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The FDA (in the United States; or similar authority elsewhere) regulates the usage of certain terms on food labels, such as "natural", "organic", "dairy", etc. But when consumers see a grocery item they don't know which of the words on the label are controlled.
In order to help consumers better
understand the labels, I propose that any word that is regulated by the FDA be marked with a (D) superscript, to indicate it's a defined term.
Therefore, an item like "Homemade Natural Tomato Sauce" would be marked as "Homemade Natural(D) Tomato Sauce" to indicate that the word Homemade is not officially implying anything about where it was cooked, and that tomato may just refer to a color and not a particular crop. If the FDA steps in and says you can't say "tomato" unless a tomato was growing within 100 miles of the factory, then "tomato" would get a (D) superscript also.
Vitamin C is good for you!
http://cutieskids.c...calories-nutrition/
[ytk, Jul 06 2012]
Overview of Dietary Supplements
http://www.fda.gov/...ation/ucm110417.htm
[ytk, Jul 06 2012]
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Actually, homemade would be protected by false advertising laws in many cases. This is why homestyle has become much more common. |
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It's for the same reason you can't say “/Our/ brand contains no
toxic chemicals!” If something hasn't been shown to be harmful—
or has been shown not to be harmful—it's disingenuous to
advertise the fact that you don't put it in your food product as
some sort of benefit. |
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As for the “this product is a nutritional supplement”, which is the
language I believe you're most likely to find, it's because there
are stringent requirements for a product to be marketed as a
drug, and putting that language on there indicates that you're not
trying to pull a fast one, for which there are severe penalties.
Health related claims about drugs are tightly regulated; health
related claims about food products and nutritional supplements
are significantly less so. |
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It's equally bewildering that so many choose to consume products labelled as "rich in anti-oxidants" when it would be so easy just to stop breathing ... |
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Interesting discussion around this one. This morning
it has come to light that Chinese vegetable exporters
are saving money on refrigerated freight costs by
spraying fruit and vegetables with formaldehyde, to
keep produce "fresh". |
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("claims substantiation" is what I do, working for a supplement manufacturer. You have no excuse to believe me unbiased.) |
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The nice thing is that we can generally rely on the FDA and the FTC to give us yes/no answers. |
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The problem is, the only question they will answer is "Have you decided whether you're going to sue us over this?" |
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What are you talking about? Citrus growers advertise their products as rich in vitamin C all the time, and
often include the known benefits thereof. See link for an example. |
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I honestly can't follow the rest of your argument. Vitamin C supplements aren't “drugs”, so any drug
marketing regulation doesn't apply. Nutritional supplements are considered foods, not drugs, so
manufacturers can claim any (reasonable) benefit they like so long as they make it clear that their claim
isn't substantiated by the FDA (specifically, they are required to print on the label “This statement has
not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any
disease”). I do not believe well-established claims, such as the benefits of vitamin C or calcium, are
required to carry such a disclaimer, but I may be mistaken about that, and it's possible manufacturers
provide one anyway just as an extra measure of protection. |
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I suspect the word "natural" is meaningless in its
common use and that attempts to define it would
take it away from common usage. I also think that
if its "natural", it probably means it's not farmed,
it's been here (for example) since the last
glaciation as a species and so forth, so you might
be able to pick a nut off a tree in a virgin forest
but as soon as you touch it or breathe on it, it
stops being natural. Also, we're natural, so
everything we make is natural. I tend to say "as
close to a physiological living state as possible",
but even then there's the construction of
pathology to be taken into consideration. |
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Also, vitamin C - not usefully conceptualised as
one substance and Citrus
here in England has been tested and found often
not to contain a detectable level. No, i can't cite
for that. |
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Toxicity depends on dose. There are very few if
any non-toxic substances - helium might possibly
be but i'm not sure. |
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Providing that they are administered at normal atmospheric pressure and temperature, and there is sufficient oxygen in the mix, helium, neon, nitrogen, and argon are all non-toxic - the noble gases because they're unreactive, and nitrogen because that's most of your atmosphere anyway. |
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I often wonder at the meaning of "organic", and how
that somehow makes other foods "inorganic". |
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// how that somehow makes other foods "inorganic".
