Do Natural Supplements Need To Follow Guidelines?

Zestra® products have been clinically tested by medical doctors to ensure its safety and efficacy. Clinical trials are a necessary part of the research process. Clinical trials let the medical community know if a drug is safe enough for human consumption.

Clinical testing must be done on humans because the human body is unique. Although many drugs are tested on animals with a similar biology – like monkeys or rats – the drugs are created for human consumption, so they must be part of the experimental process.

The Importance of Clinical Trials

The drug development process has multiple steps. The first step is discovery and research. During the discovery process, scientists test the molecular compounds of a substance to see how it affects a disease or illness. Scientists will also use medical technology to test or alter molecular compounds.

The development process is more complex. The scientists have identified an effective compound, and they continue their research by conducting experiments. The experimental phase can even take years. Researchers are taking their time to determine the best dosages for the product, its effects on humans and animals, and how it interacts with other drugs.

When testing the drug on humans and animals, scientists are examining how the body metabolizes, absorbs, and excretes the molecular compounds. The best way to determine the body’s response is by conducting clinical trials.

The Pre-Clinical and Clinical Research Phases

The second step in the drug development process is pre-clinical testing. Through pre-clinical testing, researchers gather information through in-vitro and in-vivo testing. The pre-clinical research occurs before the drug is tested on humans or animals.

In-vitro testing is done in a lab with laboratory equipment, personnel, and specific operating procedures. All of the test results are recorded by personnel and converted into a study report.

In-vivo testing is testing done on a living organism (e.g., an animal or human). Researchers carefully review their findings during the in-vitro process before testing the compounds on living organisms.

Clinical research occurs before the drug is sent for FDA review. The U.S. Food and Drug Administration plays an integral part in the research process because they approve drugs for distribution and sales. The clinical research process includes a design phase where researchers decide who will be in their test group, the length of the study, drug dosage, and how data will be collected and analyzed.

Once researchers are happy with the clinical research results, they submit a new drug application to the FDA. In the application, the drug developer lists all the testing data including pre-clinical and clinical trials.

After submission, the FDA checks the application to ensure it has the right information. Then they take 6-10 months to review the drug and approve it for sale.

Why Test Natural Supplements?

A natural supplement like Zestra® needs to be tested to assure that it meets the necessary FDA guidelines and requirements of an herbal supplement. An FDA-GRAS supplement is a supplement that is generally recognized as safe (GRAS) by the FDA.

A natural or herbal supplement must still past FDA review to prove that its ingredients are truly natural, and they won’t harm users. Zestra® is an herbal supplement made from a combination of borage seed oil, evening primrose oil, angelica root extract, and coleus forskohlii extract.

Zestra® was clinically tested in 2003 and then again in 2007. The participants in both studies were women aged 21-65 that were sexually active but displayed signs of sexual dysfunction. Female sexual dysfunction is a unique disorder that hasn’t received much attention from the medical community.

To create a product like Zestra®, researchers had to conduct extensive research into the female anatomy and the science behind the disorder.

Zestra® has proven through multiple clinical trials that it is one of the safest, and most effective herbal supplements on the market.