Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -212

Accepted - Volume 4

Comment Record
Commentor Mr. Christopher Torres Date/Time 2002-07-26 10:30:26
Organization Mr. Christopher Torres
Category Individual

Comments for FDA General
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Disclaimers should be in the same size print as claims. Unfortunately, we now live in a society that is headline oriented. No one understands this phenomenon better than the media. People do not read the text of newspaper stories, so they definaitely will not read the fine print disclaimer. traditional medicines are almost always potentially harmful in one way or another, and consumers should have ready access to possible shortcomings and contraindications. It is unfortunate that this is the case, but it is the current state of affairs in our country
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Statistical anlysis is the mnost effective. The style of warnings where X% of users experienced the following side effects gets peoples attention. It comes down to pure marketing...both pro and con.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? Claims in advertisements and claims on labels should be the same! Consistency is paramount.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? The off-label usage issue needs to address safety. If a drug has potential contraindications those need to be stated clearly. i believe lethal dose should be addressed. In the case of natural supplements that have no contraindication and no lethal dosage, a vendor should be able to mention any and all product successes.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? There are many ways FDA could advance public safety without infringing on free speech. The first that comes to mind is to level the playing field between traditional drugs (syntehsized) and natural supplements. This will create competition for the drug comapnies and force them to be more forthcoming with information in order to maintain market share. They currently have a monopoly for the treatment of symptoms of various diseases, which means they don't have to disclose everything. If highly effective supplements had the same rights as drugs, the consumer would become more educated which ultimately drives change in the supply chain. Competition works!!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Allow natural supplement manufacturers to share success stories with the gemneral population.

EC -212