Commercial Venom Production

[SCReptiles]

Several months ago, a debate on the legalities of venom production took place on the forums of veomousreptiles.org. I made the statement that I had no moral problem with producing venoms to be used in research. I was scolding by a renowned venom producer, who made the claim all venom production falls under the guidelines of the FDA, thus all venom producers must be up to FDA venom producing code. Based on direct correspondence with FDA officials, I have discovered that is not the case. According to the official I have spoken with, the FDA has no jurisdiction on venom unless it is to be used as the component of a medicine or being used directly as a medicine. Venom for educational purposes or animal and/or cellular research projects is not governed by the FDA. As he explained it to me, salt and water are not governed by the FDA, however, warm saltwater used to treat a sore throat would technically fall under their jurisdiction. Venom is its raw state is not governed by the FDA, however, venom used as treatment for a human disease or used in research on humans, would be governed by the FDA. I did not have his permission to post our emails, so I will not. Anyone wishing to see it, write me and I will forward you a copy. Thank you. Chuck@SCReptiles.com

[BWSmith]

The only problem I have with private keepers extracting venom is that it is primarily uneccesary. Most of the ones that I have talked to that have milked, did it for no real reason. Usually just to "See if they could" or to "practice". It is so stressfull on the animal and dangerous to the animal and handler. But if a researcher approaches a keeper and asks for a sample for research, then (IF the handler is qualified, BIF IF), I actually think that it is our responsibility to provide it or recommend someone who can. This is not to say that keepers should milk and freeze "just in case". Most cannot properly prepare or store venom. Also, I do not think that they should go looking for researchers just so they can milk.

I don't know if that made any sense. Basically, in my mind, if a researcher or the like asks for a sample, I would provide it according to their stipulations. Otherwise, there is really no excuse to milk.

I need more coffee.

[BWSmith]

The way I understand the laws, a keeper can basically give it away to a researcher who is in developmental stages of research, but can not sell the venom because it would then be considered a controlled substance. I could be wrong though.

[SCReptiles]

It is perfectly legal to sell, so long as you have the proper paper work for the business end. The FDA has no baring on the sell of raw venom, unless it is being used to produce medicine, being used as a medicine, or being tested on human subjects, however, to be perfectly within the law, you would still need to claim the money as income, so you would need to be legal on that end.

[BWSmith]

I am curious how venom is catagorized on a state level.

[SCReptiles]

GA has no statutes concerning raw venom. That is the only state I have checked with.

[cobraman]

The way I understand the laws, a keeper can basically give it away to a researcher who is in developmental stages of research, but can not sell the venom because it would then be considered a controlled substance. I could be wrong though.

Brian, this is not correct. I never had any involvement with FDA or any other agency when I was involved in mid-scale venom production. I only sold to a few colleges and research centers, but if I did sell to clients that were using the venom for meds, FDA could then enter the picture. The med manufacturing labs are far more strict than FDA.

[BoidKeeper]

Is the FDA involved in the milking co-ops in India? I wouldn't think so it's probably only monitored by the Indian goverment. My point is the venom collected in these facilities are used to make anti-venom which is a med and these co-ops are not exactly hygenic labs. So what sorts of guide lines would the FDA place on a private keeper who wanted to sell their venom to be used for anti-venom or to be used to creat drugs?
Cheers,
Trevor

[cobraman]

FDA can only govern USA meds. That is why we have to have a BB-IND permit to have antivenoms from other countries. Antivenoms produced in other countries are not recognized as approved meds in the U.S., rather they are considered experimental drugs. Everytime exotic antivenoms are used we have to submit a report to FDA on the use of it, and eventually FDA approves it as a recognized med. FDA does not get involved in the actual venom production, but does work with the antivenom labs that make the antivenoms. Hope this helps.