FDA Proposes New Health Claim Procedures 33530

FDA Proposes New Health Claim Procedures

WASHINGTON--The Food and Drug Administration (FDA) came up witha game plan for health claims appearing on dietary supplements and food. On July10, FDA's Task Force on Consumer Health Information for Better Nutrition (www.fda.gov/oc/mcclellan/chbn.html)unveiled a new process to provide more science-based, FDA-regulated informationabout the health consequences of foods and dietary supplements on productlabels. The task force, made up of government experts on health information andnutrition from FDA, the Federal Trade Commission (FTC) and the NationalInstitutes of Health (NIH), proposed a two-phase plan--which includes the stepscompanies should take for getting a health claim approved--to improve consumerunderstanding of the health consequences of their dietary choices. FDA intendsto use the interim procedures to ensure that its pre-market review is consistentwith the spirit of the Nutrition Labeling and Education Act (NLEA) and the FirstAmendment.

"Protecting consumers by helping them get better nutrition informationis among FDA's top priorities, because the choices that Americans make abouttheir diet have a great impact on the health of the public," said FDACommissioner Mark B. McClellan, M.D., Ph.D. "This new initiative willbetter protect consumers from making uninformed or misinformed choices abouttheir diet and nutrition, by giving consumers better information about thehealth consequences of those choices." He added the review process formaking qualified claims, combined with FDA enforcement, will reward companiesthat make healthier products while more aggressively enforcing the law againstcompanies that appeal to consumers through false and misleading health claims.

In support of the task force's efforts, FDA made available two final guidancedocuments in the June 10 Federal Register. The first, "Guidance: InterimProcedures for Qualified Health Claims in the Labeling of Conventional HumanFood and Human Dietary Supplements," explains how applicants can seek aqualified health claim for food or dietary supplements during the first phase ofthis initiative. It also describes how FDA will set priorities for reviewingqualified health claims petitions most likely to have important public healthbenefits.

The second document, "Guidance: Interim Evidence-based Ranking Systemfor Scientific Data," describes a process for systematically evaluating andranking the scientific evidence for a qualified health claim. This rankingsystem will categorize the quality and strength of the scientific evidence. Forexample, grades of "B," "C" or "D" will be givento every proposed, qualified health claim.

The highest grade, "A," indicates significant scientific agreementabout the health claim. Evidence supporting said claim will be based onwell-designed studies conducted in a manner consistent with generally recognizedscientific procedures and principles. Such a claim requires no disclaimer and istherefore referred to as an "unqualified health claim." A currentexample of an "A" health claim, according to FDA, would be calcium'sbenefits for osteoporosis.

Health claims graded "B," "C" or "D" arereferred to as "qualified health claims"; they require a disclaimer orother qualifying language to ensure they do not mislead consumers. A"B" grade would be assigned to those petitions for which there is goodscientific evidence supporting the claim, but for which the evidence is notentirely conclusive. FDA reported claims such as omega-3s' link tocardiovascular health would fall under this heading. A "C" grade wouldapply to claims for which the evidence is limited and inconclusive, while a"D" grade would be given to claims with little scientific evidence tosupport them. More on the ranking system can be found on FDA's site (www.fda.gov/OHRMS/DOCKETS/98fr/03N-0069-gdl0001.pdf).

The agency intends to begin applying these interim guidances for health claimpetitions submitted on or after Sept. 1, 2003. Within 45 days of receipt of aqualified health claim petition, FDA intends to determine whether the petitionis complete; once it is, the agency intends to file the petition. FDA recognizesthat it can evaluate petitions more efficiently and effectively if they arewell-organized and contain all the relevant information. FDA encouragespotential petitioners to meet with the agency prior to preparing a petition todiscuss their plans.

FDA plans to prioritize claims on a case-by-case basis, factoring in whetherthe food or dietary supplement that is the subject of the petition is likely tohave a significant impact on a serious or life-threatening illness; the strengthof the evidence; whether consumer research has been provided to show the claimis not misleading; whether the substance of the claim has undergone an FDAsafety review (i.e., is an authorized food additive, has been self-affirmed GRAS[generally recognized as safe]); whether the substance that is the subject ofthe claim has been adequately characterized so that the relevance of availablestudies can be evaluated; whether the disease is defined and evaluated inaccordance with generally accepted criteria established by a recognized body ofqualified experts; and whether there is prior review of the evidence or theclaim by a recognized body of qualified experts.

Upon filing a petition, FDA intends to post the petition on its Web site andrequest public comment for 60 days.

After the comment period closes, FDA may pursue any one of several optionsfor scientific review of data submitted in a petition in support of thesubstance/disease relationship. FDA may conduct the review internally, it mayconvene an advisory subcommittee, or it may use appropriate third-partyreviewers under contract to FDA, such as the Agency for Healthcare Quality andResearch (AHRQ).

