The staff of the Federal Trade Commission thinks claims made in the advertising of over-the-counter drugs must be appproved by the federal government in the same way the labels on those drugs are now regulated.
In a 309-page report released yesterday, the staff also asked for a ban on "indication-for-use" claims in advertising, the same type of claims that the Food & Drug Administration now bans from labels.
The Proprietary Association, representing companies that make nonprescription drugs, said the FTC proposal represents "an unconstitutional prior restraint on advertising and on the right of free speech."
"Consistency between labeling and advertising is especially important concerning the indications for use of OTC drugs," the FTC staff said.
"This is true for several reasons," the report added. "First, the indication-for-use claim is the major reason a consumer would buy the product. Second, drug effectiveness is difficult for the consumer to evaluate. Finally, the product in question is taken into the body so that its use involves a health and safety risk as well as an economic risk."
The FTC staff said an estimated 75 percent of the population of the U.S. has at least one medical complaint each year. Of those who do, 65 percent use OTC drugs for such ailments as colds or stomach disorders, spending an estimated $3.8 billion for them.
Advertising for such OTC drugs is "especially intensive," the commission staff said.
The staff added that "it is not uncommon for advertisements to make different indication-for-use claims than those which the FDA or its panels would allow in labeling."
For example, the staff said, while label claims cannot directly link OTC products to curing the common cold, "there are numerous advertisements on the record which suggest that products do offer relief from 'colds.'"
Also cited were laxative advertisements for products claiming to be effective against "irregularity," despite the fact that the FDA disapproves of that term.
Staff concern was expressed over what it perceived to be "overly broad" advertising claims, using terms such as "upset stomach," which the staff said "can mean anything from acid indigestion to cramps, nausea and diarrhea."
Consumers relay heavily on advertising claims over what products can do, the staff contended, revealing one study of 1,321 people who were asked where they got information on OTC drugs they purchased.
"Forty-three percent said advertising," the FTC staff noted, "compared to only 13 percent who said labeling."
The staff report and a report of the hearing officer who heard a month of hearing on the subject will be open to public comment for 60 days.
After that, the commission will decide whether to promulgate a rule.