How FDA Regulates Dietary Supplements vs. How It Regulates Drugs

June 9, 2020


The Food and Drug Administration regulates all prescription and over-the-counter drugs in the United States. Dietary supplements do not go through the rigorous testing that drugs through. Nutritional supplements are considered a special category of food, and they are unless the manufacturer decides to add harmful ingredients.

FDA and users, by extension, consider supplements to be safe at all times. They are thus not required to meet the same strict safety and effectiveness that drugs have to meet. All the drugs on the market have passed a safety and effectiveness test.

Most Ingredients Use to Make Drugs Are Not Natural

Although there are drugs made from herbs, most of the medicines are from chemicals. The FDA considers the drugs unsafe, thanks to the chemicals, and the manufacturers have to prove the safety of the drugs for human use.

A drug goes through clinical trials, which might take a year or more. Before clinical trials, drugs are tested on lab rats and guinea pigs (a practice that animal rights activists are fighting every day). During the clinical trials, the drug is tested on human volunteers in a controlled environment. The clinical trials take time because the manufacturers have to collect data from the volunteers and observe the reactions from the test subjects.

Even over-the-counter drugs have to go through the same trials. FDA then approves the drugs after a series of clinical trials. After every trial, the manufacturer needs to collect substantial evidence on safety and effectiveness.

Even after approving a drug, the FDA still following the drug production process. The manufacturer has to produce the drug in a controlled and monitored environment. The drug packaging has to have complete information on dosage, schedule, and route. The FDA also requires that the drug package indicates the condition the drug treats, side effects, conditions the drug should not be used, and harmful interactions.

The FDA still doesn’t stop even after the release of the drug for public use. Doctors can still report any adverse side effects to ensure that the drug is safe and effective, as the manufacturer indicates. The manufacturer has to continue recording any side effects not seen in the clinical trials.

Some dietary supplements undergo the same testing and manufacturing process. Some keto nutritional supplements are tested and proven to produce a product that succinctly meets the needs of users. With keto diet being a popular dietary protocol, users cannot afford to have substandard products.  Because the FDA not so much involved in the testing of dietary supplements, you have to be very careful when choosing keto dietary supplements.

Approving Dietary Supplements

The DSHEA (Dietary Supplement Health and Education Act) classified supplements as food in 1994. Automatically, the declaration meant that supplements have to undergo a treatment different from that of drugs. DSHEA requires that supplements should not contain any ingredient that can cause injury to the user if used as directed on the label.

The FDA considers a supplement “new” if it contains an ingredient not considered a food substance. Before such a supplement goes to the public, the manufacturer needs to present evidence that the substance is safe for use.

Supplements don’t need to undergo clinical trials as drugs. However, the FDA can stop the production of a supplement if it has reasonable evidence (or doubt) than an ingredient in a new supplement can cause injury to the users.

Because dietary supplements are self-prescribed, there is no controlled way for FDA to collect information on dietary supplements side effects or effectiveness. If there are any bad reactions from use, the FDA will be slow in getting the information and stopping further production. While doctors and patients can report the effectiveness and any side effects, but the FDA does not require them to do so.

Users have to Choose Supplements Carefully

It is up to the users to vet the supplements they use. Although most supplements are not harmful, users still need to read reviews before they choose a supplement. A good supplement should have natural or organic natural ingredients. Plant extracts are the most common, which makes the supplements as healthy as advertised. If, as a user, avoid ingredients that you do not understand and instead go for supplements with plant extracts.

There are supplements known to cause some serious adverse effects [1]. However, more than 70 percent of Americans take dietary supplements, either prescribed or over-the-counter. If you take the right dosage, you may not experience most of the side effects. Other supplements come with hyped up benefits that sound unreal – avoid those too.


Drugs undergo strict clinical trials for a long period. FDA only approves drugs after a series of trials. However, supplements still go through some kind of trial, but the FDA does not require it unless the manufacturer introduces a new ingredient. With drugs, you already know the side effects you might experience, but with supplements, you have to wing it and hope that it works. It is, therefore, important that you be very careful when choosing a supplement – look at the list of ingredients and read reviews.


Join Our News Letter

Email Us