American Journal of Law & Medicine

Dietary Supplements Are Not All Safe and Not All Food: How the Low Cost of Dietary Supplements Preys on the Consumer

Dietary supplements are regulated as food, even though the safety and efficacy of some supplements are unknown. These products are often promoted as 'natural.' This leads many consumers to fail to question the supplements' safety, and some consumers even equate 'natural 'with safe. But, 'natural' does not mean safe. For example, many wild berries and mushrooms are dangerous although they are natural. Another example is tobacco--a key ingredient in cigarettes: it is natural, but overwhelming studies have established the harm of cigarette smoke. The Food and Drug Administration (FDA) requires safety and efficacy testing prior to market entry for drugs. In contrast, the FDA only has limited ability to regulate the entry of new dietary supplements into the marketplace because supplements are treated as food.

Two main arguments support the current regulatory structure of dietary supplements: (1) cost and (2) access. But lower cost and increased access to dietary supplements do not necessary have any relationship to safety and efficacy. Manufacturers' marketing techniques tout the health benefits of their supplements. Meanwhile, consumers are ingesting supplements without scientific studies indicating whether or not they are harmful.

The FDA Food Safety and Modernization Act, signed into law on January 4, 2011, did not address the safety concerns regarding dietary supplements. This article discusses the regulatory deficiencies concerning dietary supplements and proposes novel solutions to address this specific sector of the food supply. This article advocates for the use of scientific data to support a multi-tiered classification system to ensure that dietary supplements on the market are safe.


A lot of justifiable concern is spent on the quality and safety of our food supply. In (2011), the FDA Food Safety and Modernization Act (FSMA) was signed into law. (1) The FSMA provides the Food and Drug Administration (FDA) with a legislative mandate to enforce preventative measures to shore-up our food system and improve safety. (2) Under the FSMA, the FDA has the authority to act in the following key areas: to prevent contamination of foods, to respond to potential food safety issues, to improve food importation standards, and to create partnerships to ensure the safety of our food supply. (3)

While the FSMA is designed to address, detect, prevent and respond to food safety issues, it is noticeably lacking any real regulations addressing the health and safety issues surrounding dietary supplements. Under the Dietary Supplement Health and Education Act (DSHEA), dietary supplements are regulated as food. (4) The thirty billion dollar per year supplement industry has its fair share of safety issues. (5) Regardless, the FDA is limited in its ability to regulate the dietary supplement industry. While many supplements on the market are safe, the safety of other supplements is unknown.

The FSMA provides authority to the FDA and notice to food manufacturers that if the Secretary reasonably believes that exposure to an article of food "will cause serious adverse health consequences or death to humans or animals, each person (excluding farms and restaurants) who manufactures, processes, packs, distributes, receives, holds, or imports such article shall ... have access to and copy all records relating to such article." (6) The FSMA, however, explicitly excludes the application of this law to dietary supplements by stating that "[n]othing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement." (7) The only section in the FSMA that creates any administrative rights for the FDA is section 113. (8) Section 113 gives the Secretary rights to notify the Drug Enforcement Administration if any ingredient in a dietary supplement may be or may contain an anabolic steroid. (9)

While the manufacturing, importation, transportation, and handling of our traditional food supply poses challenges that are distinct from dietary supplements, this article will highlight the safety concerns with dietary supplements and discuss how the current regulatory framework is ill-equipped to handle the serious health consequences associated with this industry. The FSMA, enacted to provide consumers with a safe food supply, does little to address safety and efficacy problems that exist in the use of dietary supplements.

Part II of this Article will provide background information describing the dietary supplement industry, including what constitutes a dietary supplement. Part III will highlight safety and efficacy concerns for consumers who use dietary supplements. This section includes a description of some scientific studies analyzing the safety, interactions, and composition of various dietary supplements. The purpose of this section is to demonstrate that we have limited scientific information about supplements, especially when considering the breadth and depth of the types of supplements on the market. The next section, Part IV, will describe the regulatory deficiencies regarding dietary supplements and propose novel solutions to address this specific section of the food supply. Other legal scholars have focused on the lawsuits or other legal authority. (10) This article takes a different approach by combining law and science to demonstrate that the DSHEA is inadequate to regulate the current dietary supplement industry. The DSHEA is outdated and even its findings--that is, the purpose for the DSHEA--can no longer be supported. It is likely that the growth of the industry outgrew the purpose of the Act. This Article will thus challenge the efficacy of the DSHEA in light of what we learned over the past 20 years. Importantly, this Article calls for policy decisions to be made by or supported by scientific studies establishing safety. Efficacy would be a welcome addition, although the pressing and primary concerns are about safety. Finally, this Article concludes that the FSMA failed to address the concerns about the dietary supplement industry. The discussion is warranted given the multitude of issues that the FDA must address when ensuring a safe food supply.


