Qualified Health Claim Approval May become easier for Dietary Supplement Marketers

Jun 21, 2010   
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On May 27, 2010, the United States District Court of the District of Columbia granted a summary judgment in the matter of Alliance for Natural Health US v. Sebelius, suggesting that a qualified health claim is free speech protected under the First Amendment. Sparked by the FDAs denial of a petition to approve qualified health claims, The Alliance for Natural Health (“ANH”) along with prominent dietary supplement activists, Durk Pearson and Sandy Shaw sought to invalidate the FDAs denial of the qualified health claims and permanently preclude the FDA from preventing dietary supplement marketers from placing qualified health claims on dietary supplement labels.

The ANH petitioned the FDA with ten qualified health claims touting a reduction in cancer risk from selenium. The FDA rendered a decision completely rejecting two of the ten claims, calling them misleading for a failure to state the type of cancer risk associated with the benefits of selenium supplementation. The FDA further denied seven other claims that delineated site-specific cancers citing a lack of scientific evidence. The last claim dealt with a reduction in the risk of prostate cancer. Given the scientific evidence, the FDA, deemed the prostate claim to be false and misleading but did not discard it. Instead, in an uncharacteristic move, the FDA proposed a redrafted version of the prostate claim, which the ANH deemed pointless and the Court, ironically, found to be false and misleading.

The Court, relying on the FDAs own Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims and prior case law, declared that the FDA had violated the First Amendment when it chose to suppress the qualified health claims rather than find a less restrictive means such as a short, succinct disclaimer. While the Court did not grant the permanent injunction ANH had requested, it did send the petition back to the FDA for re-review.

Unless reversed on appeal, this decision will make it almost impossible for the FDA to deny a qualified health claim that accurately reflects the scientific evidence; it would conflict with supplement marketers rights to free speech. This could pave an easy path for dietary supplement labels to bear appropriately disclaimed qualified health claims on selenium or presumably any other dietary supplement.