FDA Squashes Fish Tales

The newly appointed Food and Drug Administration commissioner, Dr. Mark McClellan, has a big job before him, not just in managing pharmaceutical regulation, which has earned a lot of attention lately, but in reforming food labels. In defiance of recent court decisions, the FDA still regulates food labels in a way that prevents most consumers from knowing the key benefits of better nutrition. Scientific news that eating fish oil can help you live longer proves the point.

Coronary heart disease (CHD), the cause of death of 700,000 Americans annually, falls markedly with increases in intake of omega-3 polyunsaturated fatty acids from oily fish such as salmon. One recent study indicates that women who ate fish five times per week had a risk of dying from CHD about 45 percent less than women who ate less than one fish meal per month. Another study reports that the omega-3 fatty acids from fish were strongly associated with a reduced risk of sudden death in men without evidence of prior heart disease. A third study shows that a randomly assigned dose of 1 gram per day of omega-3 fatty acids significantly reduced total mortality among heart attack survivors.

These studies, published earlier this year in authoritative scientific journals, confirm that it is safe and prudent to eat at least two servings of fish per week, while seeking an intake of omega-3 fatty acids of 1 gram per day.

The FDA is keeping all this diet-disease information off food labels, where it might do some good, but federal courts think food manufacturers have a right to let consumers know. In the recent Pearson vs. Thompson decision, the U.S. District Court for the District of Columbia ruled that the FDA may not constitutionally prohibit a health claim simply because it believes the supporting scientific literature is inconclusive. This decision complements the Supreme Court ruling in Thompson vs. Western Medical Center; it held that even assuming that the restriction on commercial speech directly advances an important government interest, the government can and should advance its interests by adopting restrictions less burdensome than a ban. Together, these decisions require that the FDA veer sharply from its current food-labeling policy. In a small step forward, the FDA took public comments in September about what the court decisions mean for food labels.

The case of omega-3 fatty acids shows that the FDA's prohibition of truthful and non-misleading label statements is keeping consumers from making informed decisions essential to good health.

First, the FDA bans statements like "high" or "rich" in omega-3, because it has not yet issued formal, legal definitions of these terms. While the FDA does allow statements about the absolute amount of omega-3 in a food--x milligrams per serving--why would a company bother changing labels to make such bland and uninformative statements?

Second, the FDA bans statements linking omega-3 to heart disease because it has not yet decided what description of such a link is supported by "significant scientific agreement." The FDA interprets this standard, adopted by Congress in 1990 in the ill-named Nutritional Labeling and Education Act, to mean substantial scientific certainty. The FDA asserts that it must issue a federal rule to approve mention of each specific nutrient-disease links in advance, a policy that guarantees labels are free from up-to-date information.

Third, the FDA prohibits manufacturers from making comparisons across different foods such as "When you grill, switch to salmon instead of steak to cut your intake of saturated fat and your risk of heart disease."

Consumers may well die waiting for the FDA to act.

The FDA should seize the opportunity granted it by the recent court rulings and immediately announce a safe harbor for statements about nutrients and health.

First, the FDA should legalize all labels that quote or paraphrase any diet-health links derived from peer-reviewed scientific research, such as publications in major medical journals.

Second, the FDA should explicitly authorize any relative claim that is based on reasonable scientific evidence. In the case of omega-3 fatty acids, existing studies are sufficient for companies to use "high" or "rich" in describing the omega-3 content of oily fish like salmon, herring and mackerel. Third, FDA should encourage any comparative claim, such as "higher in omega-3 than food x," provided that it is based on reasonably sound evidence, such as an assay of a sample of food x.

One pillar of the FDA's opposition to reform is an ill-founded fear that scientific information could be harmful to consumers if it is ultimately shown to be wrong. Yet, science is constantly changing--some results that are new today are overturned tomorrow. The public health implications of delaying the spread of new information far outweigh the cost of allowing it, even if it turns out to be invalid. No credible evidence suggests that much greater consumption of oily fish would hurt public health.

The other pillar is the FDA's paternalistic view that consumers misinterpret scientific information. The FDA ignores research confirming that consumers' understanding of nutrition increases when FDA's food regulations are less stringent. Better labeling rules will be a big step toward helping Americans live longer and healthier lives.

Consumers may have to be patient for sensible policies. The FDA is under new management but the new commissioner has years of bad decisions to reverse.

Randall Lutter is a resident scholar at AEI.

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