The food supplement industry: the hype continues.

While consumers spends billions of dollars every year on vitamins and food supplements in hopes of improving their health and fitness, many of these products lack scientific evidence to back up their purported health claims. Consumers can just cut out the supplement industry by eating decently and exercising regularly.

This is obviously a glorious time for the supplement industry, with more than half of U.S. adults popping vitamins, minerals, herbs  and elixirs. According to the available published evidence, retail sales of vitamins and nutritional supplements reached $28.1 billion  in 2010.¹ And between 2009 and 2014, worldwide value of retail sales of these products reached $88 billion.² This is a good news for both the small and the large producers. Take Otsuka Pharmaceuticals of Japan. The company is the owner of Pharmvite,  which churns out 15 billion pills per year. Other pharma giants from America and Germany, including Pfizer and Bayer, are also big peddlers of multivitamins.³

On the minus side, however, the industry seems besieged. First, there are concerns about the accuracy of the claims they make. The U.S. Department of Justice has accused Bayer Corporation for illegally promoting the effects of its probiotic, a supplement that it claimed helps to defend against symptoms like bloating, diarrhea and constipation.⁴ The company’s management is currently waiting for the  court ruling on the issue. Last month, America’s Federal Trade Commission held a workshop to evaluate advertising for over-the-counter homeopathic products.⁵ Yet, a lot of people as well as government agencies still worry the safety of these products. America’s Food and Drug Administration(FDA) mailed warning letters to firms selling pure caffeine  last  September. Their reason was that these firms sells pure caffeine products   that are highly concentrated, with one teaspoon of their products containing much of the stuff as, say, 28 cups of coffee. A large number of supplement makers sells products that were  illegally branded as food “supplements” even though they contain BMPEA – a stimulant similar to amphetamine. The supplement makers in this group have also received several warning letters from  FDA last April. In addition to the constant warnings, surveillance and sanctions they  receive from the regulators, the supplement industry are also in the radar of the law firms: numerous lawsuits are in the works, on everything from protein powders said to lack protein to allegedly dangerous diet pills.6

In spite of these attacks, the food supplements industry seems to has a good immune system of its own. Basically, the unique environment in which the industry operate – an environment characterized by lax regulation, potent marketing and millions of credulous consumers keen to pin their hopes of a healthier life on a pill – has catapulted it to prominence, making it a national sensation. Hence it is not an exaggeration to say here that the food supplement industry has proven time and again that it is very  resilient.

The United States, with its loyal consumers and uniquely helpful regulations, seems to be the industry’s honeypot. Though growth has slowed, the value of retail sales of vitamins and nutritional supplements in United States reached a record $32.8 billion last year.7 The Nutrition Business Journal is considered to be an authority when it comes to providing information about the industry – information  relating to the trends, operation tactics, products and consumer concerns. As was reported in the publication, dietary supplement sales in United States grew 7.5 percent to $34.8 billion in 2013(as noted in New Hope 360).⁸

The “vitamin” club

Catherine Price, an assistant professor at the University of Florida said it all in her book Vitamania – Our Obsessive Quest for Nutritional Perfection: America’s craze for food supplements started in the 1930s and 1940s.⁹ At that time, scientists validated the claim that vitamins are chemicals that can perform vital functions in the body. Hence pills containing vitamins are widely seen as magic pills that can boost soldiers and work alike. Soon scientist perfected the methods for synthesizing vitamins in factories rather than being extracted from nature. This important feat made vitamins to be cheaper and widely used. Following this medical trajectory, Linus Pauling, who was awarded a Nobel Prize in Chemistry in 1954,¹⁰ popularized the invalid claim that  vitamin C could prevent colds and cure cancer. Nevertheless, it was government regulations that gave the supplement industry the biggest boost. The FDA considered new rules for supplements’ health claims in the 1990s. With this development, the major players in the industry understood there were billions of dollars at stake. Their lobbyists sensationalized the issue thereby making access to food supplement an issue of personal liberty. Their major achievement in that regard was phenomenal: if bureaucrats regulates access to vitamins, it would mean that they are robbing Americans the freedom to care for themselves.¹¹

