For those of you who are new to the VLUeM, the purpose of this e-memo is to update the Vitamin Lawyer and Vitamin Lawyer News web sites for my contacts and client list. You got on this e-list by opting in or becoming a client of the Vitamin Lawyer Consultancy. If you want to be taken off the list, please “reply” to this email with the word “remove” in the subject line. On the other hand, you are welcomed to forward this to your own elist… J
Here are the items I am covering in this e-memo:
1. Registration of Food Processing Facilities
2. Nanotech Coming to the Vitamin World – are you as ready as the FDA?
3. VLUeM Archives now online!!
1. Registration of Food Processing Facilities
Says FDA – “Domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register their facility with the FDA.” Among the foods included are that class of foods known as Dietary Supplements. See: http://www.cfsan.fda.gov/~furls/ovffreg.html
“Who must register? Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.” The web page states that this requirement applies to Dietary Supplements.
There are three simple steps on the web site to register:
“1. Verify that your computer system meets the minimum system requirements.
2. Create an Account for the online FDA Industry Systems.
3. Register or Update a Food Facility.”
If you do not do your own manufacturing, processing, packaging or holding, the company you contract with for those services needs to be registered. You should ask for that company’s registration information.
2. Nano Technology
Here are excerpts from a recent online report; note how innuendo and distortion are used to equate dangerous drugs that kill hundreds of thousands each year with generally safe food products [my comments in brackets]:
FDA not ‘nano-ready’, says report
By Clarisse Douaud
10/5/2006 - A former FDA deputy commissioner for policy has denounced the agency's capacity to properly regulate nanotechnology products including supplements, a criticism that could inflame debate leading up to the agency’s first major public meeting on the atomic technology.
In a report commissioned by the Woodrow Wilson Center's project on emerging nanotechnologies, University of Maryland School of Medicine professor Michael Taylor concluded the US Food & Drug Administration's resource base is severely eroded. This is despite what appears to be a recent nanotechnology policy kick-start at the FDA.
The report reveals regulatory weaknesses affecting new products, such as certain dietary supplements and cosmetics, using the technology. Critics say questions over nanotechnology safety have not been answered and the FDA is not in a position to effectively police it. . . .
Nanotechnology is the ability to control things at an atomic and molecular scale of between one and 100 nanometers and has been met with enthusiasm across a variety of industries. Critics highlight the murky area of how nanoparticles affect toxicity and say nanoparticles should be treated as new, potentially harmful materials and tested for safety accordingly.
[A word to the wise: Foods (which is what Dietary Supplements are, after all) are NOT TOXIC chemicals, like pharmaceutical drugs are, and there is no evidence that nano-sized particles of those same Foods are any different. After all, the body breaks the nutrients down to molecular particles in order to use them. The above statement by the “expert” follows the political line laid down by new world order entities such as Codex, the World Food Code control organization.] …
Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by FDA before use in consumer products.
Thus, as it stands, pre-market regulation of nanotechnology in dietary supplements does not fall under FDA's regulatory umbrella, nor – according to Taylor – can fit into the agency's budget. . . .
"Business and health leaders alike should join in ensuring that FDA has the scientific tools and knowledge it needs to say 'yes' to safe and effective new products," said Taylor.
[Note: the “safe and effective” standard is the Drug standard. By law and court decision, Dietary Supplement Foods need only be safe when used as directed. The government does not evaluate the efficacy of Foods, only consumers on the open market can do so.]
The market stands to benefit from nanotechnology and therefore, stands to lose a lot according to Taylor, if it is not thoroughly regulated.
[The above statement is only possible from a former government employee who has never heard about the self-regulating abilities of the marketplace and has purposely remained ignorant of the disasters of government regulation, which have led to millions of unnecessary deaths.] …
FDA's nanotechnology public meeting will take place October 10, 2006 in Bethesda, Maryland. …
“FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices…” states an online FDA notice for the upcoming meeting. ...
3. VLUeM Archives now online!
I’ve provided update memoranda to my regular clients for several years. I’ve now begun to create an Online Archives of the memos, working backward. So you can find everything you ever wanted to know about regulating the vitamin industry… sort of. See the Index at: http://tinyurl.com/rkneb. I would appreciate any feedback.