Why Vitamins and Other Dietary Supplements Are Not Regulated

Rules and regulations are inarguably important in any field, and where the people’s health is concerned, there should never be a compromise about control. However, this is not the case in some instances going by the fact that the FDA does not regulate vitamins and other dietary supplements, which is a reason for alarm (Seres). Imagine how it would be like if there were no regulations on road usage and each driver had the liberty to choose what side of the street they want to use: There would be chaos. Also, imagine if the Federal Government did away with all the regulations that require a drug to be safe, contains what it is claimed to have, and is proven to work before being released to the market; People’s health would be compromised. This is what happened in 1994 following the enactment of the Dietary Supplement Health and Education Act (DSHEA). The FDA has been ineffective in regulating dietary supplements and there is, therefore, no regulation of the products due to Congress’ actions and the DSHEA.

Dietary supplements, as per the Dietary Supplement Health and Education Act, are a large heterogeneous group of products whose purpose is to supplement the diet and which do not fit the description of drugs, foods, or food additives. Supplements may contain, wholly or as a concentrate, a combination of one or more minerals, vitamins, amino acids or herbs and other substances that are used to increase the total dietary intake (Starr 479). Dietary supplements include products used for sports performance engagement, protein powders, and weight loss medications, among others. While most of these products serve the original intention of increasing an individual’s dietary intake, some dietary supplements such as androstenedione, melatonin, and shark cartilage are not typical nutritional items and are an indication of the FDA’s ineffectiveness to regulate dietary supplements. Nonetheless, the DSHEA, for safety purposes, prohibits the supplements that are shown to pose a substantial risk of injury to its users. Still, it has been unable to regulate dietary supplements fully.

Arguments have been put forward against dietary supplements by such reputable contributors as the Harvard Health Publishing, which portrays the risk of the supplements and the apparent ineffectiveness of the FDA to regulate them. According to Harvard Health Publishing, the DSHEA of 1994, was meant to address the concerns of both consumers and manufacturers regarding various dietary supplement products. It was also intended to ensure that safe and appropriately labeled products, particularly dietary supplements, remain accessible to those who would want to use them. However, the Act has not been effective in ensuring the safety of dietary supplements and has limited the mandate of the FDA. Manufacturers are not compelled or do not have to prove the effectiveness of their products (Harvard Health Publishing). For instance, a dietary supplement product may claim to help with visual acuity, which is not established. As such, they are required to put a warning on their labels that goes as follows: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” (American Cancer Society). This puts the effectiveness of the FDA into question.

Further, unlike drugs which are considered unsafe until proven to be safe, dietary supplements are considered safe until proven otherwise which is an indication of the ineffectiveness of the FDA to regulate them. The FDA considers any new drug to be unsafe and, therefore, a new drug has to undergo clinical trials to be proven safe before it can be released into the market (American Cancer Society). The clinical trials are studies that are conducted on human volunteers under well-controlled conditions. The studies are done to determine the safety and the effectiveness of a drug, and they must show substantial evidence that the drug is safe and effective before the FDA can approve it. After approval, the drug can be legally sold in the United States. However, on the other hand, dietary supplements do not undergo the same process as drugs. Instead of the supplements being tested for safety and effectiveness first, they are manufactured and released into the market. They can only be considered unsafe if, while in the market, they are found to be unsafe. Manufacturers are not obligated to test ingredients or supplements used for their products. Decidedly, this poses a potential risk to users and is an indication of the ineffectiveness of the FDA.

FDA has also been unable to regulate dietary supplements due to actions of Congress and the provisions of the DSHEA which limit its mandate and activities. The FDA has always been tasked with ensuring that health products remain safe beneficial to their users. However, following years of amendments to the law, this task has been significantly reduced with regards to dietary supplements regulation. Before the DSHEA was passed, in the early 1990s, the FDA instituted action against many popular dietary supplements that existed at the time using food additive regulations (Institute of Medicine (US) and National Research Council (US) Committee on the Framework for Evaluating the Safety of Dietary Supplements n.p.). In 1993, however, the FDA’s attempts to apply food additive regulations to dietary supplements was blocked by the court of law. Also, in 1973, had issued regulations that proscribed certain representations on mineral and vitamin supplement labels and set a maximum level on the amount of the ingredients per serving (Swann 273). Consumers and manufacturers protested this move which led to the enactment of the Health Research and Health Services Amendments in 1976. These amendments prevented the FDA from establishing standards limiting the potency of the mineral and vitamin supplements. This rendered the FDA’s regulatory role ineffective in controlling dietary supplements.

Due to the suppression of the FDA’s attempts to establish more restrictive rulemaking, the variety of products marketed and sold as dietary supplements expanded. The expansion, which took place in the late 1970s and 1980s, was accompanied by claims of serious illnesses resulting from the use of a few of the dietary supplements available at the time. For instance, a kid who had colic was reportedly given a high and consequently fatal dose of a potassium chloride supplement. Also, there were widespread reports of various supplements causing different complications. As a result of this reports and the FDA’s concerns about manufacturers placing unsubstantiated claims on the labels of their products, the made new attempts to regulate the industry in 1980 (Institute of Medicine (US) and National Research Council (US) Committee on the Framework for Evaluating the Safety of Dietary Supplements n.p.). The FDA was considerably successful this time since it led to the enacting of the Nutrition Labelling and Education Act (NLEA) of 1990. Through the Act, the FDA was given the responsibility to propose the criteria for making health claims by dietary supplements. However, concerns mounted that the FDA might treat dietary supplements too harshly which led to the passing of the DSHEA.

In 1993, after the passage of the NLEA, the FDA gave out advance notice of the proposed regulations regarding dietary supplements which did not please the consumers and manufacturers. The FDA suggested that it would put in place stronger regulations and restrictions against vitamins and minerals by limiting their potency to levels near those of the U.S. Recommended Daily Allowance (U.S. RDA) (Institute of Medicine (US) and National Research Council (US) Committee on the Framework for Evaluating the Safety of Dietary Supplements n.p.). The dietary supplement industry comprised of both the consumers and manufacturers reacted strongly against these potential regulations. Resultantly, due to the emotive nature of the topic, public debate about the importance of dietary supplements on health and the FDA’s regularly approach ensued and was followed the subsequent enactment of the DSHEA by Congress (Dwyer, Coates, and Smith 41: Institute of Medicine (US) and National Research Council (US) Committee on the Framework for Evaluating the Safety of Dietary Supplements). The DSHEA limited and prohibited the FDA’s regulation of dietary supplements thus the lack of regulation of the products by the body (Swann 276). The Act provided that dietary supplements are safe until proven unsafe which, at times, may take long for the FDA to prove. Also, the manufacturer is not required to share safety and effectiveness information about their dietary supplement products with the FDA. From this, it is evident, that the FDA was ineffective in regulating the dietary supplements and, as a result, it became a victim of its own doing.

Notably, although rules and regulations are essential, they do not explicitly apply to the vitamins and dietary supplements industry as mentioned before. The FDA does not regulate vitamins, and dietary supplements the way in controls drugs. Unfortunately, although not enough evidence exists to support this, this lack of regulation of dietary supplements poses a considerable health hazard to people. Notably, the ineffectiveness of the FDA to regulate the dietary supplements has been due to its own doing. Before the passage of the DSHEA, the body enacted regulations which did not please the public leading to the limiting of its regulatory activities. Therefore, while its ineffectiveness can largely be attributed to actions of Congress and the restrictions of the DSHEA, the FDA has also rendered itself ineffective and manufacturers are still able to sell their products freely despite their lack of promise of their effectiveness and safety.