The whole point of the FDA having a "nutritional supplement" category is to allow people the freedom to buy and sell substances of speculative benefit.
The FDA started cracking down on the entire industry in the early 1990s, before there was a nutritional supplement category. Turns out, a nontrivial number of nutritional supplement makers are in Utah, and Senator Orrin Hatch became their champion. He's done more than most -- possibly more than anyone -- to keep nutritional supplements unregulated. In exchange, he's gotten ridiculous numbers of campaign contributions from the industry. I'd much rather have no nutritional supplement category, and I suspect that there will be multiple attempts to get rid of it the instant Hatch leaves the Senate.
IMO, in many cases with nutritional supplements, it is quite well known what it does, because that stuff has been used for ages and a bunch of observations on it has been gathered.
It's just that, as you say, no one has a motivation to shell out the money to get a certificate for it.
Also, boggling at 100% pure caffeine. I see the appeal to great stupidity there...
The overlap between prescription meds and OTC supplements is sometimes odd. My father was told by his primary care person (a VA nurse practitioner) to take calcium and D3. She wrote a prescription, ordered it through the VA pharmacy so that he got the low co-pay deal, etc. When it became clear that my parents have trouble swallowing the massive calcium pills, we switched to the sugary gummy versions, which I buy for them at Walgreens at a fairly high price. Is it the candyfication that makes it not possible to prescribe? The efficacy seems the same, based on their blood test results. My MD told me to take D3 also, without suggesting that it be a prescription med. I went to a drug store and carefully read all the labels to compare inactive ingredients. I knew much of what you said (but you said it so well!) but there are still weird areas.
Yes, usually lactose* in the practice of pharmacy. In theory, I know how to do powder dilutions sufficient to measure immeasurably small quantities of a powder for accurate dosing. In practice, I have never had reason to do so since that one lab during pharmacy school and no one actually assayed the results of our labwork so some significant portion of the class likely did it wrong anyways.
*Not a single person in pharmacy school was able to sufficiently answer my questions about whether someone who was lactose intolerant would have issues with medications formulated with lactose as an inactive ingredient. And I bothered several faculty members with this question.
Misbranding vs adulteration is a remarkably brain-bendy set of things to look up. Some are absolutely straightforward, others are remarkably aggravating... but I should go to sleep because I don't actually remember any of the specific examples that bothered me.
Comments 20
Reply
The FDA started cracking down on the entire industry in the early 1990s, before there was a nutritional supplement category. Turns out, a nontrivial number of nutritional supplement makers are in Utah, and Senator Orrin Hatch became their champion. He's done more than most -- possibly more than anyone -- to keep nutritional supplements unregulated. In exchange, he's gotten ridiculous numbers of campaign contributions from the industry. I'd much rather have no nutritional supplement category, and I suspect that there will be multiple attempts to get rid of it the instant Hatch leaves the Senate.
Reply
"What the FDA does regulate foods for a few things ( ... )
Reply
It's just that, as you say, no one has a motivation to shell out the money to get a certificate for it.
Also, boggling at 100% pure caffeine. I see the appeal to great stupidity there...
Reply
Reply
Reply
Reply
Reply
Reply
*Not a single person in pharmacy school was able to sufficiently answer my questions about whether someone who was lactose intolerant would have issues with medications formulated with lactose as an inactive ingredient. And I bothered several faculty members with this question.
Reply
Reply
Leave a comment