Health Claims and Food Labels

What's a doctor to do when: a patient asks about the value of oat bran in a diet? which TV dinner is best? what does the American Heart Association's label mean? how do I know if I'm eating the right foods? The FDA is formulating some guidelines and they're asking for your input to avoid deceptive advertising.

In an attempt to limit the potential for false and misleading statements, the federal Food and Drug Administration is proposing sweeping changes to its policy on health claims on food labels.

Although the government has only been involved in regulating public health messages on food labels since 1987, many have contended that the 1987 regulations are vague, unenforceable and actually could sanction a whole new wave of deceptive advertising.

At this stage, it appears that the FDA will follow the recommendations of the Surgeon General that the agency direct its attention and resources these areas:

• Calcium and osteoporosis;
• Sodium and hypertension;
• Lipids and cardiovascular disease;
• Cancer;
• Dietary fiber and cardiovascular disease.

Although these regulations are still in the proposal stages, it is the FDA's intent to regard undocumented claims outside of the areas as likely to be misleading and at greatest risk for sanctions.

The death of 1987 regulations may have resulted from their simplicity. The only request is that health-related statements on foods and dietary supplements should be:

• Truthful and not misleading,
• Based on valid, reliable scientific data,
• Consistent with a sound total diet, and
• Accompanied by full-nutrition labeling on the product.

According to officials at the FDA, the regulations were so broad that some manufacturers had taken advantage of the uncertainties by making what amounted to drug claims on health food products. As a result, the FDA has completely withdrawn the 1987 proposed regulations.

The FDA historically has viewed products which convey messages relating to disease processes as drug. Drug manufacturers, of course, must verify and prove not only the safety but the effectiveness of the product. Although the FDA has attempted to support the health and fitness craze, allowing health messages on product labeling, it has labored with the apprehension that these very labels may be encouraging large numbers of people to forego regular medical treat. Therefore, the FDA has attempted to re-define the demarcation between food and drugs which many believe was obliterated by the 1987 product regulations.

Under the newly proposed regulations, manufacturers may place health messages on food if:

1. The label statement is truthful and not misleading, by either omitting significant information or generally leaving a misleading impression.
    
2. The label statement is limited to describing the value that ingestion (or reduced ingestion) of a dietary component, part of a total dietary pattern, may have in either lowering the risk or forestalling the premature onset of a chronic disease condition. The statement must be supported by a sound body of scientific evidence upon which a significant agreement exists among qualified experts as to the relationship between dietary component and the reduction of risk.
    
3. The label statement is consistent with generally recognized medical and nutritional principles for a sound total dietary pattern.
    
4. The label statement is based on and consistent with the conclusions set forth in an applicable scientific summary and consumer health message summary.
    
5. The label statement includes a reference to the applicable consumer health message summary.
    
6. The food is labeled with complete information on the nutritional characteristics to allow an individual to determine whether or not the food is compatible with that person's individual dietary needs and goals.

The scientific summary referred to above is one of four avenues the FDA is proposing to regulate these health messages. The other two are consumer health message summaries and model label statements.

The FDA hopes that the scientific summaries will focus on the safety concerns of high levels of consumption, optimum levels of consumption, and significant sources of the food component. Although the FDA is currently focused on six very specific areas of health-related claims, it is seeking comment on other chronic disease relationships and whether health messages are appropriate.

The second vehicle proposed by the FDA to regulate the content of labeling are consumer health message summaries. In response to public comment that consumer education is integral to dissemination of proper dietary recommendations, the FDA believes that this supporting scientific information on the correlation between the disease process and a specific diet should be set out in language that a layman can understand.

The FDA hopes to develop a consumer health message summary for each diet and chronic-disease relationship, and it also seeks comments on how these messages would be best developed. The summaries, themselves, are designed to be a supplement to the information included on the food labels and are designed to alleviate what the FDA sees as a potential information overload on the label.

The FDA also is proposing a non-voluntary model label statement based upon and supported by the scientific summary. Although it is currently proposed that the model label statement be voluntary, it is intended that the model set out the minimum material facts required in the label statement so as not to be misleading. As such, it is proposed that the model label include:

1. A brief capsulized statement of the relevant conclusions of the appropriate scientific summary.
    
2. A statement of the extent to which the food product contains or does not contain the key food component.
    
3. A reference that more information is available on the consumer health message summary and how the summary may be obtained.
    
4. A statement directing the consumer's attention to the nutrition label for further information.

The fourth and final element in the FDA's revamped food labeling proposals is a consumer guide that would generally discuss how the health message summaries and label statements were developed, what they mean, and how it can all be used to assist one in sound dietary practices. The FDA has proposed that if and when a final rule on health food labeling is published, a one-year grace period be allowed for implementation.

At this stage, all of this is merely a proposal. The FDA will continue to evaluate health messages on a case-by-case basis pending final ruling. Written comments will be received until April 16, 1990, and can be addressed to the Dockets Management Branch [HFA305], Food and Drug Administration, Room 4-62, 5600 Fishers Lane, Rockville, MD 20857, telephone (301) 443-4874.