2 replies to this topic

[James Phillip Turpin]

My understanding is that to market a new supplement as a supplement in the USA, FDA requires evidence of safety. Rather than concentrating on proving claims of bennefits, perhaps those interested in marketting it should concentrate first on providing evidence of safety. Perhaps that can already by done from existing science and anecdotal reports. (I would like economics of scale to drop the price.)

[niner]

My understanding is that to market a new supplement as a supplement in the USA, FDA requires evidence of safety. Rather than concentrating on proving claims of bennefits, perhaps those interested in marketting it should concentrate first on providing evidence of safety. Perhaps that can already by done from existing science and anecdotal reports. (I would like economics of scale to drop the price.)

The FDA doesn't require proof of safety for supplements, only for drugs. Considering that you can make a three year supply of c60-oo for a total expenditure of about $150, it's already extremely inexpensive, for what you get. If you buy it pre-made from one of the vendors, then it is more expensive, but even then it's not too bad compared to higher-end supplements.

[Turnbuckle]

This is the typical warning language in FDA letters to makers of supplements--

Under 21 U.S.C. 350b, a dietary supplement that contains a new dietary ingredient (i.e., a dietary ingredient not marketed in the United States before October 15, 1994) shall be deemed adulterated under 21 U.S.C. 342(f) unless it meets one of two requirements:

1. The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or

2. There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

Thus the people selling C60 in EVOO are not selling it as a supplement. I don't see how the FDA would be so easily fooled, but I doubt that they will be much interested unless the market gets somewhat bigger or some user is injured. The maker is supposed to inform the FDA of any such reports, but I'm not sure if they have to if they aren't selling it as a supplement. Plenty of DMSO gets sold this way.

Edited by Turnbuckle, 04 February 2013 - 01:28 PM.