Is any substance that comes with a therapeutic claim considered a drug?

Labeling a substance with a therapeutic claim as a drug is consistent with legal definitions found in the Federal Food, Drug, and Cosmetic Act. According to this act, a drug is defined as an article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or an article (other than food) intended to affect the structure or any function of the body. Therefore, if a substance is marketed with a therapeutic claim, it is deemed to fall under the category of a drug, as its intended use directly relates to the treatment or management of health conditions.

The rationale behind this classification is to ensure that any product making therapeutic claims is subject to regulation, ensuring safety, efficacy, and accurate labeling for the protection of the public health. Thus, any substance that is marketed with a therapeutic intent meets the threshold for being classified as a drug under the relevant regulations, affirming the correctness of the assertion.