Formula 216 - exposing the fraud

Formula 216 (archive) (MozArchive) is a supplement that claims to increase your Vitamin C levels without ingesting the actual substance. Here is one quote from the front page where that is stated:

Early experience with FORMULA-216TM shows it may be delivering on its promise to raise internal levels of vitamin C without dietary or supplemental intake of vitamin C.

And another time from some other page (archive) (MozArchive):

Results of preliminary clinical tests are in and they confirm the unique array of ingredients in FORMULA-21TM double blood serum levels of vitamin C in all subjects tested without intake of this essential nutrient from dietary or supplemental sources.

Biologically, it's long been known that humans are one of the few animals that do not make their own Vitamin C. Therefore - if a way to re-activate that ability was discovered - that would summon quite the storm in scientific circles. Here we have a product that claims to do just that. Their evidence consists of five subjects reporting an increase of blood Vitamin C levels after taking the supplement:

Test results showing an increase of blood Vitamin C in five volunteers, after taking the Formula 216 supplement

Good science usually isn't done on this few subjects. But let's ignore that for a moment and assume they've got their results on 100 people. Why did this happen? Before we dig deep into the fraud, let us remember that the supplement is allegedly able to boost Vitamin C without dietary or supplemental intake of vitamin C. Scrolling down to the ingredients list, we finally find the elephant in the room:

Ingredient list of the Formula 216 supplement

How can they say that the increase is without dietary or supplemental intake of vitamin C when the product contains actual Vitamin C in it? Even though on another page they do admit (archive) (MozArchive) to supplying 275 milligrams of supplemental vitamin C, they are still surprised that it sticks around for the next day (the volunteer took FORMULA-216TM at 11:00 PM on a Tuesday evening and woke up the next morning with a “20” reading on the urine test strip 8.5 hours later (7:30 AM) which was unusually maintained for another 12 hours (7:30 PM.)) - even though that is what is expected (archive) (MozArchive):

A dose of 500 mg taken every 12 hr led to continuously-detectable levels of vitamin C in the urine.

So, ingested Vitamin C does stick around for at least 12h. And yet, the fact that it did so in Formula 216's tests was apparently the basis upon which it was decided that the additional substances in there activate actual production of this nutrient. However, in the tables, the Vitamin C kept increasing only as long as people were taking the supplement (blood samples 1 and 2), then stopped when people didn't take it anymore (blood sample 3) and kept dropping (blood sample 4). I would really love it if a way to activate our bodies' production of this important nutrient was found - but unfortunately, that doesn't seem to be happening with Formula 216. The results are consistent exactly with a direct increase from Vitamin C ingestion, instead of any long term generation by special herbal ingredients. They also try to use the fact that alcohol seemingly increased their subject's urine Vitamin C as proof that it's somehow being regenerated, instead of being used up by alcohol:

it would be anticipated that any acute oxidative stress coming from any toxin (such as the presence of a substantial amount of alcohol) or body-wide infection would be expected to immediately DEPLETE circulating vitamin C levels, resulting in LESS TO NO spillage of vitamin C in the urine. Instead, this volunteer drank a large amount of alcohol in the form of whiskey and a prompt, sustained INCREASE in urine vitamin C spillage was seen, the exact OPPOSITE of what should be typically seen.

But it's just another fraud, for two reasons:

Formula 216 urine Vitamin C test results after alcohol ingestion

First of all, notice how they didn't test whether alcohol alone actually increased the Vitamin C losses in the urine. Because, 8 and a half hours before the test that showed the yellow (highest) result, the subject took Formula 216 which - remember - contains Vitamin C. So, the expected thing - where excess of ingested Vitamin C gets lost in the urine (archive) (MozArchive) - happened:

Less than 0.4 mg of vitamin C appeared in urine of all volunteers after single doses of 15 and 30 mg (Fig. 4). After single doses of 50 mg, six of seven subjects had <0.4 mg of vitamin C in urine. At the plateau for the 60-mg daily dose (immediately prior to the 50-mg bioavailability sampling), vitamin C excretion was <0.4 mg in 24-h urine collections from several volunteers (data not shown). From 100 mg of vitamin C as a single dose administered orally or i.v., urine excretion was 25 mg.

As you can see, even 100mg (much less than in Formula 216) is enough to increase urine Vitamin C loss in a healthy person. But even if they were able to accomplish this feat with alcohol alone (and no supplemental Vit C), that wouldn't mean anything as alcohol makes you piss away Vitamin C (archive) (MozArchive):

Alcohol in either form produced a 47% increase in urinary ascorbic acid excretion.

The test was also done on one person only, and we don't even know who she is, previous health status that might have skewed the numbers (diabetes (archive) (MozArchive) affects urine Vitamin C loss, for example), etc. It's just shady business all around. The fraud does not even end here though. One bottle of Formula 216 costs 30 US dollars (archive) (MozArchive) - this for 275mg of Vitamin C in a tablet. There are 30 tablets in a bottle - so overall, you get 8250 mg of the substance (the other ingredients are almost certainly irrelevant in terms of Vit C increase). Now let's compare that to a random other Vitamin C supplement (archive) (MozArchive). That one contains 500mg per tablet, with 120 of them in a bottle (60000mg overall). You get 7 times more Vitamin C for 3 times less price; therefore - per amount of Vitamin C - Formula 216 is over 20 times more expensive. Though Formula 216 contains a few other ingredients such as Vitamins A, D and Zinc - even if you count those, the price is still into the stratosphere. And those other substances don't have anything to do with Vitamin C production, therefore they don't erase the fraudulent claims nor make Formula 216 better than a cheap Vitamin C tablet (that's why people would want to buy it in the first place, right? For the alleged Vitamin C increase?). Even if you believed in the restoration of Vitamin C production in humans by the secondary substances from Formula 216, you can easily get those elsewhere. That cheap Vitamin C tablet contains the citrus flavonoids (or you can just eat an orange) and the effects of olive leaf extract can be presumably gotten from just using olive oil (and I can't find evidence that that increases Vitamin C production from a searx or pubmed search, anyway).

There you go, my friends. This fraud got me so angry that I actually bothered to whip out this essay. Certainly, I have never seen something so blatant (except at Mozilla). They even got a famous naturopathic doctor to endorse this product. Adding fuel to the fire, the site doesn't display at all without JavaScript. No matter, Diggy is here to bury the evil as usual. Have a nice, healthy day - hopefully without the need for trash like Formula 216.

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