only if the Secretary determines, based on the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence.
require such claim to be stated in a manner so that the claim is an accurate representation of [the nutrient-disease relationship] and so that the claim enables the public to comprehend the information provided in the claim and to understand the relative significance of such information in the context of a total daily diet.
[t]he agency believes, however, that any standard involving the evaluation of scientific evidence and opinions derived from that evidence must be somewhat subjective. FDA, in proposing not to define “significant scientific agreement” among experts [citations omitted] noted that each situation may differ with the nature of the claimed substance/disease relationship. The agency believes that in deciding whether significant scientific agreement about the validity of a claim exists, it is necessary to consider both the extent of the agreement and the nature of the disagreement on a case-by-case basis.
A few studies may often be found about a multitude of [nutrient-disease] associations, and many, if not most, of those associations will ultimately be found not to be valid. If [the] FDA were to permit preliminary claims about such a multitude of associations, the agency believes that ultimately what would be lost is the confidence of most consumers in the validity of all claims that appear in food labeling .... Congress, in its enactment of the scientific standard [for foods in conventional form], struck what it believed to be an appropriate balance between the costs and benefits of claims on foods in general. FDA is not aware of any reason to strike a different balance for dietary supplements.
In § 101.79(c)(2)(i)(H), the agency is proposing that a health claim not state that a specified amount of folate is more effective in reducing the risk of NTDs [neural tube defects] than a lower amount (e.g. 100 mg). This proposed requirement is consistent with data showing that reduction in risk of NTDs has been associated with general dietary improvement (which is assumed to increase folate intake by unspecified amounts).
The legislative history of these provisions reveals that substantial governmental interests *20 drive the NLEA and implementing regulations: preventing the spread of unsubstantiated health claims on labels so that consumers may not be deceived and follow unsound health practices; ensuring the reliability of scientific information disseminated in connection with the sale of dietary supplements; and protecting consumers from being induced to purchase products by misleading information on labels.
End of Document | © 2024 Thomson Reuters. No claim to original U.S. Government Works. |