standards, numerous articles referenced in this paper claim that the FDA struggles because it operates in a post-market surveillance system. Without a clear picture of the marketplace, it is difficult to hold companies accountable (Richardson et al.) (Fajardo) (Wallace). The FDA does, however, attempt to ensure compliance with DSHEA. They inspect manufacturing facilities to verify compliance with cGMPs, review product labeling, and manage adverse event reports to see if action needs to be taken against a product. If the FDA detects noncompliance, their first course of action is typically the sending of a warning letter, and then, in rare cases, removal or recall of the supplement from the marketplace (“FDA 101”). While these methods are effective when the FDA is aware of the product, unfortunately, in a post-market surveillance system, the FDA only discovers issues after the product has been sold to consumers. It may be important to note though, that most commercial industries function in this way. Still, due to this pitfall, some argue that current regulations do not place enough value on health and safety (Richardson et al.) (Fajardo) (Wallace).
Role of the FTC
As aforementioned, the FTC oversees the advertising of dietary supplements, even though the FDA regulates product labeling. Other forms of advertising the FTC regulates include commercial advertisements, slogans on packaging, promotional materials, and both social and general media marketing. The FTC’s overarching goal is to prevent deceptive acts or practices. Furthermore, in the FTC Act, adapted into the Health Products Compliance Guide, the agency requires advertisements to be truthful and not misleading, along with having adequate substantiation. Similarly to the FDA though, the FTC does not pre-approve dietary supplement marketing, but rather takes regulatory measures after products are being sold (“Health Products”).
When the FTC reviews advertising, they consider both what the manufacturer says and what the manufacturer does not say about the product. The agency determines whether the advertisement is truthful and clear, whether the manufacturer disclosed enough information about the product, and what claims are implicitly created by advertising. Dietary supplement companies must have substantiation in the form of credible scientific evidence for all of this. As the FTC puts it, “FTC law focuses not on the marketer’s intent, but on the consumer’s understanding” (“Health Products”). As an overview, the FTC defines credible scientific evidence as having been obtained through complete scientific methods, explained in totality, and showing relevance to the product. The FTC requires evidence to not just be present, but be of high quality, especially because consumer health is at stake (“Health Products”).
Additionally, the FTC recognizes that exaggerated statements, along with the omission of necessary ones, can make advertising false and/or misleading. A lack of transparency or substantial exclusion could be the basis for an FTC determination of noncompliance. At the same time, sometimes information omitted from advertising claims is supplied through disclosures. Still, the FTC notes that disclosures cannot directly contradict the claim, they must not be avoidable (e.g., an important disclosure that can only be viewed by clicking a hyperlink in the advertisement is “avoidable”), and they must be obvious to the consumer. The terminology used to describe a proper disclosure is “clear and conspicuous”; however, the definition of these terms is a matter of judgment and may vary depending on the nature of the advertisement (“Health Products”).
If a claim, disclosure, or advertisement in general is found to be noncompliant with FTC law, the FTC can take legal action against the dietary supplement company or manufacturer. Consequences can include mandated editing of advertisements, payment of civil penalties, and the loss of advertising abilities in extreme scenarios. In addition to litigation, the FTC may also send warning letters to companies (“Explaining the Regulatory”).
2.2 Summary
Dietary supplements are regulated by the FDA and the FTC under DSHEA. The FDA handles cGMPs, adverse event reporting, product labeling claims, and ingredient regulation. On the other hand, the FTC oversees advertising, aiming to have truthful and not misleading materials that have proper substantiation marketed to dietary supplement consumers. Both industries function in a “post-market surveillance” system, meaning products rarely seek pre-approval, and FDA/FTC enforcement happens once the supplement is already commercialized. The FDA reserves the right to remove adulterated products from the market, and similarly, the FTC has the right to mandate the removal of deceptive advertising. Both agencies also write warning letters to dietary supplement companies and take litigation against them. After gaining an understanding of this topic, questions start to arise about the structure of DSHEA, whether or not certain regulations are effective, and, overarchingly: To what extent do current regulations on the US dietary supplement industry balance governmental responsibilities to the consumer with responsibilities to corporations?
