CRN, NNFA urge supplement commission to review health claims' pre-approval requirement.

CRN, NNFA URGE SUPPLEMENT COMMISSION TO EXAMINE HEALTH CLAIM PRE-AUTHORIZATION requirements in separate comments to the Commission on Dietary Supplement Labels. The Council for Responsible Nutrition and National Nutritional Foods Association suggested that the commission consider a "more effective and efficient process" for making health claims decisions under the Nutrition Labeling and Education Act. CRN maintained in written comments that "significant concern remains over whether FDA should assert a pre-authorization role."

"Some believe that pre-authorization is not required by NLEA and that any pre-approval...is contrary to commercial free speech," the group stated. The comments were submitted to the commission at its inaugural meeting on Feb. 16 in Washington D.C.

However, if FDA must pre-authorize claims, CRN said, the agency "could enter into a unique partnership [with] the scientific community, industry and consumers in making more timely and more useful health claims decisions." Such a partnership could involve FDA employing outside experts to make recommendations, the group suggested.

NNFA also suggested that the agency consider the use of outside experts for health claim decisions. "A regulatory structure premised on agency preapproval will not work," the group asserted. "The FDA cannot keep pace with scientific research."

Preapproval under the current approach will create an "unnecessary burden and backlog" for FDA, NNFA argued. The result, the group said, "will be to discourage the submission of claims, with less information being made available to the public, rather than more."

Both groups asked the commission to "provide guidance" for interpreting the "significant scientific agreement" standard mandated by the NLEA. "Many believe that FDA has defined and applied [significant scientific agreement] in an overly restrictive way," CRN commented.

Kenneth Fisher, executive director of the commission, had predicted that definition of "significant scientific agreement" would be a "core" issue for the commission ("The Tan Sheet" Sept. 18, 1995, pp. 6-7).

CRN argued that the "House Report on the NLEA stated that this standard was not intended to require unanimous agreement among qualified experts, but only significant agreement." The group declared that the agency's current interpretation of the standard does not permit qualified health claims for which there is scientific support, and thereby limits consumer access to "important information" on diet and health.

NNFA echoed CRN's position, arguing that the agency has a too "rigid interpretation" of the standard. FDA's interpretation, the group said, "is the reason that only seven claims for food and only two for dietary supplements have been approved."

A better approach, CRN suggested, would be one that permitted emerging, preliminary or controversial findings to appear on labeling in a way that appropriately conveys the given stage of the scientific evidence. "The language of the NLEA clearly provides FDA the authority to allow statements about emerging scientific information, but FDA chose not to allow it," the comments assert.

Another way to define the standard, CRN suggested, would be to require that "at least 50% of the experts...agree, even if additional studies may be necessary, that the weight of the scientific evidence...supports the proposed claim."

CRN further advised that the commission consider whether claims "which accurately report the recommendations of governmental public health organizations" should be allowable without prior review by the agency. Such a policy might help to avoid situations "like folic acid, where food and supplement manufacturers were prevented from making a claim, even though the Centers for Disease Control and Prevention had issued a recommendation," CRN pointed out.

CRN also called the commission's attention to the need for FDA to "open its process to communications experts to develop health claim language that consumers understand."

NNFA expressed concern about FDA "requiring its seal of approval on every single claim in the marketplace." Instead, the group said, the agency's efforts "should be focused on taking action where the public is being misled."

NNFA further urged the commission to "focus its efforts on developing recommendations to create a workable regulatory structure for claims," especially given the commission's limited timeframe. "We believe there is simply not enough time for this commission to revisit all possible issues involving supplement labels," the group stated.

Congress had given the commission two years to deliver its final report. Because the commission's charter was not signed until Feb. 13, the group has set Feb. 13, 1998 as the deadline for making its recommendations. The charter notes that the commission is expected to meet six to eight times, at an estimated annual cost of $138,535.

Pharmavite Chairman Kenneth Rosenberg, in a presentation to the committee, suggested that the panel has a responsibility to "set guidelines for levels of nutrient intake to reflect optimal health targets for every American consumer."

The general public bears a "knowledge gap," he continued, which should be closed by action "at the public health policy-setting level." Before the commission can "actually deal with labeling in a meaningful way," he declared, the panel must "at least on some level" consider the most effective way to disseminate accurate information to consumers.

He commented that, in general, "a regulatory scheme" is needed that "blends the lofty public policy goals of prevention of chronic diseases through improved nutritional status [with] the appropriate use of dietary supplements both to augment the demonstrably inadequate American diet and confer other highly significant potential health benefits."

Rosenberg expressed concern about the limited time allotted the commission. "You need to report to Congress very soon," he emphasized, "on the subject of the totality of the job that needs to be done....A partial job done without adequate time and without addressing issues central to those you must deal with is worse than no result at all."