# Lentis/The Dietary and Bodybuilding Supplement Industry in the United States

According to the Food and Drug Administration (FDA), dietary supplements (DS) are any product taken by mouth that contain a "dietary ingredient" intended to supplement the diet. A dietary ingredient can include:
* a vitamin,
* a mineral,
* an herb or other botanical,
* an amino acid,
* a dietary substance for use by man to supplement the diet by increasing the total dietary intake (e.g., enzymes or tissues from organs or glands), or
* a concentrate, metabolite, constituent or extract.
In 2014, the DS industry was estimated to be an $18 billion industry. In 2008, more than 75,000 DS were available in the U.S.

## Current Legislation Governing the DS Industry
### Dietary Supplement Health and Education Act (DSHEA)

Since 1994, the DS industry has been regulated by the DSHEA. The DSHEA changed the classification of DS from drugs to food, eliminating the need for DS premarket safety testing and FDA approval. Under the DSHEA, DS manufacturers can make any claims as long as they state that their products have not been tested by the FDA and do not claim to "prevent, treat, or cure a specific disease."

### Good Manufacturing Practices (GMPs)

The FDA has established Good Manufacturing Practices (GMPs) which require DS manufacturers to establish consistent quality, packaging, and labeling to assure that the products are high quality and pose no risk to the consumer or public. Under the current GMPs for DS, "manufacturers are required to evaluate the identity, purity, quality, strength, and composition" of their products. These practices are enforced to ensure that DS do not have the wrong ingredients, too much or too little of an ingredient, improper packaging or labeling, or contamination.

### Dietary Supplement and Nonprescription Drug Consumer Protection Act

This act was put into law in 2006 and sets up a chain of reporting any adverse events caused by DS and nonprescription drugs. Under this act, DS manufacturers must include an address or phone number on their product labels, so consumers may report adverse events they experience. DS manufacturers are required to send these reports to the FDA within 15 days of receiving them.

### Federal Trade Commission (FTC) Act

The FTC Act gives the FTC the authority to regulate DS advertisements. The FTC requires advertisers to substantiate any claims made in their ads before being released to consumers to avoid false or misleading advertisement. This law has had issues with DS companies who do not directly say that taking their products will cure or prevent a disease, but insinuate such claims in their ads, such as the vitaminwater advertisement that states "Flu shots are so last year."

## Support for the DS Industry
### Manufacturers and Trade Organizations

As in any industry, DS manufacturers have formed trade groups to protect their interests. For example, the Consumer Healthcare Products Association (CHPA) and the Natural Products Association are trade organizations for dietary supplement manufacturers. To distinguish themselves from competitors and improve perception of their industry, some companies are taking it upon themselves to make their products, innovations, and advertisements more transparent to consumers.
Rob Rhinehart, software engineer and inventor of Soylent,an artificial total diet supplement which claims to act as a replacement to all food, advocates and practices a diet consisting of only supplements. Rhinehart uses his blog to defend his belief that meals can be completely replaced by his supplement. He claims, "What food company is more concerned with the nutrition of their product than its sensory appeal? We are more serious about health than any competitor in the industry."

### Media Personalities

There are a few prominent media personalities who encourage the use of DS. For example, Dr. Oz is a popular television personality with a show focused on medial and personal health issues. Dr. Oz is a proponent of homeopathy and alternative medicine. In June 2014, he was brought to a U.S Senate Committee on Commerce, Science, and Transportation’s Subcommittee on Consumer Protection, Product Safety, and Insurance hearing titled, “Protecting Consumers from False and Deceptive Advertising of Weight-Loss Products”. Senator Claire McCaskill points out that Dr. Oz airs segments on weight loss products which are then featured in advertisements. Speaking to Dr. Oz, Senator McCaskill says she is "concerned that you are melding medical advice, news, and entertainment in a way that harms consumers," implying that Dr. Oz has a role in perpetuating medical scams.

