Drug or Dietary Supplement? A Case Study

The dietary supplement industry faces unique challenges in marketing its products, most importantly the task of balancing effective marketing materials with legal requirements. In marketing a dietary supplement, a product may not claim to treat or cure a disease. Furthermore, a dietary supplement must not affect the structure of the body. As such, dietary supplements must adhere to strict rules when making specific claims of their efficacy.

The dietary supplement industry cannot be described as anything other than a behemoth. Its products are varied in scope, encompassing vitamins, minerals, diet pills, sports drinks, herbal extracts, natural remedies, alternative medicines, and various other products that are often marketed in deceptive or misleading ways.[2] Due to the broad nature of their use, issues pertaining to the marketing of dietary supplements beg for in-depth investigation and analysis. Often, marketing campaigns for dietary supplements make product claims that are unsubstantiated by evidence and make false or exaggerated claims.[4]

In comparison to the dietary supplement industry, the over-the-counter (OTC) drug industry trails behind dietary supplements, at $23 billion per year in sales.[5] This fact is not surprising, considering the relative ease with which dietary supplements may be introduced to market, as opposed to OTC drugs. As would be expected, heavily-regulated market access has led to lower sales for OTC drugs in comparison to dietary supplements. However, OTC drugs have a distinct advantage, in that they are permitted to make claims regarding their efficacy in preventing, treating, or curing diseases, once they are cleared for production and distribution by the FDA.[6]

We will analyze the statutory and practical differences between dietary supplements and drugs while providing real-life case studies of dietary supplements that have been or are currently being sold as dietary supplements but may go overboard in their claims of efficacy while tiptoeing the murky line between sales puffery and outright falsity. We will examine the marketing claims of Sensa, a popular weight-loss dietary supplement. Additionally, we will compare the marketing claims of Sensa with those of Mega Men Sport, a dietary supplement multivitamin sold by GNC for active men. These products, different in scope, cost, and form, are both dietary supplements and therefore must both adhere to the same legal marketing requirements.

Drugs Defined

The Food, Drug, and Cosmetic Act of 1938 (FCDA) marked a turning point in federal food and drug legislation. The FDCA defines the meaning of “drug” at 21 U.S.C. §321, providing among other things, that a drug is “an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”[7] In simpler terms, a drug must affect the composition of the body in some tangible way, while treating or preventing a disease, or curing an ailment.

One key piece of the FDCA requires premarket approval through the New Drug Application (NDA) process for every drug that is sold on the market.[8] [9] Documentation included in NDA includes clinical test results, drug ingredients, how the drug acts when ingested, the process of manufacture, and quality control information.[10] This has the potential to create more expensive barriers to enter the market as opposed to dietary supplements, with the benefit of enhancing consumer safety.

Dietary Supplements Defined

In 1994, the Dietary Supplement Health and Education Act of 1994 (DSHEA) amended the FDCA by defining dietary supplements under Section 321(ff).[11] Unlike drugs, dietary supplements do not require premarket approval and are products intended to merely supplement a person’s diet, and may contain vitamins, minerals, herbs, amino acids.[12] Furthermore, dietary supplements must be labeled as such, and their manufacturers are prohibited from certain marketing claims.[13] However, a product may make specific health claims about an ingredient’s effectiveness. If, for example, a dietary supplement has ingredient X, the product may make a substantiated claim, based on scientific research, that ingredient X may reduce the risk of disease Y.[14] However, the dietary supplement may not go as far as to say that it alone will be a sufficient treatment for disease Y.[15] Doing so would cross the line into marketing the product as a drug, violating the FDCA.[16]

Most importantly, dietary supplements fall outside the category of “drugs” and may not “affect the structure of the body of man” nor be marketed as “an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals.”[17] It is for this reason that a multivitamin, although long held to be a beneficial staple of one’s diet, is not a drug; it does not do anything other than supplement a person’s diet and it is not intended to replace anything in a person’s diet.

Case 1: Sensa Weight Loss System

The Sensa Weight Loss System, also known as “The Sprinkle Diet,” is marketed as a “revolutionary weight loss system that will change your life.”[18] Designed to inhibit a person’s appetite, Sensa is applied to food prior to ingestion and purports to make eaters feel satiated after only a few bites of food.[19] The ingredients of Sensa include malodextrin, tricalcium phosphate, silica, and flavoring.[20] The product claims to enhance the olfactory parts of the brain related to smell and taste, which engages the body’s hunger mechanism sooner in the meal, causing people to feel full thus reducing total food intake per meal.[21] However, the clinical efficacy of Sensa is a matter of debate, as it has not undergone any peer-reviewed studies.[22]

