Botanical Product Approval - From Research to Development
According to the FDA, botanical products that are regulated as medications include a variety of plants, flowers, herbs, trees or other plants, mixtures containing one or more botanical substances with the intent of treating, preventing, curing, or mitigating a disease. A number of plants or their parts are commonly included in herbal dietary supplements. Some botanical substances which are used in herbal dietary supplements have been used in traditional medicine for centuries, and are recognized by the FDA. Others have been used for minor infections only; these are generally not considered medically essential and are not subject to the same safety regulation as medications.
These botanical products that are considered herbs, include herbs such as camellia sinensis, echinacea, ginseng, gingko biloba, lavender, Rosemary, chamomile, and lemon balm. Herbal dietary supplements which are considered medications are those which treat, prevent, or mitigate a disease. Examples include ingredients like antihistamines, antibiotics, anti-cancer agents, and herbal remedies. Many herbal dietary supplements also contain vitamins, minerals, and other nutrients that are considered good for the body. These nutrients may not always be considered medically essential; however they still play an important role in maintaining health. When purchasing an herbal supplement, you should ensure that it contains all the ingredients that have been given indications for use in the product. Visit this link and learn more about botanical products.
Because the FDA has not approved any botanical products to be as medicines, they cannot be sold as such under the provisions of the Dietary Regulations. Therefore if you purchase an herbal preparation from a retailer or online, you must make sure that it is FDA approved. The reason for this is that although many manufacturers claim to use botanical products in their preparations they may not be using material that has been tested as having medical value in controlled tests. Therefore it is very important to check the information provided on any website regarding botanical products to ensure that it is a reputable company that follows good manufacturing practices.
To better understand the significance of botanicals in supporting human health and wellness, we need to look beyond their physiological makeup. Botanicals exist in nature and are produced in significant quantities by the earth. Their therapeutic properties were discovered through extensive scientific investigation over the past century. Through this research scientists have identified a number of botanicals that have strong medicinal properties that have the potential to improve human health.
So, how does an effective botanical product reach its clinical trial stage? This is a process by which manufacturers gain approval to sell their botanical products to consumers in a retail or commercialized form. Once a product reaches the phase of clinical trials then it is eligible for sale as a pharmaceutical or generic product. In most cases the company that markets the botanical product obtains a pharmaceutical license in order to be able to sell the product.
The Etanicals, a pharmaceutical company is always working towards developing botanical drug combinations that have the potential to treat, prevent or cure a specific medical condition or disease. The company then obtains botanical drug approval from the FDA (Food & Drug Administration) to proceed with testing the new botanical combination. Once the botanical drug has undergone rigorous testing, it is released to the market for use as intended. At this point the manufacturer of the botanical drug would obtain market approval from the U.S Food & Drug Administration (FDA) for the intended use intended. This is ultimately the pathway that all pharmaceutical products travel on to reach consumers. Check out this post for more details related to this article: https://en.wikipedia.org/wiki/Dietary_Supplements_(database).
