Would It Be a Scam?

[Quath]

Imagine a water bottler decided a new marketing tactic. Say they took their regular bottled water and renamed it "Placebo Aqua." They could claim that "it has been shown to help cure thousands of diseases, illnesses and maladies of humanity by the well documented Placebo Effect." They could list all sorts of studies that show that this is a valid claim.

Would this be a scam? On one level, the claims are truthful and scientifically valid. However, it would really only work on ignorant people who really don't know what the placebo effect is. So their customers would be the ignorant masses and people who think it is funny. Would how much they charge matter?

[sphenisc]

Yes, however the scam part is getting people to buy bottled water at ~100 times the price of tap water. The rest is just dressing it up.

[brodski]

http://www.fdhom.co.uk/products.asp enough said ;)

[JWideman]

Yes, however the scam part is getting people to buy bottled water at ~100 times the price of tap water. The rest is just dressing it up.

You mean like every other bottled water?

[tsg]

They could claim that "it has been shown to help cure thousands of diseases, illnesses and maladies of humanity by the well documented Placebo Effect."

In the US, this statement puts in under the jurisdiction of the FDA which says it has to have clinical trials that show it to be more effective than placebo.

[EvilEye]

Clorets gum did this years ago... touting "Clorets....with Clorophyll!"

They never claimed FOR the agent... just made you excited that it had it.

[vita10gy]

You mean like every other bottled water?

I'm pretty sure that was his joke.

As far as I know they could do something like this, as long as they didn't THAT it cured various ailments. They could however say something like "Do you have any of the following ailments?" then list everything known to man, then discuss the ailments, then say "Buy Placebo Water!!"

Technically they didn't state any cause and effects, it was just a non-sequitur question. Much like if their add campaign was "How's the weather over there? Do you like cats? Lost sure is a confusing show. Drink Placebo Water!!"

Edit: Come to think of it, I kind of like that campaign. I should go into marketing.

[Gagglegnash]

Hi

I remember a commercial, years ago, for a pill to treat a number of difficult diseases.

It was advertised as containing, "100% sucro-placebon."

They had to take it off after a bit. Small victories are still victories!

[Peter S.]

Many years ago I remember reading an ad for "Placebo Sex aids". The ad began with the words, "These powerful placebos...".

I laughed till I cried!

[ServiceSoon]

In the USA you could probably put an asterisk next to your claim that says "The FDA does not recognize that this product does (insert your claim)." I am not a lawyer, but I play one on the internet.

[tsg]

In the USA you could probably put an asterisk next to your claim that says "The FDA does not recognize that this product does (insert your claim)." I am not a lawyer, but I play one on the internet.

The FDA doesn't play that way. You don't get to make a claim and later disclaim it in the fine print.

[ServiceSoon]

The FDA doesn't play that way. You don't get to make a claim and later disclaim it in the fine print.
The label on my vitamins disagrees with you. Take it up with them :)

[tsg]

The label on my vitamins disagrees with you. Take it up with them :)

Your vitamins are dietary supplements, and I highly doubt they are claiming to have "been shown to help cure thousands of diseases, illnesses and maladies". In fact, I'd be willing to bet if the package says anything at all it's "These statements have not been evaluated by the FDA and this product is not intended to diagnose, treat or cure any disease."

[ServiceSoon]

Your vitamins are dietary supplements, and I highly doubt they are claiming to have "been shown to help cure thousands of diseases, illnesses and maladies". In fact, I'd be willing to bet if the package says anything at all it's "These statements have not been evaluated by the FDA and this product is not intended to diagnose, treat or cure any disease."
It says "Vitamin B-12 prevents megalobiastic anemia by helping to form red blood cells.* Vitamin B-12 helps to maintain normal levels of homocysteine which is important for heart and circulatory health.* Plays an important role in nervous system and proper funtion of all body, brain and ner cells.*"
and
*These statements have not been evaluated by the food and drug administrations. This product is not intened to diagnose, treat, cure or prevent any diseases.
Yes, however the scam part is getting people to buy bottled water at ~100 times the price of tap water. The rest is just dressing it up.There is a sucker born every minute.

[tsg]

It says "Vitamin B-12 prevents megalobiastic anemia by helping to form red blood cells.* Vitamin B-12 helps to maintain normal levels of homocysteine which is important for heart and circulatory health.* Plays an important role in nervous system and proper funtion of all body, brain and ner cells.*"

Notice that it doesn't say taking B-12 orally will affect any of these.

and
*These statements have not been evaluated by the food and drug administrations. This product is not intened to diagnose, treat, cure or prevent any diseases.

