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U.S. Food Labelling Regulations vs. Freedom of Speech – Creation of “Qualified Health Claims”

Monika Jankowska


Until 2000, the U.S. federal regulations required that a health claim had to meet the “significant scientific agreement” (SSA) standard to be authorized by the FDA for use in food labelling. However, the commercial speech doctrine, derived from a general principle of freedom of expression, provided grounds for challenging these regulations, which led to creation of a new type of health claims used in food labelling – qualified health claims. This article begins with a presentation of the commercial speech doctrine. Further, it summarizes the U.S. regulations concerning the use of health claims in food labelling. Then, it describes how the application of the commercial speech doctrine changed the health-claims authorization system in the U.S.A. and shows some results of this process.

Monika Jankowska holds Master of Laws degree from the University of Warsaw, currently she is a Trainee Legal Advisor at the Regional Bar of Legal Advisors in Warsaw.

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