In the United States, herbal and non-herbal dietary supplements can be sold without any assurance of safety or efficacy as a result of a hastily-passed, late-night, final-session piece of legislation put forth by Sen Orrin Hatch (R-Utah). (Aside: Utah has several large dietary supplement manufacturers.) This piece of legislation is named the Dietary Supplement Health and Education Act of 1994, or DSHEA. A FAQ for consumers is provided by the US Food and Drug Administration here.
An unusual aspect of the law is that supplement manufacturers can make a variety of wellness or structure-function claims as long as 1) they do not refer directly to disease treatment or prevention and 2) that the following statement appears somewhere on the label and in advertising:
“This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease”
This statement is lovingly referred to by my physician-blogger colleague, PalMD, as the Quack Miranda Warning. This disclaimer is usually printed in such small font on labels and websites as to be unreadable by people over 35 (the primary dietary supplement demographic) and we all know it is, well, – sensitive readers: please cover your eyes and ears – bullshit. These products are often available in pharmacies, right beside drugs with proven efficacy and known safety profiles. And even though people pay out-of-pocket for these remedies while complaining to the pharmacist about their $20 co-pays on prescription drugs, the industry racks up around $20-30 billion in sales.
So, it was with great mirth that I took this photograph last time the PharmKid and I were at our favorite purveyor of Mexican-style paletas, Locopops (2006 interview with founder, Summer Bicknell, here).
Here we have an advertisement that carefully follows the DSHEA guidelines. However, in print large enough to see even in this photo we have a precisely truthful, non-misleading statement:
What is so unreasonable or draconian about requiring dietary supplement manufacturers to print such a factual, readable statement on their labels?
We all know, from several well-controlled clinical trials for example, that Echinacea supplements have no effect on reducing the incidence or severity of colds and flu – so let’s be truthful and put that statement on all Echinacea products (excellent 2005 NEJM example here).
Actually, to be perfectly honest, I have to admit that Locopops do more for the health of the PharmKid and I than does any dietary supplement. My favorite new flavor is their Ginger Lime but I also love their regulars: Mighty Mojito, Very Berry, and Pomegranate Tangerine, while the PharmKid is an exclusive Strawberries and Cream aficionado.
And since I missed writing a Friday Fermentable post this week, I should also mention that our local wine merchants, Wine Authorities, have also teamed with Locopops to offer wine pops: Grüner Veltliner and Dry Rosé (and non-alcoholic Cookies and Cream for the kids) – only at their store