Labeling Functional Foods

On Aug. 20, 2003, FDA announced a five-part action plan entitled "Protecting and Advancing America's Health: A Strategic Plan for the 21st Century." The five plans include: a dedication to efficient, science-based risk management; enhancement of patient and consumer safety; better ways of informing consumers of their choices toward improved health; a dedication to counter-terrorism measures; and a strengthened FDA.

A large part of this plan, as directed toward food, was established earlier, in December 2002, with the launch of the "Consumer Health Information for Better Nutrition Initiative." This initiative called for the formation of a task force, and resulted in the FDA Task Force on Consumer Health Information for Better Nutrition, named on Jan. 16, 2003. The task force develops recommendations, enforces public-health laws and helps protect consumers against false and misleading dietary-supplement claims.

The task force was to report, within 6 months, how FDA should regulate "qualified" health claims on conventional foods, identify how health-claim petitions should be reviewed, and determine how best to present scientifically based information to consumers. The task force met eight times in a span of 6 months and delivered its final report on July 10, 2003. Part of the package delivered in this report was a guidance document detailing a review process for "qualified" health claims on food labels.

In an industry response, Alison Kretser, M.S., R.D., director, scientific and nutrition policy, Grocery Manufacturers of America, Inc., Washington, D.C., stated: "FDA's regulatory structure for approving qualified health claims will allow the food industry to get the newest health information on the food label and into the hands of the consumer. More importantly, the ability to use qualified health claims by the food industry will provide food manufacturers with new incentives to develop and market new healthier-for-you products."

The natural reaction of many who have not followed this process -- including some consumers and many food scientists -- might be to ask: "What is a qualified health claim and why is it qualified?" The best way to answer this is to review how the process began.

First, let's examine the kinds of claims that can be made on food and dietary-supplement labels. Under the Nutrition Labeling and Education Act of 1990 (NLEA), claims currently fall into three broad categories: health claims, structure/function claims and nutrient content claims.

Health claims describe a relationship between the food and a health-related condition or disease. The Dietary Supplement Health and Education Act of 1994 (DSHEA) created structure/ function claims for use on dietary supplements. FDA does not preapprove these claims. Responsibility for accuracy and truthfulness belongs to the manufacturers. Structure/function claims may describe how a dietary ingredient affects a structure or function in humans, or may describe general well-being from consumption of the ingredient. Examples are "antioxidants maintain cell integrity," "fiber maintains bowel regularity" and "calcium builds strong bones." Structure/function claims must also state that FDA has not evaluated the claim, and that the dietary supplement is not intended to "diagnose, treat, cure or prevent any disease." Although FDA does not require preapproval, the manufacturer must submit a label notification to FDA no later than 40 days after marketing the dietary supplement.

Foods and dietary supplements may also make nutrient content claims. These claims are usually limited to nutrients or dietary substances that have an established daily value, and they can only be made if a regulation is in place specifying criteria to meet the claim. (Choline regulations were recently added). The Food and Drug Administration Modernization Act of 1997 (FDAMA) gives guidance to allow for "authoritative statements" relative to nutrient content. These are approved claims for foods and dietary supplements. Current accepted claims relate whole-grain foods to reduced heart disease and certain cancers, and foods rich in potassium and low in sodium to a reduced risk of high blood pressure and stroke.

Another reason for the Consumer Health Information Initiative was a widespread concern regarding the truthfulness of structure/function claims (a second need was the pressure to address qualified health claims for foods). FDA, in a March 7, 2003 report, stated that they had received about "7,000 dietary-supplement-related voluntary adverse-event reports" since 1993. What was most striking was the number of events reported in the past 4 years: In 2002, there were 1,214 adverse-event reports; 2001 had 553, 2000 had 500 and 1999 had 528.

Not all of these were related to misbranding -- many of the others have resulted in a "Proposed Rule for Dietary Supplement Current Good Manufacturing Practices (cGMPs)," announced March 7, 2003.

