Dietary Supplements

On Tuesday I told you about what is happening at the moment regarding the EU Supplements Directive. Now I want to alert you to what is happening on the other side of the pond... as this really is a global issue that affects us all.

In a previous e-Alert I told you about the situation in the US regarding senate bill (S. 722), which is designed to broadly expand the US Food and Drug Administration's authority to control the dietary supplement market. If passed, this bill like the EU Supplements Directive, could seriously inhibit the freedom of Americans to make their own health care decisions.

But now a new bill has been introduced in the Senate (S. 1538), which challenges the need for S. 722, while strengthening the 1994 legislation that was specifically designed to help protect the supplement industry from unnecessary constraints in the first place.

Let's hope that that S. 1538 becomes the voice of reason in the US dietary supplement debate... and that a similar bill will be passed in the UK to help overturn the current EU Supplements Directive.

Unnecessary and overreaching
If passed in its current form, S. 722 (titled 'Dietary Supplement Safety Act of 2003') will give the FDA sweeping new powers.

For instance, under S. 722, FDA officials would have the ability to remove an entire class of supplements from the market in response to the filing of only one serious adverse reaction complaint - even if the complaint was filed by someone who used the supplement in contradiction to the instructions and warnings of the manufacturer.

In such a case, supplement makers would then be required to demonstrate the safety of their products; a process that would put a heavy financial burden on accused manufacturers - heavy enough to drive some out of business.

For those supplements that did reach the evaluation stage, the FDA would set the standards for the evaluations and then determine if the standards were met. In effect, the FDA would act as prosecutor, judge, and jury, while accused manufacturers would be forced to pay the bill against a stacked deck.

The sponsor of S. 722 - Senator Dick Durbin - says his bill will 'save lives and restore America's confidence in the use of dietary supplements.'

First: With dietary supplement sales at an all time high, American's are displaying a growing confidence in their use of supplements, not a lack of it. And second: It's simply nave to think that additional regulations will save lives when the current regulations that promise safety for prescription drug users are powerless to prevent thousands of drug-related deaths every year.

The alternative
Think of S. 722 as a staging area from which the FDA will have the opportunity to dismantle the dietary supplement freedom that the US has enjoyed for almost a decade under the Dietary Supplement Health and Education Act (DSHEA).

In a nutshell, DSHEA classifies and regulates dietary supplements as food. Under DSHEA, the FDA and the FTC regulate the manufacturing of supplements, as well as labelling and advertising.

And yet critics of DSHEA would have you believe that the act doesn't regulate supplements at all. What they're really saying is that DSHEA doesn't regulate supplements in the same way that drugs are regulated. In fact, DSHEA has been a boon for the supplement industry, by not hampering the manufacture of supplements with unnecessary regulations.

This is where the new Senate Bill 1538 comes in. Titled 'DSHEA Full
Implementation and Enforcement Act,' S. 1538 was introduced by senators Tom Harkin and Orrin Hatch to help strengthen DSHEA, making S. 722 irrelevant.

Under S. 1538, the FDA would receive additional funding to ensure that DSHEA is fully carried out, as originally intended. The new bill also increases funding for dietary supplement research and consumer information through the National Institutes of Health.

As many e-Alert readers are aware, I'm no fan of regulations and I don't believe that the best way to solve problems is to throw money at them. But I do believe that DSHEA provides more than enough regulation of dietary supplements. Therefore, S. 1538 offers a reasonable and responsible alternative to the completely unnecessary extremes of S. 722.

Predicting how and when Congress might act is a longer shot than predicting the stock market. But it appears that both S. 722 and S. 1538 may come before the Senate for a vote in the next few weeks. I'll obviously keep you fully updated on developments as they happen.