Sensa is a prime example of a dietary supplement that makes extraordinary marketing claims without being able to scientifically bolster them. On the Sensa website, the closest it gets to describing the mechanism of action is a vague recitation of explanations found from external sources. It states the following:

SENSA® works with your sense of smell to help you feel full faster – so you eat less and lose weight. There are NO pills, NO stimulants and NO diuretics. SENSA® is sugar-free and sodium-free. Simply shake SENSA® on everything you eat to help you eat less and lose weight. You can still enjoy the foods you normally do. No prepackaged meals. No counting calories. No traditional dieting.[23]

As predicted, the product comes with the FDA’s boilerplate disclaimer, stating “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.”[24] Although from a technical standpoint, Sensa is in legal compliance with the FDA by placing the above disclaimer on their products and literature, one wonders what impact, if any, this will have on the multitude of consumers desperate to lose weight.

The central question in analyzing Sensa is whether Sensa is actually being marketed as a drug under the guise of a dietary supplement; conversely, it is possible that Sensa is actually a drug being marketed as a dietary supplement. We must decide whether Sensa is accurately categorized as a dietary supplement, and then analyze whether its marketing claims are in accordance with that classification.
First, we must identify specific marketing claims being made by Sensa. After scouring their website, there are surprisingly few health claims present. They include: “[Sensa will] help you eat less and lose weight!”[25] “It works with your sense of smell to help you feel fuller faster!”[26]

Based on the very limited and non-descript health claims made on Sensa’s website, it stands to reason that this product’s marketing plan underwent piercing legal scrutiny prior to its release. There are no promises, no effectiveness guarantees, and a very sparse description of how the product actually works. We will examine both of the marketing claims above and determine if they are fairly representing Sensa as a dietary supplement.

Sensa will help you eat less… and lose weight?

We must ask whether the above statement is positioning this product as a drug or a dietary supplement. A drug is “an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease [which is] intended to affect the structure or any function of the body.”[27] First we must ask whether the above marketing claim is referencing a disease. On its face, it would appear that it is not. However, scientists are divided over whether obesity qualifies as a disease.[28] Assuming for the sake of argument that obesity is in fact a disease, it would appear that the marketing statement referenced above still falls short of trying to “cure, mitigate, treat, or prevent” obesity, because of course it does not follow that all people who lose weight are obese. The statement does not reference obesity directly, although it is likely that many consumers of Sensa are, in fact, obese. Furthermore, although losing weight is one of various ways to “cure” obesity, obesity is a more complex medical condition than simply having excess weight.[29] Therefore, it does not stand that “helping you eat less and lose weight” is purporting to “cure” the implicit disease of obesity. According to preventative medicine physician Dr. Scott Kahan of Johns Hopkins University,

“Obesity goes way beyond its outward appearance. Most affected people develop a cluster of metabolic, hormonal and cellular disruptions—so much so that having obesity increases the risk of dozens of other chronic diseases, and ultimately premature death.”[30]

Alternatively, we can look at whether Sensa, based on the above-referenced marketing claim is “intended to affect the structure or function of the body.”[31] This standard is deserving of closer scrutiny. The product claims to “help you eat less and lose weight.” On its face, it stands to reason that losing weight is affecting the structure of the body; metabolic rate increases, fat tissues are used as energy, and bodyweight decreases.[32]

However, upon further analysis, it becomes clear that this statement alone does not rise to the level of claiming to affect the structure or function of the body. In other words, it is helping you do act X (eat less) in order to achieve the goal of Y (lose weight). Nowhere does the statement say that the goal of Y will be achieved by virtue of taking Sensa alone.[33] Instead, it claims that Sensa will help an individual eat less, because eating less will lead, in theory, to weight loss. Had Sensa’s marketers made a more straightforward statement like “Sensa makes you lose weight,” it is possible that this would be in violation of the FDCA because the claim would suggest that the product alone causes weight loss. It is fair to say that the above-referenced marketing claim could also be stated, perhaps less elegantly, as such: “Sensa will help you eat less food per meal, and eating less typically leads to weight loss.”

It works with your sense of smell… to help you feel fuller faster?

Again, we will analyze whether the statement above positions Sensa as a drug or a dietary supplement pursuant to 21 U.S.C. §321. On its face, the above-referenced statement does not claim that it is “for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”[34] Nowhere is a specific disease expressly mentioned, or even alluded to, as opposed to the “Sensa will help you eat less and lose weight!” analysis.

