What the FDA doesn't want you to know about dietary supplements

[Guest guest]

September 24, 2003

http://www.reason.com/rb/rb092403.shtml

 

Snake Oil or Health Tonic?

What the FDA doesn't want you to know about dietary supplements

 

Ronald Bailey

 

 

 

Snake oil is a worthless preparation fraudulently sold as a cure for

many ills. Nineteenth century medicine shows notoriously peddled all

manner of tonics and physicks to cure everything from bunions to

cancer. The U.S. Food and Drug Administration (FDA) was established

ostensibly to protect the public against such hucksters. But nowadays

the FDA is also treating companies and people who want to communicate

scientific findings about nutritional supplements to the public as

though they, too, are snake oil hawkers.

 

For example, I recently got a form letter from William Faloon, who

heads up the Florida-based Life Extension Foundation (LEF), from

which I receive discount vitamins and supplements, warning me to

stock up on a three-month supply because the FDA had " initiated an

intrusive multi-day inspection " of the group's facilities. (Full

disclosure: I've been a member of the LEF for a couple of years.)

Faloon is worried because the FDA has actually arrested him and LEF

founder Saul Kent in the past for allegedly violating FDA

regulations. This is not to say that there are not real snake oil

sellers out there, but the LEF hardly seems a likely candidate.

 

What's at issue? " The fundamental question is whether or not

consumers can receive information based on peer-reviewed scientific

studies and authoritative government statements about how foods and

supplements affect their health, " says Jonathan Emord, one of LEF's

attorneys. In 1997, Congress enacted the Food and Drug Administration

Modernization Act, which explicitly allows supplement makers and

distributors to make health claims for their products if a government

agency " has published an authoritative statement, which is currently

in effect, about the relationship between a nutrient and a disease or

health-related condition to which the claim refers. " That is, vitamin

and supplement makers can communicate to their consumers the findings

of conclusive government research. Only, the FDA now says that they

cannot.

 

Emord notes that the FDA has set up guidelines that clearly undermine

the intent of the law. The rules allow the FDA alone to decide

whether or not a government agency's statement is sufficiently

" authoritative. " Furthermore, according to Emord, the FDA has now

worked out tacit agreements with most federal scientific agencies to

issue disclaimers with their research findings saying that they're

not " authoritative. " This bit of underhandedness is " a way to

restrict scientific information to government elites and disallow

access to it by the public, " says Emord.

 

Let's look at a few telling cases. Supplement makers Durk Pearson and

Sandy Shaw (again full disclosure: Pearson and Shaw have been

supporters of the Reason Foundation) wanted to add the following

claims to their supplements based on peer-reviewed scientific

studies:

 

.. " Consumption of antioxidant vitamins may reduce the risk of certain

kinds of cancers. "

 

.. " Consumption of fiber may reduce the risk of colorectal cancer. "

 

.. " Consumption of omega-3 fatty acids may reduce the risk of coronary

heart disease. "

 

.. " .8 mg of folic acid in a dietary supplement is more effective in

reducing the risk of neural tube defects than a lower amount in foods

in common form. "

 

The FDA opposed all of them. Yet the American Association for Cancer

Research cited many peer-reviewed articles in 1999 supporting the

claim that antioxidant vitamins helped prevent cancer. As it turns

out, there is now some doubt that high fiber diets protect against

colon cancer, yet that had been the advice of nutritionists and

oncologists for nearly three decades. The case for the

cardio-protective effects of omega-3 fatty acids has only been

strengthened over the years. And most bafflingly, whereas the FDA

wouldn't allow supplement makers to point out the benefits of folic

acid, in 1996 the agency required that bread and pasta makers include

the nutrient in their products.

 

In 1999, the Federal District Court for the District of Columbia

ruled against the FDA in Pearson v. Shalala, ordering the FDA to set

up a procedure whereby such claims could be properly evaluated.

Nevertheless, since then the FDA has resisted nearly every proposed

benefit claim for a nutritional supplement that has been brought

before it.

 

For example, the FDA nixed the claim that B vitamins can lower

homocysteine levels. (High homocysteine levels are increasingly

associated with heart disease.) The FDA also disallowed the claim

that saw palmetto extract may relieve the symptoms of enlarged

prostates. Fortunately, the agency has lost nearly every one of these

cases in court.

 

Companies should, of course, be held legally accountable for

disseminating false and/or misleading information. Furthermore, if a

supplement has a defined level of toxicity, e.g., vitamin A, then

warning labels are appropriate. But surely the Federal District Court

was right when it noted in Pearson v. Shalala that: " Truthful

advertising related to lawful activities is entitled to the

protections of the First Amendment. " It's high time that the FDA

recognized that that includes scientific information about health

supplements and vitamins.

 

 

 

Ronald Bailey is Reason's science correspondent and a fellow at the

International Policy Network.

http://www.policynetwork.net/