Food Regulation. Neal D. Fortin

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СКАЧАТЬ Juice Beverages and Cranberry Dietary Supplements and Reduced Risk of Recurrent Urinary Tract Infection in Healthy Women

       EHA and DHA and Reduction of Blood Pressure in the General Population

       Folic Acid 0.8 mg and Neural Tube Birth Defects

       Folic Acid, Vitamin B6, and Vitamin B12 and Vascular Disease

       Green Tea and Cancer

       Ground Peanuts and Reduced Risk of Developing Peanut Allergy

       Nuts and Coronary Heart Disease

       Olive Oil Monounsaturated Fatty Acids and Coronary Heart Disease

       Oleic Acid and Coronary Heart Disease

       Omega‐3 Fatty Acids and Coronary Heart Disease and Hypertension (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega‐3 fatty acids)

       Phosphatidylserine and Cognitive Dysfunction and Dementia

       Selenium and Cancer

       Soybean Oil and Reduced Risk of Coronary Heart Disease

       Tomatoes and/or Tomato Sauce and Prostate, Ovarian, Gastric, and Pancreatic Cancers

       Walnuts and Coronary Heart Disease

       Whole Grains and Diabetes Mellitus Type 2

      Each accepted qualified health claim includes specific standards that a food must meet in addition to the general requirements for the claim. For example, a food with a heart claim may not exceed disqualifying levels of saturated fat and so forth. Some of the qualifications regarding the strength and weakness of the evidence are elaborate; for instance, the sample qualified claim below:

One study suggests that consuming tomatoes does not reduce the risk of pancreatic cancer, but one weaker, more limited study suggests that consuming tomatoes may reduce this risk. Based on these studies, FDA concludes that it is highly unlikely that tomatoes reduce the risk of pancreatic cancer.⁴¹

      NOTES AND DISCUSSIONS

      1 5.7. Lengthy qualifications. How likely are food distributors to use long and elaborate qualified health claims?

      2 5.8. Unreliable scientific evidence. When a qualification for a claim indicates that it is more likely than not to be invalid, is the qualification enough to cure the misleading element? What about a qualified claim where the evidence is unreliable? E.g., “Green tea may reduce the risk of breast or prostate cancer. FDA has concluded that there is very little scientific evidence for this claim.” Do such qualified claims prevent consumers from being misled?

      5.6.6 The Pearson Claims Revisited

      Regarding the particular health claims proposed by the Pearson plaintiffs, the FDA developed “qualified” claims that would be appropriate on food labeling, even in the absence of evidence meeting the “significant scientific agreement” standard.

      One of the agency’s qualified claims for folate is:

      Healthful diets with adequate folate may reduce a woman’s risk of having a child with a brain or spinal cord birth defect. Women capable of becoming pregnant should take 400 mcg of folate per day from a supplement or fortified foods and consume food folate from a varied diet. It is not known whether the same level of protection can be achieved by using lower amounts.

      The agency’s qualified claim for omega‐3 fatty acids and CHD is:

      The scientific evidence about whether omega‐3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, but not conclusive. Studies in the general population have looked at diets containing fish, and it is not known whether diets or omega‐3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega‐3 fatty acids may or may not have on risk of CHD in the general population.

Regarding dietary fiber, the FDA found no basis to conclude that the available evidence permitted a comparably nonmisleading use of qualified information. Regarding the antioxidants and cancer risk claim, further evidence suggests other factors in whole food or the relative presence of some foods and the absence of other foods are more important than the level of individual nutrients consumed. Research indicates that taking some antioxidants dietary supplement, such as beta carotene, increase the risk of cancer. In addition, there are unknown implications on public health of shifting the emphasis away from whole food toward nutrient supplements.⁴²

      5.6.7 Assessing Significant Scientific Agreement

      * * * * *

       Guidance for Industry: Evidence‐Based Review System for the Scientific Evaluation of Health Claims

       FDA (Jan. 2009)

      … Significant scientific agreement refers to the extent of agreement among qualified experts in the field. On the continuum of scientific evidence that extends from very limited to inconclusive evidence, SSA lies closer to consensus. FDA’s determination of SSA represents the agency’s best judgment as to whether qualified experts would likely agree that the scientific evidence supports the substance/disease relationship that is the subject of a proposed health claim. The SSA standard is intended to be a strong standard that provides a high level of confidence in the validity of the substance/disease relationship. SSA means that the validity of the relationship is not likely to be reversed by new and evolving science, although the exact nature of the relationship may need to be refined. SSA does not require a consensus based on unanimous and incontrovertible scientific opinion. SSA occurs well after the stage of emerging science, where data and information permit an inference, but before the point of unanimous agreement within the relevant scientific community that the inference is valid.

For qualified experts to reach an informed opinion regarding the validity of a claim, the data and information that pertain to the claim must be available to the relevant scientific community. A finding of SSA then derives from the conclusion that there is a sufficient body of relevant, publicly available scientific evidence that shows consistency across different studies and among different researchers. The usual mechanism to show that the evidence is available to qualified experts is that the data and information are published in peer‐reviewed scientific journals. The value of an expert’s opinion will be limited if he or she did not have access to all the evidence.

      In determining whether there is significant scientific agreement, FDA takes into account the viewpoints of qualified experts outside the agency, if evaluations by such experts have been conducted and are publicly available. For example, FDA intends to take into account:

       documentation of the opinion of an “expert panel” that is specifically convened for this purpose by a credible, independent body;

       the opinion or recommendation of a federal government scientific body such as the National Institutes of Health (NIH) or the Centers for Disease Control and Prevention (CDC), or the National Academics of Sciences (NAS);

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