How the FDA defines 'drugs'

[draco664]

In a letter to Diamond Foods, the FDA said...

Based on claims made on your firm’s website, we have determined that your walnut products are promoted for conditions that cause them to be drugs because these products are intended for use in the prevention, mitigation, and treatment of disease.

So, a food that has been eaten for millennia is now a drug by bureaucratic fiat.

Is it just me, or are the various bloated agencies trying even harder to justify their existence?

[Andara Bledin]

That... I ... but...

The FDA owes me a new brain. >_<

Pretty much every fruit, vegetable, nut, etc, will be subject to precisely the same claims. This is just plain stupid. No, this is beyond stupid. In fact, it's so far beyond stupid that stupid can't even see it any more.

^-.-^

[Rapscallion]

I can see both sides of this. To a reasonable definition, malnutrition is a disease, so food intended to curb hunger could be taken as being a drug. By logic it could be taken that far, but it's unlikely to be seen that way by any sensible person.

However, drugs as we know them came from observing the effects eaten substances on the human body during different conditions.

Also, as I work in the wholefood industry, I often see outlandish claims and bullshit paraded as fact - misdirection and selectiveness designed to sell one product or another. Try reading http://www.badscience.net for some interesting stuff about how statistics are often manipulated in the health industry. The Patrick Holford stuff is pretty indicative, and most of that happens in the UK where the pharmaceutical industry isn't allowed to market its drugs to the patients. http://www.badscience.net/2007/02/pa...h-africa-tour/ for a section where he claims that vitamin C is better than AZT against AIDS.

Regulation is needed when bullshit merchants seek to part coin from purse for snake oil.

Rapscallion

[draco664]

Regulation is needed when bullshit merchants seek to part coin from purse for snake oil.

Regulation of regulators is needed bullshit bureaucrats seek to classify foods as drugs.

[Andara Bledin]

From a few articles I read, this comes off as a money-grab by the FDA because Diamond didn't pay them to get approval to state proven facts on their labels.

Regulation is a necessary thing, but when you get to the point of an agency trying to claim that because there are comments of health benefits on the package suddenly reclassify a food item in to a drug item, you know that the system has become corrupt and out of control.

They're not saying anything about what's in the package; they only say that due to the claims not having been approved by them, that means that the item is a drug instead of a food. If you don't put the claim, then it's still a food. If you get the claim approved (and pay the related fees to do so), then it's still a food. This whole story is ridiculous and a good display of just how bad the FDA can be.

^-.-^

[BlaqueKatt]

two things:

First and most importantly apparently no one checked the source of this "news" saying the FDA is horrible(probably because it's in their best interests to be able to make unsubstantiated claims about their products). They are in the business of selling vitamins, they claim to have "life extending, anti-aging properties" And that they're better because they say so at $25 on up for 60 capsules, but if you become a "member" you get 25% off, and a one year membership is $75.

Interestingly they have zero proof of any of their scientific claims, such as high doeses of CoQ10 reverse both congestive heart failure and parkinson's disease. Interestingly they claim with zero proof that they have been at least 10 years ahead of every single major medical breakthrough since 1980-they claim that vitamin C is "toxic to HIV infected cells"(yes in the lab and in amounts that would kill a human being as well) and that Whey protein "contains all essential and nonessential amino acids"(a specific amino acid[homocysteine] in high protein diets causes premature atherosclerosis)

this link has some interesting facts from a study done on "superfruits", the label claims are quite false, and bilking people out of money under the guise of providing healthy products is huge business

Do these superfruit juices really contain significant amounts of antioxidants? They better, because they base their entire marketing campaign around this claim specifically.

Choice magazine(the publication of the Australian Consumers Association) found that the marketing literature says that goji berries have ten times, and açai berries six times, the antioxidant capacity of blueberries. Well, this might well be true. The difference is due to the fact that you're drinking a juice made from the fruit, you're not eating the whole fruit itself. For example, the mangosteen fruit has a huge amount of antioxidants and other nutrients. However, it's all contained within the inedible rind. The edible pulp of the fruit has only a negligible amount of either. This is how it's possible for the marketing claim to be, well, accurate if misleading; but the product itself to be devoid of the claimed benefits.

the pure juices were found to have 10% of the antioxidants of a single red delicious apple.

Second there is no "fee" for getting label claims substantiated by the FDA and the guidelines for label claims can easily be found here-Diamond violated these laws, plain and simple.

[Sleepwalker]

Good for the FDA.

[Rapscallion]

Regulation of regulators is needed bullshit bureaucrats seek to classify foods as drugs.

Have a careful look at the page link in the original post. Diamond Foods' defence is basically to reiterate their advertising that tried to portray their walnuts as medically beneficial.

I consider that them claiming their food is a drug. I think the FDA is perfectly right to crack down on this lot.

Rapscallion

[Panacea]

In a letter to Diamond Foods, the FDA said...

So, a food that has been eaten for millennia is now a drug by bureaucratic fiat.

Is it just me, or are the various bloated agencies trying even harder to justify their existence?

The FDA isn't saying walnuts are a drug.

They are saying that the way this company promotes walnuts health benefits is to turn it into a treatment for disease, and that they cannot do.

The FDA exists to protect us from snakeoil salesmen like this company (the owner of which, btw, is a literal nut job who cut off his own mothers head and put it in liquid nitrogen in the "belief" she can be brought back to life at some point--and there's some evidence she wasn't dead when he did this).

The FDA are the goodguys in this.

[FArchivist]

So, a food that has been eaten for millennia is now a drug by bureaucratic fiat.

Is it just me, or are the various bloated agencies trying even harder to justify their existence?

It's just you.

The FDA has ALWAYS considered as a drug any "products that are intended for use in the prevention, mitigation, and treatment of disease." The operative words here are prevention, mitigation, and treatment of disease.

What isn't being mentioned here is that Diamond Foods has aggressively advertised and claimed that walnuts can prevent heart attacks, cure heart disease, and have all of these health benefits that, frankly, are mostly naturopathic claims that haven't been backed by scientific study. There's a short name for that: It's called food woo.

Scientifically? Walnuts have lots of fiber and protein, and it turns out they might help lower the icky bad cholesterols. That's it. Claims of affecting your heart health are completely unsupported by science at this time.

The FDA telling Diamond Foods to screw off is a good thing, people. It's all well and good to say this or that food is healthy for you; it's bad science and outright fraud to claim that tea tree oil will cure the cancer or that lemons will totally eliminate common cold viruses.

[FArchivist]

Pretty much every fruit, vegetable, nut, etc, will be subject to precisely the same claims. This is just plain stupid. No, this is beyond stupid. In fact, it's so far beyond stupid that stupid can't even see it any more.

No, I really haven't seen every fruit and vegetable subjected to the outrageous claims that Diamond Foods has made about walnuts.

Regulation of regulators is needed bullshit bureaucrats seek to classify foods as drugs.

So if Diamond Foods claims that their walnuts could prevent heart attacks and cure heart disease when they objectively, scientifically can't, you have no problem with this?

From a few articles I read, this comes off as a money-grab by the FDA because Diamond didn't pay them to get approval to state proven facts on their labels.

State proven? I need citation on that. There's no proof yet on the direct benefits of walnuts for your heart health by an independent study.