Ethical Analysis
Dietary supplement regulation poses a unique ethical dilemma, centering around three main stakeholders: the US government, dietary supplement companies, and dietary supplement consumers. An integral part of addressing this dilemma is determining what responsibility the US government holds to either stakeholder, and how these duties should be balanced. In this way, the issue lends itself to a deontological lens, as this is where the primary friction lies. If the US government has competing responsibilities, how do they make ethical compromises between the two, and whom should they prioritize if necessary? This becomes a question of weighing corporate autonomy and the health of the public.
In the following section, I will complete an ethical analysis to define what responsibilities the US government has to the two stakeholders, and how I think these should relate to one another. I will consequently apply that conclusion to current regulation, determining what changes should be made based on my ethical reasoning. Next steps and solutions will be explored in the concluding section of this paper.
3.1 Defining Key Terms
Responsibilities of the US Government
To the Consumer
DSHEA was enacted because “improving the health status of United States citizens ranks at the top of the national priorities of the Federal Government” (“Dietary Supplement” sec. 2). The phrase “improving the health status” is not necessarily the same as protecting consumer safety, though. To merely keep consumers safe, the government should be creating regulations and doing work to avoid consumer harm. This pertains to the bioethical principle of nonmaleficence and would likely involve the prevention and management of adverse events through heightened regulation. Yet improving health goes beyond mitigating harm, but rather it attempts to increase benefits for an individual or population, prioritizing the bioethical principle of beneficence. For dietary supplements to do good for Americans, they must be effective to a certain extent, which could possibly be achieved through heightened pre-market screening. While DSHEA is only one thought process regarding the role of the consumer, it brings forth an interesting idea as to whether the US government should be prioritizing the prevention of consumer harm or the maximization of consumer health.
Solely considering the consumer, it seems most ethical to prioritize their overall health, as opposed to just their safety. This transcends farther than the consumer, but it is in a nation’s best interest to better public health, because it will likely decrease healthcare expenditures and help their society function better. At the same time, one could argue it's not up to the government to impose such protection. They may have a duty to keep consumers safe, but they don’t need to concern themselves with consumer health. Rather, it is up to the consumer to optimize their own health, not the government. This argument is enhanced by the consideration that to prioritize consumer health, the government would need to heighten regulations, minimizing some corporate, and even consumer, autonomy.
Still, it seems to me that public health cannot be achieved by individuals, but rather through larger-scale regulations, and that public health should be the top priority of a nation. This is in the interest of the consumer, but also of the government. For the consumer, while they have the autonomy to manage their medical needs, it becomes easier to lead a healthy lifestyle when the government is also supporting them. For the government, healthcare expenditures would decrease, as I mentioned, but additionally, by having a healthier population, the US could have more optimal national outcomes. Therefore, my understanding of the US government’s duty to the dietary supplement consumer is that it goes beyond keeping them safe, but also attempts to improve their health.
To dietary supplement companies
Moving into the following section about the relationship between the US government and dietary supplement companies, it is important to remember the distinction between ethicality and legality, as I will discuss both ethical values and ones of the American government. Generally speaking, an ethical action may not be legal and vice versa, but when examining public policy, it is important to consider both, because realistically, feasible changes are ones that fall into the existing system, as opposed to ones that try to trump legal boundaries.
In America’s free market economy system, governmental intervention in business is fairly conservative and holds clear intention behind it. In this way, the US government fulfills its duty to preserve the autonomy of dietary supplement companies, allowing them to generate profit, be competitive in the marketplace, and utilize their creativity to contribute original products for consumers. However, fulfillment of this duty is typically a result of fewer regulations, which, as explained previously, contradicts how the US government may fulfill its duty to improve consumer health. Another DSHEA justification reads, “although the Federal Government should take swift action against products that are unsafe or adulterated, the Federal Government should not take any actions to impose unreasonable regulatory barriers” (“Dietary Supplement” sec. 2). As the title of the next section suggests, how, specifically from a deontological perspective, should these responsibilities be balanced?
