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FDA Disclaimer Information

What this statement means:
These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

FDA protocol states that it is not their responsibility to review and approve or disapprove dietary supplements before they reach the consumer. According to the FDA website under the Overview of Dietary Supplements, it states: "Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer."

..."The FDA has limited resources to analyze the composition of food products, including dietary supplements. It focuses these resources first on public health emergencies and products that may have caused injury or illness. Enforcement priorities then go to products thought to be unsafe or fraudulent or in violation of the law... The agency does not analyze dietary supplements before they are sold to consumers."

The reason why the FDA does not utilize their resources to monitor nutraceuticals prior to consumer sales is because dietary supplements have been determined a minimal risk, in comparison to the drug industry. If you were to look at any dietary supplement baring any type of health benefit or claim, you will find this FDA statement because it is required by law.

The FDA statement does not mean the products are not safe. Rather, if it is read closely, it actually references THE STATEMENTS MADE ABOUT THE PRODUCT, NOT THE PRODUCT ITSELF:

"These statements" (referencing any health benefit statements in the marketing content) "have not been evaluated by the Food and Drug Administration" (because the FDA does not have the time or resources to monitor low risk products prior to consumer sales). "This product is not intended to diagnose, treat, cure, or prevent disease." (Currently the FDA does not recognize any dietary supplements/nutraceutical products to diagnose, treat, cure, or prevent disease. Only licensed medical practitioners and certain drugs have been approved by the FDA to diagnose and treat disease.)