Dietary Supplements: Why the FDA Doesn’t Have To Approve Them

By Mike Bloom, Dan Blair and Paul Bousche’

There is a fine line that differentiates the terms drug and dietary supplement. Both are prevalent necessities in the everyday lives of many American citizens and account for billions among billions of dollars in annual gross for pharmaceutical companies.

Drugs (whether to be perceived as good or bad) aid in the diagnosis, treatment, or prevention of a condition or disease by definition. On the other hand, the general public tends to generalize drugs by their crude nature: substances such as a narcotic or a hallucinogen that affects the central nervous system that is used recreationally for perceived desirable effects on personality, perception, or behavior. Marijuana being the most commonly used illicit drug in the United States, and possibly around the world.

Nutritional supplements are products taken by mouth that contain a “dietary ingredient” intended to supplement the diet, according to the U.S. Food and Drug Administration. The “dietary ingredients” in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders.

They can also be in other forms, such as a snack bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet.

“The use of supplements to obtain and maintain optimal health should be a second course of action. The best way to maintain your health is by eating fresh fruit, vegetables, lean meats and whole grains and exercising regularly,” says Maryanne Oleksowicz, professor at Mercy College and at Pacific College of Oriental Medicine. “Unfortunately, due to our busy lifestyles, especially as college students, this is not always possible.”

In the United States, these supplements are regulated as “foods” and not “drugs.

While the two are very similar, by law, a product sold as a dietary supplement and promoted on its label as a treatment, prevention or cure for a specific disease or condition would be considered an unapproved and illegal drug. Supplements never claim to cure anything – instead they are supposed to be used as an effective enhancement to an ordinary diet, yet that is not always the case.

According to, supplment manufacturers not have to register their proucts with the FDA and just have to ensure that the label is truthful and not misleading. Therefore, a product can be released on the market without any type of government testing or approval..

the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer,” said the FDA.

Nor does the agency take responsibility if a product has been reportered while it is on the market.

“Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products,” said the FDA.

Under the Dietary Supplement Health and Education Act of 1994, signed by the Clinton administration, these products were able to be marketed before being tested. Under the current structure, once the product is marketed, the FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace.

clinical Testing

In the 1960s a drug named AZT was being studied as an anti-cancer drug with disappointing results. However, as a result of the data compiled through testing, it was found that the drug could treat the deadly disease of AIDS.

It is not uncommon that certain drugs are found to help in areas it was not originally intended, and it is through extensive testing that this is possible. The path a drug travels from a laboratory to commercial use all across the United States is usually a long and unique journey.

It may be unclear what exactly needs to be done for the drugs that are ingested on a daily basis to be fit for prescription or retail, especially in a time where the pharmaceutical industry has become such an economic giant.

In terms of developing a new drug, it is possible for anyone to apply for an Investigational New Drug Application (IND). However, the Food and Drug Administration (FDA) has laid down what they deem a rigorous evaluation process that must be followed in order for that new drug to even be considered for review.

The application usually includes a set of tests that the company who developed the drug has performed to display that the drug has potential. The company proposing the drug must show the FDA results of preclinical testing they’ve done in laboratory animals and what they propose to do for human testing.

At this stage, a review board consisting of both scientists and non-scientists decides whether it is reasonably safe for the company to move forward with testing the drug in humans.

The first sets of human tests are usually performed on 20-80 healthy individuals. The goal is to determine how the drug is metabolized and the most frequent side effects of the drug. If this first phase doesn’t reveal any unacceptable toxicity, phase two studies will be allowed and followed through with.

While the first phase focused on the safety of the drug, the second phase focuses on the effectiveness. This phase aims to obtain preliminary data on whether the drug works in people who have a certain disease or condition. The number of test subjects increases to about 300 individuals and during observation safety continues to be evaluated, and short-term side effects are noted.

The next phase of studies focuses on the use of different dosages on different dosages. Also, the drug is observed in conjunction with other drugs. The number of test subjects increases from several hundred to about 3,000 people.

Drug Application Process

At this point, the sponsor or financial backer of the drug must formally request a new drug application (NDA). The application must include all animal and human data and analyses of the data, as well as information about how the drug behaves in the body and how it is manufactured. When a NDA comes in, the FDA has 60 days to decide whether to file it so that it can be reviewed. The FDA can refuse to file an application that is incomplete such as required studies missing from the report. In terms of review time, the FDA hopes to make a decision on all NDA’s within ten months of application.

Although the FDA is involved somewhat in the preclinical trials of a drug, the official review time is the length of time it takes to review a new drug application and issue an action letter, an official statement informing a drug sponsor of the agency’s decision.