### Pro-DS Advocacy Groups

Advocacy groups, such as the Citizens for Health Education Foundation (CFH), work to influence government policy decisions (such as Senate Amendment 2127 to the Food and Drug Administration Safety and Innovation Act) and to challenge unfavorable government actions legally. In the 1999 case Pearson v. Shalala, two manufacturers, the American Preventive Medical Association (APMA), and the CFH, filed a lawsuit against the FDA, claiming the FDA could not require companies to scientifically validate health claims. The courts initially ruled in favor of the FDA, but later overturned the ruling. Following this case, the FDA lost a number of other cases surrounding the issue of product labels.

### Medical Professionals

Some doctors do believe that some DS, such as vitamins and minerals, can benefit patients, especially when the "food quality [of patients] is...poor." Doctors and physicians are increasingly recommending DS to their patients. A recent study found that health practitioners constituted the third fastest growing sales channel for DS in 2009.

### Low Adverse Event Reporting

Annual reports from the American Association of Poison Control Centers revealed 177 deaths linked to DS consumption from 1994-2010, amounting to less than 11 deaths annually. In fact, this annual death rate is lower than many daily activities, such as falling out of bed (450 deaths annually). Manufacturers and trade organizations, such as the Council for Responsible Nutrition (CRN), claim the number of adverse event reports is low because the industry has a good safety track record.

## Concerns with DS Industry
### Scientific Concerns

Some medical professionals, including dietitians and nutritionists, claim their patients misuse supplements. Some people take supplements despite the fact that they do not have a nutrient deficiency in their diet, causing them to consume over the 100% recommended daily dosage. In some cases, the excess nutrients consumed are excreted from the body without harm. A study conducted in Japan found this to be the case with many water soluble vitamins. However, other reports have found that overdosing on supplements can lead to harmful side effects including liver, kidney, and gastrointestinal problems. Although some medical professionals believe DS are beneficial, many are skeptical of the industry, believing the DS industry is unregulated and manufacturers can "sell whatever [they] want" as long as they do not get caught. This belief comes from DS manufacturers not always pre-testing their products for safety and effectiveness. Even when third-party testing takes place, it is difficult for scientists and doctors to determine the veracity of product claims. It has been so difficult to prove the danger or ineffectiveness of DS that only one has been banned by the FDA - ephedrine. Although many DS claim to provide benefits, it is unclear what portion of them are effective.

### Manufacturing Problems
##### GMP Compliance

By 2010, all DS manufacturers had to comply with Current GMPs established by the FDA. This meant that manufacturers are responsible for evaluating the identity, purity, strength, and composition of their products. However, under the Interim Final Rule, companies are permitted to petition for exemption from conducting identity testing for 100% of ingredients used in their supplements. In 2010, the FDA found that 25% of the DS manufacturers they inspected were in violation of GMP requirements. Such FDA findings have caused consumer awareness groups, such as ConsumerLab.com, to alert consumers of the dangers of DS. Increasingly, large companies have independent organizations (such as the United States Pharmacopeial Convention (USP) and the Natural Products Association (NPA)) verify they abide by adequate manufacturing and product quality standards. Three leading DS companies, NBTY, Pharmavite, and Perrigo, are currently participating in USP conventions to verify the quality and safety of their products. Manufacturers like these welcome new regulations as "clean up measures," but also fear that bad press from the failing companies may impact their business.

##### Product Adulteration

A product is considered adulterated if it becomes contaminated or contains a substance that may be unsafe to the users health.In 2001, human placenta samples taken from some women revealed abnormally high levels of colchicine, a medication commonly used to treat gout. This was due to the adulteration of Ginkgo biloba, an herbal dietary supplement the women had taken. Adebowale et al. (2000) studied the labeled claims of eleven DS that contained chondriotin sulfate and found that the percentage of claimed chondriotin sulfate in the products ranged from 33% to 110% of the claim main ingredients.

