Final answer:
OTC drug manufacturers must ensure their labels provide proper use, benefits, and side effects information, adhering to FDA regulations. Companies can only advertise drugs for FDA-approved uses, maintaining a fair balance of information. Misconduct, like data falsification, leads to regulatory action against the manufacturer.
Step-by-step explanation:
Over-the-counter (OTC) drug manufacturers must adhere to specific labeling requirements as regulated by the Food and Drug Administration (FDA) to ensure the safety and efficacy of the drug products. The labeling should provide clear information on the usage, benefits, and risks (side effects) associated with the drug. A company can advertise or promote an OTC drug only for the indication or medical use for which it is approved by the FDA. Furthermore, there must be a "fair balance" between the benefits and risks. OTC drug ingredients that have been approved are considered safe enough for use without a doctor's supervision, like ibuprofen and aspirin.
OTC drugs, which include a wide array of products from the FDA's list of approved ingredients, do not require a prescription. However, if a drug is marketed off-label for indications not approved by the FDA, it is subject to regulation and potential enforcement actions. Overall, manufacturers are scrutinized to prevent any misleading or false information that could potentially harm consumers. In cases of misconduct, such as falsifying data for FDA approval, severe consequences have been imposed on manufacturers, as seen with Vitarine Pharmaceuticals and the Bolar Pharmaceutical Company.