FDA's New Health Claims Process

As part of its "Consumer Health Information for Better Nutrition" initiative, FDA will begin accepting petitions for qualified health claims on September 1, 2003, suggesting that petitioners meet with the agency prior to preparing a petition. In total, FDA plans to respond to petitioners within 270-330 days of petition filing. This includes third party and agency review. Comments on FDA's proposed process are being encouraged.

In the past, different standards could be applied by FDA to health claims for dietary supplements than those which were applied to food health claims; this new health claim framework appears to establish a level playing field.

The Guidance put forward by FDA states "Different levels of evidence will result in different qualifying language " including:

* FDA Category A, which means that there is significant scientific
agreement (SSA) about the health claim: the evidence is derived from well-designed studies. Such a claim requires no disclaimer and is therefore referred to as an unqualified health claim.
Categories B through D are Qualified Health Claims.
* FDA Category B is qualified by: "...although there is scientific
evidence supporting the claim, the evidence is not conclusive."
* FDA Category C will say: "Some scientific evidence suggests ...
however, FDA has determined that this evidence is limited and not conclusive."
* FDA Category D reads: "Very limited and preliminary scientific
research suggests ... FDA concludes that there is little scientific evidence supporting this claim."

Hide comments


  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.