FDA continues to target alternative health

Seeing Double Standards

Emboldened by their recent move to ban ephedra, FDA officials are chomping at the bit. Now they have three more supplement ingredients in their sights – all marked for official extinction.

Speaking last week at the University Mississippi School of Pharmacy, FDA commissioner Mark McClellan said that the agency, “will be doing more work in the coming months to more closely evaluate the potential safety risk of these products, and we could take further action to remove unsafe dietary supplements from the market.”

Mr. McClellan said he was “concerned” about several dietary supplements, specifically mentioning three that are used in some weight-loss formulas: bitter orange, aristolochic acid and usnic acid.

From what I’ve read, those who use any of these supplements should be careful with them and certainly only take them as directed. But outlawing their sale with an FDA ban is like killing mosquitoes with a bazooka. Is the fuss really worth it?

Don’t bet on it. Something else is going on here.

No contest

Should bitter orange, aristolochic acid and usnic acid be banned?

Problems have been reported with all three of these botanicals – mostly due to their misuse. But unlike ephedrine (the synthetic form of ephedra that has caused most of the problems for which ephedra has been blamed), these three have not been associated with the deaths of any high-profile athletes or teenage boys, prompting emotional scare headlines.

In fact, bitter orange, aristolochic acid and usnic acid may not have contributed to any deaths at all. (In Belgium, several kidney failures were associated with aristolochic acid, but they were erroneously reported as deaths.) But of course, a supplement that has the potential to cause kidney failure or, in the case of usnic acid, severe liver problems should be used with the greatest care.

Which brings us once again to acetaminophen. Just last week, in the e-Alert “Flick of the Wrist” (1/19/04) I told you how easy it is to overdose on acetaminophen, prompting liver failure that results in more than 100 deaths each year. From what I’ve read (there’s not much out there on this topic) usnic acid has been cited as “playing a role” with one death due to liver failure, and nine cases of liver problems from which patients recovered.

So let’s check our scorecard here:

  • Acetaminophen: Multiple deaths yearly.
  • Usnic acid: One death, maybe.

And yet, the day the FDA calls for a ban on acetaminophen will be the same day that pigs fly south for the winter. But somehow the FDA has decided that usnic acid is so dangerous that it needs to be classified as a forbidden poison.

Planting the seeds

What’s really going on here?

For ten years, FDA officials have been frustrated by the Dietary Supplement Health and Education Act (DSHEA), which limits the agency’s power to regulate food supplements in the same way drugs are regulated. In the e-Alert “Under the Gun” (11/10/03) I told you about congressional efforts to give the FDA greater latitude over supplements, but for the moment those efforts seem to have stalled.

So the ephedra ban was a sweet victory for the FDA (provided the ban survives a court challenge, which it probably will). Finally, FDA officials got to have things their way. But more than that, they helped their efforts to pass legislation for more regulatory control by sending a message to congressmen and the public: The safety of dietary supplements is unreliable.

The fact that this message is untrue is beside the point. The point is to get the message out there and repeat it until people believe that legislation to increase FDA powers is absolutely necessary. Is the public really in grave danger when products that contain bitter orange, aristolochic acid and usnic acid are on the shelves? That’s very unlikely. But with the announcement that there are three more reckless culprits out there, the idea is planted again. And it appears that as the year goes along the idea will be repeated and planted again and again and again.

And more to come

In his Mississippi speech, Mr. McClellan stated that new dietary supplement regulations for manufacturing and labeling will be announced sometime in 2004. He said, “When these regulations are finalized later this year, the public will not be faced with ‘buyer beware’ any longer.”

But I disagree. The public will be faced with a much more serious “buyer beware.” Buyer, beware: Your health care choices are being stripped away.

To Your Good Health,

Jenny Thompson
Health Sciences Institute

“U.S. Probing Dietary Supplements, Besides Ephedra” Lisa Richwine, Reuters Health, 1/21/04, reutershealth.com
“FDA Plans to Expand Inquiry” Elizabeth Weise, USA Today, 1/21/04, usatoday.com
“FDA Plans More Scrutiny of Supplements” Scott Spoerry, 1/20/04, cnn.com