However, it appears as though the claim suggests that Sensa is “intended to affect the structure or any function of the body.”[35] Sensa’s mechanism of action appears to alter the body’s sensory perception in order to reduce food intake, by virtue of “work[ing] with” a person’s olfactory senses. Once again, the power of words allows Sensa to infer things without explicitly saying them. What exactly does this mean? Does this mean the structure of the olfactory senses is changed after a certain number of uses? Does this mean there is a temporary suppression of the olfactory senses? Does the product change the body over time? The claim is ambiguous. Of course, from our research, we know that the structure of the body is not changed by this product, yet its claims allude to the contrary.[36] Therefore, Sensa’s marketing materials are trying to give the product an advantage of the best of “both worlds”—that is, making a claim that the product affects the olfactory senses in a significant way, as would a drug, in order to reduce food consumption.[37] The average consumer might interpret this statement as meaning there is some underlying change occurring to his or her body, consistent with the effect of a drug.

Trading well-articulated marketing nuances and concision for greater verbal precision, a more exact statement might say: “When sprinkled on food, Sensa temporarily heightens the acuity of your sense of smell and taste, which clinical research suggests may make you feel full sooner in your meal, potentially causing you to eat less food as a consequence.” Upon analyzing Sensa’s marketing claims, we have determined that although it makes statements that infer certain things, such as the product’s effectiveness and its means of action, its claims do not go beyond mere puffery. Carefully-worded marketing phrases pepper their literature and on occasion straddle the line between truth and falsity without ever crossing it. Therefore, Sensa is being properly marketed as a dietary supplement.

GNC Mega Men Sport Factual Background

In addition to the abundance of dietary supplements claiming to aid in weight loss, there are also various performance-based supplements currently on the market. One such dietary supplement is GNC Mega Men Sport, which is manufactured and sold by General Nutrition Centers (GNC).[38]

Mega Men Sport is a dietary supplement that is best described as a multivitamin in a sporting package. It is priced at $19.99 for 90 caplets, placing it in a higher price echelon than other non-sporting multivitamins.[39] [40] It claims to be a “clinically studied multivitamin” that is “for physically active men whose bodies demand more.”[41] It is a fine example of a less in-your-face type of dietary supplement marketing strategy in comparison to Sensa, as it does not make any weight loss claims or athletic performance-based claims.[42] However, this product is still worth analyzing because it positions itself uniquely as a multivitamin for athletes, something that few other products do in its class.[43]

As we did with Sensa, the central question in analyzing Mega Men Sport is whether the product is actually being marketed as a drug under the guise of a dietary supplement; conversely, it is possible that Mega Men Sport is actually a drug being marketed as a dietary supplement. Both of these alternatives will receive consideration. We must decide whether Mega Men Sport is accurately categorized as a dietary supplement, and then analyze whether its marketing claims are in accordance with that classification. Mega Men Sport’s advertising copy starts out with a quote by Dr. Frank J. Costa, acclaimed men’s health expert. One of “America’s Top Physicians,” Dr. Costa lectures nationally and internationally on men’s health topics. Dr. Costa is regularly featured in television, radio and newspaper interviews and has published articles in both professional journals and popular magazines. “When men work out, their bodies need additional nutrients. That’s why I recommend Mega Men® Sport. It provides the vitamins, minerals and proprietary sports blend active men need to support physical performance and to stay healthy.”[44]

The below marketing claims have been chosen as representative of the overall marketing style used by Mega Men Sport. Therefore, they will be the subject of our analysis: “Fuels muscles and supports recovery with amino acids”[45], “Cushions joints with vitamin C, collagen and hyaluronic acid”[46]

The marketing claims made by Mega Men Sport are not as offensive to the casual reader in comparison to Sensa’s. Perhaps it is because there is less here at stake; Mega Men Sport does not claim to promote weight loss or pose as a “magic pill” supplement; rather, it appears to be claiming what dietary supplements are supposed to do—supplement a person’s diet. As to be expected of a dietary supplement, its marketing materials are peppered with the FDA disclaimer, “These statements have not been evaluated by the Food and Drug Administration…”[47] However, the product page still makes health claims deserving of further analysis. We will examine both of the marketing claims listed above and determine if they are fairly representing Mega Men Sport as a dietary supplement.