Balancing of Responsibilities
While both stakeholders are significant, based on my understanding of this topic and the framework of deontology, the stake of consumer health seems more significant than the stake of corporate autonomy. This leads me to believe that the US government should consider consumer health to a larger extent than the autonomy of dietary supplement companies. It is important to recognize both stakeholders, but simultaneously recognize their larger context and importance. As either stakeholder is vastly different than the other, they necessitate different levels and kinds of attention. Therefore, it is most fair to not treat either stakeholder the same, but in accordance with their circumstances and the level of urgency they lend themselves to. This embodies the value of equity; stakeholders that are not equal should not be treated equally.
However, one could also argue that corporate autonomy in fact holds a larger stake. The dilemma not only introduces tensions between safety and autonomy, but health and money, and depending on one’s personal values, answers will vary. For myself, health is the most important aspect of life, and I believe that by prioritizing this, companies can create better products, so while they may not have the highest levels of autonomy, they can remain competitive in the marketplace. Still, without any regard for corporate autonomy, the barrier to enter the industry may become too complex, possibly hindering innovation and limiting overall competition. I therefore suggest that consumer health take precedence over corporate autonomy in dietary supplement regulation, though both should still be considered throughout the process. Additionally, if the US government needs to decide between the two, consumer health should be held in a higher regard.
3.2 Application to Current Industry
In many ways, current regulations do strike this balance; however, there are areas for improvement. Returning to the ethical question that asks, “to what extent?”, it is difficult to say exactly how much or how little the balance is upheld, but I have been able to recognize areas of industry that the US government does and does not consider both stakeholders in the way I see ethically fit.
Areas of Balance
The cGMP standards the FDA has established create reasonable expectations for dietary supplement companies, without infringing on their autonomy. Most importantly, they set expectations that will likely benefit consumer health. However, it becomes difficult to actually enforce these standards, which is an area of improvement discussed later on (Richardson et al.).
The adverse event reporting system is imperfect in many ways. There are concerns that not all adverse events get reported by consumers, and that they don’t communicate with their clinicians, who would be able to issue reports. Yet, this seems to be a logistical problem as opposed to one that involves balancing the stakes of consumer health and corporate autonomy, and with the introduction of AEMS, some of these practical issues should be improved. The pressing regulatory dilemma is the very presence of adverse events in the first place, suggesting an alternate need for reform. I will go into further depth about why this presents itself as a sign of an inadequately balanced system and potential ideas for reform in coming sections.
The GRAS and NDI pathways are areas where dietary supplement regulation balances consumer and corporate interests especially well. GRAS not only provides companies with the autonomy to use certain ingredients, but convenience in doing so, ultimately allowing more efficient product development without sacrificing safety. Similarly, the NDI pathway acts as a safeguard for consumers; however, it does not completely deny a dietary supplement company the autonomy to utilize one in their products. Overall, the NDI pathway functions well for the industry, while also setting an example for how the FDA could possibly hold a larger role in dietary supplement pre-market phases. Still, it is important that the FDA has the ability to completely ban ingredients they deem harmful, such as ephedra and 1,3-DMAA. While this undoubtedly restricts corporate autonomy, it is not only in the interest of consumer health, but merely consumer safety. Autonomy should be overridden in this scenario.
Product labeling claims, regulated by the FDA, are a platform for dietary supplement companies to make their products appealing, and while they often utilize more ambiguous language consumers may misinterpret, so long as they are complying with legal guidelines, they do not pose a direct risk to consumer health. Indirectly, these claims may inform what decisions consumers make regarding their health; however, it is too farfetched to respond with a hindrance in corporate autonomy. More time should be spent attempting to create better supplements, as opposed to focusing too heavily on marketing claims that are already regulated.
