FDA cGMP manufacturing
Soundbites softgel capsules are produced in an FDA-certified pharmaceutical facility using RP Scherer softgel technology to enhance bioavailability. Manufacturing processes strictly comply with current FDA Good Manufacturing Practices (cGMP). Capsules are packaged and shipped to us under climate control, stored in our climate controlled warehouse.
Refrigeration is not necessary. When stored at room temperature, stability tests guarantee that the statement of active ingredients is accurate until the expiration date imprinted on the bottle label.
Vitamin A (in the form of beta-carotene, provitamin A); Vitamin C (as calcium ascorbate); Vitamin E (in the form of dl-alpha tocopheryl acetate); Magnesium (in the form of magnesium oxide). Other ingredients: Refined soybean oil (carrier), soy lecithin (emulsifier), glycerol, mono- and di-glycerides (stabilizers)
FDA regulatory statements
Soundbites is a nutraceutical for hearing preservation, regulated as a dietary supplement by the U.S. Food and Drug Administration (FDA) under Dietary Supplement Health and Education Act (DSHEA) law.
The FDA does not approve dietary supplements or their claims. Instead, supplement makers, not the FDA, are responsible for ensuring the accuracy and truthfulness of their claims, which are restricted to health maintenance and health promotion. By law. supplement makers are not allowed to claim that their products diagnose, cure, treat or prevent any disease. Only approved drugs can make those claims.
Soundbites helps maintain normal auditory function, helping you keep the hearing you have by maintaining the health of hearing system cells and prolonging their lives. Soundbites can improve hearing sensitivity and reduce tinnitus symptoms, but cannot regenerate hearing or cure tinnitus.