So, what types of health claims can be made on conventional foods and dietary supplements? These health claims have, over time, become subdivided into three categories: NLEA-authorized claims (or "Unqualified Claims"), claims based on authoritative statements and qualified health claims.

The enactment of the NLEA in 1990 established the health-claim requirements for food labels. NLEA requires that the evidence supporting a health claim must be submitted to FDA, and this evidence must meet a standard of "significant scientific agreement." This must include agreement among experts in the field, supported by publicly available evidence. Twelve claims have been accepted under these standards. The most recent of these closely scrutinized claims relates to "soy protein and risk of coronary heart disease (CHD)," and "plant sterol/stanol esters and risk of coronary heart disease." An example of a claim for soy protein is: "25 grams of soy protein a day, as part of diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies ___ grams of soy protein." For stanol esters, the claim reads, "diets low in saturated fat and cholesterol that include two servings of foods that provide a daily total of at least 3.4 grams of plant stanol esters in two meals may reduce the risk of heart disease. A serving of [name of food] supplies ___ grams of plant stanol esters." Note that FDA attaches no qualifications or doubts about this relationship -- data exist to establish a "significant scientific agreement" that these statements are true.

With the enactment of FDAMA in 1997, FDA allowed for a second type of "unqualified" statement. If it can be established that there is an "authoritative statement" from a scientific body of the U.S. Government or the National Academy of Sciences regarding a nutrient and condition or disease relationship, a food label can carry this statement with FDA approval. As with unqualified claims, these may be used as long as established requirements are met. FDA has approved two of these "authoritative statements." For "whole-grain foods and risk of heart disease and certain cancers," the required statement is "diets rich in whole-grain foods and other plant foods and low in total fat, saturated fat, and cholesterol may reduce the risk of heart disease and some cancers." The second approved statement is (in foods with a good source of potassium and low in sodium, total fat, saturated fat and cholesterol), "diets containing foods that are a good source of potassium and that are low in sodium may reduce the risk of high blood pressure and stroke."

Many things have changed since 1990, the most significant (related to food) being the mounting concerns regarding the relationship of diet and health. Research has established links between diet and several leading causes of death, including coronary heart disease, cancer, stroke and type-2 diabetes. Consumers are looking for ways to control their diets through food selection, leading to a growing need for consumer education. These issues have, in turn, placed pressure on the health-claim requirement for "significant scientific agreement."

FDA's rejection of four proposed dietary-supplement health claims resulted in a lawsuit, Pearson and Shaw v. Shalala, in which the plaintiffs challenged FDA's rejection. Although the District Court found for FDA, the U.S. Court of Appeals for the D.C. Circuit reversed this decision in 1999. The health claims under dispute were: antioxidant vitamins and certain cancers; omega-3 fatty acids and (CHD); fiber and colorectal cancer; and dietary supplements as a superior source of folic acid for reducing the risk of neural- tube defects. The decision directed FDA to reconsider the claims, to clarify the "significant scientific agreement" standard used to authorize health claims, and to consider whether claims could be approved with appropriate disclaimers so that statements could be made on the label without meeting the standard, but still fall within a standard of being truthful and not misleading.

By the end of the year 2000, FDA had issued guidance to define its "significant scientific agreement" standard, and revoked its regulations denying the four health claims. In the course of further review, FDA denied the health claim for fiber and colorectal cancer and the claim for folic acid. Subsequently, FDA approved dietary-supplement (not foods) "qualified" claims for omega-3 fatty acids and CHD, and antioxidant vitamins and certain cancers.

These claims, in the course of being truthful and not misleading, also are relatively long: "The scientific evidence about whether omega-3 fatty acids may reduce the risk of coronary heart disease (CHD) is suggestive, not conclusive. Studies in the general population have looked at diets containing fish and it is not known whether diets or omega-3 fatty acids in fish may have a possible effect on a reduced risk of CHD. It is not known what effect omega-3 fatty acids may or may not have on risk of CHD in the general population."

