I took a look at the FTCs discussion of DSHEA: http://business.ftc.gov/documents/bus09-dietary-supplements-advertising-guide-industry
As I understand it, as long as colloidal silver discussion is very detailed, accurate, and discussed in adequate context, we can say everything we need to while still following the letter of the law. The document says: "The FDA has primary responsibility for claims on product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale." and it says: "The FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, and similar direct marketing materials. Marketing on the Internet is subject to regulation in the same fashion as promotions through any other media." What I get from this document as a whole is that the following approach might satisfy everyone: 1. Don't include any package inserts or make claims on labels or packaging. This "in theory" satisfies the FDA part of the picture. 2. Have all the marketing material you want on the website where product it sold - such as quotations from physicians, informal clinical studies, testimonials, etc, as long as you discuss it in a thorough enough context. Help consumers understand the problems with interpreting information, and how this or that is not undeniable proof of anything, but just information to be subjectively assessed while keeping XYZ in mind. I for one cannot really say that I have seen any vendor truly make a thorough enough attempt to adequately contextualize what can be be construed as medical claims by the FTC or the FDA. The way those FTC guidelines on DSHEA are written, it seems to me that as long as you put the necessary context, disclosures, disclaimers, or other balancing information, one could follow the letter of the law while still getting all the information across that you want to. I wonder if there really may exist a happy medium that frankly everyone has so far been missing? Though I guess that in the end, if the FDA wants to send you a letter, they will do so even if you follow the letter of the law... Part of the reason I am thinking more and more about these issues is that I am seriously starting to consider getting a certificate as a "clinical research associate" and just rolling up my sleeves and doing whatever it then takes to do clinical research on a number of things, starting with CS. To do clinical research that satisfies main stream journals can be mind boggling. But to do research that is meaningful to the average joe is not so hard. Such research could be cited by CS vendors as long as they put it in proper context (i.e. "this is not really proof...FDA does not recognize CS...there was no control group...this and that make it more difficult to draw conclustions,... etc). An example: imagine say 20 patients with say HIV just took a bunch of CS and their local docs supplied before and after blood tests showing improvements. Mainstream journals may laugh such a study off as being very inadequate for many reasons, but I think many of the more "natural medicine" type of journals would readily publish such research, and I think vendors and consumers would find it valuable. It could be cited on websites, as long as it is done tactfully. There are some other potential problems I see with researching CS that I am not sure what to make of: You need to file for "IND" (investigational new drug) approval if the supplement being studied is used in a diseased population. You don't need to file for an IND if a supplement is studied in a healthy population. But this makes it hard to show health benefits. That is a catch 22 if you ask me. So the trick is how to design a study that shows real health benefit, but looks like it does not need approval as an investigational drug, but remains a supplement. Some suggest you get a population that is not diseased, but "at-risk", and show benefits with them. Even then, if the FDA wants to say you've invented a drug and not a supplement, I guess they can anyway. So the next option is to just screw it and do a study anyway in a diseased population and not file for an IND. I don't know what the possible repercussions of that are though. But one site warns that this may help to get a supplement classified as a drug across an entire industry, thereby making things more difficult for others. But seeing as how there already is an FDA ruling on colloidal silver and that they say you can market it as a supplement as long as it is without medical claims, I doubt that is a problem. I get the feeling about clinical research is that probably a ton of published research don't follow all the rules and regulations down to a T, and no one checks, and even if someone checks, at most people become more incredulous about the results. Regardless, why does it have to be so complicated!? In the end, I feel that good people need to do whatever the they know really needs to be done, regardless of ignorant rules and regulations... David p.s. In the FDA final ruling, a physician leaves a comment about an informal study he performed on patients with prostate problems. That was new to me. -- The Silver List is a moderated forum for discussing Colloidal Silver. Rules and Instructions: http://www.silverlist.org Unsubscribe: <mailto:[email protected]?subject=unsubscribe> Archives: http://www.mail-archive.com/[email protected]/maillist.html Off-Topic discussions: <mailto:[email protected]> List Owner: Mike Devour <mailto:[email protected]>