Fuels muscles and supports recovery with amino acids

We must ask whether the above statement is positioning this product as a drug or a dietary supplement. A drug is “an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease [which is] intended to affect the structure or any function of the body.”[48]

First we must ask whether the above marketing claim is referencing a disease. At first glance, it would appear that it is not; no disease is explicitly mentioned. However, the word “recovery” would imply that this product is helping the consumer recover from something—whether it is a sports injury, fatigue, soreness, pain, or a host of other ailments that are commonly associated with the active lifestyle that this product is proposing to supplement.[49] After a workout, a person’s muscle fibers have been depleted of glycogen.[50] In fact, this state of muscular disarray following an intense workout is precisely when proper nutrients are needed most to fuel muscle recovery.[51] Without its delivery in the crucial moments following a workout, growth may be compromised.[52]

Once again, we face the challenge of attempting to define a problem that is not commonly referred to as a disease or ailment. There is no such disease as “post-workout muscle fatigue.” Therefore, although Mega Men Sport claims to aid in muscle recovery, it is doing so without stating that it is a cure for any particular disease. As such, its marketing claims fall within the scope of dietary supplements.
Second, we need to ask whether Mega Men Sport is claiming to “affect the structure or any function of the body” in its marketing literature. As with the Sensa analysis, at first glance it would appear so. Amino acids are the building blocks of protein and muscle tissue which “play a major part in physiological processes relating to our energy, recovery, mood, brain function, muscle and strength gains, and losing fat.”[53] As the building blocks of our muscles, amino acids are quite literally part of the structure of the body.[54] Therefore, it stands to reason that marketing literature claiming to affect amino acids, which is what muscle is comprised of, is by definition affecting the structure of the body.

This deduction breaks down, however, when considering how amino acids function within the muscle tissue. They are ingredients used by muscles for growth and recovery, but they are not part of the muscles themselves.[55] Although this may seem a minor detail, it is important because it permits GNC to market Mega Men Sport as merely assisting in the development of muscle without stating that the product will affect the structure of the body. Also consider the fact that Mega Men Sport merely claims to “support” recovery, in much the same way that Sensa “assists” consumers in eating less. Therefore, it is evident that Mega Men Sport does not affect the structure of the body, and it is not claiming to do so. A more comprehensive advertising statement for Mega Men Sport might say: “Mega Men Sport contains amino acids, which studies suggest are beneficial for muscle growth and recovery.”

Cushions joints with vitamin C, collagen and hyaluronic acid?

The above statement would seem to appear even more benign than the last. We need to ask whether it is positioning this product as a drug or dietary supplement. First, as we did with the prior marketing statements, we must ask whether the claim above is referencing a specific disease. One disease associated with poor joint health is arthritis, and a misinformed consumer could take the above statement to mean that Mega Men Sport could alleviate this disease because it “cushions joints,” which is exactly what arthritis sufferers need.[56] The main symptoms of arthritis are joint pain and stiffness, and it stands to reason that cushioning joints with “vitamin C, collagen, and hyaluronic acid” would lead the average consumer to believe that this product could alleviate those symptoms. [57]

But alas, the literature makes no mention of arthritis directly, and once again we face the same issue in this analysis as we did with the others; the product does not overtly say that it is designed to treat a specific disease, but makes vague claims about how the product supplements the body’s health, which of course, could alleviate symptoms. This claim demonstrates that there is no disease being referenced directly and, as such, it is within the scope of proper dietary supplement marketing law.

Second in our analysis, we must ask whether Mega Men Sport is claiming “to affect the structure or any function of the body” in the above statement. At first glance, it certainly appears to. The product claims to “cushion joints,” and doing so is affecting the structure of the body. Perhaps it is more useful in this case to turn to the operative word “with” to determine what the product is really trying to do. Keep in mind that it does not say Mega Men Sport “cushions joints” on its own. Rather, it says that “vitamin C, collagen, and hyaluronic acid” are the items doing the cushioning of the joints. This is akin to many of our analyses prior, where the marketing claim gives credit to the specific ingredients in the drug instead of saying that Mega Men Sport, itself, cushions joints. As to be expected, a disclaimer on the page appears describing how vitamin C, collagen, and hyaluronic acid work in the body and that they are “associated with” joint health. Therefore, Mega Men Sport is within the confines of the law for this particular statement because it gives credit to its constituent ingredients, rather than to itself. A more precise way to say the above marketing claim would be: “Mega Men Sport contains vitamin C, collagen, and hyaluronic acid, which studies suggest promote joint health.”

Upon analyzing Mega Men Sport’s marketing claims, we have determined that although it makes statements that infer certain things, such as the product’s efficacy and its mechanism of action, its claims do not go into the realm of falsity. As with Sensa, selecting words carefully is key, and the attorneys at GNC have done a praiseworthy job allowing Mega Men Sport to make certain claims without being in violation of the law. Therefore, Mega Men Sport is being properly marketed as a dietary supplement.

