Label health statements what TTB's new regulations really mean

Wines & Vines, Oct, 2003 by Elisabeth Holmgren

Winemakers and producers of all alcohol beverages may now put health statements or health-related directional labels on their bottles. However, such labels must be highly detailed or accompanied by certain disclaimers in addition to the existing onproduct warning label.

This reflects some of the major conclusions of a government regulation released earlier this year in an attempt to balance wine industry proposals with concerns by the public health and alcohol abuse prevention communities. In essence, this decision attempts to strike a balance between a prudent, nonmisleading health-related statement on alcohol and the requirement of commercial free speech. With this new, very restrictive regulation by the U.S. Treasury Department's Tax and Trade Bureau (TTB), scientifically truthful statements can be made if they are put into a proper context, informing about both the potential adverse effects of abuse as well as the health risks and benefits of moderate consumption.

Limitations For Labels

After an extensive review, on Feb. 28, 2003, TTB issued final regulations providing new limitations on health-related statements appearing on labels of alcoholic beverages. The text of the final regulation was published in the Federal Register Mar. 3. It provides detailed rules on health-related claims in advertising and labeling of alcoholic beverages and addresses for the first time regulations on directional labels. Those labels refer consumers of wine, beer or spirits to third party scientific information.

Specifically, one directional statement refers consumers to talk to their family doctor "about the health effects of wine enjoyment." Another advises the consumer to send for the government's official nutrition policy, the U.S. Dietary Guidelines for Americans, "to learn the health effects of moderate wine consumption." The physician's statement was initially proposed in the early '90s by the Coalition for Balance and Truth and has been especially advocated by Laurel Glen Vineyard. In the late '90s, Wine Institute (WI) spearheaded the dietary guidelines directional label proposal.

It is important to note that the dietary guidelines, which are published by the departments of Agriculture (USDA) and Health and Human Services (DHHS), include the pros and cons of moderate alcohol consumption. The alcohol guideline clearly cautions against any abuse and outlines who may want to abstain. At the same time, however, the guideline acknowledges coronary heart disease benefits for certain individuals, but explains the limitations and emphasizes that these benefits can also be obtained through other dietary and lifestyle factors. In sum, the guidelines are significant because they acknowledge the potential positive role of moderate consumption by those adults who choose to drink as part of a balanced diet. U.S. healthcare providers, including family physicians, often refer to this document when advising their patients on dietary issues.

TTB's Feb. 28 press statement underscores that any such directional label cannot be misleading, and therefore must be accompanied by a disclaimer in addition to the current on-product warning label. A model disclaimer is included, stating, "This statement should not encourage you to drink or to increase your alcohol consumption for health reasons." The new regulation also outlines how the TTB will consult with the Food and Drug Administration (FDA) with respect to any health claims in advertisements or labeling of alcoholic beverages. If the FDA determines that a specific health claim is a drug claim that is not in compliance with the Food, Drug and Cosmetic Act, a label would not be approved. In general, it explains how such statements must be backed up with medical evidence, disclose the health risks associated with moderate and heavy consumption, and outline categories of individuals for whom any consumption poses risks. It emphasizes that TTB's statement considers both the first amendment protections of commercial free speech and the need to prevent health-related references from leading to irresponsible consumption.

Historical Background

Since the early 1980s, health- and social issues-related labeling has been debated in different U.S. forums. Simultaneously, an antialcohol movement has been pervasive, reflected in many alcohol policy reports and deliberations. Governmental and policy organizations commonly lumped alcohol with tobacco and illegal drugs, often failing to distinguish between moderate use and abuse, and without acknowledging the emerging scientific evidence associating moderation with potential cardiovascular health advantages. Alcohol consumption of any kind was often referred to as risk-taking behavior with no redeeming health or social benefits. Proposals for sin taxes, advertising bans and other availability restrictions were common. Most significantly, the alcohol abuse prevention community and other advocacy groups spearheaded the 1988 mandatory on-product warning label/surgeon general's warning, mainly in an effort to reduce alcohol misuse and abuse problems. At the same time, the Bureau of Alcohol, Tobacco and Firearms (BATF) emphasized in various regulations that no health-related claims could be used in labeling and advertising.