See no evil, hear no evil, speak no evil

The outcome of their activities was clear: a new law was passed to cover not only vitamins and minerals, but also botanicals, pills made from animal organs, amino acids, enzymes and metabolites. A 1994 law also made life more easier for the supplement industry: it allowed them to sell supplements without requiring FDA’s approval for efficacy or safety. The rule also authorized producers of food supplements to tout their health benefits. According to the provisions of the rule, these firms cannot claim that the pills they market to the public can diagnose, prevent, treat or cure a disease. They can, however, make vague claims that their supplements are essential for strong bones or that they can support a healthy heart, and so on. Hence, instead of restraining these supplement industry, the government, via the FDA, actually unleashed them. It is thus not surprising that since 1994 the growth of supplement products has reached exponential proportion.¹²

The logical deductions from these rules are that they fail to ensure safety and efficacy. Starting with safety, the rules on manufacturing standards apply only to the supplement-makers only. In other words, they do not apply their suppliers. In addition to this, the rules did not place any cap on the amount of nutrient that a pill may contain. Furthermore, the FDA’s powers over supplement products that are already on sale are limited. Thus, the agency cannot just ban a supplement product as they can do with other drugs. They must first of all prove that the product is unsafe before they can withdraw it from the shelves. Examined against this background, it was no surprise that it took seven years for the FDA to provide evidence that certain pills caused liver disease – an outcome that led to the outright banning of the pills. The saving grace for some food supplement –makers is that, given the FDA’s limited role, they can hire consultants to check their products’ quality. While many of the supplements-makers do this, others do not.

Studies have found problems with lots of food supplements. Earlier this year, New York’s Attorney-General Eric Schneiderman alleged that many food supplements did not contain what they claimed on their labels.¹³ While some industry groups and consumers argued that Schneiderman’s testing method were faulty, other studies have also found problems with food supplements: a test conducted on 42 multivitamins by ConsumerLab.com, a provider of independent tests results and information on health and nutrition products, revealed that 16 of them either have too little or too much of the nutrients claimed in the label.¹⁴

Other cases dealing with the safety or purported benefits of food supplements are more serious. In October 2014, an infant from Connecticut died from a contaminated probiotic.¹⁵ In 2013, the FDA received almost 30 complaints of averse incidents associated with  a vitamin B pill(Health Life Chemistry by Purity B-50), which was later found to contain steroids. The people  who took this pill reported many bad things happening to their body: the women reported facial hair growth and missed menstruation while men reported low testosterone and impotence. Lab results also found that using the product can impact cholesterol level as well as cause abnormal liver and thyroid function.¹⁶ During the same year, the U.S. Center for Disease Control (CDC) linked Oxy-Elite Pro, a dietary supplement, to acute hepatitis. Of the nearly 50 people that were hospitalized after using the product, at least 3 received a liver transplant while person died.¹⁷

The efficacy of these products is also questionable. What made dietary supplements more dangerous is that while firms must have some substantiation  for the claims they make on the labels and ads under the Dietary Supplements Health and Education Act (DSHEA) of 1994, they are not required to submit safety information about their products to FDA  before marketing them.¹⁸ This simple fact makes it difficult for the FDA  to monitor and regulate thousands of products being marketed by these firms. So it may not be surprising that the FDA had had to rely on adverse event reports, information in the scientific literature, product sampling and other sources of evidence of danger to combat public confusion about food supplements. This further means that the consumers are virtually unprotected against unsafe food supplements.

This, however, does not mean that all food supplements are bad. A few of them does have sound scientific evidence behind them. For instance, vitamin B12  is good for the elderly and folic acid is good for women planning to become pregnant. Low levels of vitamin D is linked to cognitive decline, even though evidence that the supplement can solve the problem is lacking.¹⁹ The supplement industry’s relentless central argument is that since many Americans eat unhealthily, supplements therefore fill a need. The problem with this argument is that it is difficult to discern many supplements’ benefits. For instance, in a drug trial the individuals in the control groups takes no medicine. In contrast, in in a study of a vitamin, the people in the control group still ingest various levels of that vitamin from food, making it a big challenge to judge the effects of the supplement. Not only that, the evidence that does exist about the benefits of food supplements is often mixed. Some botanicals, such as gingko (a supplement for improving cognitive function and for treating, preventing  or reducing the effects of Alzheimer’s disease) show no effect in large studies. Another popular herbal supplement known as John’s wort is ineffective because it can interfere with blood thinners.  In one surprising study, researchers conducted a test to determine if a precursor to vitamin A can cut the risk of cancer among smokers. Their results showed that the supplement seemed to increase it.²⁰ Another study with disturbing results was conducted in 2011. According to this study results men who take vitamin E have a higher risk of getting prostate cancer than those on a placebo. Two similar studies were also conducted around the same period which showed positive results:  one showed that multivitamins  may lower the risk of cancer in men while the other suggests they may lower heart-disease deaths in women. These outcomes were contradicted by researchers in three  studies in 2013.These researchers presented  data that showed that multivitamins supplements  showed no effect on cancer, heart disease, cognitive decline or death.²¹

