FOOD HEALTH CLAIMS: "SUBSTANTIAL EVIDENCE" TO BACK UP
FOOD HEALTH CLAIMS: "SUBSTANTIAL EVIDENCE" TO BACK UP health messages should be required by FDA instead of consensus of scientific opinion, the Council for Responsible Nutrition maintained in May 15 comments to the agency. Responding to FDA's reproposed rule on health messages, CRN suggested that the agency "make clear in the final rule that 'substantial evidence,' and not a consensus of scientific opinion, is required for substantiation of health messages." CRN noted that FDA's most recent proposal on food claims "speaks of 'significant agreement' as the standard for health claims substantiation." CRN said it is concerned "that, in practice, the line between 'significant agreement' and 'consensus,' if left undefined, will prove to be all too ephemeral." FDA published its reproposed rule on health messages in the Feb. 13 Federal Register ("The Pink Sheet" Feb. 19, p. 7). The reproposal allows manufacturers to continue making disease-specific claims for foods while it develops a definitive policy. The agency has said it will scrutinize the appropriateness of messages on a case-by-case basis until the final rule is published. However, the reproposal sets out six food component/disease combinations that FDA would use as a basis for health messages. The notice says that use of the phrase "may reduce the risk" or "may forestall the premature onset of" in one of the six areas "about which significant and general agreement exists, in and of itself, is less likely to result in regulatory action than will a claim that more firmly asserts the relationship between the food component and the disease." CRN commented that "the substantiation issue is not about whether false health messages will be allowed. Rather, the issue before the agency is whether messages that accurately represent the state of the evidence will be permitted when the underlying basis for the claim is less than certain." CRN maintained that "any insistence on consensus will likely prove elusive and perpetually deprive consumers of valuable information on many issues of diet and health." CRN also recommended that FDA add four additional categories for development of model messages and consumer summaries: "1) multivitamin supplements and neural tube defects; 2) fish oils and heart disease; 3) fruits, vegetables, antioxidant vitamins and cancer; 4) and nutrients and the immune function in the elderly." FDA's list of six areas, CRN stated, "does not reflect the evidence rapidly accumulating on many other possible types of health messages." In May 11 comments on the reproposal, Hoffmann-La Roche also suggested that there are other areas outside of the six specified categories that should be given consideration, including beta carotene's effect on cancer risk reduction and the use of multi-vitamins containing folic acid to reduce neural tube defects. CRN maintained that FDA should apply the same criteria to "a petition for a new type of health messages that has been filed with the agency in good faith and accompanied by supporting evidence...as it proposes to apply the interim enforcement policy to the favored categories of health messages initially targeted for regulatory action." CRN also wants FDA to clarify its interim enforcement policy. CRN also suggested that FDA "not arbitrarily limit health messages...to serious chronic diseases." The council pointed out that FDA has not explained "how it would define what diseases are 'serious,' nor has it explained why consumers should not be made aware of any foods that have some health benefit with respect to acute conditions." Regarding supplements, CRN stated that "FDA should make clear, once and for all, that supplements will be treated in the same manner as other foods for all types of health messages absent some valid scientific proof that a distinction is justified."
You may also be interested in...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials
Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth