Why Are Supplements So Unregulated?

If you ever wondered why supplement manufacturers can get away with practically anything, the answer has two components: DSHEA and Orrin Hatch.

Oh No, Not Again!

I can almost hear you groaning “here he goes again,” with me already having written multiple pieces about the sorry state supplement safety is in right here, here and here and, oh, many more.

But this time it’s a bit different. This time we’ll  have a look at why supplements are so unregulated.

The Diet Supplement Health and Regulation Act

At the beginning of the 1990s, the US Congress pondered two bills:

• The first was to give the FDA mucho power to hand out penalties when the Food, Drug and Cosmetic Act was violated
• The second would have made nutritional and, more importantly, unproven therapeutic claims on labels illegal

Supplement companies were not happy about these developments. A huge lobbying effort ensued, which went from industry leaders putting direct pressure on Congress to as far as telling consumers the outright lie that the FDA wanted to “take their vitamins” away (which, in hindsight, might have been not that wrong, after all).

What emerged out of this concerted effort was the 1994 Diet Supplement Health and Regulation Act (DSHEA). It was the direct opposite of  the original idea and gave birth to what practically was a new regulatory category, the “dietary supplement.”

Everything Is A Supplement

This category allowed for practically anything to be a supplement – vitamins, minerals, amino acids, herbs and any combination of these.

In the bat of an eye, a whole host of over-the-counter medications weren’t medications anymore. Instead of being subject to some rather harsh safety regulations, they were now classified as harmless little friendly helpers. That a neurohormone like melatonin graces US Wal-Mart shelves in 200 pc. bottles, while in the EU it requires a prescription, is a direct result of this.

Furthermore, to make the tiger really toothless, the DSHEA also ensured that the FDA was only able to take action against any unsafe dietary supplement product after it reaches the market.

That is, in my opinion, the central reason for many of the unfortunate developments we saw over the last years. Stephen Barrett of Quackwatch put it succinctly:

If I were FDA Commissioner, I would drop any pretense of being able to protect the public. Instead, I would announce that unless Congress provides an adequate law, the FDA cannot protect the public from the deceptive marketing of what DSHEA calls “dietary supplements.”

But who was responsible for all this? You’ll now meet the central figure.

The Honorable Orrin Hatch

The man who pushed the DSHEA through is Orrin Hatch, senator for the state of Utah. Utah, whose supplement industry is worth around $7.2 billion and represents 1/5th of the entire market pie.

Senator Orrin Hatch.

With an industry this size in your home state, it apparently is hard to avoid some, shall we say, “entanglement.” And avoided it apparently wasn’t:

• Already by 1992, Senator Hatch owned 72,000 shares in a Utah supplement company
• In the mid-90s, one of his former chiefs of staff started supplement lobbying firm Parry and Romani Associates
• Parry and Romani Associates later employed Hatch’s son Thomas
• Hatch Sr.’s 2000 presidential primaries campaign was managed by one Kevin McGuiness, another lobbyist with ties to the supplement industry
• When Thomas Hatch started his own his own lobbying firm in 2002, it promptly received $45,000 from an association representing supplement companies
• In 2010, Senator Hatch received a generous re-election campaign contribution from 4 Life Research, after federal regulators accused the company of making exaggerated claims about their nutritional products

Senator Hatch Stays On Course

But he remains unphased by any criticism and to this day is the DSHEA’s sturdiest supporter, even though the numbers of deaths possibly connected to dietary supplements is ever mounting.

When in 2011 the FDA attempted to establish a bit more safety at least about supplement ingredients introduced after 1994 (the so-called “new dietary ingredients”, NDI), Senator Hatch wasn’t amused (PDF):

For example, the draft guidance would require a manufacturer to submit an NDI notification for every dietary supplement containing an NDI. This is directly contrary to the language of the DSHEA, which requires notification only of the intent to use an NDI. The FDA’s misinterpretation of this provision is far from harmless. Indeed, this burdensome requirement would impose substantial, additional costs on manufacturers […].

It goes without saying that the PR machine was back in action as well.

You Decide

I leave it to your judgment if Senator Hatch had consumer freedom and protection at his heart when he labored so hard to make the DSHEA reality. In the meantime, the list of supplement scandals keeps on growing.

Pictures courtesy of John Liu and the U.S. Senate.