Feds Speed Up Health-Claim Approval Process

 Feds Speed Up
Health-Claim Approval Process
April 1998 -- Regulatory Insight

By: Gerry Clark

  In recent years, consumers have increasingly encountered food labels boasting a cornucopia of strange and familiar healthful components, among them ginseng, echinacea, olive oil and bran.  Still, as the food industry knows, it's one thing to list these ingredients on product labels, yet another to claim they actually do something. But a new law promises to ease the federal approval process for food companies seeking to place health claims on product labels.  Under the new provisions, effective Feb. 19 and included in The Food and Drug Administration Modernization Act of 1997, manufacturers must submit premarket notification to FDA at least 120 days before introducing a food label containing a health claim. If FDA doesn't deny the claim, it's cleared for take-off. The caveat: the new law only extends to claims based on an "authoritative statement" from an official government scientific body or the National Academy of Sciences. Claims based on third-party research still must follow the petition process.  "All along, one of the reasons we said that a health claim must be based on significant scientific agreement is so that the consumer must be confident that they could trust it," says Elizabeth Campbell, acting director, Office of Food Labeling, FDA. "We have been concerned that it would confuse the consumer. When it's (based on) an authoritative statement of one of these bodies, there is an assumption that there is significant scientific agreement."  Therefore, the new law "excludes the concept of a single scientific study" as support for an expedited claim, Campbell says, but "it will be a speedier process than the current process."  The group that successfully lobbied for the new law, the National Food Processors Association (NFPA), mirrors that sentiment. "What we've done here is establish an expedited system for approval," says Brian Folkerts, vice president of government affairs, NFPA, which is based in Washington, D.C.  Folkerts cautions that health claims proceeding through this new avenue must continue to abide by the rules established by the Nutrition Labeling and Education Act (NLEA): "The statutory standards that existed before the (new) law remain in effect. This does not relax standards; it just expedites procedure.  "We're trying to enable more information to reach consumers," Folkerts says. "That doesn't mean it doesn't have to fall within the realm of sound science."  The extent to which the FDA's altered stance will impact the food industry remains to be seen, and NFPA is not aware of any pending health claims that would immediately benefit from the new law.  "I think it's a tool for the future," Folkerts says. "Again, this is flexibility. If people want to take advantage of it, it might lead to change."  Surveying the recent past, Folkerts claims that the new procedure would have sped up FDA's approval of health claims positing a link between folic-acid consumption in women of childbearing age and prevention of infant neural-tube defects. "This is one example where you could have seen a claim make it to the marketplace faster than three-and-a-half years," he says.  Officials at Quaker Oats Company -- the firm that gained FDA approval to make claims linking whole-oat consumption to reduced risk of coronary disease -- are remaining somewhat tight-lipped about their assessments of the new law, and whether the company will use it to bypass the traditional petition process.  "The health-claim changes are modest and their impact upon Quaker will be modest as well," Quaker spokeswoman Karen Savinski says. "I can't comment on anything that's for future use."  Nevertheless, Quaker officials seem pleased that the new act will eliminate the need for manufacturers' labels to include referral panels, thereby offering companies more label-space autonomy. "We feel any refinement to the NLEA up to this point has been positive," Savinski says.  "We support anything that allows consumers to make better informed decisions about the foods they purchase," states General Mills spokeswoman Pam Becker.  Others remain cautious about a scenario in which grocery-store shelves are glutted with product sporting labels claiming this substance does this or that ingredient does that, suspecting that consumers might be overwhelmed by it all. Add to that a seemingly contrary stream of information: One week the media publicizes a study linking a certain substance to disease prevention; the next week, new research repudiates the claim.  "It's difficult; it's also contradictory," says Hans-Peter Wild, president, Wild Flavors Inc., Cincinnati. "I don't know what to eat anymore. The FDA is right -- they should put brackets on what claims can say. The most important thing is not to deceive the consumer."  Others see this new law as a plus for consumers and food companies alike.  "I don't think it's going to overwhelm consumers," says Mariellen Voit, business director, Canadian Harvest, a business unit of DCV Food Ingredients, Wilmington, DE. "I think it's going to guide them into the right decisions.  "I think it will take a while for the impact to be felt," Voit says. "I think it will require a cultural change (on the part of consumers). I think it's going to be a matter of trusting (the health-claim label), understanding it and using it in everyday life."  Campbell stresses that FDA is adamant that companies must include an effective level of a healthful substance in products. "If the claim is about the substance having a benefit," she says, "the product must have enough of the substance to provide that benefit."  Also, the agency is prepared to scrutinize every claim, to ensure they accurately reflect the appropriate government body's authoritative statement. "We have the obligation to ensure that these two fit together. If they don't fit together, that would give us reason to deny the claim or have a company reword it." In the case of a one-word change, for example, FDA is "more likely to make the word change...if it's that easy. If it's not an obvious fix, we're likely to deny it."  However, Voit questions whether FDA has sufficient manpower to devote to properly enforcing the law, particularly the 120-day time restriction. "A company submitting a claim might get approval by default," she claims. "That could be a negative to the public. What makes FDA think they're going to have the manpower? Unless they're going to get more people, something might slip through."  But FDA officials say they believe the new law won't endanger the public, and that they'll be able to force companies to withdraw statements within the 120-day window if necessary.  "It would be difficult to do," Campbell says, "but we're confident we can do it."Back to top