Dangerous Lawsuit Threatens the Few Supplement Health Claims Currently Allowed

A new lawsuit filed by a "consumer watchdog" group says most Americans are not vitamin deficient and don't benefit from supplements. Huh?

October 28, 2014 | Source: Alliance for Natural Health | by

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A new lawsuit filed by a “consumer watchdog” group says most Americans are not vitamin deficient and don’t benefit from supplements. Huh?

Earlier this month we told you about international pharmaceutical company Bayer AG’s battle with the Federal Trade Commission over whether its marketing statements about its probiotic colon supplement are unsubstantiated disease claims (not allowed) or structure/function claims (allowed). This week, the Center for Science in the Public Interest (CSPI) filed a class action lawsuit in federal court against Bayer because of its “false claims on ads and labels” for its One A Day Vitamins. The group is asking for an injunction against specific marketing statements, and seeking refunds to consumers.

According to CSPI, the multivitamin’s claims-“supports heart health,” “supports immunity,” and “supports physical energy”-amount to “illegal disease prevention claims designed to deceive consumers.” Bayer, on the other hand, contends these are structure/function claims. The landmark Dietary Supplement Health and Education Act of 1994 created special protections for structure/function claims-and they do not require preapproval by the FDA.

Structure/function claims are statements that describe the role of a nutrient or dietary ingredient as it affects normal structure or function in humans-for example, “calcium builds strong bones” or “vitamin D boosts immune system function.”

S/F claims are an important way dietary supplement makers can inform the public about the health benefits of their product, since they are prevented from making health claims. But it all comes back to our famous “Catch-22”: that no supplement company will spend the exorbitant sums needed to run clinical trials (which is the only way health claims can legally be made) if the product can’t be patented and turned into a huge money-maker. Because health claims are impossible for such supplements, structure/function claims are even more critical-while they don’t provide specific information, they at least guide the consumer toward optimal health in a specific area.

CSPI claims-speciously, in our estimation-that “scientific studies prove that supplementation with [vitamins A, C, and E, as well as selenium, iron, beta carotene, and zinc] have no effect on adults’ immunity in developed countries like the United States.” In fact, many developed countries (like the United States) have an overfed but undernourished population. We document the obesity/malnutrition issue thoroughly in our comments to the FDA regarding their proposed nutrition fact panel changes.