In Canada we call these “Disease Risk Reduction” or “Therapeutic” health claims DO require preapproval by the FDA before being used on labels US has many more approved health claims than Canada o Health claims based on FDAs review of the scientific literature + assessment of Significant Scientific Agreement (SSA) Calcium + osteoporosis Dietary fat + cancer Sodium + hypertension o Health claims authorized based on an Authoritative Statement by Federal Scientific Bodies: Whole grains + risk of heart disease + certain cancers Potassium + risk of high blood pressure + stroke US Health Claim Legislation Qualified Health Claims 2003 – claims can be made with “emerging evidence” but not sufficiently established for a SSA health claim o The qualifying language in the claim is included to indicate that the evidence supporting the claim is limited o Ex. Green tea may reduce the risk or breast or prostate cancer though the FDA has concluded there is little scientific evidence for this claim Much more difficult to put products on the market in Canada vs in the US o Can make more claims in the US – this is one example US – Dietary Supplement Health + Education Act (DSHEA)
1994 - dietary supplements are not considered as a category separate from food & drugs and subject to their own regulations Product safety or effectiveness does NOT have to be demonstrated before the product enters market Burden of proof of safety is on the FDA “FDA Science + Mission at Risk” The investigation concluded that science at the FDA is at a precarious position: the Agency suffers from serious scientific deficiencies + is not positioned to meet current or emerging regulatory responsibilities William Hubbard (former FDA associate) claims “the FDA cannot even do its job now” US – Dietary Supplement + Non-prescription Drug Consumer Protection Act (DSNDCPA) 2006 – US came out with consumer protection act to emphasize the safety of dietary supplements Dietary supplement manufacturers MUST report to the FDA any serious adverse events potentially associated with their products Adverse Events Reporting System (AERS) the FDA’s post-market safety surveillance system “Serious Adverse Event ” – event that results in death; a life-threatening experience; inpatient hospitalization; a persistent or significant disability or incapacity; or a congenital anomaly or defect; or requires, based on medical judgement, a medical or surgical intervention to prevent an outcome described above US – Current Good Manufacturing Practices (CGMPs) 2007 – Ensures that: o Products labeled properly with all ingredients listed o Product is free of contaminants or impurities o Strength/potency of product is as claimed Does NOT require proof of efficacy (the ability to produce a desired or intended result – effectiveness) The Global Perspective – FAO (Food + Agriculture Organization of UN) 1963 – Codex Alimentarius: food regulations written by the FAO o Purpose: protect health of consumers + ensuring fair trade practices in the food trade (used in international trade), and promoting
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- Fall '16
- Nutrition, health claims, functional food