FDA concluded that the weight of scientific evidence for the claim outweighed the evidence against the claim, and that products using the claim must limit the amounts of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) to no more than 2 grams per day. A petition was recently submitted for approval of a qualified health claim for omega-3 fatty acids in conventional foods as well. In the case of the antioxidant vitamins claim, this was further litigated in Whitaker v. Thompson in 2000. FDA had denied the claim, ruling that the evidence weighed more heavily against the relationship. On Dec. 26, 2002, the U.S. District Court for D.C. ruled that the claim was only "potentially misleading," and that FDA should permit the claim with a disclaimer. This has, in the end, created a system in which FDA will also consider the strength of evidence supporting a claim.

The Pearson decision was clearly a turning point in the use of health claims, both for dietary supplements and conventional foods. In December 1999, FDA announced its plan for use of qualified claims in dietary supplements, and in October 2000 stated that it would rely on enforcement discretion to provide for this type of claim. In December 2002, FDA announced that it intended to further apply the Pearson decision to conventional foods, allowing for qualified claims. This action resulted in the formation of the Task Force on Consumer Health Information for Better Nutrition mentioned at the beginning of this article. As stated earlier, this Task Force delivered its final report on July 10, 2003, and laid out an interim plan for the review of qualified health claims, with a start date of Sept. 1, 2003. FDA will continue to evaluate unqualified health claims under its regulatory standard for "significant scientific agreement," but will evaluate qualified claims under the interim procedures designed to be sensitive to the learnings of Pearson and Whitaker.

The influence of the Whitaker decision is prominent in the ranking system set out of rating scientific evidence. The language of the qualified health claim will be dictated by a ranking of "A", "B", "C" and "D" levels. The A level is the gold standard and is really the "significant scientific agreement" of an unqualified statement -- so it would never actually be used for a qualified statement. The petitioner would be informed that their claim, if it met the A-level conditions, would be an unqualified claim, and the approved statement would reflect that. The language of the other levels follows. Level B: "... Although there is scientific evidence supporting the claim, the evidence is not conclusive." Level C: "Some scientific evidence suggests...however, FDA has determined that this evidence is limited and not conclusive." Level D: "Very limited and preliminary scientific research suggests... FDA concludes that there is little scientific evidence supporting this claim."

This language is based on FDA experience enforcing dietary-supplement claims, and it may vary case-to-case. Part of the interim strategy involves consumer research on helpful wording of claims. An example of this wording is in the approved wording for selenium and certain cancers: "Selenium may reduce the risk of certain cancers. Some scientific evidence suggests that consumption of selenium may reduce the risk of certain forms of cancer. However, FDA has determined that this evidence is limited and not conclusive."

Another version might read: "Selenium may produce anticarcinogenic effects in the body. Some scientific evidence suggests that consumption of selenium may produce anticarcinogenic effects in the body. However, FDA has determined that this evidence is limited and not conclusive."

Based on the categories released in July, this would be a level C claim. It is anticipated that the Task Force's interim plan will run through June 1, 2004, at which time all of the consumer studies and evaluations should be complete. In addition to the health claims discussed up to this point, FDA has also allowed the use of "health messages" to communicate the benefits of eating 5-to-9 servings a day of fruits and vegetables for reducing the risk of some cancers and other chronic illnesses, and the benefits of replacing solid fats that are high in saturated and trans fats with vegetable oils containing unsaturated fats for reducing the risk of heart disease.

The goals of the Consumer Health Information for Better Nutrition Initiative were "to encourage the kind of marketplace where healthy foods can compete readily among all foods available," to encourage more responsible research, and to protect the consumer. Clearly, FDA has taken very deliberate, responsible steps toward accomplishing these goals.

Ronald C. Deis, Ph.D., is the vice president of applications development and technical service at SPI Polyols, Inc., New Castle, DE. Deis has 20 years of experience in the food industry, both in food ingredients (starches, polyols, high-potency sweeteners, bulking agents) and in consumer-product companies (cookies, crackers, soups, sauces). He has been a short-course speaker (polyols, fat replacers) and a freelance writer on a number of food-science-related subjects in food journals, and has contributed chapters on sweeteners and fat replacers for several books.