The clinical research process is long and arduous that includes discovery development and a host of other steps before the product is given to the FDA to review.
The Food and Drug Administration is the foremost authority on pharmaceutical-drug safety in the country. Their regulations have changed the way products are developed and tested throughout the world.
The stringent guidelines of the FDA make FDA-approval a true feat and vital to a drug’s success on the market.
What is the Food and Drug Administration?
The U.S. Food & Drug Administration is a federal agency tasked with protecting the public health and safety of the country’s residents. In addition to monitoring food and drug production and supply, the FDA regulates medical devices, cosmetic products, tobacco products, and biological products.
The FDA tries to be as transparent as possible about the health effects and ingredients within products to help consumers make educated decisions about what they’re putting in their bodies. The FDA started regulating products in 1906 and has since created over 200 laws to ensure public safety. The Kefauver-Harris Amendments of 1962 enforced proper researching and testing of drugs before marketing them in the United States.
The FDA also asks all drug developers to submit an application to the agency before they start production. The new drug application includes all pertinent information concerning the discovery, development, testing trials, and results of the research.
FDA officials review the application and have the developers submit any additional information. Once the application has been completed, the FDA starts their review. The review process can take 10 months. A medical officer, statistician, and pharmacologist are all part of the review team. They meticulously review the data and send FDA inspectors to observe the test site.
After the inspection is complete, the inspectors create a report and a project manager organizes the materials into an action package for a senior official to review.
How Does the FDA Regulate Natural Supplements?
The FDA has received citizen petitions as well as correspondence from the federal courts asking them to clearly define what “natural” ingredients are. Currently, the FDA lists a natural product as something without any synthetic or artificial ingredients. This terminology is quite broad and can be confusing to the average consumer.
Unfortunately, many manufacturers are calling their products “natural” with only one or two natural ingredients. Consumers have been getting tricked into buying fake natural products – which is why the federal court system has gotten involved. It’s important for consumers to read the ingredients on the package before making a purchase. Ingredients should be listed under their scientific and common names.
The ingredients in our products are 100% natural and have received approval from the FDA. Our product formulation is also patented and has undergone the rigorous patent approval process.
Zestra® is marketed as a collection of botanical oils and extracts. Ingredients including borage seed oil, vitamin C, and evening primrose oil.
Our products have been tested in two clinical trials by women 21-65 years old. In both studies, Zestra® significantly improved their arousal and sexual response.
Is Zestra® Safe to Use?
Per our clinical testing and FDA review, our products are completely safe to use. The FDA has given us the GRAS (generally recognized as safe) stamp of approval. The best part is that you don’t need a prescription for Zestra®! Our herbal supplement is available over the counter.
Women seeking a safe, all-natural product for sexual dysfunction should look no further than Zestra®. Consumers can buy our glide products, conveniently packaged in a lump bottle, or purchase our single-use packets.
Our products are also available at most major retailers.