// |
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Using the Chemistry definition, "organic" substances are those which contain carbon and hydrogen. |
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Calcium Carbonate, Calcium Phosphate, Carbon Dioxide, and Water are all "inorganic". None qualify as foods, although they are found in foodstuffs. |
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A secondary definition might include the requirement that the compound should combine exothermically with oxygen. |
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This discussion reminds me of the joky "physics warning labels" from college, e.g. "WARNING: This Product Attracts Every Other Piece of Matter in the Universe, Including the Products of Other Manufacturers, with a Force Proportional to the Product of the Masses and Inversely Proportional to the Distance Between Them." |
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Search for "Physics Warning Labels" to read more. |
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//Vitamin C supplements aren't “drugs”, so any drug marketing regulation doesn't apply.// |
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OK, I can only talk about the US market, but a large part of the regulations are called the Dietary Supplement Health and Education Act of 1994, aka DSHEA. |
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//Nutritional supplements are considered foods, not drugs, so manufacturers can claim any (reasonable) benefit they like so long as they make it clear that their claim isn't substantiated by the FDA (specifically, they are required to print on the label “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”).// Again, not true. |
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Let's take the Vitamin C example again. It has been known for hundreds of years that Vitamin C cures scurvy, so let's imagine that a supplement company - LimeysInc - wants to sell a supplement with that on the label. "Cures scurvy!" No can do, for two reasons: "cures" is a drug claim. That's US law: only drugs can cure or treat disease. You can't claim water will treat dehydration, you can't claim calcium carbonate will treat heartburn. Second, "scurvy" relates to a disease condition. No supplement can make any claim about a disease condition. In fact, if LimeysInc changed their label to "Doesn't cure scurvy!" they'd still be breaking the law because they referred to a disease condition. |
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//I do not believe well-established claims, such as the benefits of vitamin C or calcium, are required to carry such a disclaimer, but I may be mistaken about that,// |
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Yep, you would be. Yesterday I was trying to track down substantiation on calcium carbonate (you know, like Tums uses) (yes, suddenly the FDA is concerned over whether there is citable evidence that we didn't just come up with this on our own) and I ended up having to read Pliny the Freaking Elder in the original Latin to prove that "Yes, this a well established claim." |
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//and it's possible manufacturers provide one anyway just as an extra measure of protection.// The disclaimers are prescribed by law. If you sell a supplement, all of the disclaimers go on; the manufacturer gets no choice on whether or no. |
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So it's really a problem of the legal environment. Every single question one side wants to ask the other requires a law suit, with literally millions spent on each side. This produces two viable business models for supplement companies: one, keep all your claims completely defensible, keep track of every possible related study and shred of evidence, and keep a huge stable of lawyers; or two, spawn off little "shell" companies for each product or product line, with little or no associated assets, so they can be serially sued out of existence. The second method is, unfortunately, easier to operate; it has the drawback of being difficult to grow to IPO scale. |
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Well, I got my information from the FDA's website (see link): |
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“This statement or "disclaimer" is required by law (DSHEA) when a manufacturer makes a
structure/function claim on a dietary supplement label. In general, these claims describe
the role of a nutrient or dietary ingredient intended to affect the structure or function of
the body. The manufacturer is responsible for ensuring the accuracy and truthfulness of
these claims; they are not approved by FDA. For this reason, the law says that if a dietary
supplement label includes such a claim, it must state in a "disclaimer" that FDA has not
evaluated this claim. The disclaimer must also state that this product is not intended to
"diagnose, treat, cure or prevent any disease," because only a drug can legally make such a
claim.” |
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I may not have been clear, [lurch]. When I said manufacturers may make any reasonable
claim they like so long as they make it clear that the claim is not substantiated by the FDA,
that means it's not being marketed as a “cure” for a disease (and they therefore can't claim
that it is), because, well, that's what the disclaimer explicitly says. I was implicitly
excluding drug related claims, which /are/ substantiated (or, rather, evaluated) by the FDA.
