Food manufacturers were picking bones with the FDA even before they sent their official comments to the agency on its major proposal for food labeling law changes. The National Food Processors Assn.'s (NFPA) ire focuses on the December 21, 1995, proposed rule, which included a number of key industry-sought reforms of the Nutrition Labeling and Education Act (NLEA). In that proposal, the Food & Drug Administration requested specific data on how consumers would react to "split" health claims, abbreviated health claims and the use of synonyms, all of which were proposed by the FDA. The FDA asked for consumer research data from industry by March 21, 1996, the end of the public comment period. The industry argued that there is no way they could produce that data in 90 days, and asked for an extension of the March deadline. NFPA also cited a second reason that will be covered later. As this is being written, the FDA has made no decision on an extension. Regina Hildwine, director of technical and regulatory affairs for the NFPA, says, "There is some research around that is relevant. But we want to let consumers look at exactly the language and format the FDA is proposing." Hildwine adds that a second problem has to do with an FDA prohibition on foods being labeled "healthy" because they do not contain at least 10% of at least one of six specified nutrients. The FDA proposal on December 21 exempts fruits, vegetables and enriched grain products from that rule. But another FDA proposed rule released on February 12, 1996, dealing narrowly with the use of the term "healthy," proposes an exemption that does not square with the December 21 proposal's version, according to Hildwine. The comment deadline for that proposal is April 29, 1996. "The FDA is not under any statutory deadline," she explains. "We'd like to see them extend the comment period for both proposed rules until July." This late-breaking brushfire does not change the NFPA's generally enthusiastic reaction to many elements of the FDA's December 21 proposal. "The proposal is an excellent example of needed reform brought about by the Agency itself in an expeditious manner, in response to an industry problem," says Hildwine. "But the devil is in the details, as they say, and the details of the proposal leave much to be desired." The December 21 proposal makes changes in final rules issued by the FDA in January 1993 implementing the NLEA passed by Congress in 1990. Those rules set out guidelines for making eight health claims and for use of terms such as "low-fat" and "low-cholesterol." Many companies have argued that it is too difficult to meet the test for making claims, and even when a product meets all the criteria, the claim is pretty anemic, or qualified. Rob Longendyke, a spokesman for the Pillsbury Co., says the current restrictions on health claims makes using them "not very desirable." Green Giant, the Pillsbury vegetable line, makes a cancer claim in the nutrition panel on the back of some of its labels. It is buried more than ballyhooed. "The language is so careful we have found it does not have much of an impact on the consumer," explains Longendyke. One way the FDA wants to broaden the use of health claims is to allow fruits, vegetables and bread to be able to make a health claim even though current law requires them to have at least 10% or more of the Daily Value (DV) of one of the following: vitamin A, vitamin C, iron, calcium, protein or fiber. Bread, for example, is barred by the FDA's standards of identity from containing any of those six ingredients. However, the FDA does not plan to relax the 10% requirement for fruits and vegetables with added oils, sodium, syrups or other ingredients. Unwrapping bread, vegetables The lifting of the 10% requirement will help Pillsbury's Green Giant-brand vegetable products. Longendyke, says most of the Green Giant vegetable products come without sauces or additives. Some already make health claims. Others do not because their serving sizes are too small to meet the 10% requirement for one of the six nutrients. But products in that latter category would be able to make health claims if the FDA proposal becomes final. "The FDA proposal would be good news for us," notes Longendyke. Green Giant's Create a Meal! brand products could not make a health claim, though. Those products contain individual packets of sauce and vegetables which are mixed in a skillet. That line accounts for relatively small sales, but is growing faster than the non-sauced vegetable products, admits Longendyke. Lee Sanders, director of legislative and regulatory affairs for the American Bakers Assn., says her group is very happy with the tentative decision to allow bread to make health claims. "We think that is good," she adds, noting that issue was at the top of the ABA's wish list. While she notes the FDA did not address every element in the ABA's petition, she says, "For the most part, we are very pleased with the their solutions to the elements they did address." Not only would more products be able to make health claims, but the wording of those claims would be shortened. Currently, the FDA requires claims for each of the seven diet/disease relationships to contain certain bits of information. The FDA also provides a "model" claim for each of the seven, but their use is not mandatory. Now the FDA wants to move some of those "information elements" from the mandatory to the optional category. In the past, the health claim for dietary lipids and cancer had to make reference to the fact that cancer depends on many factors and one or more of a specified list of "risk factors" had to be mentioned. The revised claim could just allude to the fact that dietary fat consumption is not the only risk factor for cancer. The FDA would also allow abbreviated health claims on the principal display panel on the label. They have been barred to date. There would have to be a "prominent" reference next to the abbreviated claim directing the consumer to the full text of the claim elsewhere on the label. Backpedaling The FDA also seems willing to backpedal on its policy of prohibiting health claims if a product contains a "disqualifying level" of total fat, saturated fat, cholesterol or sodium. Food manufacturers have vilified this as the "jelly bean" rule. The disqualifying levels are typically 20% of the Daily Value, which translates to 13 grams of total fat, 4 grams of saturated fat, 60 milligrams of cholesterol and 480 milligrams of sodium. If companies are over the limit on any of these four substances, they can petition the FDA to allow a health claim, but no such petitions have ever been filed. The NFPA wanted to transform the disqualifying level into a disclosure level. If a food had over 13 grams of fat, for example, the company would have to note that on the label, but it could still make a cancer health claim, for example (but not a heart claim). A product could not make a "good for the heart claim" based on fiber content if the product contained too much sodium. The FDA wants to set out some guidelines that would allow it to approve some, but probably not many, disclosure levels. One might be where there is a "significant" public health problem, and a food that might otherwise be disqualified has a "critical" role to play in addressing the problem. Another might be where the application of the health claim is so limited because of the disqualification levels, and there is a threat to public health as a result. Synonym for confusion? Another of FDA's proposed changes deals with "synonyms" for expressed nutrient content claims. The idea is to allow synonyms that have not been approved if they are in effect "anchored" to authorized terms. The FDA approved and defined numerous nutrient-content claims in 1993. The term "low-fat" has a number of synonyms; "not much fat" is not among them. But companies who wanted to use "not much fat" on their label could petition the FDA and Campbell says, "It would be a good candidate." The synonym cannot "confuse or mislead" consumers, and it must be clear and unambiguous. Not only must the term be clear semantically, it must be clearly visible, which is to say occupying a prominent and conspicuous position on the product label. That means the approved nutrient claim must appear adjacent to the largest type-size listing of the synonym on the label, and it must be at least half the "prominence" of the synonym. The FDA will measure compliance with that requirement based on type size, style, and color. Whether these proposed changes--which in some cases, such as synonyms, have at least the potential to further obfuscate label language--help consumers is another question entirely. They are having a hard time untangling label language now. The 1995 "Shopping for Health" survey from the Food Marketing Institute provides evidence that label confusion has caused unhappiness. When the sample of 1궛 persons was asked whether too many foods claimed to be healthy, 44% "strongly" agreed and 32% "mostly" agreed. The FDA's Campbell admits, "There needs to be more consumer confidence in the claims." But she adds that the public is beginning to believe the claims are reliable, and that the NLEA requirements have only been in effect for about 18 months. c
