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Supplement Industry Regulation

Author: Philip A. Crochen

Troy University (E-Troy) Community Nutrition, Troy University Library

In the United of States of America, all food products are regulated by the Food and Drug Administration (FDA), who categorizes food products as safe or not safe. Supplementation is a growing trend that is seemingly gaining popularity at an exponential rate within the United States; however, the Food and Drug Administration does not currently recognize dietary supplements as food products. Why? The lack of regulation is due to the mass quantity of supplements being created, not because of the dietary supplement composition. Therefore, there are essentially too many products being created and making claims to cause improved health and muscle adaptations for the Food and Drug Administration to monitor. The more popular and trendy dietary supplementation becomes throughout the country, the more potential dangers arise. It is supposed to be the responsibility of the Food and Drug Administration to qualify food as ‘generally recognized as safe,’ however; there is an injustice being committed towards the people (consumers) by not including dietary supplements in the food product category. There is a lackadaisical approach towards regulation in the supplement industry. There is no burden of proof for label claims; there are no ethics or scientific research required, yet the firms producing the products are solely responsible for evaluating the safety and labeling of their products before advertising to ensure that be sure that the products meet the acclaimed standard of the Dietary Supplement Health and Education Act of 1994 (DSHEA). In a society that thrives off of capitalism, this is hypocrisy. The dietary supplementation trend is growing in the United States, but no general education for the public is being provided. The advertisements are displayed virtually everywhere, yet there is no legal repercussion for neglect unless someone is hurt and or deceased; which at that point it is too late to call for ethical reform. It is more appropriate to call for reform prior to disaster, and to call for it now. There are products that yield great gains and promote improved health, but there are also products that have equal and or greater risk. A label disclaimer in a reduced font is not adequate for proper informing to the consumer. It is pivotal that the regulations on dietary supplements go above and beyond a label and “lack of” evaluation by the Food and Drug Administration, because currently regulation is politely stated as inadequate (Fda.Gov, 2015).

Supplementation in the U.S. has an intriguing background extending twenty-one years. The history of it is commonly unknown to most. Its popularity and understanding has grown over the years and is continuing to do so. The background of supplementation continues to become more extensive, while the definition is becoming more clear and concrete. According to Congress, a dietary supplement is defined as a product other than tobacco that is intended to supplement the diet. It contains one or more dietary ingredients; which includes: vitamins, minerals, herbs or other botanicals, amino acids, and other substances or their constituents. A dietary supplement is intended to be taken by means of mouth as a pill, capsule, tablet, or liquid; and is labeled on the front panel as being a dietary supplement. This was defined in the Dietary Supplement Health and Education Act, which became law in 1994. Dietary supplements are regulated incredibly different when comparing to food products. In the past, prior to 1994, foods on the shelves could be rotten, nutritionally useless, known to be dangerous, or potentially dangerous. Today, through the FDA regulation, Americans are confident that the terms “fresh,” “organic,” and “no cholesterol,” accurately describes the explicit components of that food because of sound scientific research and proper handling of food products. Classification of a dietary supplement is determined by the information that the manufacturer provides on the product label, and or in the accompanying literature; although many food and dietary supplement product labels do not include this information. The ingredients of a food product follow a specific pattern on the label. It is easy to find and easy to read. Label regulation is ALL that the FDA influences with dietary supplements. “These statements have not been evaluated by the Food and Drug Administration,” is the guaranteed statement seen on the products, nothing more. This should do nothing but reassure a consumer that extensive personal research should be done to ensure his or her health (LeDoux, 2015).

The intention is never to undermine the multitude of health benefits that supplementation can and do provide. The benefits of supplementation can be superb, however different brand names can virtually lie on their label due to the lack of requirement of proof. It is very common to see a multitude of brands making the same claims all the while containing different ingredients. Many professional and recreational athletes use the ergogenic aids often found in dietary supplements. For a hard training competitive athlete, supplementation is often a very critical part of his or regimen. Nutritional dietary supplements are commonly viewed as agents used in promoting muscle adaptations when training, allowing more consistent and intensive training by promoting recovery between training sessions, reducing interruptions to training because of illness or injury, and enhancing competitive performance. The trend of supplementation use is growing rapidly in the United States. Current ergogenic aids trends in popular culture are easily found everywhere. The most popular trends are supported throughout the Internet, in gymnasiums, word- of- mouth outside of nutritional professionals, etc. Surveys show that the prevalence of supplement use is widespread among sports men and women, but a sound research base supports the use of only few of these products, and some may even be harmful to the athlete (LeDoux, 2015) For example, creatine is the most researched dietary supplement in the world and has conclusive evidence showing efficacy and safety. No other supplement can compare to creatine use due to inconclusive evidence. Unfortunately, firms will make claims based in theory and often times have a less than desirable effect. Reliable supplement companies often guarantee their products by sending it to a third party testing agency prior to putting the supplement on the shelves for sell. The additional testing is noticed by the prominent blue seal on the product label. The rapid growth of supplement production accompanying the occlusion of regulation is what arises new dangers. For example, advertisements are virtually found everywhere. It is being argued that regulation must increase now that Facebook can run supplement advertisements on the website (Bompey, 2011). Facebook is the most used social media median and most frequently visited website in America. Within the last year, 2014, Facebook became a public company, ultimately making it a large commercializing entity.

