According to the Food and Drug Administration (FDA), a dietary supplement (DS) is a product taken by mouth that contains 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.
Current Legislation Governing the DS IndustryEdit
Dietary Supplement Health and Education (DSHEA) ActEdit
Since 1994, the DS industry has been regulated by the DSHEA act. DSHEA changed the classification of DS from 'drugs' to a food, eliminating the need for DS premarket safety testing and FDA approval . Under DSHEA, DS manufacturers can make claims if product labels state the products has not been tested by the FDA and do not claim to "prevent, treat, or cure a specific disease" .
Good Manufacturing Practices (GMPs)Edit
Dietary Supplement and Nonprescription Drug Consumer Protection ActEdit
This act requires companies to include an address or phone number on the product label, so consumers may report adverse events they experience. DS companies are required to report any adverse events to the FDA .
Federal Trade Commission (FTC) ActEdit
The FTC Act gives the FTC authority to regulate DS advertising campaigns. The FTC requires advertisers to substantiate any claims before being released to consumers to avoid false and misleading advertising .
Support for the DS IndustryEdit
Manufacturers and Trade OrganizationsEdit
As in any industry, DS manufacturers have formed trade groups to protect their interests. 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 .
Pro-DS Advocacy GroupsEdit
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 .
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 ReportingEdit
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 low compared to those of many Americans' 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 of the industry has a good safety track record .
Concerns with DS IndustryEdit
Some medical professionals, including dietitians and nutritionists, claim their patients misuse supplements . In fact, 73% of Americans would rather "treat themselves than go to a doctor” . 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 . They believe this because DS manufacturers often do not pre-test 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 and effectiveness of DS products that only one DS has been banned by the FDA - ephedrine . Although many products claim to provide benefits, it is unclear what proportion of DS is actually effective.
In 2010, the FDA stated there was a 25% failure rate of GMP compliance for DS manufacturers, as opposed to the expected 4-5% GMP violation failure rate . Many violations are cited for not meeting ingredient specifications and failure to record product specifications . 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. Further, 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 .
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 . Findings such as these are common and the FDA issues warning letters to companies that are known to produce adulterated DS products .
DS are marketed with the use of testimonials and various product claims. Although there is little scientific evidence to support many DS claims, DS advertisements and product claims are vague and leave room for consumer misinterpretation .
DS manufacturers often use customer testimonials in advertising. A common technique is the use of before and after pictures. Celebrity endorsements are particularly effective. 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.
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 .
Snake Oil SalesmanEdit
DS salespeople have been known to make misleading promises to close a sale. These fraudulent sales techniques are similar to those of the snake oil salesmen. 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 .
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 DSEdit
In the US, 20% of people are regular consumers of DS, 32% are occasional users of DS, and 48% do not use DS .
There is a widespread belief by consumers that DS, even if untested, can improve health. This is the concept of truthiness popularized by Stephen Colbert - 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 would not know anything about supplements or would be biased against them . In fact, 67% of people who take DS would continue to do so even if the FDA found them to be ineffective .
Some people believe in the power of DS so strongly that they experience what is known as the 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 ability in the treatment to improve their health. The placebo effect can explain why some DS manufacturers can claim success stories even if their product contains no medically active ingredients.
Many Americans use DS a form of risk compensation, feeling DS are adequate to make up for an unhealthy diet. Experts, however, say DS products to do not make up for the health effects of a poor diet . People who took vitamin supplements were more likely to not exercise and less likely to eat healthier, organic meals . Chiou et al. (2011) demonstrates risk compensation is linked to DS products by showing people feel they are guaranteed "health protection" and think they are "licensed [to] self-indulgence" .
According to Harvard University researchers, people who eat well and take DS do so often as a form of “nutritional insurance,” just in case they are excluding any necessary nutrients from their diet . A good example of this phenomena is children’s multivitamins – The American Academy of Pediatrics does not recommend supplemental vitamin use for healthy children over a year old, yet 32% of children (70% of which are active) are given multivitamins by their parents because parents know they have more to gain by betting that DS work rather than by betting that they don’t worth, especially when the costs are so low .
