In keeping with the season, here are five scary things for the supplement industry, four that are silly, and one that is less so:
Nightmare No. 1
The NDI Guidance comes to represent not FDA’s current thinking on the subject of New Dietary Ingredients but its FINAL word. Like the protagonist in The Cask of Amontillado, the dietary supplement industry would have drunk from a poisoned flagon of DSHEA, only to awake to see the final brick—with the words “Premarket Approval” etched upon it—being mortared into the wall.
Nightmare No. 2
The FTC clamps down further, requiring two double-blind, placebo-controlled clinical trials to support every health claim for every company every time, not just for those companies that have signed consent decrees which is—at least in theory—the way it works now. Got something you’d like to say about your product? Not so fast, my pretty! Manacles are affixed two-by-two along the dank walls of the Dungeon Where Free Speech Goes to Die.
Nightmare No. 3
Our hero (I’m thinking of a cross between The Medicine Hunter and Indiana Jones) strides from the fastness of the Amazonian rainforest to report having found a tribe whose members can’t remember the last time someone died. Their secret? The pulp of a rare fruit. After the bioactives of this miracle orb are analyzed and distributed, people start living longer. And longer and longer, until the day when the human population broke the 7 billion barrier is just a quaint memory. And people are reminded that there are things worse than dying.
Nightmare No. 4
EU regulations are strangling innovation on the continent. Foremost among these is the labyrinthine and dysfunctional EFSA health claims (dis)approval process. Yet for all of the Sturm und Drang coming out of Europe, the EU regulatory scheme holds a strange allure for regulators in other countries. In our nightmare scenario, some simulacrum of the EFSA claims approval process crosses the Atlantic like Dracula hidden in his casket aboard a freighter. Having sucked the blood from the European healthy products industry, it sets about to do the same on this side of the pond.
Nightmare No. 5
And now I’ll take my tongue out of my cheek and talk about something that is legitimately scary. More products show up all the time spiked with undeclared pharmaceutical ingredients in the weight loss and erectile dysfunction categories. In the case of weight loss, the crooks are lacing their offerings with sibutramine, a pharmaceutical appetite suppressant that until 2010 was marketed under the name Merida. It was pulled from the shelves for safety reasons because of increased risk of cardiac problems and stroke. Tainted ED products are laced with knock off sildenafil citrate (Viagra). While this drug seems fairly safe when used as directed, you can’t do that if you don’t know you’re taking it (and if you don’t know what the dosage is). Like any pharmaceutical, sildenafil and sibutramine have contraindications and potential side effects that must be taken seriously.
The statistics of toxicology would tell us that risk goes up with exposure. While I don’t have data on the sales of counterfeit products, the sheer volume of new ones that show up proves the demand is huge and growing. With more people taking this stuff all the time, how long will it be before someone dies? And where will the mainstream media likely lay the blame for such an event?
Cantaloupes just killed a number of people, but you didn’t hear the mainstream media complaining about the “unregulated” food industry, did you? No, the focus was on the sloppy practices of one supplier and how the system in place to inspect its plant failed in this case. If (when?) someone dies after using one of the tainted ED or weight loss products, it’s unlikely the supplements and functional foods industry will be treated in a similarly balanced fashion. The industry will need a more effective story line other than to mewl, “Yes, we are regulated!” and then start pointing to GMPs and so forth.