The dietary supplement industry is a thirty billion dollar per year endeavor." Dietary supplements include vitamins, essential minerals, protein, amino acids, and herbs. (12) Dietary supplements are classified as food. (13) This classification is important for regulatory purposes because it defines the categorization and authority by the FDA to regulate this industry. Since 1994, this portion of the food supply has been regulated under the DSHEA. (14) The DSHEA provides that the FDA can respond to proof of harmful ingredients in dietary supplements, but it does not provide any authority similar to the FDA's ability to regulate drugs prior to the entry to market. (15) Manufacturers therefore maintain a lot of control when bringing supplements to market because they do not have to obtain FDA approval. (16) This is problematic in part because, as will be discussed below, some dietary supplements contain pharmaceutical or pharmaceutical-like ingredients; this challenges the notion that all supplements should be classified as food. (17)

Consumers are not necessarily aware that dietary supplements, often sold down the aisle from FDA approved over-the-counter (OTC) drugs (also known as nonprescription drugs), are not tested for safety or efficacy prior to market entry. In fact, some consumers prefer dietary supplements to OTC drugs because they prefer not to take drugs for some ailments. (18) Manufacturers exploit this preference in their marketing techniques, by touting their supplement as 'natural.' (19) The perception of some consumers is that anything that is natural is safe. (20) But, of course, that is not true. Many poisonous and dangerous things are natural, such as wild mushrooms. (21) Tobacco is another natural ingredient that is linked to adverse health consequences. (22)

On top of the 'natural = safe' problem, information is lacking about how dietary supplements interact with each other or with other drugs. For example, evidence suggests that a popular dietary supplement, St. John's Wort (SJW), causes adverse consequences when it interacts with certain drugs. (23) While we have some information about supplements' adverse interactions, the data is limited. Few scientific studies address possible interactions. In part, this is because there are so many supplements on the market. It also may be because it is challenging to hypothesize about interactions that unknown ingredients at unknown concentrations may cause. Part III, below, will provide information about the problems with content and formulation.

Consumers are often unaware that dietary supplements for medical and medical-like conditions are not FDA approved. (24) In an industry-sponsored study, 3,500 Americans were surveyed about their use of dietary supplements for weight loss. (25) The results of the study revealed that many respondents believed that not only were weight-loss supplements approved for safety and efficacy prior to market, but that weight-loss supplements were actually safer than OTC or prescription medications. (26) This study was sponsored by the pharmaceutical company GlaxoSmithKline, who had just received FDA approval for a non-prescription weight loss drug. (27) Presumably, GlaxoSmithKline was interested in market analysis of consumer preference for nonprescription drugs versus dietary supplements for weight loss. The results demonstrate a disconnect between consumers and their understanding of the regulatory oversight of drugs and supplements. Consumers appear to actually trust dietary supplements more than FDA approved drugs--and this might, in part, be due to good marketing techniques. Weight loss supplements are actually among the most potentially dangerous supplements; studies show that they are more likely to contain active or adulterated pharmaceuticals--even some that are banned. (28) This makes it difficult for a consumer to decipher which weight loss supplements are safe and which are unsafe.

Many consumers take vitamin supplements. Companies market to different age groups, telling consumers to buy children's vitamins to assist with brain development or to buy vitamins that are made specifically for seniors. (29) It turns out that it is not clear that use of all vitamins is safe or effective. There is no scientific consensus that vitamin supplements actually improve health. (30) While it is true that specific vitamins can prevent certain ailments--for example, Vitamin C can prevent scurvy--it is unclear whether vitamins offer any health benefits to healthy people. (31) On top of that, too much of a particular vitamin can actually lead to health problems. (32) Other problems with vitamins include that different brands may contain different amounts of active ingredients, and the level of absorption may be different when vitamins are taken as a supplement rather than ingested through food. …

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