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Letter from the National Consumers League to the Council of Better Business Bureaus on dietary supplement in infant formulaMs. Andrea C. Levine
Dear Ms. Levine: The National Consumers League (NCL) commends your efforts in holding manufacturers of consumer products to being truthful in their advertising, as illustrated by your recent action with regard to advertisements of the Neuromins® dietary supplement targeted at pregnant women. We are also aware of several recent actions NAD has taken with regard to infant formula advertising. We are urging you to extend the same degree of scrutiny to advertising for the soon-to-be-launched infant formulas containing the same ingredient that is present in the Neuromins® supplement. As you may know, NCL is a nonprofit consumer advocacy organization founded in 1899 to represent consumers in the marketplace and workplace. NCL provides information and educational materials to consumers so that they can make informed decisions, participates in the legislative and regulatory arenas, and is an active member of several boards and coalitions that focus on healthcare. Among the priority public policy concerns of NCL are issues relating to food, drugs and health care. NCL often works with the government agencies that have supervisory responsibilities over these market segments when issues are raised regarding the safety and economic well-being of consumers. For example, we recently brought to the attention of the Food and Drug Administration (FDA) the possible mislabeling of a wide range of dietary supplements containing isoflavone-based ingredients.
It has always been NCL’s view that
consumer products, including dietary supplements, that target such
sensitive populations as expecting mothers and their infant children
must be ready to withstand the highest degree of scrutiny. For this
reason, we are concerned about the impending introduction of infant
formula enriched with docosahexaenoic acid (DHA), the fatty acid
contained in the Neuromins® dietary supplement, as well as arachidonic
acid (ARA), a related fatty acid.
This introduction will no doubt be
accompanied by substantial and high-profile marketing and advertising
campaigns. It has already been the subject of a focused public
relations effort by the
manufacturer of these oils. Although there has been some interesting
and suggestive research, there is no hard evidence or unanimous expert
opinion on the benefits of DHA and ARA when added to formulas for
full-term infants. Even in premature infants, where many experts
consider benefits more likely, a recent report by the Life Sciences
Research Office developed under FDA's mandate noted that any effects on
visual and neurological development appeared to be either “small” or
“transient.” Despite the apparent lack of a scientific consensus with regard to the precise benefits of enriching infant formulas with DHA and ARA, parents will soon be seeing these products on the market. As a consumer organization, NCL is concerned that these products not carry labeling or advertising claims that mislead parents, especially since we understand they will carry a higher price tag. We therefore urge the NAD to exercise the same degree of scrutiny in monitoring advertising claims concerning these new infant formulas that it extended to the Neuromins® dietary supplement. This should include careful attention to advertising claims for fatty acid enriched infant formulas outside of those labeling claims that have been reviewed by FDA as part of its new infant formula review and to which that agency has not objected. We note that claims permitted for dietary supplements under the Dietary Supplement Health and Education Act of 1992 are not necessarily permitted for foods, especially infant formulas. Claims to which FDA may not have objected for supplements of DHA and ARA may nevertheless be inappropriate for infant formulas. FDA’s requisite premarket review of infant formula products may or may not include review of label claims. Therefore, it may be necessary to consult with FDA to identify what claims the agency finds appropriate. In conclusion, NCL urges NAD to examine any advertising claims for DHA- and AHA-enriched infant formulas and act promptly to ensure that all claims are adequately substantiated and consistent with label claims reviewed and found appropriate by FDA. Thank you in advance for your consideration.
Sincerely,
LINDA
F. GOLODNER
President
cc: Mr. Joseph A. Levitt, Director CFSAN,
FDA |