Laudanum of opium tincture prevails today only because opium tincture was sold prior to the Federal Food, Drug & Cosmetic Act of 1938. Its "grandfathered" status protects opium tincture from being required to undergo strict FDA drug reviews and subsequent approval processes. However, the FDA closely monitors the labeling of opium tincture. Bottles of opium tincture are required by the FDA to bear a bright red "POISON" label given the potency of the drug and the potential for overdose (see discussion about confusion with Paregoric below). Despite opium tincture being an "unapproved drug" as discussed above, a search of FDA's website
Crude drug Crude drug Crude drugs are vegetable or animal drugs that contain natural substances that have undergone only the processes of collection and drying. The term natural substances refers to those substances found in nature that have not had man-made changes made in their molecular structure. They are used as medicine for human being and animal, internally and externally for curing disease, e.g., Senna and Cinchona. A crude drug is any naturally occurring, unrefined substance derived from organic or inorganic sources such as plant, animal, bacteria, organs or whole organisms intended for use in the diagnosis, cure, mitigation, treatment, or prevention