Medical Foods vs. Pharmaceutical Drug vs. Dietary Supplements


  Medical Foods Rx Drug Dietary Supplements
Intended Use Nutritional or dietary management of a specific disease or its metabolic processes. To cure or treat a specific disease or symptoms. To maintain the well-being of a particular function in the body (e.g., maintain healthy joints).
Safety Ingredients must attain FDA GRAS (Generally Recognized As Safe) status. GRAS denotes broad scale safety. Ingredients not GRAS, but all drugs must be pre-approved by the FDA for safety. Ingredients have some “expectation” of safety as evidenced by having been sold in the U.S. market prior to October, 1994. Ingredients are not GRAS listed.
Effectiveness & Clinical/Scientific Support The distinctive nutritional requirements of the specific disease and product performance must be shown by medical evaluation and determination. PTL is supported by clinical/scientific studies. The efficacy and disease specific claims must be supported by clinical/scientific studies (e.g. Animal toxicity, Phase I/II, Large Phase III, IV, and post-marketing clinical studies), and pre-approved by the FDA Normal, healthy adult.
Medical Care Must be used under a medical physician’s supervision. Must be used under a medical physician’s supervision. No specific requirements for pre-market testing.
Manufacture Requirement FDA Good Manufacturing Practices for foods are required, but TMF uses drug GMPs. FDA Good Manufacturing Practices for drugs. None. Supplements are typically self-administered by the consumer and are sold and bought without a prescription.