For Better or Worse: New FDA Guidelines

By ACSH Staff — Aug 07, 2003
A trip to the supermarket should be a simple task, but nowadays it seems that you need a science degree to figure out which foods should be on your shopping list. Due to revised Food and Drug Administration (FDA) rules regarding health claims on products, it is about to become even more difficult. The new health claims will allow food packages to communicate possible health benefits as opposed to proven benefits. The new food label guidelines will allow scientifically supported health claims to be made on food packages, but this refers to scientific support of almost any strength.

A trip to the supermarket should be a simple task, but nowadays it seems that you need a science degree to figure out which foods should be on your shopping list. Due to revised Food and Drug Administration (FDA) rules regarding health claims on products, it is about to become even more difficult. The new health claims will allow food packages to communicate possible health benefits as opposed to proven benefits. The new food label guidelines will allow scientifically supported health claims to be made on food packages, but this refers to scientific support of almost any strength. Health claims will be graded "A" through "D" depending on the strength of the supporting research, but all the claims will allowed to appear on labels, and it is not yet clear whether the letter grades themselves will be printed on the labels or merely a matter of record at the FDA. The grading scale will make it easier for weak claims to slip through the system and appear on labels because of the disclaimer that will accompany them.

A grade of "A" indicates claims that have strong scientific support. These will include the claims that currently appear on food labels, such as "diets high in calcium may reduce the risk of osteoporosis." These claims are allowed under the Nutrition Labeling and Education Act (NLEA) of 1990. The new claims will be under the "B," "C," and "D" grades. A "B" grade will be granted when the science supporting the claim is good but inconclusive. A claim will receive a "C" when limited science supports a statement and a "D" when there is hardly any research backing the health claim. One may wonder why the FDA is allowing the "C" and "D" claims at all.

FDA commissioner Dr. Mark B. McClellan says that the new guidelines "will help people choose healthier diets." However, while claims that receive grades of "A" or "B" may help to foster consumer knowledge, the "C" and "D" claims can be quite confusing. The mere fact that the claims appear on labels may be enough to make some consumers assume they're valid. Furthermore, if a "C" or "D" claim is later proven to be false, consumers may lose faith in the system altogether. It is one thing to report preliminary evidence on the news, quite another to let food companies manufacture millions of labels with an FDA-graded preliminary health claim. According the Consumer Federation of America, pressure from food companies may have contributed to the new laws because the companies wanted the same loose regulations as dietary supplements, also overseen by the FDA.

Although claims will have a built-in disclaimer, the FDA has not yet ruled on whether the letter grade will be printed on the food label. If the letter grade does not appear, consumers may be more confused than they were without the claims. Consumers will then simply find a health claim followed by a disclaimer that there is insignificant research to fully support this statement quite confusing given that any claim has some appearance of credibility once approved by the FDA and that not all consumers will understand the subtle difference between "hardly any science" and "limited science." The FDA will come to a decision about whether to put the letter grades on packages after a consumer research panel and public comment period. The visible grades might help discourage dubious claims: many companies may not want a "C" or "D" claim on the label if they are required to print the actual grade. There might also be increased competition to create foods healthful enough to earn "A" and "B" grades though consumers should worry more about having diets that are balanced overall than about adding one grade-"A" healthful item to an otherwise inadequate diet.

This increased attention to health claims is fitting in an increasingly health-conscious society. As FDA Commissioner McClellan stated at a recent conference, "a well-informed public is one of our best weapons against some of the biggest health threats facing the country." In an ideal world health claims foster informed decisions and consumer involvement, but many health claims are unwarranted, some potentially harmful. Public health experts will be watching closely to see whether the new, more relaxed FDA labeling guidelines aid consumers or merely leave them even more confused than before.

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