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FDA Details New Process of Making Qualified Health Claims

Date: Sep 01, 2003


The U.S. Supreme Court's determination that commercial speech is worthy of First Amendment protection is rooted in the notion that informed citizens will make better decisions. Thus, truthful, non-misleading information about products and services should not be unduly restricted by government.

Mark McClellan, commissioner of the Food and Drug Administration (FDA), has a similar philosophy when it comes to health claims for foods: the flow of such information should be encouraged.

FDA first created the Consumer Health Information for Better Nutrition Initiative. It has just taken another significant step by issuing two guidance documents to help industry understand FDA's procedure for approving qualified health claims for foods.

Keep in mind that these documents apply to qualified health claims. That is, claims that cannot meet the statutory standard of "significant scientific agreement," and, therefore, cannot be the subject of an FDA authorizing regulation, but for which scientific evidence in support outweighs the evidence against.

How to get approval
The Agency's guidance entitled "Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements" explains the FDA review process qualified health claim petitions. FDA will use these procedures until it is able to issue final regulations.

To obtain clearance for a qualified health claim, a petition must be filed with FDA, which FDA will review for completeness within 45 days of submission. FDA will then prioritize for review all complete qualified health claim petitions according to several factors, including the following:

    • " whether the food that is the subject of the petition is likely to have a significant impact on a serious or life-threatening illness;


    • the strength of the evidence;


    • whether consumer research has been provided to show the claim is not misleading;


    • whether the substance of the claim has undergone an FDA safety review (that is, is an authorized food additive or has been generally recognized as safe);


    • whether the substance that is the subject of the claim has been adequately characterized so that the relevance of available studies can be evaluated;


    • whether the disease is defined and evaluated in accordance with generally accepted criteria established by a recognized body of qualified experts;


    • and whether there is prior review of the evidence or the claim by a recognized body of qualified experts.

After an opportunity for public comment, FDA will conduct a scientific review of the data either itself or by way of an appropriate third party.

The review must be competed within 270 days of receipt of the petition (except for good cause), at which time FDA will issue the petitioner a letter setting out the agency's determination as to whether to exercise enforcement discretion.

Interim ranking system
FDA's second guidance document, the "Guidance on the Interim Evidence-Based Ranking System for Scientific Data," describes the standards the Agency intends to use, on an interim basis, to evaluate and rank the scientific evidence in support of a substance/disease relationship that is the subject of a qualified health claim. This system will be used until FDA makes final regulations.

This guidance establishes how FDA will categorize the qualified health claim into one of three levels ("B," "C" or "D" level) based on the strength of the scientific evidence to support the health claims. ("A" rankings are reserved for claims meeting the significant scientific agreement standard.)

The rankings are based on an evaluation process that involves three separate rating systems: (1) a rating for study design; (2) a rating for study quality; and (3) a rating for the strength of the entire body of evidence. Based on the classifications from all three rating systems, a final rank of the scientific evidence supporting a health claim will be assigned.

Based on all of these ratings, FDA will rank the strength of the evidence for the health claim, which is really a way of stating the Agency's level of comfort that the qualified scientific community considers the claim to be valid. Because these are "qualified" health claims, they will be permitted only with language noting the strength of the evidence supporting it.

Thus, a claim with a rank of "B," that is, a moderate level of comfort, will include the phrase "&although there is scientific evidence supporting the claim, the evidence is not conclusive." One with a rank of "D", however, must include the phrase "Very limited and preliminary scientific research suggests&FDA concludes that there is little scientific evidence supporting this claim."

Where to go from here?
In the coming months, the FDA Task Force charged with implementing the Initiative will conduct consumer research, establish working processes for the scientific review of petitions, refine its methodology for evaluating health claim evidence in petitions and consider whether to draft updated regulations. So it's likely that the process outlined in the guidance documents may be modified. In the end, though, the new regulatory framework provides industry with a clear way to make health claims on an expedited basis.

Used with permission. Copyright FOOD & DRUG PACKAGING, September, 2003.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.