Which is exactly what I said it would say.

[ServiceSoon]

So the answer to the OP’s question is he could get away with using the same format as found on vitamins except substituting certain words when necessary to make it relevant to his cause ?

[vita10gy]

Well, water itself is vital to human health anyway, so I'm not even sure he'd have to lie. Just list all the things dehydration can cause or exacerbate.

BTW TSG - I got a good chuckle out of your "in the beginning" signature line, but just so you know, God didn't start with light.

[tsg]

So the answer to the OP’s question is he could get away with using the same format as found on vitamins except substituting certain words when necessary to make it relevant to his cause ?

To a point. From here (http://www.cfsan.fda.gov/~dms/supplmnt.html):

FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements.* Manufacturers must make sure that product label information is truthful and not misleading.

FDA's post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.


Extensive information about what health claims can appear on a dietary supplement label can be found here (http://www.cfsan.fda.gov/~dms/hclaims.html). Most pertinent to the conversation:

A "health claim" by definition has two essential components: (1) a substance (whether a food, food component, or dietary ingredient) and (2) a disease or health-related condition. A statement lacking either one of these components does not meet the regulatory definition of a health claim. For example, statements that address a role of dietary patterns or of general categories of foods (e.g., fruits and vegetables) in health are considered to be dietary guidance rather than health claims, provided that the context of the statement does not suggest that a specific substance is the subject. Dietary guidance statements used on food labels must be truthful and non-misleading. Statements that address a role of a specific substance in maintaining normal healthy structures or functions of the body are considered to be structure/function claims. Structure/function claims may not explicitly or implicitly link the relationship to a disease or health related condition. Unlike health claims, dietary guidance statements and structure/function claims are not subject to FDA review and authorization. There are some regulatory requirements associated with the use of structure/function claims; see http://www.cfsan.fda.gov/~dms/labstruc.html.


The statements on your vitamin bottle are structure/function statements which fall under this (from the link in the last quote):

Structure/function claims have historically appeared on the labels of conventional foods and dietary supplements as well as drugs. However, the Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory procedures for such claims for dietary supplement labels. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect normal structure or function in humans, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity," or they may describe general well-being from consumption of a nutrient or dietary ingredient. Structure/function claims may also describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not pre-approved by FDA but must be truthful and not misleading. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim. Further information regarding structure/function claims can be found in FDA's January 9, 2002 Structure/Function Claims Small Entity Compliance Guide: http://www.cfsan.fda.gov/~dms/sclmguid.html.


The OP's hypothetical claim that "[Placebo Aqua] has been shown to help cure thousands of diseases, illnesses and maladies of humanity by the well documented Placebo Effect." is well outside those boundaries, even if it was marketed as a dietary supplement, specifically because it does claim to cure many diseases.

[tsg]

BTW TSG - I got a good chuckle out of your "in the beginning" signature line, but just so you know, God didn't start with light.

I stole it from my fortune file. Take it up with them.

[Quath]

The OP's hypothetical claim that "[Placebo Aqua] has been shown to help cure thousands of diseases, illnesses and maladies of humanity by the well documented Placebo Effect." is well outside those boundaries, even if it was marketed as a dietary supplement, specifically because it does claim to cure many diseases.
I am trying to recall if I have this correct, but didn't the skeptoid podcast on fluoridation say that the FDA does not approve water? I am not sure if this applies to bottled water as well.

But it sounds like the problem is that you have to state how the product will help you overcome a disease, injury or other malady. The simple reason is "because you believe it will, you change your body chemistry in some way to affect your malady." Now that is too straightforward for such a product. I think someone could doctor it up somewhat to be more technobabble. Something like "[Placebo Aqua] works from the body's own natural healing effect from physiological expectation."

[tsg]

I am trying to recall if I have this correct, but didn't the skeptoid podcast on fluoridation say that the FDA does not approve water? I am not sure if this applies to bottled water as well.

The FDA does regulate bottled water (http://www.cfsan.fda.gov/~dms/botwatr.html). The EPA is responsible for tap water.

But it sounds like the problem is that you have to state how the product will help you overcome a disease, injury or other malady. The simple reason is "because you believe it will, you change your body chemistry in some way to affect your malady." Now that is too straightforward for such a product. I think someone could doctor it up somewhat to be more technobabble. Something like "[Placebo Aqua] works from the body's own natural healing effect from physiological expectation."

It all depends on whether the claim falls under what the FDA considers a "health claim". But even if it doesn't, they are pretty clear that it must be true and not misleading.