The Dietary Supplement Safety Act (S. 722)

Largely in reaction to the deaths of six individuals who used ephedra products, Senator Richard Durbin (D-IL) has introduced a bill that would give the Food & Drug Administration new, and totally discretionary, powers to regulate the dietary supplement industry.

While I'm no fan of ephedra, much of the current public outcry is misplaced.  I say this for two reasons:

• Many, many more deaths occur each year from taking FDA-approved medications, both OTC and by prescription.  FDA regulation is clearly not the answer; and
• The role of ephedra in the recent death of that baseball player is not cut-and-dried.  There were many other factors at play in his tragic death, many of which by themselves could have caused his untimely death.  (See this article from the Vitamin Research Products website.)

If passed, this act would:

• expand the FDA's regulatory authority over dietary supplements, largely undoing the protections we gained with the Dietary Supplement Health and Education Act of 1994 (DSHEA, pronounced du-shay) from the FDA's strong bias against things non-pharmaceutical,
• limit your freedom to choose an alternative to the toxic, and largely ineffective, options available with the dominant healthcare system, and
• allow the FDA to pull hundreds of products from the market, based on a single adverse effect report.

Note: S. 722 [Sec. 416 (a)(1)] requires such adverse effect reports to be submitted to the FDA, even when there is no causal link between the dietary supplement and the adverse effect.

A little historical background:

To put things into perspective here, we need to consider what went on before DSHEA.  (Do you really want to go back to that?)

In the late 1980's or early 1990's, a licensed medical doctor was treating his patients nutritionally, instead of using drugs.  Worse still (from the FDA's point of view) the B vitamins he was injecting into his patients were preservative-free.  The FDA found this to be wholly intolerable, and made this doctor the subject of a criminal investigation.

In the course of this investigation, agents went through the garbage bins behind this doctor's clinic, and found some moldy syringes.  This was all that was required to mount a raid.

Agents from the FDA, along with the local sheriff's department and the DEA, burst into this doctor's office with guns drawn, and essentially terrorized the staff for hours while they looted the office.  All of this, and no charges were ever filed.  But the doctor never had his files or computers returned.

Interviews with the DEA agents involved, as well as the sheriff's deputies, indicated that they went in expecting to find dangerous drug traffickers.  When they learned what the real circumstances were, they were understandably upset.  They felt snookered.

A new Dark Age:

The point is this: Passage of S. 722 could easily return us to this kind of nightmare.  The FDA is far too biased to be trusted with regulation of the dietary supplement industry.  And the total discretion this bill would give to the FDA as to what is safe to have on the market could very well be the death-knell to your freedom to choose an alternative to pharmaceutical-based healthcare.

This bill may be voted on later this summer (2003), or there may be attempts to attach it to another bill, and push it through the back door.  We all need to act immediately to help avoid this significant threat to your freedom to choose, and your health and welfare.

Action you can take:

The following are a few things you can do to help protect your right to healthcare outside the traditional healthcare system:

• E-mail the message below — or something similar — to your senators.  An easy, automated way to do this is through the National Nutritional Foods Association (NNFA) website.  [Editor's note: this option is no longer available.]  Just follow the link to S.722 (or see the bill here).
• The NNFA site also provides information on how to phone your senators, and provides a great deal of information on the bill.

One natural health lobbyist suggested that for US Senators, e-mail may currently be more effective than a handwritten letter.  But a handwritten letter would still work.  You can find your senators' addresses in the "government" information section of the phone book white pages.  If each letter is deemed to represent 1500 constituents, imagine the impact we could collectively make.

Contact friends and neighbors, and urge them to do the above.

Sample letter to send to your Senators:

Obviously, a personal letter would be better than a form letter (like this).  However, this letter deals with the issues that need to be addressed, and can be personalized by you before sending.

Please take the time to contact your Senators.  Our freedom may well depend on it.

[your name and address]

[date]

[Senator's name and address]

Dear [Senator's name]:

[Insert here some personal information about yourself, so that all messages do not look the same.]

As your constituent, I urge you to oppose any efforts by your fellow Senators to pass S. 722, the so-called Dietary Supplement "Safety" Act, recently introduced by Senator Richard Durbin.  I am deeply concerned that rather than passing this new act — which would unnecessarily expand the authority of the Food & Drug Administration — Congress should instead investigate and oversee ways in which the Food & Drug Administration can make full use of its current and more-than-adequate authority as granted by the Dietary Supplement Health and Education Act of 1994 (DSHEA).

I have read that the Durbin bill, despite its title, would allow no more consumer protection than current law provides.  It does, however, contain new and discretionary enforcement powers that would significantly undermine many of the freedoms that American consumers of dietary supplements — like myself — hold dear.

If adopted, this bill would subject nearly all vitamins, minerals, herbal products and other supplements to a level of scrutiny that is both unwarranted and unnecessary.  Products that have been used safely and beneficially for hundreds or even thousands of years would be subject to clinical evaluation using standards that are at the complete discretion of the FDA.

I am concerned that this bill, by questioning the safety of any dietary supplement that receives even one complaint, will result in potentially hundreds of products being removed from the marketplace.  Under this new legislation, the FDA has complete discretion to make this determination, regardless of whether the product was used under conditions cautioned against by the manufacturer on the label.

By almost every measure, and by a wide margin, dietary supplements can be used more safely than conventional foods and OTC drugs.  Yet this legislation exempts foods in these product categories from being classified as stimulants.  Specifically, the bill unfairly excludes the most common "stimulant" ingredient in foods: caffeine.

I ask you to oppose this extreme and unnecessary legislation, and instead take the opportunity to encourage and support the FDA in fully utilizing its enforcement powers as granted by DSHEA.  I look forward to hearing your thoughts on this important matter.

Sincerely,

[your name]