FDA Regulation of Diet & Herbal-Supplement Industry: Fraud, False Claims

Since the days of snake-oil medicine, Americans have been incredibly gullible when it comes to allegedly scientific claims about the promising effects of medicine, vitamins and supplements. The pharmaceutical industry, both the official industry that produces approved pharmacological products and the unofficial, unregulated industry that produces popular, best-selling supplements and vitamins, are reaping unprecedented profits as the result of robust consumer demand for these products (Connor, 2001; McTavish, 2004).

At present, this industry reaps almost $19 billion every year in profits (Sine, n.d.). In addition to the ever-increasing, mind-boggling number and variety of supplements and vitamins entering the market, the persistence of the marketing and advertising machines behind these products is largely responsible for their widespread acceptance by the consumer public. According to Speed Weed (2004), who conducted an informal experiment in which he recorded the frequency and types of scientific claims that he heard about products in the media in the course of a single day, the pharmaceutical industry engine is so successful and powerful that it circulates claims about the effectiveness of its products no less than every ten minutes.

The vitamins and supplements currently available purport to treat a wide variety of physiological and psychological conditions, including obesity, sexual dysfunction, anxiety, and depression, to name just a handful of the ailments (Sine, n.d.; Spector, 2005). As Sine (n.d.) indicates, the producers of supplements exploit the fact that the general public believes that vitamins are a necessary part of good health and nutritional practice. The power of repetition in advertising claims as noted by Speed Weed (2004) constantly reinforces the idea that these magic-bullet pills and powders, our modern-day version of snake oil, can help people recover from ailments, as well as feel and look better. Due to the fact that many consumers either have no insurance or have difficulty accessing quality medical care, supplements are often seen by consumers as a viable alternative to traditional pharmacological treatment and other interventions. These consumers, then, rarely receive a professional opinion to challenge or correct their beliefs about the alleged efficacy of these products.

As Sine (n.d.) notes, however, even those consumers who do seek a professional opinion from their primary medical care provider are not always like to receive completely accurate information about the potential benefits and side effects of such supplements and vitamins. As is the case with the formal pharmaceutical industry, the supplement industry also provides doctors and other medical care providers with powerful incentives in order to encourage them to recommend these products. Such incentives range from vacations and cars to cash and other luxury gifts (Sine, n.d.). Often, these professionals are not even aware of the potential benefits and side effects of the supplements and vitamins; there is surprisingly little clinical research about the efficacy of these products, so it is difficult for doctors to evaluate the claims that the manufacturers and marketers make.

At present, vitamins and supplements are not regulated by the U.S. Food and Drug Administration, which is responsible for the oversight of all traditional pharmacological products that are available on the U.S. market. Thus, consumers purchase vitamin and supplemental products without any reliable information and without the product having been subjected to the rigorous testing and evaluation that typically precedes the approval of conventional medicines. Instead, consumers rely upon the emotional and psychological appeals that producers make in their attempts to capture a desperate audience who wants to be thinner, sexier, or happier (Sine, n.d.). The claims that producers make are often ridiculous and false, but consumers have no protection at present when they are disappointed by the outcome of using the supplement or, worse, when they recognize that the supplement may have harmful side effects. As the U.S. Food and Drug Administration (2002) warns, over-the-counter supplements and vitamins may have deleterious effects, especially when they are used in combination with other prescribed medications. Given the fact that little, if any, clinical testing has been performed on these products, it is impossible to predict just how severe such side effects may be (U.S. Food and Drug Administration, 2002). In addition, it is not unheard of for counterfeit versions of vitamins and supplements to be promoted and sold, both in retail stores and on the street, which further reduces the consumer's ability to know what he or she is ingesting each time he or she takes a supplement or vitamin (U.S. Food and Drug Administration, 2002).

For all of these reasons, it is important for the government to pursue a policy which supports the regulation of the vitamin and supplement industry that is required of conventional medicine. Recently, the U.S. Food and Drug Administration drafted a proposal that would bring vitamins, supplements, herbs, and "even vegetable juices" under its regulatory umbrella (Adams, para. 1). At present, the U.S. Food and Drug Administration does have some limited oversight over herbs, vitamins, and supplements that are promoted as dietary aids (U.S. Food and Drug Administration, 2006). According to the U.S. Food and Drug Administration (2006), "the Dietary Supplement Health and Education Act of 1994 (DSHEA) [mandates that] the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed" (para. 1). The manufacturer "must make sure that product label information is truthful and not misleading" (U.S. Food and Drug Administration, 2006, para. 1). The role of the FDA is to be "responsible for taking action against any unsafe dietary supplement product after it reaches the market" (U.S. Food and Drug Administration, 2006, para. 1). Despite this move towards more rigorous oversight, manufacturers are not required to "register their products with FDA nor get FDA approval before producing or selling dietary supplements" (U.S. Food and Drug Administration, 2006, para. 1). The new proposal, however, will make the U.S. Food and Drug Administration directly responsible for testing, evaluating, and approving all traditional and non-traditional pharmaceutical products before they can enter the consumer market.