The FTC guidance provided for dietary supplement advertising, and the methods they use to enforce it, create a suitable balance between the two main stakeholders of this industry. Dietary supplement companies, in general, have autonomy in the marketing space; however, they must hold substantiation for their claims, helping to prioritize consumer health. Corporate autonomy, in this case for advertising their products, is restricted, though not eliminated, to first and foremost think about the consumer. While the post-market surveillance system the FTC utilizes presents some issues, the method is appropriate for matters of advertising—an area that does not directly impact consumer health, but can rather indirectly inform decisions related to consumer health. The only improvement I suggest, which will be discussed in the coming section, is that regulations need to be more codified and objective to make compliance and enforcement more straightforward.
Areas for Improvement
FDA Post-Market Surveillance System
The largest area for reform I have identified is the FDA’s post-market surveillance system. The issue with this framework is that adulterated or potentially dangerous products must reach the marketplace and have negative impacts before the FDA can take action. This is also true of advertising and marketing claims, but in terms of product quality, the stakes are much higher, with there being a potential for unfavorable impacts on consumer health and safety. A pre-market surveillance system could verify evidence for product claims, conduct cGMP inspections, and ensure overall compliance with federal regulations, helping to avoid current difficulties.
One of the largest potential benefits of a pre-market surveillance system is a reduction of dietary supplement adverse events. Pre-screening would help inspect supplements for adulteration and verify that claims properly inform the consumer about safety and efficacy. This would not eradicate adverse events, especially considering that some are inflicted by the consumer or not even caused by the dietary supplement, but it would certainly help. Furthermore, while this system may limit corporate autonomy, adverse events have some of the gravest impacts on consumer health with regard to the dietary supplement industry, so need to be prioritized.
More specifically, pre-market examination of cGMP standards could aid in the reduction of adverse events, along with boosting supplement efficacy, by verifying adulteration and potency of products. As aforementioned, current cGMP standards emphasize consumer health, while simultaneously allowing dietary supplement companies ample autonomy. To improve their impact though, I believe they need to hold a role in pre-market phases. If the FDA could verify that products meet cGMPs before they reach the market, safety, efficacy, and overall benefits of dietary supplements would likely be increased.
This type of regulatory change would reduce the autonomy of dietary supplement companies in the sense that they would have stricter requirements to adhere to and would be forced to slow down their production. However, as has been consistently established in this paper, consumer health needs to be prioritized in this scenario, as it holds the larger stakes of general and public health, whereas corporate autonomy has, subject to interpretation, less significant economic impacts. Furthermore, this reform does not completely disregard corporate autonomy, making it the equitable action to take. The new challenge it would pose though, is governmental financial constraints. This paper will not go into FDA budgeting too deeply, but it is important to know that it is limited for dietary supplement regulation, so the practical side of this change would need to be considered (Richardson et al.).
Alternate Suggestions
A relatively small change I think would have a major positive impact on the industry is eliminating the proprietary blends policy from DSHEA, and replacing it with the requirement for companies to disclose all ingredients. While the autonomy and intellectual property protection this gives dietary supplement companies is important, consumers being able to understand what they are putting into their bodies is vital to their health. A clear distinction in the importance of corporate autonomy and consumer safety is apparent in this scenario, calling for the removal of this piece of legislation.
As previously suggested, dietary supplement regulation could strike a better balance between the consumer and corporations by removing some subjectivity from FTC law. At the moment, despite there being FTC warning letters and court cases available to manufacturers as examples, it is often difficult to know if an advertisement is “not misleading,” if a disclosure is “conspicuous,” or if a mandated statement is “prominently displayed.” Not everything needs to be shifted, but perhaps there could be certain font size or disclaiming requirements. This would be an alternative to completely dismantling the FTC post-market surveillance system because quantitative regulations are easier to follow and easier to enforce.
