Nutraceutical Knowledge

Dietary Supplement Regulation by the FDA

the regulation of drugs

All non-prescription and prescription drugs are regulated by the Food and Drug Administration in the US. However, you should know that dietary supplements are usually treated differently and are considered special foods. As dietary supplements are not deemed drugs by the authorities, they do not go through the same stringent and rigorous effectiveness and safety requirements that most drugs go through.

As a result, all drugs that you can purchase, even without your doctor’s prescription, have to be proven effective and safe; in contrast, dietary supplements are not subject to these requirements.

As a general rule of thumb, the US FDA treats all new drugs as unsafe until these are proven effective and safe via clinical trials. And a drug cannot be legally sold in the US until the FDA approves it. For approval, clinical trials are conducted under closely controlled conditions. In most cases, human volunteers are paid to take part in clinical trials.

Keep in mind that the tests are done on all types of drugs – even the ones that are often sold without a prescription (over the counter). The approval process of the FDA mandates that the relevant drug be proven safe and effective in various clinical trials. These clinical trials have to provide “substantial evidence” that a new drug is effective and safe for all of the intended uses.

After the FDA is satisfied with the clinical trials it approves the new drug. After approval, the drug has to be carefully manufactured under closely monitored conditions. After the manufacturing phase the drug is packaged. The packaging must include complete and relevant information pertaining to the most suitable route, dose as well as schedule.

 In addition, the packaging information should include:

  • Any known side effect
  • The specific condition the drug is intended to treat
  • Any unsafe interaction when used in combination with other drugs
  • Any contraindication (particular conditions under which patients must not use the drug as it will pose excess risk)

 

Dietary Supplements are Deemed Safe 

According to the US Dietary Supplement Health and Education Act of 1994, dietary supplements are designated as special types of food. This is why the regulations and rules applicable to drugs do not apply to them. As a result, these supplements are considered fit for human consumption until proven unsafe.

The DSHEA contends that a majority of dietary supplements do not contain ingredients that can pose an unreasonable or significant risk of illness, disease or injury. This is true when a dietary supplement is strictly used in accordance with the directions given on its label, or used under the guidance of health care professional in case there are no instructions or directions on the product label.

The law considers a dietary supplement “new” if the supplement contains any ingredient or ingredients that are not under the category of food. However, this condition is not applicable if the dietary supplement was sold or market under the category of supplement prior to October 1994. In case the supplement is deemed new by the FDA, the producer must furnish the FDA with credible and reasonable evidence demonstrating the new ingredient(s) are safe. The supplemented cannot be marketed and sold to the public unless the FDA is satisfied.

However, it is important to keep in mind that manufacturers of supplements are not mandated by law to test their new supplements or ingredient in clinical trials. As a result, there is no way to find out if they are any potential risks and adverse reactions associated with a new supplement. Similarly, it is hard to determine whether there is a risk of interaction with other drugs or supplements.

The DSHEA mandates the FDA to prevent an organization from producing a dietary supplement in situations where the FDA establishes (using evidence) that the supplement can pose a significant and reasonable risk to the well-being and health of Americans. Note that this is the opposite treatment when compared to prescription drugs.

As a majority of dietary or health supplements are often self-prescribed, there is a lack of a controlled system to identify and report adverse reactions or side effects. Although both patients and doctors may report problems, they are not under any legal obligation to do so. As a result, in case a dietary supplement has any unknown adverse interactions or side effects, they are less likely to be unearthed as soon as in the case of new drugs that are launched in the market.

Who’s Accountable for Drug and Supplement Safety?

Despite all of the above-mentioned issues and risks, the US FDA is not legally responsible or accountable for the safety or even efficacy of dietary or health supplements; however, the manufacturers and marketers are. The manufacturers and marketers are responsible for ensuring that the ingredients are safe for human consumption. They also need to make sure that the ingredients are the same from one package or pill to another.

On the other hand, the FDA will only intervene in cases where there are reported safety hazards, problems or adverse reactions. To avoid tainted or subpar supplements, please do not buy the following products:

  • Dietary supplements that claim to function just like prescription medications – (claiming to treat or cure a disease or a health condition)
  • Products or supplements which are mass marketed or advertised via mass e-mails.
  • Products or supplements marketed only in foreign languages.
  • Products or supplements that make unrealistic promises of weight loss improved sexual performance or muscle building
  • Products or supplements that claim to be legal or effective alternatives to anabolic steroids

Regular Checks by the FDA

After the public is allowed to use the newly approved drug, the FDA performs regular follow ups to learn about any side effects that patients or doctors may report. There is a specific procedure for reporting adverse reactions triggered by a drug to the FDA.

In addition, the drug manufacturer has to file any information they receive regarding the side effects or adverse reactions caused by the drug. This information helps make sure that any side effect or adverse reaction not noticed during the drug’s clinical trials would eventually surface and will be tracked to ensure the safety and health of other patients.