Since the passing of DSHEA, the DS industry has significantly increased in market size . People continue to take DS for psychological reasons, despite a lack of supporting evidence for most product claims. Supporters for the DS industry emphasize a desire for "freedom of health choices" and cite the historically low risk from 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- they want their government to regulate DS safety yet have the freedom and access to choose any DS they desire. Therefore, the DS industry is an example of a myriad of technologies that are continuously changing in product form and advertising due to the influence of surrounding social groups.
- U.S. Food and Drug Administration. (2009, December). What is a dietary supplement? http://www.fda.gov/AboutFDA/Transparency/Basics/ucm195635.htm.
- IBISWorld. (2012). Vitamin & Supplement Manufacturing in the US Market Research. Vitamin & Supplement Manufacturing in the US: Market Research Report. http://www.ibisworld.com/industry/default.aspx?indid=490
- Marcus, D. M., & Grollman, A. P. (2012). The consequences of ineffective regulation on dietary supplements. Archives of Internal Medicine, 172(13).
- Mason, S. A. (2010-2011). Dietary supplement regulation: A comparative study. Journal of Transnational Law and Policy, 20, 103-127.
- Cassileth, B. R., Heitzer, M., & Wesa, K. (2009). The public health impact of herbs and nutritional supplements. Pharm Biol., 47(8), 761-767. doi:10.1080/13880200902991581.
- U.S. Food and Drug Administration. (2010, December). Guidance for industry: Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements; Small entity compliance guide. Food website:http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation.
- S. 3546 (109th): Dietary Supplement and Nonprescription Drug Consumer Protection Act, S. S.3546, 109th Cong., 1st Sess. (2006).
- In the Matter of Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body; Docket No. 98N-0044 before the DEPARTMENT OF HEALTH AND HUMAN SERVICES and FOOD AND DRUG ADMINISTRATION (1998) (testimony of Bureau of Consumer Protection of the Federal Trade Commission).
- (June 1, 2010 ). '09 Sales Growth Sputters in Every Nutrition Category as Economy Takes its Toll. Nutrition Business Journal, www.lexisnexis.com/hottopics/lnacademic.
- Vladeck, D. C. (2000). Truth and consequences: The perils of half-truths and unsubstantiated health claims for dietary supplements. Journal of Public Policy & Marketing, 132-138.
- Emord & Associates. (2010). Significant cases. http://www.emord.com/.
- BodyLogicMD. (2012). Will you prescribe me vitamins and supplements? [Video file]. http://www.bodylogicmd.com/faq/will-you-prescribe-me-vitamins-and-supplements.
- (September 1, 2010 ). Recession Makes Wellness a More Urgent Priority for Most Consumer Groups. Nutrition Business Journal, www.lexisnexis.com/hottopics/lnacademic.
- American Association of Poison Control Centers. (2012). Annual reports. http://www.aapcc.org/annual-reports/
- Nationmaster. "Mortality".
- Link, C. (2012, February 23). CRN refutes supplement adverse event statistic as 'outdated and irrelevant'. http://m.newhope360.com/regulation-and-legislation/
- Consumer Reports. (2010, September). Dangerous supplements: What you don't know about these 12 ingredients could hurt you [Video file]. http://www.consumerreports.org.
- Desai, K. (2012, August 2). Hidden dangers in vitamins, supplements? CNN, Health.
- PRoper Starch Worldwide, Inc. (2001). Self care in the new millenium: American attitudes toward maintaining personal health and treatment.
- Lipson, P. A., M.D. (2009, July 20). DSHEA: A travesty of a mockery of a sham. Science-Based Medicine website: http://www.sciencebasedmedicine.org/.
- Collins, N., Tighe, A. P., Brunton, S. A., & Kris-Etherton, P. M. (2012). Differences between dietary supplement and prescription drug omega-3 fatty acid formulations: A legislative and regulatory perspective. Journal of the American College of Nutrition, 31(3).