Obviously, they can't claim it's a cure and say it's not a cure on the same bottle, so it doesn't
make any sense to talk about such a claim. The sorts of claims I'm referring to are things like
“boosts immune function” or “improves concentration”—claims that are not evaluated or
regulated by the FDA. See the third and fourth sentences above. |
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//The disclaimers are prescribed by law. If you sell a supplement, all of the disclaimers go
on; the manufacturer gets no choice on whether or no.// |
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I don't think that's quite accurate. The relevant language is “required by law (DSHEA) when
a manufacturer makes a structure/function claim on a dietary supplement label”. So if the
manufacturer were to sell a plain bottle simply labeled, say, “ginkgo biloba dietary
supplement”, and no claims were made on the bottle about the product's uses or
effectiveness, no such disclaimer would be required. |
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You have to realize, however, that what they say on their website and what they say in court are two completely different beasts. |
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With the example of the "ginkgo biloba dietary supplement", even if you put nothing else on the label, that's still a claim. In fact, it might be multiple claims. (I *know* it doesn't make sense. Welcome to my life.) First, you are claiming that the bottle contains ginkgo biloba; second, you may be found to be "inferring" a claim of X, where X is anything a "rational"* person might commonly believe ginkgo biloba is good for. In fact, since you didn't make any other claim, it would be very likely you would be held responsible for an "inferred" claim. However, the mere presence of the content claim would be sufficient to trigger the disclaimer. |
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Remember, too, that the FTC (Federal Trade Commission) (repeating my own disclaimer, I'm only talking about US law) has their own grimy mitts in play as well, and a label which passes FDA muster may still have problems with the FTC. They're the ones who would be interested in whether your content claim was really true. |
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*Some of the things the FDA attributes to their putative "rational persons" are utterly jaw-dropping. I'm sorry - If I told you more, you'd have to shoot me. |
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I think you've put your finger on the reason why
Rentisham's is not sold overseas. We looked into it
once, but the words "Universally", "Heralded",
"Finest", "Emolliative", "Restores", "Flegative" and
"Empire" caused insurmountable problems. And that
was only the wording on the banner around the
Bassett. |
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//Pliny the Freaking Elder |
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I suspect that's one of the more modern translations.? Looking forward to the updated Iliad with Paris dissing Agamemnon... |
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The question of hwether noble gases and molecular nitrogen are
non-toxic depends on hwether one considers narcosis at high
pressure to be poisoning. So far as i know, helium is insoluble
in water and lipids, and the other noble gases and molecular
nitrogen seem to cause narcosis by dissolving in the lipids of
neurones. That might stretch the definition of toxicity, but not
as much as if a boulder was regarded as toxic because if it fell
on me from a height it would interfere with the physiology of my
body. |
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On a slightly more serious note, nothing i use on my hapless
victims has any medical claims attached to it in legal terms by
myself or any supplier. |
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//If I told you more, you'd have to shoot me.// As
little as I would enjoy participating in your demise
and as highly as I regard you my curiosity must no go
unsated. Let's do this. |
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I wasn't being entirely facetious - continuing any farther would involve revealing court-sealed information I have agreed to hold in confidence; a breach would leave me with no means of supporting the wifey save my life insurance, hence the form of the comment. |
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(Perhaps, someday when I have a job elsewhere, I can give enough hints somebody can FOIA the whole thing, which I think would be very good indeed.) |
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Or you can just purchase more life insurance and tell us
the secret. |
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Drops ten bucks in hat for [lurch]'s life insurance,
passes hat to [Alter]. |
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It's about time we put pressure on government to
get rid of the huge departments whose sole purpose
is writing new laws; making new regulations;
inventing new taxes and generally fucking up people's
lives. |
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