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Association of American Physicians and Surgeons, Inc.
A Voice for Private Physicians Since 1943
Omnia pro aegroto

Testimony on SB 722 – Dietary Supplement Safety Act

October 21, 2003 Dear Sen. ____________

The Association of American Physicians and Surgeons, a national, non-partisan professional association of physicians in all specialties founded in 1943, opposes S. 722, the Dietary Supplement Safety Act.

In 1994, our hundreds of thousands of patients, along with the rest of the country made it very clear that they wanted unrestricted access to dietary supplements when they supported passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). This new bill would be a step backwards.

  1. Patients oppose measure that would decrease access to dietary supplements;
  2. The bill creates a double-standard that can not be met by any product;
  3. It would result in affordable, beneficial products being pulled from the market;
  4. It would unnecessarily expand the power and budget of the FDA;
  5. The FDA acknowledges it already has a monitoring system and tools to alert consumers on safety issues.

Senate bill 722 would impose unnecessary, onerous, and expensive regulations o’n an industry that is exceptionally safe. It sets up a double standard for dietary supplements, a standard that could not reasonably be met by any product. It demands “proof” of the safety of any substance ever “associated” with a serious adverse event, without regard to known causality. The standard is far higher than that applicable to prescription or over-the-counter drugs, even though these drugs are inherently more dangerous than dietary supplements that have been used for centuries. For example, it is estimated that there are more than 16,000 deaths a year from non-steroidal anti-inflammatories such as ibuprofen. (New England Journal of Medicine, Volume 341, Number 18, 1397-1399, October 28, 1999)

The same standard applied to garlic, for example, would require multimillion dollar tests the first time someone experienced a heart attack after eating garlic bread. Such events would eventually occur, purely by coincidence.

Interestingly, caffeine is specifically exempted from the provisions related to stimulants, even though it is considered addictive and far more likely to cause adverse events than the covered dietary supplements. Once again, the double standard for the covered supplements is not appropriate.

One of the reasons that these supplements are affordable is because there is no prospect of patenting substances such as Vitamin C or other naturally occurring substances. But that low cost also means a lower profit margin, making it impossible to recover the enormous costs of testing and monitoring. Manufactures will be forced to remove many safe and beneficial substances from the market–permanently.

In addition to multi-billion dollar industry costs to consumers, this is an open-ended budget item. While the initial authorization is $10 million, this can be expanded exponentially as it becomes more apparent just how huge is the task of mandatory testing and monitoring every single dietary supplement.

Further, we are opposed to expanding the powers of the FDA, which already delays patient access to life-saving drugs and devices for many years. We are also opposed to FDA regulation of the practice of medicine. Physicians need the ability to recommend safe, natural products to patients who desire this option.

Perhaps the most compelling reason to oppose this bill is that the FDA already has the system and ability to monitor dietary supplements and sound the alarm to consumers. The Director of the FDA’s Center for Food Safety and Applied Nutrition enthusiastically told the House Committee on Government Reform just how well the Special Nutritional/Adverse Event Reporting System (SN/AERS) was working:

“…the Agency uses a variety of regulatory tools from enforcement actions to rulemaking when it has found dietary supplements that cause safety concerns. This case also is a good example of how AERS serve as our early warning signal and how just one AER can be a powerful indicator of a safety concern.” (Testimony, Joseph A. Levitt, May 27, 1999)

The Director goes on to point out how the FDA used the monitoring system and its powers to prompt recalls of Digitalis lanata and GBL (a pre-cursor to “date-rape” drugs), as well as issue consumer alerts on ephedra.

S. 722 is an unacceptable intrusion into the patient-physician relationship. It would abrogate important liberty rights of both patients and physicians. It will increase the cost of medical care. It will impede efforts to improve safety by placing insuperable barriers to choosing the safest options.

Our patients tell us they want more choices in affordable dietary supplements. We urge you to oppose S. 722.

Sincerely,

Jane M. Orient, M.D.
Executive Director