. The concern is that people might come to incorrect conclusions about the use of alcohol. BATF is also concerned that the two statements approved in February for wine labels will not provide the intended benefit to the consumer and might by misleading.
For the past twenty-five years the BATF has had exclusive control over the labels of alcoholic beverages. This brief analysis of some of the policy decisions of the BATF illustrate that the agency is heavily influenced by the industry, which it is supposed to control. On two occasions the BATF attempted to require ingredient labeling. And, on two occasions the BATF rescinded their proposal because of the cost that it would impose on the industry. The current shift in policy in favor of health claims labeling makes BATF subject to extreme scrutiny. The agency is trying to balance the industry interest with the consumer’s interest. Within the last ten years the industry influence has changed with the possibility of positive health benefits of moderate consumption. Now that health effects on labels may provide economic benefit, the industry is ready and willing to support this new policy. Once again BATF is attempting to balance these interests as evidenced by the statement that labeling can include positive health effects as long as it presents balanced information regarding the negative effects of alcohol consumption. The BATF does not have the experience or the neutral position to properly evaluate health claims for alcoholic beverages. It is therefore necessary to look to other approaches. The FDA currently evaluates health claims under the Nutrition Labeling and Education Act. This approach will be examined to determine its applicability to this issue.
B. The NLEA
In 1990 Congress passed the Nutrition Labeling and Education Act. The NLEA was revolutionary because for the first time the FDA was allowing health claims on food labels. Previously health claims could not be put on food labels because this type of statement would bring the food within the scope of the drug laws, which require much greater scrutiny. The NLEA was a response to consumer interests, changes in the marketplace, and advances in science. As the advances in science showed the connection between a healthy diet and decreased risk of disease, it was necessary for the FDA to recognize these links. Although the FDA did not issue any new regulations to address these issues in the 1980s, the FDA did relax its policies. Surprisingly, FDA did not take regulatory action against Kellogg’s All-Bran® when the label included a statement that fiber could reduce the risk of cancer. In 1990, Congress ended the ambiguousness of their 1980s policy by enacting the NLEA.
The NLEA allows health claims to appear on food labels. The health claim must be preapproved by the FDA through notice and comment rulemaking. In order to obtain approval for a health claim it was necessary to meet a very high scientific standard. The FDA will approve health claims if the totality of the publicly available scientific evidence indicates that there is significant scientific agreement among qualified experts that the claim is supported by scientific evidence. In addition, the food may be disqualified if it goes above the specified levels for fat, saturated fat, or sodium. The substance that is the subject of the health claim must be contained in the food at a minimum threshold level and have minimal nutritional value. Lastly, the health claim must identify factors besides the substance in a person’s diet that influence the diet-disease relationship.
From 1990-1994 the FDA used the NLEA in an effective manner by approving several health claims and assuring that no misleading claims appeared on food labels. The success of the NLEA was short lived, the Food and Drug Administration Modernization Act of 1997 (FDAMA) ended FDA’s authority to require approval of each and every health claim. Manufacturers may now make health claims based on an authoritative statement published by a scientific body of the United States government. The manufacturer mu