General Consensus
In short, my answer to the central ethical question for this paper is that current regulations mostly balance governmental responsibilities to the consumer and corporations, but fail in certain regards. With the value of equity and the framework of deontology in mind, I have ultimately decided that consumer health should be a higher priority for the US government in comparison to the preservation of dietary supplement corporate autonomy. In order to strike this balance, some changes need to be made in legislation, including the removal of the proprietary blends rule from DSHEA and the addition of more clarity to FTC law. The largest change I see needed for this industry is the introduction of an FDA pre-market surveillance system, which would verify dietary supplement substantiation, ensure cGMP compliance, and review labeling claims prior to product launch. This would aim to increase both the safety and efficacy of dietary supplements. My conclusion does not suggest the elimination of dietary supplement corporate autonomy, but it advocates for higher standards that will help improve consumer, and, consequently, public health.
Conclusion
4.1 Overview of Ethical Opinion
Before being able to compare US governmental responsibilities and answer the question: “To what extent do current regulations on the US dietary supplement industry balance governmental responsibilities to the consumer with responsibilities to corporations?”, I had to decide what I thought those responsibilities were. Ultimately, I concluded that the US government has the duty to improve consumer health, extending beyond the protection of consumer safety and based on the principle of beneficence, and to preserve the autonomy of dietary supplement companies—a decision informed by both ethical values and national norms. The ethical dilemma arises due to the juxtaposing nature of these stakeholders; when one is prioritized, it seems the other is undermined, so how are ethical compromises made?
For a deontologist, having to decide between two stakeholders is a very difficult task that has no clear answer. In the end, I decided that the US government should consider both the consumer and corporations, prioritizing the consumer when necessary. I came to this decision due to a belief that the consumer has more at stake in this scenario and that equity should be upheld.
Applied to the current regulatory framework, the areas I suggested do strike this proper balance were cGMP standards, the adverse event reporting system, GRAS and NDI pathways, the banning of ingredients, FDA product labeling standards, and FTC enforcement methods. On the contrary, areas of improvement were proprietary blends, ambiguous sections in FTC law, and the FDA post-market surveillance system. Furthermore, I would suggest that these changes be made by amending DSHEA, so that positive aspects of the law can remain, while new reforms are implemented.
4.2 Recommendations
I urge the US government to make this policy reform a top priority in the US, as public health is absolutely vital to a nation’s functionality and prosperity, and the American population is increasingly interested in wellness. Still, I recognize due to financial, time, and productivity constraints, this may not be possible. As a compromise, I think that mandatory product listing needs to be implemented so the FDA truly knows what is on the market and what is in need of regulatory action. This would work within current DSHEA parameters, but still have major positive impacts.
In addition to regulatory frameworks I’ve suggested, I think that awareness surrounding dietary supplement regulation is highly important. Before writing this paper, I had no idea what regulation looked like, and I assume others are in the same position. This is important because a lack of knowledge can skew consumer expectations, lead to misuse, and have an impact on levels of adverse event reporting.
Education could come in the form of more media coverage or word of mouth, but I think the majority of change would come if people began to talk to their local pharmacists. Pharmacists are an excellent, reliable, and fairly accessible resource, and, compared to online materials, they offer individualized, in-person advice, which is important for health-related matters. I additionally see great benefit in having there be information concerning adverse event reporting on each dietary supplement bottle, encouraging this practice and also spreading awareness about adverse impacts.
4.3 Final Thoughts
As the title of this paper suggests, dietary supplement public policy is a complicated endeavor, so I am well aware that my suggestions or any form of regulation will be imperfect; however, I still think it very important to discuss from an ethical standpoint. This conversation serves as a continuous effort to think about society’s areas for improvement and a reevaluation of how government should fit into the ever-changing world. These are both truly critical efforts that will hopefully transform America’s equity, autonomy, and, most importantly, public health.
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