According to the FDA's Guidance, botanical products which can be regulated as medications have met the requirements for registration as drugs. These may contain a substance that is considered to be generally recognized as safe (GRAS) or one that has been determined to be effective in treating, preventing or curing a disease. Botanical Products which are manufactured and used for medicinal purposes do not meet the definition of drugs in terms of containing ingredients that are considered to be generally recognized as safe, unless they also state that they are specifically designed for use as medications. Products from the Etanicals suppliers are not subject to the statutory restrictions on marketing drugs. However, since they are not considered drugs, they cannot be patented, and their sale and distribution are subject to the provisions of the Income Tax Laws.
Some states have developed statutes that allow the use of botanical products that have been found by the FDA to be beneficial for treatment of a disease in its generic or traditional form. However, this status is not recognized nationwide, as some member states require that any botanical product that contains a claim for its treatment for a disease must be regulated according to the guidelines set forth by the US FDA. Currently, there are eleven states which allow the regulation of medicinal products based on the claims that they make. These states include Arkansas, California, Florida, Hawaii, Kentucky, Maryland, Montana, New Hampshire, Oregon, Pennsylvania, and Washington. You can click here for more information about these products.
Other states have limited the application of botanical products to claims only for use as an ingredient in a pharmaceutical product that is intended for human use. In these states, the use of botanical ingredients for the purpose of healing, preventing or curing a disease does not meet the statutory requirement for drugs or for the development of drugs. In the absence of regulatory guidelines, it has been found that manufacturers of herbal remedies have been prosecuted for marketing products meeting the statutory requirements for drugs or for the development of drugs. The prosecution of manufacturers of botanical products involved the submission of inadequate data to the FDA regarding the safety and the efficacy of the herbal remedy.
The Botanical Products Act has been the cause of many arrests and the shutting down of companies involved in the production and distribution of botanical ingredients. This Act was passed by the FDA in 1938 and was designed to protect the consumer's interest in obtaining Botanical Products that have been determined by the FDA to be beneficial for treatment of a particular illness. Among the types of Botanical Products that fall within the statutory definition set forth in the Act are the herbal remedies such as eucalyptus and chamomile, which have been used historically for treating a variety of ailments. It was not until the late nineteen seventies, that scientists began to understand the therapeutic properties of botanical ingredients and the ability of these natural compounds to treat medical conditions. Over the past century and more, a great number of pharmaceutical products have been derived from botanicals and their extracts.
Today there are dietary supplements that have been designed and contain substances such as vitamins, minerals, protein peptides, amino acids, and other nutrients that have been found to have a positive effect when used as therapeutic treatments for a particular illness or for prevention of disease. Dietary supplements have become a huge business opportunity for naturopathic health care providers and holistic health practitioners. These individuals use botanical products and other natural substances to heal patients and prevent illness. Most of the dietary supplements are derived from herbs, crops, and other natural substances that have been found to have medicinal properties and can help to reduce or eliminate disease symptoms.
Although food supplements and herbal remedies have been used for centuries, the Food and Drug Administration (FDA) has approved the manufacturing of botanical products for use as dietary aids since 1938. The Dietary Supplements Safety Act protects the consumer's rights to demand safe and effective products, without having to fear that the substance being purchased is unsafe and ineffective. Botanical drugs are now considered as prescription drugs, which means that they must be administered by a physician and they carry a hefty level of responsibility. Check out this post for more information on this topic: https://en.wikipedia.org/wiki/Mitragyna_speciosa.