### Misleading Marketing

DS are marketed with the use of testimonials and various product claims. DS advertisements and product claims can be vague and leave room for consumer misinterpretation. In 2009, the Great Britain Advertising Standards Authority (ASA) banned a poster campaign of POM Wonderful LLC for exaggerating the health benefits of its pomegranate juice. The advertisement featured a fruit juice bottle with a severed noose around the top which read "Cheat Death" The ASA received 23 complaints from people who felt the advertisement was misleading since drinking the juice would not make them live forever. In 2010, the FDA sent POM Wonderful a warning letter addressing unsubstantiated claims on their website. These claims included benefits in lowering blood pressure and cholesterol as well as therapeutic benefits in prostate cancer and erectile disfunction. In 2014, the FTC sued Sensa, L'Occitane, LeanSpa, and HCG Diet Direct; four weight loss supplement companies who used descriptive marketing techniques to sell their products.
DS salespeople have been known to make misleading promises to close a sale. To investigate fraudulent sales techniques, Government of Accountability Office (GAO) informants (disguised as elderly people) called DS companies for supplement advice. The informants were often told by the salespersons that their products would prevent or cure serious conditions. A video of some of these calls can be seen here.

##### Product Testimonials

DS manufacturers often use customer testimonials in advertising. A common technique is the use of before and after pictures, however, not all DS manufacturers show accurate results from use of their product. Wu-Yi Tea Company sells teas that they say contain a natural antioxidant which can help improve energy and metabolism and promote weight loss. One customer testimonial published by Wu-Yi Tea featured a picture of a young woman who had lost 68 pounds due to drinking their tea. The woman claims she lost the weight over the course of a year through diet and exercise and Wu-Yi Tea Company stole her photographs from her personal blog for the use of their advertisement. When interviewed by the TODAY Show, she said, "I haven't even tried the tea. I don't even know what this tea is!" The TODAY Show did further research on other weight loss supplement ads and found that one woman was featured in several ads under different names. Their investigation found that this photo was of a German plus-sized model which had been photo shopped to appear thinner in the "after" shot.
Celebrity endorsements are also used for marketing. For example Steve Garvey, a former MLB player known as "Mr. Clean" for his sterling reputation, was enlisted by Enforma Natural Products in the 1990s to endorse "The Enforma System." Together, they claimed the system caused weight-loss without dieting or exercise. The FTC banned the company from advertising the weight loss supplements citing the use of misleading claims. Although some DS advertising testimonials are genuine, many are just an appeal to consumers to purchase their products.

##### Fine-Print

Clinical or pre-market tests are often performed in-house, so the “proof” and experimentation of these claims is often unclear. Products with fine print, such as clinically proven or clinically tested on labels and in advertisements, frequently lack specificity, leaving room for consumer misinterpretation, which can eventually lead to adverse effects. In 2009, the FDA warned consumers about the "clinically tested" Hydroxycut products following 23 cases of serious health problems, which prompted manufacturers to the recall the products. As previously mentioned, the USP and the NPA offer "seals of approval" to companies for meeting quality manufacturing standards; however, many consumers may mistake this to mean the product is safe or effective.

### Regulatory Concerns

The GAO published a report expressing concern about the FDA’s lack of authority and limited access to information, recommending that the FDA Commissioner request additional authority to oversee DS products and new DS ingredients. Further, the U.S. Department of Health and Human Services (DHHS) has expressed concerns to the US Senate about a study which estimated that only 1% of adverse events from DS products are reported to the FDA. Senator Richard Durbin of Illinois attempted to deal with these concerns by adding Senate Amendment 2127 to the Food and Drug Administration Safety and Innovation Act, but the amendment was defeated 77-20.

## Social Influences on the Consumption of DS

In the US, 20% of people consume DS regularly, 32% are occasional users, and 48% do not use DS.

