This is a post from a group which discusses micro-electric therapies and devices. It is a warning to group members concerning the language they use when discussing their uses of micro-current therapies, and devices. I learned a lot from it, as I have often wondered what on earth was meant when an article claimed that a supplement "supported" a health function or disease system. I begin to understand.
-------------------------
The FDA has some rather stringent, even though ridiculous, laws that, because of what you
SAY, will allow them to come into your house, or place of business with guns and haul you
off to jail. They can legally confiscate your computers, office papers, bank accounts,
houses and cars. Literally! I am not joking and neither is the FDA. I have been a part of
a complementary medicine field called glyconutrients for several years, and I am constantly
lectured by the legal staff of that company of what we can and cannot say about a product or
device that has not been evaluated by the FDA for efficacy. You can NEVER make a medical
claim for anything that is not a pharmaceutical chemical and which if consumed at some level
can kill you.
The bad thing is that because the products I take and educate people about are nutrition,
they can NEVER be evaluated by the Food and Drug Administration. In order to be evaluated
by the FDA the product MUST be able to kill 50% and 100% of test animals. If it is non
toxic, the FDA will not even look at it. They don't even want to bother with Godzilla,
Rife, or Beck devices, even though other country's version of FDA can evaluate those.
If you thought that since you are in the USA that you could tell the truth, you are
extremely wrong. The bill of rights freedom of speech does not include things that the FDA
has determined are not legal to "SAY". Sad but true.
There are several words you cannot say about any product that contributes to ones state of
health.
Unless you are a medical doctor and you comply with the FDA line, you cannot say the words
Cure, mitigate, ameliorate, when it comes to any disease that has been given a name. In
most cases you may not say health, but you can say wellness. When dealing with alternative
or complimentary medical things you cannot say the word disease in most cases. You also
cannot say health condition but you may say health concern.
You can say someone got well or got "results" but you cannot say they were cured or that
such and such disease "went away." You may address overall state of health, but you cannot
say something made you healthy. When I find the rest of these regulations, perhaps I can
post them as a file. They are extensive and the penalties of breaking them are severe.
The bad thing is that because the products I take and educate people about are nutrition, they can NEVER be evaluated by the Food and Drug Administration. In order to be evaluated by the FDA the product MUST be able to kill 50% and 100% of test animals. If it is non toxic, the FDA will not even look at it. They don't even want to bother with Godzilla, Rife, or Beck devices, even though other country's version of FDA can evaluate those.
Excuse my bluntness, but these statements are simply not true.
"Request for Qualified Health Claim status" for non-pharmaceutical "products"--including food (nutrition)--can be pursued through this process.
Until 20 years ago, FDA was ill-equipped to protect Americans from dangerous or useless medical devices, because the agency had to prove a device was unsafe or ineffective before it could take action to remove the device from the market. In 1976, the landmark Medical Device Amendments were signed into law by President Gerald Ford. The law requires manufacturers of most medical devices--particularly moderate- or high-risk devices--to provide FDA with safety and effectiveness data before marketing.
FDA's Center for Devices and Radiological Health is charged with implementing the device law. The center has many functions, including working with FDA's field force to inspect device manufacturing plants; keeping track of problems with devices already in use and taking prompt action to correct them; and helping manufacturers produce better products by conducting laboratory research on the ways companies test their products and on specific device safety problems.
One of the most visible and important functions of the center is to review devices for safety and effectiveness before they are marketed. The center clears for marketing everything from contact lenses and artificial joints to x-ray machines. More than 550 categories of low-risk medical devices, including surgical gloves and therapeutic massagers, are exempted from premarket approval.
Food and Drug Administration: Center for Devices and Radiological Health https://www.fda.gov/cdrh
Ruby, the conversation on that group has advanced to the point where they decide that fear of FDA action is needless. As there is no "product" and no one sells it, how can there be any action. It's just another public open internet group.
It was the lesson in language and how to understand the way supplement sellers have to express themselves, that interested me.
Yes, it's interesting to note how supplement makers couch their claims. Kevin Trudeau had to be pursued through the FCC (Federal Communications Commission), not the FDA, because he wasn't selling any actual products--just talking about alleged cures!
It seems that the supplement industry's ubiquitous "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." just about covers their collective butt.
They let just about anyone in here and I am proof!
Hello everybody. Glad to hear from some old posters with new names and some with the old ones. I have been extremlely busy lately and it is not going to let up for awhile. This looks like a very good site and I am glad to have been informed of it.
I do have an interest in what can be said by the average person regarding alternative therapies because I may be posting a rather interesting account of my personal experimentation. It will be a couple of months before I am confident enough to elaborate.
I will not say anything now because it is too preliminary but I will say if results continue it will be a first and could help a whole lot of people.
Then again the whole thing could turn out to be much less. Let me just say I am hopeful at this point.
Anyway, I would like to know if I am going to get harassed by making factual statements about an alternative treatment and the observed results of the treatment. I will put any conclusion I would come to in the form of an opinion of course. But who has some experience with this? If this thing turns out I cannot just keep it to myself. I would consider that inexcusable if it could benefit someone else. Is there some weasely lawyer language that covers this?
Welcome, D Bergy!
If you have had an interesting personal experience, and you write about it on a public forum, how can you go wrong? Providing you aren't giving medical advice - that is, claiming expertise in the subject of a named disease and advocating a cure, which you sell, you should be fine.
This statement is made by someone who is not a lawyer.
D Bergy.
Arrowind has a signature line that might fit your needs.
All the above is written for educational purposes only. What you decide to do for your health is strictly your business. Whatever you do, look into all the options carefully and remember that natural remedies my provide you with safe alternatives.
Understanding FDA language
Linear Mode
