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FDA Will Allow More Health Claims on Food Labels

Date: Mar 01, 2003


When he became commissioner of the Food and Drug Administration (FDA) last November, Dr. Mark McClellan said one of his goals would be to give consumers more non-misleading health information.

He's wasting no time in fulfilling that promise. McClellan has established FDA's Consumer Health Information for Better Nutrition Initiative as the Agency's plan for "usher[ing] in a new era of consumer empowerment."

The initiative applies the same standards for making qualified health claims about conventional food products as for dietary supplements, putting the food industry on a level playing field with supplement manufacturers.

Guidance document explains all
FDA has just issued a guidance document that formalizes its policy on allowances for dietary supplement health claims in appropriate circumstances—and has expanded that policy to include conventional food health claims under the same circumstances.

Specifically, FDA has decided that it will allow a health claim that is not the subject of an authorizing regulation if:

    • The health claim is the subject of a petition that has been accepted by FDA.


    • Scientific evidence in support of the claim outweighs the scientific evidence against the claim, the claim is appropriately qualified and all statements in the claim are consistent with the weight of the scientific evidence.


    • Consumer health and safety are not threatened.


    • The claim meets the other general requirements set out in the regulations.

It is important to note that FDA is not waiving the petitioning requirements for health claims. Enforcement discretion will be provided only if:

    • a petition to authorize a health claim has been submitted;


    • the Agency has filed the petition; and


    • the Agency has completed its scientific evaluation of the claim and communicated that evaluation by letter to the petitioner.

If, under these circumstances, FDA agrees that such a health claim can be made (qualified or not), the Agency will propose a rule to authorize the health claim.

If, on the other hand, FDA determines that the statutory standard of significant scientific agreement has not been made, but that the scientific evidence in support of the claim, nonetheless, outweighs the scientific evidence against the claim, FDA will notify the petitioner that the Agency intends to "exercise enforcement discretion" (that is, allow) the health claim with appropriate qualifying language.

FDA hopes that this policy will give consumers additional, scientifically supported health information, while recognizing that, as scientific inquiry into the role of dietary factors in health proceeds, some qualified health claims may be fully substantiated - while others may be shown to be inaccurate. Thus, the Agency has decided that companies should be encouraged to publish information about food products that is not inherently misleading or deceptive, even though qualified health claims on food labeling may change over time.

Consumer interpretation
In assessing whether food labeling claims are misleading or deceptive, the Agency has decided that it will use a "reasonable consumer" standard. Use of such a standard - in place of one designed to protect, in the words of one court, "the ignorant, the unthinking and the credulous" consumer - will make FDA's regulation of dietary supplements and conventional food labeling consistent with the Federal Trade Commission's regulation of advertising for these products.

To better promote the initiative, FDA formed a task force to develop scientific guidance for establishing standards for qualified health claims in food. The task force is chaired by FDA deputy commissioner, Dr. Lester Crawford, and the vice chair is Joseph Levitt, the director of the Center for Food, Safety and Implied Nutrition. The new task force will craft regulations (to give the new policies legal force) and will conduct research on how consumers interpret label information.

The FDA plan received enthusiastic support from the chairman of the FTC, Timothy Muris. The chairman noted that "when food companies compete based upon the health effects of food products, companies will produce better products. Indeed, for almost 20 years, the FTC under five chairmen of both political parties, has vigorously supported truthful advertising in labeling because it can convey critical health information to consumers."

In conjunction with its announcement that it intended to ease up on qualified health claims for food products, Dr. McClellan also announced that the Agency will take a hard line on unauthorized, and false and deceptive claims for both food and dietary supplement products. FTC cooperation in this area is expected as well.

Several consumer groups have already lashed out at FDA for its position. However, it's likely to take an act of congress or a change in administrations to reverse the Agency's course.

Used with permission. Copyright FOOD & DRUG PACKAGING, March, 2003.

For further information about this article, please contact George G. Misko at 202-434-4170 or by e-mail at misko@khlaw.com.