Getting a good healing remedy blessed by the FDA is a huge expense so it just doesn't get done. Not because the remedy is bad, but because it is 1. usually a realatively inexpensive herb or mixture of herbs. And 2. because it is a natural product it is unpatenable. (You have to mess with something, change it someway from nature to be able to patent it... go figure). While the FDA has its place, and does some good work protecting us from some bad pharmaceuticals and medicines it also keeps good healing remedies and alternative medicines that have not been 'approved' out of our hands.
The FDA is not playing games. I know way too many people personally who have been to prison or who are in prison now for me to believe otherwise.
How an inventor, healer, seller operates in this kind of environment is more "art" than science, as well as "the luck of the draw".
The FDA has a few "trigger points" that will send it into high gear and this is my "rough" order of priority:
Claims of "cancer cures"
"Supplements" that are hormone-related especially aimed at athletes and body builders.
Any claim of cure or treatment that is not FDA approved
I think the FDA is wrong in its approach. Wrong in its mission. And has totally hurt the healthcare system not just in the U.S. but around the world. Our opinions in this matter are irrelevant. This is a juggernaut of a beast and it will eat anyone for breakfast that gets in its way.
The enforcement arm of the FDA is usually the Federal Trade Commission (FTC). This is usually because the FDA claims its jurisdiction from "unapproved treatment for pay" situations. Many alternative practitioners get around this by not charging. Sometimes they take donations. Sometimes this "works" in the sense that their file is not selected for immediate trouble because they are by definition small and financially unsuccessful. But there is no true work-around to the FDA and the FTC. When it's your turn, if you qualify for selection, you're screwed.
Here are some things to keep in mind if you sell healthcare products on the internet:
Success is not your friend. The more of a following you have, the better your chance of getting ground up. Lawyer up (FDA specialized lawyer only) as soon as you hit success.
Complaining customers are your worst enemy. You can do a lot of smart "agreements" in dealing with sick and dying people that might give you a fighting chance in civil court, but nothing will stop an FDA on a mission or a customer who is angry that Gramps died on your watch while taking your "cure" and screams to the FDA. The fact that Gramps had six days to live when your protocol was used or that his immune system was killed by radiation before the family found you is not relevant. Read this carefully: THERE IS NO SUCCESSFUL DEFENSE TO AN FDA CHARGE.
Offering advice on how to use your unapproved protocol by phone or internet is risky business. See an FDA specialized lawyer. And another lawyer about the unauthorized practice of medicine unless you're a licensed physician. Then just see the FDA lawyer.
Anyone selling a healthcare product on the internet is legally responsible for the claims and the sale even if you are a downstream affiliate of a distributor or an MLM system. You cannot claim that "they" wrote the copy, not you. You are charged with being either a direct promoter or a facilitator. Neither pleasant charges, believe me.
What you can do to save yourself and still sell your product:
Do your own research and save the results in a safe place. Get as close to third party professional studies as you can about "your" product.
Keep a journal of the research you did and why you decided the product was ok to sell.
Discover if there are complaints about the specific brand you're selling or the product in general. Either stop selling the product if there is trouble or resolve the matter in your journal, such as, "I have found six claims in my research of 100 websites that the product does not work. I have found no adverse medical claims. I have found positive claims for the product that far out weight the negative claims. Here are the web addresses of the people who claim that it helped them."
Be careful about your claims:
No product is 100% safe and never even think about making that kind of claim. Drink a large enough quantity of water and it CAN KILL YOU. Do you know what those quantities are? NO YOU DON'T. NOBODY DOES. EVERYONE IS DIFFERENT.
Do NOT make 100% "curative claims" absolutely nothing -- works for "everyone". A 30% cure rate is not sexy to advertise, but it is a major breakthrough for most serious diseases. ALL CURATIVE CLAIMS ARE DANGEROUS. TRUTH IS NOT A DEFENSE.
Investigate and notify customers on your website of any adverse claims and contraindications RIGHT IN YOUR PROMO COPY not buried in some weasel clause in a purchase agreement.
Quoting God or "mother nature" is not going to keep you out of prison. I don't care if you want to be a martyr for the cause. It's a good cause and it needs martyrs. If that's your calling in life, then I thank you from the bottom of my heart.
The FDA is pretty sure we all hate it by now. But they have a big budget and a legal mission to save us from people just like you. From ourselves. To play "Big Daddy" in our lives and keep us from being adults capable of making our own informed decisions about healthcare. They believe they have the only truth. This belief makes them dangerous because they also have guns and badges. There is no need to take a belligerent attitude against them on the same site you are trying to sell your product. Do not shove a stick in the lion's cage and expect the lion to forget you.
******Disclaimer: The author is an attorney, but not your attorney. While he thinks this information is correct, it's up to you as adults to verify it to your own satisfaction and/or seek legal counsel where you live. ******
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