FDA Disclaimer

These statements have not been evaluated by the food and drug administration. These products are not meant to diagnose, treat or cure any disease or medical condition. Please consult your doctor before starting ANY exercise or nutritional supplement program or before using these or any product during pregnancy or if you have a serious medical condition.
Comments on FDA Issues

The FDA has a regulation that requires a statement similar to, or identical to the one above, be included on all nutritional product labels and literature.

Some nutritional products are known to prevent or cure diseases. Manufacturers of such products, however, are not permitted to make such claims unless the product in question has been subjected to the same FDA-supervised rigorous multi-million dollar trials and tests that apply to drug companies for their products. The primary function of drug companies is to research, develop and manufacture patentable synthetic drugs. Patents protect profits, which in turn is what justifies the millions of dollars that are spent on trials and testing.

Patent protection is not available for products that occur in nature or products that are naturally available. A “use patent” is occasionally allowed on natural products, but a use patent does not prevent other companies from manufacturing the same products. Exclusive profit protection on natural products is difficult or impossible. In the absence of protection to ensure exclusive rights to a product, nutritional companies cannot afford to spend the millions of dollars necessary to obtain FDA approval. Hence, nutritional companies rely on evidence which is usually anecdotal, historical or based on studies and research which, hopefully, are valid and authoritative – but are usually not in compliance with the more costly FDA regulations that apply to drugs.