In recent years, a new Facebook policy has emerged allowing supplement advertisements on the website. Since Facebook’s IPO, the company is now a public monster. With shared stocks, there is more potential revenue involved. This creates a problem simply because in a capitalist country such as the United States, where ever revenue is created, morality is generally diminished. The moral standard as well efficacy of the supplements is virtually non-existent when there is mis-education, lack of proper informative information on potentially dangerous products, and misleading results plastered across such a popular sight with so many views. The disclaimer is this: Facebook will not allow the promotion of supplements containing “anabolic steroids, chitosan, comfrey, dehydroepiandrosterne, ephedra, human growth hormones (HGH), melatonin, and any additional products deemed unsafe or questionable by Facebook in its sole discretion.” There are no nutrition professionals monitoring “questionable” products because there is no guideline for it. The FDA has not made a change in stance regarding regulation of dietary supplement composition so far however, it was stated the “FDA has not thus far focused on Facebook, but if this does increase the amount of dietary supplement advertising, they are definitely going to be taking a closer look at it” (Bompey, 2011) .

Another agency also able to affect this outcome is the Federal Trade Commission pertaining to its power residing over advertisements. Judy Blatman, senior vice president of communications at the Council for Responsible Nutrition, said while the group applauds Facebook for making the policy change, it is “unfortunate here that they made selections based on things that are not exactly right,” (Bompey, 2011)? and would like the chance to have a conversation with Facebook to explain the situation with some ingredients. Facebook is taking the policing of the science into its own hands and making guidelines respectively. Attorney Andrew Wasson at Frommer Lawrence and Hang says, “I think it also potentially sends a signal to FDA: you have got to get moving because companies are starting to begin taking these issues into their own hands. While it is good to put the idea of reform of regulation into the circulating atmosphere, Wasson is right and it is evident. The health and safety of the people have been afforded a price in the eyes of the United States government. Its value has been diminished to that of a dollar; in result nutritional status has fallen with terribly adverse consequences accompanying.

The issues of supplementation regulation run together, and the heart of these issues are all rooted at the lack of oversight in the products being sold. Dietary supplements are not required by federal law to be tested for safety and effectiveness before they are marketed, so the amount of scientific evidence available for various supplement ingredients vary widely. Some ingredients in dietary supplements have been carefully evaluated for human consumption but not efficacy. Production companies will always take advantage of a customer who assumes there is a moral code being followed. The manipulation of the people is only made possible due to the laziness displayed in the United Stats Food and Drug Regulation suboptimal approach the regulating dietary supplements as well as the label. This is the equivalent to selling street drugs with a tax. The safety of the dietary supplement is not even questioned if the ingredients have been sold in the United States prior to the Dietary Supplement Health and Education Act of 1994. Considering the advancements in research and medicine established in the last twenty-one years, this should be illegal and prosecuted as negligence at the direct expense of consumer health/life in the court of law.

Regulations and limitations of oversight are substantially poor. Efficacy of products are often not evaluated, but are rather estimated. Each year Americans spend more than $28 billion on supplements assuming that they are both safe and effective, however, the Food and Drug Administration only test supplements after something goes drastically wrong and or someone is hurt or dies. For example, a dietary supplement company in Utah announced the recall of Zortex. It was found that the supplement is not only not an established dietary supplement, but contained a number of substances never tested in humans. By the time the recall occurred, the company had already distributed nearly 14 million capsules containing the untested substances (Bompey, 2012).

Millions of Americans consume vitamins, minerals, amino acids, etc. through dietary supplements. Often times consumers are getting more than what they bargain for with the expectation of safe and effective supplements on the shelves. Unfortunately, ingredients sold in the United States before October 15, 1994, are not required to be reviewed by FDA for their safety before they are marketed because they are presumed to be safe based on their history of use by humans. This approach allows thousands of harmful agents to be legally put into products and sold to turn a profit. It is not that the information is not there, it is lack of care, oversight, and will to strengthen regulation for these supplements, that is harming individuals. The FDA put one small foot forward for new supplements sold in the country after 1994. Now, for a new dietary supplement’s ingredient, a supplement not sold as a dietary supplement before 1994, the manufacturer must notify the Food and Drug Administration of its intent to market a dietary supplement containing the new dietary ingredient and provide information on how it determined that reasonable evidence exists for safe human use of the product; it is not extensive however. This new guideline does not call for required effectiveness, dosage, or purity. It does not change how it can written on the label. The new guideline only requires knowing is it “reasonably expected to be safe for human consumption,” (Bompey, 2012) which Zortex was not. Since the Dietary Supplement Health Education Act (1994) became law, availability of dietary supplements have elevated from levels of 4,000 to 55,000. Out of the new estimated 51,000 dietary supplements, it is not known how many were manufactured and or sold in the United Stated prior to 1994 (Cohen, 2013). Progressively, the Food and Drug Administration is aware of the issues formulating, and since July 2011, the FDA has proposed a new guidance designed to help it assess the new ingredients. The new ingredients are now evaluated based on three key factors: one; documented history use: including food, herbal, or supplemental use inside and out of the United States. Two; formulation and proposed daily dose. Three; the recommended duration of use (MacKay, 2103). The new guidance is a positive step in the correct direction, long although over-due, it is not too late.

The supplement Industry’s current regulations and guidelines are far less than adequate. The Food and Drug Administration have taken steps forward but no strides to ensure safety and efficacy of all dietary supplements available for purchase and to correct the problem within the system. There needs to be a more adamant and aggressive approach to reform in supplement regulation. Substances have evolved so much since 1994 when the Dietary Supplement Health Education Act was put into law. The Food and Drug Administration’s approach to safety and efficacy in Homo sapiens must also evolve, for evolution is the basic fundamental of life. In order to ensure the safety of the people, and for the Food and Drug Administration to succeed in carrying the burden of proof regarding the safety and effectiveness of ALL food products distributed in the United States of America, dietary supplements must be entered into that category. The same nutrients are provided in the supplements as in the food products, there is no excuse. If regulation is not increased, the safety of people looking to sustain or enhance in any area safely, by means of supplementation is in jeopardy.


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