Terra Sigillata

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).

i-90bfd30760d18eb63b91b0fe51e3d140-Locopops Cure wide 515px.jpg


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:

i-f0c115a24551670991354e6f2e58b215-Locopops Cure closeup 515px.jpg

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

Comments

  1. #1 chezjake
    July 26, 2009

    I hadn’t heard of paletas before, probably because I’m in upstate NY where the Hispanic population is growing but not big yet. However, I’m going to have to start researching a source, particularly of some of the savory flavors mentioned in the Wikipedia article. I really want to try that cucumber with chile and lime one.

  2. #2 Abel Pharmboy
    July 26, 2009

    chezjake, y’all come down to ScienceOnline’10 and I’ll take you over personally to try every flavor.

  3. #3 local grad student
    July 26, 2009

    i’m gonna have to gorge on the local fare before i leave next month. i almost forgot how teh srsly awesomz locopops are.

  4. I loves me some locopops. It definitely cures what ails yah.

  5. #5 Coturnix
    July 26, 2009

    Mexican Spicy Chocolate – that’s my favourite Locopops flavor.

  6. #6 Ashley
    July 27, 2009

    I’m an undergrad across the street from a Locopops, and they saddened me so much by not having the pickle flavour I’d always buy from Hispanic vendors in TX that I’ve only swung by a few times. That Mexican spicy chocolate sounds good now, though. Gotta try that one come fall. (:

  7. #7 Abel Pharmboy
    July 27, 2009

    @local grad student – you are leaving next month? where for? has it been that long? e-mail me pls

    @Coturnix – hmm, never tried it. I’m more a fan of the icy ones, not the dairy-based ones. Perhaps I need to expand my horizons.

    @SouthernFriedScientist – Do you have Locopops down your way or do youse need me to bring some out for you boys?

    @Ashley – mmmm, pickles. Remember that you can always suggest new flavors/flavours. The one on Durham’s Hillsborough Rd has a mailbox there in which you can submit your suggestions – I think you also have a compelling reason that they should consider it seriously.

  8. #8 Travis
    July 27, 2009

    I wrote my Master’s Thesis on DSHEA- I am glad to see some satire of that travesty. Part of any healthcare reform must include eliminating useless plant waste from drug store shelves.

  9. #9 John
    July 29, 2009

    According to the Council for Responsible Nutrition:

    “Structure/function claims describe effects of the product on the body. However, the law requires these claims
    must have substantiation (i.e., scientific support) that the claim is truthful and not misleading; FDA must be
    informed of these claims; and it may request to review the substantiation. A disclaimer must be added to a product’s label stating that the structure/function claim “has not been evaluated by” FDA. Health claims describe the relationship between a substance and a disease (e.g., folic acid can reduce the risk of neural tube birth defects). These claims must be submitted to and approved by FDA and be supported by “significant scientific
    agreement.” FDA has approved a handful of health claims for key ingredients like calcium and vitamin D, folic
    acid, and psyllium (fiber). FDA may also consider granting qualified health claims when there is some evidence
    of a health benefit, but not complete scientific agreement, if qualifying language can be developed that truthfully describes the state of the evidence.”

    Abel Pharmboy, are you saying the CRN has it all wrong?

  10. #10 Susan
    July 30, 2009

    Scientists who attempt to write about law (DSHEA) are engaging in an extreme sport. Stick to science, please Professor, and leave the blawging to others more a-b-l-e.

  11. #11 Susan
    July 30, 2009

    P.S. Come hear my lecture on DSHEA next semester! I might even use this post (with your permission of course)as a source of mis-information.

  12. #12 John
    July 31, 2009

    Abel, I’m sure you’re aware of the Lancet meta-analysis which found a specific brand of Echinacea decreased the odds of developing the common cold by 58% and the duration of a cold by 1·4 days.

    http://www.thelancet.com/journals/laninf/article/PIIS1473309907701603/abstract

    The proper conclusions: Not all Echinacea products are equal. Correctly formulated echinacea can be effective.

  13. #13 Dave, RN
    August 11, 2009

    As an RN I’ve seen herbal remedies take care of problems quite well, including in my own life. Many drugs come from herbs that are then sythesized. If they can’t synthesize it, they can’t patent it, then they can’t make money from it. That’s one reason why drug companies would love to see suppliments outlawed. Peopel realize they work, then they don’t need to spend their money on drugs and fatten thier already huge wallets. The FDA needs to stay out of the suppliemt area. They are not my mommy and daddy, and I don’t need them to protect me from myself.