On or before day 270 after receipt of the filed petition, FDA plans to notifythe petitioner in a letter of: a) the agency's determination; b) the basis forits determination; and c) if the agency decides to consider exercisingenforcement discretion, the qualified claim for which the agency intends toconsider exercising such discretion and the provisions of 21 CFR 101.14 forwhich the agency intends to consider exercising such discretion. FDA also plansto notify the petitioner of any other factors the agency intends to consider indeciding whether to exercise enforcement discretion when the claim appears inlabeling of conventional human food or dietary supplements.

FDA is conducting further consumer research to make sure that the languageused is easily and accurately interpreted by consumers. FDA will also complete,and encourage other research groups to complete, a consumer studies researchagenda designed to improve understanding of the most effective way to presentscientifically based, truthful and non-misleading information to consumers--aswell as identify the kinds of information known to be misleading.

According to Joseph Levitt, director at FDA's Center for Food Safety andApplied Nutrition (CFSAN), "If companies do their own consumer researchdata, that would be one criteria that would help move them further along to thefront of the line."

In support of this new measure, FDA has refocused its Applied Nutritionprograms in its Center for Food Safety and Applied Nutrition, to provideadditional resources for, and senior staff involvement in, the "ConsumerHealth Information for Better Nutrition" initiative. For example, FDA hasestablished new policy expert positions in the Office of the Commissioner onnutrition, risk management and risk communication to assist in these appliednutrition activities. FDA is also establishing closer ties between its dietarysupplement program and the experts in its drug program who have extensiveprofessional knowledge of the medical risk factors for various diseases. Plus,FDA is enhancing its enforcement activities related to misleading claims aboutthe health benefits of products, particularly dietary supplements, that are notsupported by scientific evidence.

These moves are part of FDA's effort to implement the Pearson v. Shalalacourt decision that found FDA could not reject health claims unless the claimswere both misleading and that no disclaimer would clear the misunderstanding. In2002, the FDA was challenged by the judicial system for violating the protectionafforded to company claims proffered under the First Amendment. As a result, FDAissued a request for public comment in the May 16, 2002, Federal Register as towhat its boundaries should be for limiting commercial speech.

"This process is one that will allow us to get a handle on the recentseries of court losses related to the times FDA has said a claim cannot beallowed rather than letting it go forward with the appropriatequalification," McClellan said during the June 10 conference. "Theremay be things we learn from this process that we can relate tostructure/function claims. We'll see."

McClellan admitted it may be a long shot for a claim to get an "A"rating. "It's hard to get above a B claim and we haven't seen many claimscome in at that level in the last decade because the evidence standard is highand it's hard to do that level of research on food nutrition," McClellantold INSIDER. "However, that's why we think it's important to givepeople access to the information that's been developed by nutritional scienceover the past decade. If health claims are already out there, they'refine." Those health claims already established, such as soy for hearthealth and fiber for cholesterol levels, are already considered "A"claims, he added.

Industry Comment

Not since FDA's Good Manufacturing Practices (GMPs) came out in March hasthere been such a stir in the industry. For one, the Grocery Manufacturers ofAmerica (GMA)--reportedly the ones to propose this pre-market notificationsystem in May 2003--was pleased with FDA's actions. "The ability to usequalified health claims by the food industry will provide food manufacturerswith new incentives to develop and market new, healthier-for-you products,"said Alison Kreser, R.D., director of scientific and nutrition policy.

David Seckman, executive director of the National Nutritional FoodsAssociation (NNFA), found FDA to be moving in the right direction. "Theseprocedures will allow the manufacturer to provide more accurate and relevantinformation to consumers. That's a definite plus, both for the consumers and themanufacturers. FDA's health claim procedure clearly supports an industry likeours."

It still remains to be seen how the new health claim procedure will affectthe well-being of the industry. At the 12th Annual Conference of the FunctionalFoods for Health Program, held at the University of Chicago, Ill., Peter BartonHutt of the law firm Covington & Burling (www.cov.com),spoke at length on FDA's proposed health claim process. In particular, he mademention of FDA's wording for its grading system: "The Constitution does notsay that FDA can create its own dictionary."

Jonathan Emord of Emord Associates P.C. (www.emord.com),an industry-recognized expert in health claim petitions, saw this announcementas a "good thing." "The commissioner has made a bold move in theright direction to ensure American consumers get more and more accurateinformation about nutrients on disease," he said. "The FDA cancharacterize the relevant level of [a claim's] strength as scientists see it aslong as those characterizations are reasonable. The critical factor is thatpeople get more of this cutting-edge information about the effects of differentnutrients on disease. Some of it's well-established, some of it'spreliminary--but all of it should be available to the public to assess."