Warning: Danger Ahead

Written By:
Kaylynn Chiarello-Ebner
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No one wants to receive a warning letter from the U.S. Food and Drug Administration (FDA). But, the fact of the matter is that they are a normal part of how many industries, including ours, are regulated.

Warning letters don’t automatically result in jail time, fines or seizures. They don’t even always mean a company is guilty of a misstep (though many times it is). Rather, a warning letter is a notification that there could be a violation. The process outlines potential problems and gives companies time to respond and/or comply. Many firms do indeed straighten out any issues and move on, perhaps with simply a bruised ego.

Though they were never intended to do so, recent warning letters are triggering something far scarier than bad press and wounded pride: pricey litigation.

Trouble for One, Trouble for All
In April, 10 makers of dimethylamylamine (DMAA) supplements received warning letters from FDA for similar reasons: safety concerns, not going through the new dietary ingredient notification process and selling a substance the agency claims is synthetically produced. The situation isn’t without controversy. Many (including the American Herbal Products Association) feel that the production of DMAA from geranium oil is fair game as a supplement for several reasons.

The buildup to the letters was enhanced by other issues. The 2011 deaths of two military personnel were blamed on cardiac arrest caused by DMAA. This caused the U.S. military to ask that stores on its bases stop selling supplements with DMAA.

Whether you are for or against DMAA in supplements, the bottom line is this: no definitive changes have been made in the regulations with regard to DMAA. Stores can still legally sell it, and manufacturers following good manufacturing practices can make it.

Well, that’s not how everyone sees it. A California law firm was chomping at the bit, pacing and wringing their hands in anticipation of the letters. The moment the letters were signed, sealed and delivered, the firm swiftly launched class action lawsuits against the companies (and a few others) citing all of the reasons in the warning letters. This is far from the only case. Just in February, for instance, another law firm filed a suit against GNC and others for selling DMAA.

I fear that this kind of action sets a terrible precedent. Again, the companies have a couple of weeks to respond to the letters, and could very well work things out with FDA. Yet, they instead must defend themselves in court (and pay all the costs associated with that) or settle, another expensive option; all for doing something that may not be illegal.

To that point, I learned at a recent industry convention that some class actions are even being waged against companies making permissible health claims. And, one speaker indicated that since the term “all natural” has no regulated definition, we could see class-action-happy lawyers attack companies making those label claims. Where would it end? Could it wipe “all natural” wording off the map due to fear of lawsuits?

These lawsuits could be the next big threat against the industry—not an uncertain economy, unsympathetic regulators or even Big Pharma. Litigation like this not only makes for bad press, but also could break a small company. It’s something we can’t really control, but nonetheless, we should be ready for some turbulence ahead. WF

Kaylynn Chiarello-Ebner
Editor/Associate Publisher

Published in WholeFoods Magazine, June 2012