### Truthiness

There is a widespread belief by consumers that DS, even if untested, can improve health. This concept of Truthiness popularized by Stephen Colbert - follows the logic that "when you feel it in your gut, you know it must be right." Most people who take DS do not discuss their DS usage with their doctor because they believe their doctors are uninformed about supplements or biased against them. In fact, 67% of DS users would continue to do so if the FDA proved them to be ineffective.

### Placebo Effect

Some DS consumers believe in their DS so strongly that they experience a placebo effect. The placebo effect occurs when a patient sees an improvement in their health after a medically ineffective therapy due to their belief in the treatment. The placebo effect can explain why some DS manufacturers have success stories despite their product not containing medically active ingredients and why users continue to take them.

### Risk Compensation

Many Americans use DS as a form of risk compensation and believe taking DS makes up for an unhealthy diet, despite experts who refute risk compensation thinking. People who took vitamin supplements were less likely to exercise or eat healthy in a study on DS Risk Compensation. Chiou et al. (2011) links risk compensation to DS products by showing that people feel guaranteed "health protection" after taking a vitamin.

### Licensing Effect

Similar to risk compensation, the licensing effect deals with the negative actions of someone after doing something that they think to be healthy, such as taking a DS. The licensing effect states that a choice which boosts a positive self-image justifies a more self-indulgent choice later. Researchers in Taiwan aimed to study the licensing effect by observing the habits of daily smokers after being told they were given a daily vitamin. The smokers were all given sugar pills, but half were told that they had just taken a multivitamin. After taking the pills, 89% of the people who had been told they took a vitamin smoked a cigarette within the hour, while only 62% of those who knew they took a sugar pill smoked in the same time frame. As science has yet to prove that taken a daily vitamin is good for your health, but has proven that cigarettes are bad for you, it is easy to see the licensing effect at work in the DS industry. Believing that a DS is good for you, even if it is not, may increase the risk of doing something that is genuinely bad for you, as seen in the smoker's study.

### Nutritional Insurance

According to Harvard University researchers, people who eat well and take DS may do so as a form of “nutritional insurance,” in case they miss any necessary nutrients in their diet. A good example of this phenomena is seen in children’s multivitamins use. The American Academy of Pediatrics does not recommend supplemental vitamin use for healthy children over one year in age, but 32% of children (70% of whom are active) are given multivitamins by their parents. Parents are giving their children the multivitamins as a safety net for any missed nutrients in their child's daily diet.

## Conclusion

Since the passing of the DSHEA, the DS industry has significantly increased in market size. Many people continue to take DS, despite a lack of supporting evidence for many product claims. DS users are taking supplements for a host of different reasons and the industry continues to grow annually. A large contributing factor to this growth seems to be a lack of knowledge about DS among the general population. Many people do not know much about DS, but know that some of the active ingredients in them are supposed to be good for you. Supporters of the DS industry emphasize a desire for the freedom to make our own health choices and cite the historically low risk of consumption. However, there is broad support for DS industry regulations to ensure that supplements are safe, manufactured with good practices, and advertised truthfully. Americans seem to want the best of both worlds- the regulation of DS to ensure safety, but also to have the freedom and access to choose any DS they desire. Therefore, the DS industry is an example of a continuously changing technology, which is shaped by the influence of its surround social groups.

## References

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* ↑ Sen Durbin, R. Senate Amendment 2127 (2012). 112th Congress. http://thomas.loc.gov/cgi-bin/bdquery/z?d112:sp2127:
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* 1 2 Chiou, W.-B., Yang, C.-C., & Wan, C.-S. (2011). Ironic effects of dietary supplementation: Illusory invulnerability created by taking dietary supplement licenses health-risk behaviors. Psychological science, 22(8), 1081-1086.
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* ↑ Ulfat Shaikh, M., MPH; Robert S. Byrd, MD, MPH; Peggy Auigner, MS. (2009). Vitamin and Mineral Supplement Use by Children and Adolescents in the 1999-2004 National Health and Nutrition Examination Survey. Arch Pediatric Adolescent Medicine, 163(2), 150–157.