We’re talking a lot in Washington these days about limiting principles.
In the healthcare debate, we wonder if government can make you buy health insurance, what stops it from making you buy broccoli or lobster or a Prius. In the arena of foreign engagements, if we can lead from behind to take down Khadafi in Libya, why not Assad in Syria, Chavez in Venezuela or the newest Great Dear Fabulouser-Than-All-Before-Him leader of North Korea?
How much airport security is enough? And why? And when and how should government be able to listen to our phone calls and monitor our texts and emails?
Then, there is the great American regulatory machine. How much of our freedom will we surrender to ensure our air and water are clean, our banks and financial institutions responsible and our food and drugs safe? What responsibility does the government have to present this information responsibly, to act without favor and with restraint? At what point do costs outweigh benefits?
Because, just as we didn’t need the financial crisis of 2008 to tell us money men sometimes lose their bearings, we didn’t need the Pink Slime controversy of 2012 to know the Safety Cops themselves are not immune from hysterical overreach.
Which brings us to the case of – and I’m only going to type this once – dimethylamylamine. This chemical, better known as DMAA, is a stimulant extracted from the geranium plant. The recommended dosage produces an energy burst comparable to two to three cups of coffee. It is used in dietary supplements and by those wanting to get energized for a strenuous workout.
It is an ingredient in about 200 pre-workout products, including such name-brand stimulants as Code Red, Hemo Rage Black, Hydroxystim, Jack3D, Napalm, and Nitric Blast.
It works the way most stimulants do, by restricting blood vessels. Narrow the vessels and you force the blood to push harder to get through. Pushing harder takes more energy. Once the body begins to unleash that energy, it begins to produce it more efficiently and then can be harnessed for other uses.
The FDA, with which Americans have had a, shall we say, complicated relationship through the years, has sent letters to 10 manufacturers demanding they go to the same lengths to prove DMAA is safe as those who seek approval for prescription drugs – or remove it from the market.
GNC says it has sold 440 million doses of DMAA and had exactly one complaint about side effects. But the government says it knows of 42 cases of deaths, heart attacks and other problems experienced by DMAA users but not definitely linked to DMAA. And the military has banned the sale of DMAA on all military installations after two soldiers died of heart attacks after having used it.
The FDA isn’t that certain about its case-it has yet to recall DMAA. But it has sent letters to 10 manufacturers saying it wants them to prove why a plant extract in a bodybuilding substance shouldn’t be treated as a prescription drug in the eyes of regulators – with all the research and safety testing costs that entails.
Most DMAA products sold today use a synthetically created form – as do other vitamins first derived from botanicals, such as Beta-alanine, vitamin C, vitamin E, beta-carotene, lycopene, alpha lipoic acid and various amino acids. The FDA is using this to buttress its case for upping the regulatory ante on DMAA.
Here’s a limiting principle: If Congress thinks an agency is overstepping the bounds established for that agency by Congress, perhaps the agency should step back. Under this policy, FDA would leave the makers of DMAA alone. The authors of the legislation that governs dietary supplement sales in the United States – Sens. Orrin Match, R-Utah, and Tom Harkin, D-Iowa, -- both say FDA has better things to do than harass DMAA makers.
I think that’s what bothers me most about this. Here you have 45 complaints – combined – out of what has to be close to 1 billion doses sold at this point. And none of those … not one … can be definitely laid on DMAA. With all the real e coli out there, why is FDA involved in this?
The Regulations R Us crowd would have us believe the FDA does this because otherwise GNC will put profits first until DMAA-drugged dead bodies litter the streets. In reality, GNC’s bottom line depends on its products being perceived as safe, beneficial and effective, and the company has spared no expense to evaluate the government’s claims. After DLA removed DMAA products from its shelves, GNC reviewed its “adverse events reports,” had an independent toxicology lab study the safety of the products, reviewed all published peer-reviewed studies and requested and reviewed the military’s records. It concluded – as did the Vitamin Shoppe, its largest competitor – DMAA is safe.
So where do we go from here? What will be FDA’s limiting principle? We want the FDA to protect us from hoaxes and real danger. But we also want some restraint, some sense that its priorities are our priorities.
Is it too much to ask the FDA not to overreact here? Is it too much to ask it to at least define a limiting principle? Pretty much the entirety of the vitamin and supplement industry depends on it getting this right. And pretty much any industry could be next.