Concluding Thoughts

Sensa is a weight loss supplement that suppresses hunger by virtue of stimulating the olfactory system. The marketing statements on its website at times come close to crossing the line into the category of “drug,” but they never do. Although Sensa’s materials might be misleading to the average consumer, Sensa has complied with the law and is presenting its products fairly to the public.
Mega Men Sport is a sport-oriented multivitamin marketed to athletes. Its claims are less significant than Sensa’s, as it does not claim that it induces weight loss. However, it does make certain claims regarding its mechanism of action, such as the way in which specific vitamins in the product work. Like Sensa, it comes close to making marketing claims that are extraneous but never actually follows through with them.

• [1] Council for Responsible Nutrition, Dietary Supplements: Safe, Beneficial and Regulated (retrieved 4/5/2013).
• [2] Id.
• [3] Park, Madison, Half of Americans Use Supplements, CNN Health, www.cnn.com/2011/HEALTH/04/13supplements.dietary/index.html (September 2010).
• [4] Id.
• [5] Consumer Healthcare Products Association, The Value of OTC Medicine in the United States (January 2012).
• [6] 21 U.S.C. §321
• [7] Id.
• [8] U.S. Food and Drug Administration, www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/ucm074201.htm, (retrieved 4/5/2013).
• [9] Id.
• [10] Termini, Roseann, Food and Drug Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods, Dietary Supplements, Cosmetics, Veterinary and Tobacco Products, Forti Publications (2012) p. 107.
• [11] Id.
• [12] Id.
• [13] Id.
• [14] Whitaker v. Thompson, 353 F.3d 947 (D.C. Cir. 2004).
• [15] Id.
• [16] Id.
• [17] Id.
• [18] Woolston, Chris, The Healthy Skeptic: Sensa Promises to Curb Eating, Los Angeles Times, http://articles.latimes.com/2011/mar/14/health/la-he-skeptic-sensa-20110314 (3/14/2011).
• [19] Id.
• [20] Zelman, Kathleen, The Truth About Sensa, Web MD, http://www.webmd.com/diet/features/truth-about-sensa (retrieved 4/6/13).
• [21] Id.
• [22] 20/20, Does the Sprinkle Diet Work? ABC News, http://abcnews.go.com/2020/video?id=5500964 (8/1/2008).
• [23] www.sensa.com (retrieved 4/6/2013).
• [24] Id.
• [25] Id.
• [26] Id.
• [27] 21 U.S.C. §321
• [28] Kahan, Scott, Why Obesity Is a Disease, Huffington Post, http://www.huffingtonpost.com/scott-kahan-md/obesity-disease_b_861087.html (5/19/2011).
• [29] Id.
• [30] Id.
• [31] 21 U.S.C. §321
• [32] Nunley, Kimberly, Science Behind Weight Loss, Livestrong, http://www.livestrong.com/article/258994-science-behind-weight-loss/ (6/14/2011).
• [33] Id.
• [34] Id.
• [35] Id.
• [36] Zelman, Kathleen, The Truth About Sensa, Web MD, http://www.webmd.com/diet/features/truth-about-sensa (retrieved 4/6/13).
• [37] Id.
• [38] GNC Mega Men Sport, http://www.gnc.com/product/index.jsp?productId=4033435 (retrieved 4/7/13).
• [39] Id.
• [40] Amazon.com, http://www.amazon.com/Centrum-Multivitamin-Adult-Under-200-Count/dp/B003G4BP5G/ref=sr_1_11?ie=UTF8&qid=1365350381&sr=8-11&keywords=vitamin (retrieved 4/7/13).
• [41] GNC Mega Men Sport, http://www.gnc.com/product/index.jsp?productId=4033435 (retrieved 4/7/13).
• [42] Id.
• [43] Id.
• [44] Id.
• [45] Id.
• [46] Id.
• [47] Id.
• [48] 21 U.S.C. §321
• [49] Barr, Dave, Top Ten Post Workout Myths, Simply Shredded, http://www.simplyshredded.com/top-10-post-workout-nutrition-myths-dave-barr-2.html (retrieved 4/6/13).
• [50] Stoppani, John, The Six Most Important Post-Workout Nutrients, Muscle and Fitness, http://www.muscleandfitness.com/supplements/recover/six-most-important-post-workout-nutrients (retrieved 4/7/13).
• [51] Id.
• [52] Id.
• [53] The Importance of Amino Acids, Muscle and Strength Magazine, http://www.muscleandstrength.com/articles/the-importance-of-amino-acids.html (retrieved 4/7/13).
• [54] Id.
• [55] Id.
• [56] Mayo Clinic Staff, Arthritis, Mayo Clinic, http://www.mayoclinic.com/health/arthritis/DS01122 (recovered 4/13/13).
• [57] Id.
• [58] 21 U.S.C. §321
• [59] Id.