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FDA Takes Steps to Allow Qualified Health Claims on Labels

April 1, 2004

By Keller and Heckman LLP’s Packaging Practice Group

The Food and Drug Administration announced March 31, 2004, that a qualified health claim will soon appear on product labels for walnuts and the reduced risk of coronary heart disease. "This qualified health claim is part of the FDA's initiative to provide Americans with better information to help them make healthier dietary choices," the agency explained. Click here to see the qualified health claim.

In July 2003, FDA issued two guidance documents regarding "qualified health claims" on food labels. A qualified health claim is one that is accompanied by a qualifying statement to indicate that there is some degree of uncertainty regarding the scientific validity of the claim. FDA will approve qualified health claims in situations where the scientific evidence supporting the claim falls short of that required for an unqualified health claim under the Nutrition Labeling and Education Act of 1990 (NLEA).

Under NLEA, for a health claim to receive authorization, (1) it must be supported by the "totality of publicly available scientific evidence," and (2) there must be "significant scientific agreement" (SSA) among qualified experts that the claim is supported by such evidence.

Under the new regime, health claims will be assigned one of the following rankings:

1. Level 1/SSA/High Level of Comfort – Scientific evidence supporting the substance/disease relationship meets the SSA among qualified experts standard. This is the unqualified health claim under NLEA.

2. Level 2 – "B" Claim – Moderate/Good Level of Comfort – Highest level for a qualified health claim representing a moderate/good level of comfort among qualified scientists that the claimed relationship is scientifically valid. B Claims will be qualified with language to the effect that "although there is scientific evidence supporting the claim , the evidence is not conclusive . . . ."

3. Level 3 – "C" Claim – Low Level of Comfort – Middle level for qualified health claim representing a low level of comfort among qualified scientists that the claimed relationship is scientifically valid. C Claims will be qualified with language to the effect that "some scientific evidence suggests . . . However, FDA has determined that this evidence is limited and not conclusive."

4. Level 4 – "D" Claim – Extremely Low Level of Comfort – Lowest rank of scientific evidence to support the claimed substance/disease relationship representing an extremely low level of comfort among qualified scientists that the claimed relationship is scientifically valid. D Claims will be qualified with language to the effect that "very limited and preliminary scientific research suggests . . . FDA concludes that there is little scientific evidence supporting this claim."

5. No Appropriate Claim – If the scientific evidence to support the claim is below the fourth level, no claim will be appropriate.

Guidance on Interim Procedures for Qualified Health Claims

The Agency's guidance, "Interim Procedures for Qualified Health Claims in the Labling of Conventional Human Food and Human Dietary Supplements," sets forth the interim procedures FDA has implemented for petitioners to submit qualified health claim petitions. FDA plans to use these procedures to respond to qualified health claim petitions until it is able to issue final regulations governing this process. Under the interim procedures, FDA began, in September 2003, to accept petitions for qualified health claims for foods and dietary supplements.

Guidance on the Interim Evidence-Based Ranking System for Scientific Data

A separate document, "Guidance for Industry and FDA: Interim Evidence-based Ranking System for Scientific Data," describes the process FDA is using, also 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. As with the interim procedures, this system will be used until FDA can promulgate regulations governing this process. The primary purpose of this guidance is to provide petitioners with a description of the major points that FDA intends to consider in evaluating supporting scientific data. This guidance does not apply to unqualified health claims, which must meet the SSA standard.

ANPRM

On Nov. 25, 2003, FDA issued an advance notice of proposed rulemaking (ANPRM) to request comment on, among other things, alternatives for regulating qualified health claims in the labeling of conventional food and dietary supplements (68 Fed. Reg. 66040). Because the two guidance documents issued in July 2003 merely established interim procedures and do not have the force of law, FDA issued this ANPRM to solicit comment on various approaches the Agency might adopt to regulate qualified health claims.

In particular, the ANPRM discusses three options FDA is considering for regulating health claims that do not meet the significant scientific agreement standard. Under the first option, FDA would codify the current interim procedures and evidence-based ranking system, or some variation of the current procedures and ranking system, into a regulation. The second option would be to require each qualified health claim to undergo notice-and-comment rulemaking, which is the statutorily prescribed method for approving health claims for conventional foods. Under the third option, qualified health claims would be regulated outside of the purview of the NLEA on a postmarket basis under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act, which provides that food is misbranded if its labeling is false or misleading.

The comment period on the qualified health claims ANPRM closed on Jan. 26, 2004. After the Agency has an opportunity to review the comments received in response to the ANPRM, it will presumably move forward to promulgate regulations in this area.