Armed and proud

The industry experienced some signs of weakness in 2014, the year in which it grew more slowly than at any time since 2002.²² But the major players in the industry are not giving up irrespective of the negative attention and criticisms of the industry and its products. They have three reasons for adopting this mindset.

First, further regulation of the industry in America appear unlikely. Ideally there are bills to improve oversight. However, such bills never got anywhere at the Congress. The FDA doesn’t seem to have any plan about using its existing powers to police the industry. The Council for Responsible Nutrition(CRN), a trade association representing dietary supplements and functional food manufacturers,²³ has $6 million budget to boost the interests of its members. In contrast, the FDA has only $5.2 million to police the entire supplement industry. Besides,  its strongest boss to date, who had since returned to lobbying business, was a former lobbyist for the food supplement industry.²⁴  So, you do the math: more regulation is simply impossible given the agency’s resources. The FDA’s failure to issue warnings about the stimulant BMPEA on time illustrates the agency’s limits. The FDA knew that a range of popular diet pills and spots supplements contained BMPEA since 2013. But the agency did not issue warnings to the manufacturers of these products until last April. The FDA’s failure to take regulatory action on time, as appropriate, to protect consumers may have been due to conflicts of interests. It may also be that the agency has too many tasks with no cash to accomplish them at the time. Even the agency cannot confirm that products with BMPEA  are off the shelves  for nearly five months after sending its warning letters.²⁵

Second, the food supplement industry are expert in bouncing back. So, while a negative publicity can hurt sales, they usually bounce back up: the industry has indeed consistently shown notable prowess for getting back to their feet. For instance, a study on the risks of excessive amounts of vitamin D in a body – known as vitamin D toxicity – helped depress sales growth in the supplement industry from 16.7 percent in 2011 to 1.3 percent in 2012. But in 2013, sales growth in the industry rebounded to 9 percent.²⁶ Generally speaking, if one particular product does not make a comeback, the industry simply offer a new one – a strategy that has huge resonance with the consumers.

Third, Americans and the Western Europe in general love taking supplements. As a matter of fact, almost 50 percent of Americans take supplements regularly. The general belief that supplements are the holy grail of general health fuels their passion and craving for the product. Thus it is not surprising that Americans take them for their bones, their hearts and their minds, among other reasons. Added to the hype is the fact that supplement industry are also good marketers, who regularly craft targeted messages that will reach correct consumers. Not only that, conventional health care is expensive. So consumers sees supplements as an alternative, cost-effective solutions to the costly conventional health care since supplements lets them take charge of their health. Next is another important factor is what is generally known among scientists as the placebo effect: the customers’ brains responds positively to their belief that a given pill will help improve their body functions.²⁷

All these mean that the greatest threat to the industry may not be the regulators or the results of clinical trials. Their main threat is actually something that is very simple: consumers are earnestly searching for natural and organic foods. They are also willing to pay more for them. Thus in 2014, sales revenue from natural and organic foods grew by 12.7 percent compared to supplements’ rise of 5.1 percent.²⁸ But, as was expected, the supplement industry are already adapting. Last year, GNC launched a new line of whole-food-based supplements.²⁹ That same year Pharmvite acquired FoodState, a whole food supplement company which makes vitamins from fresh and local foods.³⁰

A final point: consumers can just cut out the supplement industry by eating decently and exercising regularly. But I do know that the supplement industry will not like this idea. And nobody will really blame them: they have good reason to hope that the consumers will not be that smart.

References

¹Retail Sales of Vitamins & Nutritional Supplements in the United States from 2000 to 2017 (in billion U.S. dollars). (2015). Statista. Retrieved October 19, 2015 from http://www.statista.com/statistics/235801/retail-sales-of-vitamins-and-nutritional-supplements-in-the-us/.

²Vitamins and Supplements - Miracle Healers. (2015, September 19). The Economist. Retrieved October 19, 2015 from http://www.economist.com/news/business/21665064-despite-scandals-and-scepticism-americas-supplement-industry-looks-healthy-miracle-healers.