Once a new drug application is filed, an FDA review team which consists of medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use. The FDA makes it a point that no drug is absolutely safe; all drugs have side effects. “Safe,” in this sense, means that the benefits of the drug appear to outweigh the risks.

The review team analyzes study results and looks for possible issues with the application, such as weaknesses of the study design or analyses. Reviewers determine whether they agree with the sponsor’s results and conclusions, or whether they need any additional information to make a decision.

If the FDA determines that the benefits of a drug outweigh the risks, then that drug can be marketed and sold in the United States. However, there is a grey area where a drug may be deemed approvable, but some minor issues must be resolved first such as the way the product is labeled.

A designation of “not approvable” describes deficiencies that are so significant that approval cannot be obtained in the near future unless some major data is added.

Manufacturing issues are one of the biggest reasons for a drug’s delay in approval or even outright denial. If a facility isn’t ready for inspection, approval can be delayed. Any manufacturing deficiencies found would need to be corrected before approval.

The FDA outlines the justification for its decision in an action letter to the drug sponsor. When the action is either approvable or not approvable, the sponsor is given a chance to meet with agency officials to discuss the deficiencies. At that point, the sponsor can correct any deficiencies and submit new information, or they can withdraw the application.

Performance Enhancers

Eating properly and getting the right amount of sleep have always assisted in achieving a healthy lifestyle, but when it comes to working out, many people want something extra to get more pleasing results at a faster rate.

The answer for the average workout connoisseur is supplements. They range from whey protein to supplements that release HGH (Human Growth Hormone.) These pills, shakes, and powders claim to do all sorts of things such as providing more strength, helping with weight loss, or aiding in muscle repair.

The only problem with taking these supplements is that there is often a massive amount of misinformation floating around the workout world that can often lead to expectations not being met and possibly even some bodily harm.

According to WebMD, protein is a key ingredient that is the foundation for muscle, bone, and skin. The daily allowance ranges from 46 to 56 grams of protein a day. Many people look to protein shakes and powders to help repair muscle and build size. What protein actually does is aid replenishing muscle glycogen, a source of fuel for exercise, which is used up during workout routines. A common myth is that taking protein supplements will actually help to make muscles bigger, but protein does not increase muscle mass despite what many people think.

For those that want to take the scientifically engineered supplement route for weight loss, there is Proactol. It claims to reduce fat intake by 28 percent, burn stored fat, suppress appetite, and lower cholesterol. According to, a website that reviews diet pills, Proactol has gone through extensive clinical testing and has been approved by numerous doctors. It also claims to have no harmful side effects.

Not everyone is concerned with exercising to lose weight; there are those who train to build strength and size. Protein may also be a part of their daily diet, but they may feel it is not enough. They turn to products that claim to give them the results they are after.

One of the most popular supplements is Nitric Oxide, or NO. Many supplements on the market are NO products because it increases blood flow, increases oxygen delivery to muscles, aids in glucose (sugar) absorption, and increases muscle growth. Taking NO supplements can also help repair muscles quicker and provide endurance.

This may sound like the perfect type of tool that every bodybuilder needs to get fast results, but there are numerous NO products out there and all contain slightly different ingredients. Most come in the form of an amino acid known as Arginine which increases HGH levels in the body.

The only problem with Arginine is that it can also be found in many of the protein supplements. This surplus of Arginine can cause nausea, diarrhea, and weakness. This is the reason for checking the labels of all potential products.

“When selecting an herbal supplement, you should compare products based upon the percentage of the standardized extracts. Certified potencies let you know what percent of the active ingredient is within the product,” says Oleksowicz. “Other products that do not have this labeling can contain ground plant parts that are not effective just to present the customer with a higher milligram capsule but with little clinical efficacy.”

The best thing to do before taking any supplements is to ask physicians and do research. There are many websites like WebMD and that know a great deal about these products and can provide truthful information about the side effects as well as benefits, and are not directly tied it to advertisers.

“Side effects due to improper supplementation vary depending on the product. Some can be as mild as a slight rise on body temperature or as serious as kidney failure,” Oleksowicz would go on to say. “If you notice any negative effects related to your supplement intake, you should discontinue use immediately.”

When it comes to working out, understanding that the supplements are only to aid in weightlifting and not to provide a false sense of confidence is crucial.

“It’s extremely important to set realistic, achievable goals so that you don’t get discouraged, and so that you don’t try to do too much too soon and increase your risk of injury,” says Mike Ryan, a weight expert from the Gold’s Gym Fitness Institute