The Process of Testing Supplements and Medicines

There is a huge difference in the testing protocol used between medicines and dietary supplements. All medicines and supplements first need to be screened in the United States by the agency known as the Food and Drug Administration (FDA). Medicines, on one hand, are put through an extremely rigorous testing protocol that usually involves clinical test trials, laboratory analysis, and other scientific methods to determine that the medicines are safe to be intaken by consumers. With regard to dietary supplements, they are typically tested using a similar protocol to how general foods are tested.

In the article below we’ll discuss the main testing methods used for dietary supplements and medicines. As both require a different set of testing protocol, we’ve prepared a separate list to entail the primary processes for each category of product.

The Top 4 Main Testing Methods Used For Supplements

  1. Safety Testing – The first wave of testing that a dietary supplement will go through is a safety test protocol. This series of tests analyze the ingredients in any given supplement and determines whether or not such ingredients are harmful to humans in their present quantities. The safety tests may include clinical research, laboratory analysis of samples, clinical trials, and animal testing research.
  2. Quality Testing – Once a dietary supplement passes a safety test, it is then tested for quality. These series of tests carefully analyze samples of the product to determine that all of the stated ingredients are present and that these ingredients are of a quality standard that allows them to be suitable for human consumption. Most of these tests are carefully undertaken in a laboratory.
  3. Regulatory Oversight – Dietary supplements that have passed safety and quality testing are usually retested by the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) to make sure that the products pass the strict and separate regulatory protocols set up by both governing bodies. Both governing bodies also carefully analyze the labeling of such products to ensure that they meet all Federal and State laws regarding food safety and food marketing.
  4. Post-transport Testing – Once a food product or supplement has been manufactured and shipped to a distribution center, they will often be reanalyzed for quality, especially if the products have been imported from outside of the US. There are specific companies like PBMMI that specialize in safely transporting foods, supplements, and medicines to ensure they are not contaminated during transit.

Testing Duration: Supplements are usually tested for 6 months to 2 years before being approved to enter consumer markets It is the same length of time evolved with food product testing required by the Food and Drug Administration (FDA). The duration of time it takes to conduct all of the necessary testing is a long process due to the regulatory oversight process, which involves slow government agencies that are sometimes inundated with work and have strict budgetary restraints.

The Top 2 Main Testing Methods Used For Medicines

  1. Pre-clinical Trials – This is typically the first testing protocol used to test anything considered a medicine. During this testing phase researchers from universities and commercial laboratories across the United States carry out initial tests on the disease or ailment that the medicine seeks to treat. Once the disease or ailment is understood, the researchers will then begin to identify how the medicine treats such an ailment and whether or not it is safe for human consumption. It is quite common for these researchers to cooperate with other labs and universities in cases where more than one agency is analyzing the medicine.
  2. Clinical Trials – Once a medicine has cleared all testing in the pre-clinical testing phase, it moves on to the clinical testing phase. This protocol uses the medicine on an actual human subject with their knowledge and consent and closely monitors the medicine’s rate of effectiveness at treating the intended ailment. Researchers closely watch for any adverse side effects or reactions to the medicines.

Testing Duration: Pre-clinical and clinical trials combined typically take 10-15 years to complete or longer. The reason the time period is so long is that every medicine approved by the Food and Drug Administration (FDA) must prove that it is effective in treating the ailment it is designed for. Screening a specific medicine for potential side effects is also a lengthy and drawn out process, as it requires a wide range of varied test subjects that fill the requirements of a rigorous testing spectrum.

Supplements and medicines are used in a variety of industries. They are important for the health industry, the economy and for individuals who rely on them for their well being.

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