³Ibid

⁴Long, J. (2015, June 12). Bayer Braces for Trial in Probiotic Supplement Dispute with FTC. Natural Products Insider. Retrieved October 19, 2015 from http://www.naturalproductsinsider.com/blogs/supplement-law/2015/06/bayer-braces-for-trial-in-probiotic-supplement-di.aspx.

⁵Federal Trade Commission. (2015). Homeopathic Medicine & Advertising. Press Release. Washington DC: Federal Trade Comission. Retrieved October 19, 2015 from https://www.ftc.gov/news-events/events-calendar/2015/09/homeopathic-medicine-advertising

⁶Vitamins and Supplements - Miracle Healers, op. cit., p. 57

⁷Retail Sales of Vitamins & Nutritional Supplements in the United States From 2000 to 2017 (in billion U.S. dollars). (N.D.). Statista. Retrieved October 26, 2015 from http://www.statista.com/statistics/235801/retail-sales-of-vitamins-and-nutritional-supplements-in-the-us/.

⁸The state of supplement sales in 2014. (2015). New Hope 360. Retrieved October 26, 2015 from http://newhope360.com/supplements/state-supplement-sales-2014.

⁹Price C.(2015): Vitamania – Our Obsessive Quest for Nutritional Perfection. New York, NY: Penguin Press.

¹⁰Linus Pauling - Biographical. (2015). Nobel Media.  Retrieved October 27, 2015 from http://www.nobelprize.org/nobel_prizes/chemistry/laureates/1954/pauling-bio.html

¹¹Vitamins and Supplements - Miracle Healers, op. cit., p. 58

¹²Ibid

¹³Esch, M. (2015, April 2). 14 Attorneys General Seek Congressional Probe of Herbal Supplement Industry After New York Investigation. NBC New York. Retrieved November 9, 2015 from http://www.nbcnewyork.com/news/local/Herbal-Supplement-Warning-Congressional-Probe-New-York-Ingredients-Schneiderman-Consumer-Health-298522901.html.

¹⁴Vitamins and Supplements - Miracle Healers, op. cit., p. 58

¹⁵Kroll, D. (2014, December 17). Infant Death Triggers FDA Health Provider Warning On Probiotic Risks. Forbes. Retrieved November 9, 2015 from http://www.forbes.com/sites/davidkroll/2014/12/17/infant-death-triggers-fda-health-provider-warning-on-probiotic-risks/.

¹⁶Jaslow R.(2013): FDA: Anabolic Steroids Found in Vitamin B Supplement. CBS News. Retrieved November 9, 2015 from http://www.cbsnews.com/news/fda-anabolic-steroids-found-in-vitamin-b-supplement/

¹⁷FDA Investigation Summary: Acute Hepatitis Illnesses Linked to Certain OxyElite Pro Products. (2013). U.S. Food and Drug Administration. Retrieved November 9, 2015 from http://www.fda.gov/food/recallsoutbreaksemergencies/outbreaks/ucm370849.htm.

¹⁸U.S. Congress (1994). Dietary Supplement Health And Education Act of 1994. Retrieved November 9, 2015 from http://health.gov/dietsupp/ch1.htm.

¹⁹Vitamins and Supplements - Miracle Healers, op. cit., p. 58

²⁰Tanvetyanon T., Beplar G.(2008). Beta-Carotines in Multivitamines and the Possible Risk of Lung Cancer Among Smokers versus Former Smokers. Cancer, 113(1), 150-157.

²¹Vitamins and Supplements - Miracle Healers, op. cit., p. 58

²²Ibid

²³About CRN. (n.d.). Council for Responsible Nutrition. Retrieved November 18, 2015 from http://www.crnusa.org/who_about.html.

²⁴Vitamins and Supplements - Miracle Healers, op. cit., p. 60

²⁵Ibid

²⁶Ibid

²⁷Ibid

²⁸Ibid

²⁹Get Fit, Feel Great With GNC PUREDGE™ Line of Whole-Food-Based Supplements . (2014). PR Newswire. Retrieved November 23, 2015 from http://www.prnewswire.com/news-releases/get-fit-feel-great-with-gnc-puredge-line-of-whole-food-based-supplements-300000553.html.

³⁰Vitamins and Supplements - Miracle Healers, op. cit., p. 60