- Murdoch, D. R., MD, Slow, S., PhD, Chambers, S. T., MD, Jennings, L. C., PhD, Stewart, A. W., BSc, Priest, P. C., DPhil, . . . Scragg, R., PhD. (2012). Effect of vitamin D3 supplementation on upper respiratory tract infections in healthy adults: The VIDARIS randomized controlled trial. JAMA, 308(13), 1333-1339.
- Li, K., Kaaks, R., Linseisen, J., & Rohrmann, S. (2012). Associations of dietary calcium intake and calcium supplementation with myocardial infarction and stroke risk and overall cardiovascular mortality in the Heidelberg cohort of the European prospective investigation into cancer and nutrition study. Heart, 98, 920-925. doi:10.1136/heartjnl-2011-301345.
- Powers, H. J. (2003). Riboflavin (vitamin B-2) and health. The American Journal of Clinical Nutrition, 77(6).
- Zimmermann, M. B. (2009). Iodine deficiency. Endocrine Reviews, 30(4), 376-408. doi:10.1210/ er.2009-0011.
- U.S. Food and Drug Administration. (2004, November 23). FDA acts to remove Ephedra-containing dietary supplements from market [Press release].
- Wright, J. (2012, February 17). FDA GMP inspections: How to comply. http://www.naturalproductsinsider.com/news.
- U.S. Food and Drug Administration. (2001, July 6). FDA advises DS manufacturers to remove comfrey products from the market [White paper].
- U.S. Pharmacopeial Convention. (2012). Companies participating in the USP verified program for dietary supplements. http://www.usp.org/.
- Adebowale, A. O., PhD, Cox, D. S., MS, Liang, Z., MS, & Eddington, N. D., PhD. (2000). Analysis of glucosamine and chondroitin sulfate content in marketed products and the Caco-2 permeability of chondroitin sulfate raw materials. Journal of American Nutraceutical Association, 3(1), 37-44.
- U.S. Food and Drug Administration. (2012, November 20). Warning letters - health fraud. For Consumers website: http://www.fda.gov/ForConsumers/ProtectYourself/HealthFraud/ ucm255474.htm.
- (February 1, 2011 ). How Weight Loss Ads Slip Past the FTC. Nutrition Business Journal, www.lexisnexis.com/hottopics/lnacademic
- Federal Trade Commission (2000, April 4). Marketers of "The Enforma System" settle FTC charges of deceptive advertising for their weight loss products, [Press Release].
- Office of Dietary Supplements. (2011, June). Frequently asked questions. http://ods.od.nih.gov/
- (February 1, 2011 ). Weight-Loss Sales in 2010 Return to 2003 Levels in Wake of Hydroxycut Recall. Nutrition Business Journal, www.lexisnexis.com/hottopics/lnacademic
- Government Accountability Office, Examples of Deceptive or Questionable Marketing Practices and Potentially Dangerous Advice, Rep. No. GAO-10-662T (2010).
- Government Accountability Office, FDA Should Take Further Actions to Improve Oversight and Consumer Understanding, Rep. No. GAO-09-250 (2009).
- Consumer Safety and Weight-Loss Supplements: Hearings before the Oversight of Government Management (2012) (testimony of Michael F. Mangano, Principal Deputy Inspector General Department of Health and Human Services).
- Sen Durbin, R. Senate Amendment 2127 (2012). 112th Congress. http://thomas.loc.gov/cgi-bin/bdquery/z?d112:sp2127:
- Blendon, Robert J., DesRoches, Catherine M., Benson, John M., Brodie, Mollyann, Altman, Drew E. Altman. (2001). Archives of Internal Medicine, 161(6). doi:10-1001/
- Donaldson, M. S. (2004). Nutrition and cancer: A review of the evidence for an anti-cancer diet. Nutrition Journal, 19(3), 1-21. doi:10.1186/1475-2891-3-19
- Nichols, B., Nielsen, F., Spence, J., & Turnlund, J. (2012, November 19) Founding American nutrition science. Agricultural Research Service/USDA website: http://www.ars.usda.gov
- 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.
- Harvard School of Public Health. (2012). Nutrition Insurance Policy: A Daily Multivitamin. The Nutrition Source. http://www.hsph.harvard.edu/nutritionsource/what-should-you-eat/multivitamin/
- 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.