11 votes

FDA Cracks Down on Aloe Peddling Quacks

Letter sent by FDA...

Dear Ms. Heinrich:

The Food and Drug Administration (FDA) reviewed your websites at the Internet addresses www.set-n-me-free.com and www.setnmefree.net in May 2012. Based on our review, we have determined that the products “Aloe Milk Moisturizing”, “Aloe Moisture Cream”, “Day-Night Emollients”, “Moisturizing Aloe Lotion”, “Aloe Comfrey Gel”, “Aloe Facial Cleanser”, “Aloe Stic”, “ 99.5% Natural Aloe Liquid”, “Lavender Spa Bath”, “Aloe Heat Creme”, “Aloe Body Wash” and “Set-N-Me-Free body wrap systems” are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC §§ 321(g)(1)(B) and 321(g)(1)(C)].

The therapeutic claims on your websites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or any function of the human body. The marketing of these products with these claims violates the Act. You may find the Act and the FDA’s regulations through links on FDA’s home page at www.fda.gov.

Read more here...

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2...

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Definition

is the poison of law,,,

NOSHEEPLE

Aloe will not be pleased with

Aloe will not be pleased with this news, but I think he will smile anyway.


http://youtu.be/5XjZloJKZm8

They mean it too

A few years ago they were threatening to pull Cheerios off the shelf as "contraband" for claiming they may reduce risk of heart attacks. It's all about the FDA's definition of a drug: "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

Mom used to have a big Aloe plant in the house

It was used for everything - cuts, scrapes, bruises, sunburn and on and on.

It was the Neosporin before Neosporin. And it works better.

My question is - wouldn't this fall to the state's division of commerce for deceptive advertising?
What the hell does the FDA have to do with it?

another reason we need small government

does anyone really doubt that Aloe Vera is a moisterizer? I use it on my face if I get sunburned. Heck, I even use Trader Joe's Aloe Vera crap for shaving cream because it makes my skin soft and I hardly have to use any of it. A former girlfriend used it when she was going through radiation treatment, on the advice of a doctor. This is just silly.

It all goes back to the FDA only allowing non natural substances to be considered drugs (or effectively doing that).

"Two things are infinite: the universe and human stupidity; and I'm not sure about the the universe."-- Albert Einstein

Drop the claims, just sell great product.

Howver, Dr. Joel Wallach has sued the FDA 5 times and won.

He makes claims he can verify, then presents the evidence as needed.

Also, Word of Mouth is slower but tends to be more reliable.

Free includes debt-free!

And be sure to include the boilerplate disclaimer that is

tailored to avoid such accusations of violation.

Quacks?????

Do you have any particular knowledge that the advertised claims for aloe are false? Neither does the FDA. The FDA is "cracking down" on people who have not gone through the FDA's million-dollar extortion program to "prove" that a product is safe and effective. Natural substances like aloe vera cannot be patented, and therefore it does not pay for a company to spend millions of dollars to satisfy the FDA's demands -- they will not be able to compete with folks who sell the stuff WITHOUT bearing the astronomical costs of FDA compliance.

The word "quack" does not appear in the story. I strongly suggest you delete it. Aloe vera DOES have useful medicinal properties -- whether or not it has as many as its merchandisers claim, I do not know. And I doubt that you do either. Unless you do, give them the benefit of the doubt.

Recommended reading: The Most Dangerous Superstition, http://www.amazon.com/Most-Dangerous-Superstition-Larken-Ros...

It was a joke mister. I am VERY into natural health.

I am also too sarcastic sometimes. :)

I assumed everyone on the DP would know since the FDA is such a hated organization around here.

Christians should not be warmongers! http://www.lewrockwell.com/vance/vance87.html

Advice

Use sarcasm sparingly online.

_________________________________

Freedom - Peace - Prosperity

But

not quite as sparingly as the OP used it here. Putting ONE sarcastic word into the title of an otherwise serious post does not give adequate notice that sarcasm is intended.

Recommended reading: The Most Dangerous Superstition, http://www.amazon.com/Most-Dangerous-Superstition-Larken-Ros...

I don't think the issue is not jumping through the expensive

hoops of the FDA, but rather making unsubstantiated claims.

Anecdotal testimony is NOT substantiation despite that it is what people fall for every time.

An evidence based claim is one backed by a double blind study which measured an effect greater than what could be explained by a placebo. There may be lighter requirements that could be met to get the FDA off their backs, but the simple step would be to remove any and all claims of "cure" and to include a disclaimer.

People already KNOW what aloe is. You don't need to blow smoke up their rear to sell it to them.

Anecdotal testimony

may not be scientifically rigorous proof, but it IS substantiation. "Substantiation" means: "To support with proof or evidence." Anecdotal testimony (from a trustworthy source, about their personal experience) does constitute "evidence."

For example, a recommendation from a friend may be worth a lot more than a "study" done by a drug company. Drug companies have an incentive to fake studies "proving" their products' safety and effectiveness; whereas a friend giving you "anecdotal" testimony about their personal experience has an incentive to be genuinely helpful.

Recommended reading: The Most Dangerous Superstition, http://www.amazon.com/Most-Dangerous-Superstition-Larken-Ros...

Have you read some of these websites? There ARE plenty of quacks

out there.

Probably at least 80% of what I encounter in this genre are quacks. Or they at least make themselves look like it.

I've seen it dozens and dozens of times: lots of hype, never getting to the point, full of personal stories you can't verify from people you never met, or never even existed.

It just isn't necessary to engage in such business practices - ever. (unless you really ARE a charlatan)

Sure, there are quacks. Unfortunately . . .

the FDA is run by and for some of them. It works like this: Only the quacks who have paid off the FDA can peddle their dubious nostrums, and the FDA "cracks down" on people who haven't made the payoff, regardless of whether or not they're selling effective and safe medicine. Such is our modern pharmaceutical industry and its "regulators."

So who are you going to trust? The drug peddlers or the natural remedy pushers? Neither one, very much. But in general, I figure the natural remedies, vitamins and herbal extracts, are more likely to be safe than the drugs -- which means one can try them out to SEE whether they are effective or not, without undue risk of serious side effects.

Recommended reading: The Most Dangerous Superstition, http://www.amazon.com/Most-Dangerous-Superstition-Larken-Ros...

I do not disagree.

I do weed out many "natural" products with a healthy dose of common sense when looking at their websites and packaging. I also do my own homework on such products, just like I do on "approved" stuff.

Here's an example of a quack site that is selling repackaged dish soap as a one-cure-fits all "miracle."

http://www.miraclesoap.com/producthistory.htm

I haven't read the entire site, or any others for this product as this one page was all I needed. Some people are even swallowing this stuff in caplets!!

THIS is what gives the FDA ammunition.

"...adequate directions

FDA quote from letter:"...adequate directions cannot be written so that a layman can use these products safely for their intended uses."

Company Response:
Then the layman needs to get off his ass and do some research. We make an assortment of Aloe based creams, we don't cure stupid.

If ignorance is bliss, Washington DC must be heaven.

No, you can't fix stupid, but even shampoo and toothpaste come

with directions.

It isn't difficult to write them. Just do it.

FYI Aloe Vera consumed in capsule form will make one...

'poo.'

Rapidly.

Don't feed the pandas. Ever.

This phenomena is

Also known as a Chevron.

"Freedom Is A Road Seldom Traveled By The Multitude." - Frederick Douglass

Point being, why does the FDA need to test and approve...

with their microscopes and centrifuges...

when they could simply pop a capsule and experience for themselves the 'properties' of aloe?

Don't feed the pandas. Ever.