(MEDICAL-HEALTH) CLAIMS (FIM’S NUTRACEUTICAL PRINCIPLES)
1. There must be sufficient clinical data to reasonably support the claim. (They need not be doubleblind.)
2. Reasonable surrogate markers instead of clinical endpoints can be sufficient to support a claim.
3. Acceptable preclinical data to support the product rationale is desirable but not always necessary.
4. All pertinent data must be published in respectable medical-scientific journals. (This is the first step of the peer review process.)
5. Independent, consensus or expert group opinion should be obtained. (This is the second step of the peer review process.)
6. Post-marketing surveillance. This effort should concentrate particularly on the aspect of safety.