Q&A on the FDA Request for Comment on First Amendment and Commercial Speech Issues

What is the FDA's Request for Comment?

When are comments due?

How do I submit comments?

What should I say in my comments?

How should I present my comments?

What is the existing law with regard to commercial speech?

Why shouldn't commercial speech have strong constitutional protections?

Relevant FDA Notices and Related Material

Relevant FDA Notices and Related Material

Suggestions for Submitting Comments

On corporate constitutional rights and commercial speech

On Direct-to-Consumer pharmaceutical advertising

On Tobacco advertising

Background Infromation

Corporate Constitutional Rights and Commercial Speech

Direct-to-Consumer Pharmaceutical Advertising


If you want to comment on tobacco advertising, you might want to say:

* While the FDA does not currently have jurisdiction over tobacco, there are numerous initiatives to give the agency such jurisdiction -- including some legislative proposals favored by the tobacco industry -- and good reason to expect Congress will confer jurisdiction in the near future. FDA should consider the issue of tobacco advertising in determining its posture on commercial speech issues.

* There is an abundance of evidence that tobacco advertising has extremely harmful consequences, leading to increased smoking rates, especially among youth.

* Studies have found that:

- advertising campaigns using universal themes -- not just those obviously directed at youth -- are effective at luring youth into smoking;

- the same advertising that encourages or discourages brand switching is also effective at convincing new smokers to start;

- even very young children have enormous recall of cigarette brands and advertising, thanks to industry marketing efforts;

- internal industry documents show Big Tobacco acutely aware of the importance of advertising and marketing in seducing new smokers.

* Appropriate public health policy would involve a complete prohibition on tobacco advertising and marketing. Lesser measures might include various bans on restrictions on particular types of advertising most likely to reach kids. There are significant public health benefits to be obtained from restrictions on advertising that could probably not be justified on the grounds that they are untruthful or misleading.

* Moreover, there is a wide array of desirable tobacco control measures (such as cigarette tax increases). If every advertising restriction must show it is the least-speech-restrictive means to lessen smoking, a court could argue that one or another of these alternatives should be used in place of restrictions on advertising. It is thus crucial that FDA work to advance a constitutional jurisprudence that is less protective of marketing.

* There is wide international support for advertising bans -- or at least severe advertising restrictions -- based on overwhelming evidence of the public health benefits from outlawing tobacco advertising.

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