All ingredients offered for sale in the U.S. are regulated by the FDA, USDA, and/or FTC, regardless of whether they are sold directly to consumers. Ingredient claims must align with the intended use in the market. We use the U.S. FDA’s Compliance Guide on Structure Function claims in evaluating claims. Claims about diagnosing, treating, curing, or preventing disease could cause an ingredient to be classified as an unapproved drug. Explicit claims mention a specific disease or class of diseases such as cancer (anti-tumor), diabetes, heart disease, Alzheimer’s, Parkinson’s, osteoarthritis, COPD, fibromyalgia, ADHD, hyperthyroidism, etc. A statement is also a disease claim if it states an effect on a specific disease or class of disease by using descriptions of the disease state. Examples of such claims include and are not limited to lessens chronic or acute cough, reduces inflammation, relieves headaches, protects against tumors, stops hair loss, pain relief, antibacterial, antifungal, anti-viral, and syndromes such as IBS and Metabolic Syndrome, and/or other known symptoms of diseases. Claims are also context dependent, for instance, relief from aches or stiffness due to overexertion and exercise could be acceptable, but when these claims are associated with arthritis, the claims would be non-compliant and subject to a compliance fine (see below, What is a Compliance Fine?). Images, symbols, and vignettes can also establish an association with a disease. Structure Function claims are not acceptable for ingredients intended solely for cosmetic/topical applications.