Spector's (2005) article, "Miracle in a Bottle," provides further evidence to support the argument that all pharmaceutical products should be regulated by the U.S. Food and Drug Administration. Spector (2005) explains that part of the reason why supplements and vitamins have become so popular is that some research has begun to disseminate results about the benefits of certain natural products. Anyone who listens to or reads popular media can probably name a number of natural products that have been alleged to have positive health benefits: blueberries, green tea, ginkgo, and cranberries are just a few that come to mind immediately. These and other herbal and natural foods are claimed to have particular positive health benefits, and the public has become interested in learning more about their alleged health benefits, and the pharmaceutical and marketing industries have been quick to promote these products in a variety of forms. Supplements and vitamins are sold as pills, powders, and drinks (Spector, 2005).

Despite the 1994 bill that authorized the U.S. Food and Drug Administration to increase its involvement in monitoring the vitamins and supplements that are sold as obesity treatments, during the same year Congress killed a bill that would have extended the Food and Drug Administration's oversight over the rest of the supplement industry (Spector, 2005). The pharmaceutical industry responded immediately by increasing the variety of products available and disseminating them more widely (Spector, 2005). Knowing that there were no rules that could dictate their claims and their actual efficacy, these producers responded by flooding the market. As Spector (2005) observes, this action of Congress resulted in a condition in which "companies have been able to say nearly anything they want about the potential health benefits of what they sell. As long as they don't blatantly claim to have a cure for specific disease...they can assert-without providing evidence" (Spector 2005). In short, even though there are definite positive benefits of some natural products and vitamins, the producers of these sorts of products exploit the fact that they are not regulated, and now think they can get away with anything, resulting in a multi-billion dollar industry that has a direct impact on the health and well-being of millions of Americans.

Unfortunately, Americans are terribly naïve about the nature of these vitamins and supplements. Spector (2005) reported that "most people believe that if a supplement is on the market it must have been approved by some government agency," even though this is not the case. In addition, the marketers of these products often make claims that appear to be based on science, but which are actually either falsified or come with qualifications in small print that the consumer never notices or reads (Spector, 2005). Happy, healthy people are shown in advertisements for these products, often with a before and after picture, which lends a personal feeling to the claim that this product can be life-changing. Again, the public often fails to apply critical thinking to conduct personal evaluations of the exaggerated claims made by manufacturers and marketers. There is a dangerous and false sense of security on the part of the public, which believes that they are protected by a federal agency evaluating the value and safety of these products (Spector, 2005). Since Americans are accustomed to have regulatory oversight of medical products, it is a natural extension of policy and practice for the U.S. Food and Drug Administration to begin taking responsibility for the vitamins and supplements as well.

From the earliest days of this country, entrepreneurs have seen-and have seized-the opportunity to manufacture products that they market as panaceas and quick cures for any manner and number of physical and psychological ailments. Even though these products rarely, if ever, have any scientific evidence accompanying their marketing to substantiate the enthusiastic claims that are made about them, they respond to a need on the part of a public that is comprised of desperate people who want to change their condition. The manufacturers of vitamins and supplements which have not been tested and evaluated for clinical efficacy and safety are taking advantage of the consumer public who is willing to spend its disposable income on any product that offers the promise of feeling better, relating better, and looking better.

There are a number of problems with the current lack of regulation and oversight of this particular aspect of the pharmaceutical industry. Introducing a mechanism for the Food and Drug Administration to oversee and regulate herbs, vitamins, and supplements would be one valuable step towards reducing the potential harms posed by unsubstantiated products that pose as medical treatments and interventions. First of all, research would help clarify the exact nature and potential of such products. It may well be the case that some of these products can actually help people recover from temporary and chronic conditions, whether of a physical or psychological nature. However, one cannot assume this without clinical and empirical research.

While regulation of the herb and supplement industry by the U.S. Food and Drug Administration would not resolve all problems related to these products, it would be a positive move in the right direction towards safeguarding Americans' health. Although the undue influence of manufacturers would, like the traditional pharmaceutical industry, be likely to continue encouraging medical care providers to recommend these products by providing them with compelling incentives of cash and goods, consumers could at least have the benefit of knowing whether the claims being made are true.

References

Adams, M. (2007, April 11). Health freedom action alert: FDA attempting to regulate supplements, herbs, and juices as "drugs." Retrieved on May 2, 2008 from http://www.newstarget.com/021789.html

Connor, J.M. (2001). Global price fixing: Our customers are the enemy. New York: Springer.

McTavish, J.R. (2004). Pain and profits: The history of the headache and its remedies in America. New Brunswick, NJ: Rutgers University Press.

Sine, R. (n.d.). Vitamins: Separating fact from fiction. WebMd.com. Retrieved on May 2, 2008 from http://www.webmd.com/diet/guide/vitamins-fact-from-fiction?page=1

Spector, M. (2005). Miracle in a bottle. In The Best American Science Writing 2005. Weiner, J., Ed. New York: Houghton Mifflin.

Speed Weed, William. (2005) 106 science claims and a truckful of baloney. In The Best American Science Writing 2005. Weiner, J., Ed. New York: Houghton Mifflin.

U.S. Food and Drug Administration. (2006). Dietary supplements. Retrieved on May 2, 2007 from http://www.cfsan.fda.gov/~dms/supplmnt.html

U.S. Food and Drug Administration. (2002). Tips for the savvy supplement user: Making informed decisions and evaluating information. Retrieved on May 2, 2008 from http://www.cfsan.fda.gov/~dms/ds-savvy.html