Do you really expect most people to understand significant digits and apply them properly?
I think most people just assume that the pharmacy people know how to get them their pills and make them “right”.
Its a conversion. A simple one, to be sure, but still an opening for a mistake to drift in, and still requires a bit of mental math to get oriented with it, thus making it slightly more difficult to use or understand in relationship with something else at a glance.
There is a big advantage to picking a unit and sticking with it for a particular application for the sake of easy comparison. Well, maybe not big, but big enough to not warrant pedantism. Notice nobody advocated using decigrams as a measure.
There is also probably an FDA regulation specifying the units that these dosages should be expressed in. It would not be the least bit surprising for bureaucrats to fine a company that uses grams on their label when the regs say to use milligrams.
Does Gaudere’s Law apply to precision in significant digits?
Yes, while smugly snarking about precision in significant digits, I used the wrong degree of precision.
Anyhow, Saltire, I don’t believe the FDA does specify units in dietary supplements, but they do come down hard on confusing labeling. For example, I suspect they would frown on the ingredients being listed in micrograms if common practice is to use milligrams.
I do know that no company ever wants to use decimals; QC’ing the labels would be torture.
- Actually, I meant 501, because how to appropriately round 0.5 is far too controversial a topic for GQ.
I briefly looked for an FDA regulation on this. Didn’t find one. That doesn’t mean there isn’t one, though. Their website is crap.
I have recently moved to Canada, where meat and cheese are priced per 100g in the deli. The nice people working at the deli are unfamiliar with the kilogram. Seriously. “Half a kilogram” means nothing to them, while they readily understand 500 grams. Sigh.
Bear in mind that it’s the Food and Drug Administration, and until relatively recently supplements weren’t quite either.
The actual regulations are very broad and, frankly, not much use. Most FDA findings are based on the guidance documents and the inspectors’ manuals. Guidances are current thinking on an issue and do not impose additional obligations. Is there a ‘yeah, right’ smilie?
This drives me crazy. I cannot allow ‘best practices’; we must have clear and specific procedures, tolerances, specifications, etc. based on scientific evidence; the FDA can issue an observation based on a footnote in an employees’ manual.
So, believe me, if I were in charge of a label for a dietary supplement, I would use grains if every one else was.
But please do NOT complain about the website; they just re-did the whole thing and I’ve just located all my old links. Please do not encourage them to put me through this again.
The website actually isn’t bad, but the search function is a nightmare.
The FDA’s been overseeing supplements through DSHEA for over 16 years. Granted, not to the same extent as drugs, but they’re still the boss of labeling for supplements.
'Sides which, anything with “Antacid” on its label is either a drug or a supplement about to get slapped with a warning letter from the FDA’s lawyers. That’s a health claim, which isn’t allowed for supplements. All my answers have been framed with drugs, not supplements, in mind.
Sixteen years is relatively recent; 21 CFR 210 was last revised … apparently 13 years ago.
However, drugs and supplements are very different. An antacid certainly makes a claim about the “the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body”, but does it make the claim that the calcium does so? No.
The antacid is a drug; calcium is a dietary supplement OR a drug believed to prevent osteoporosis. The antacid cannot use labeling promoting its use to prevent or mitigate osteoporosis.
And labeling is much more than the label. The label actually isn’t a problem; that is generally approved with the drug. But labeling includes everything a company prints, including ads.
You can make an excellent and effective drug, under conditions that meet all regulatory agencies requirements and guidances, and still get in trouble if one RA inspector decides that any thing you print might be confusing.
So, I’m using milligrams if everyone else does.
(And the lawyers don’t issue the warning letters. Or the untitled letters. Even if the signatory is a JD.)
No, but the pharmacists who print those boxes are legally required to. FDA and their equivalents in other countries frown upon boxes containing “pchsah… between half a gram and gram and a half, who cares” of something.
Also, you seem to forget that in some countries you can get OTC medication as off-the-shelf, no “pharmacy people” involved. The old lady grabbing Aspirin off a shelf is the one who needs to be able to get the correct box.