Health Freedom Group Opposes Mandatory AER For Dietary Supplements
11 Jul 2006
After careful review, the American Association for Health Freedom (AAHF) was unable to support the Dietary Supplement and Non-Prescription Drug Consumer Protection Act (S.3546), despite enduring gratitude to the bill's originators and long-time dietary supplement advocates, Senators Hatch and Harkin. Though their efforts on behalf of the dietary supplement consumer have been significant, the S.3546 falls short of the public's best interests.
S.3546 would amend the Food, Drug, and Cosmetic Act to require the reporting of "serious" adverse events for both over-the-counter drugs and dietary supplements to the Food and Drug Administration. This is one step closer towards treating dietary supplements more like pharmaceuticals.
AAHF, as the politically active voice for healthcare practitioners and their patients, emphasizes that dietary supplements, as concentrated nutrient forms, should continue to be handled as conventional food.
AAHF also doubts the efficiency of the S.3546 requirement to submit adverse events. The accuracy and reliability of a consumer's submission would be questionable, especially without a practitioner's estimation. Complaints should not be sent to manufacturers and retailers who have little or no knowledge of the consumer's health factors. Furthermore, there is a serious potential for abuse of the system as supplements could easily be blamed in place of things as divergent as pharmaceutical or recreational drugs, genetic sensitivities, food intolerances, or alcohol abuse, among others. A healthcare professional is crucial to determining the adverse event.
The FDA's recent faltering and systematic setbacks show that it cannot manage such a bill. The FDA's enforcement reports for drug products show it to be an agency under increasing pressure to do more with less. The number of warning letters issued to pharmaceutical companies has dropped over the past 10 years even as product recalls have increased. In other words, the agency is allowing more manufacturer product mistakes to reach the market. Adding supplements would further reduce enforcement efficiency for both drugs and supplements.
The S.3546 bill is a demonstration of the federal government wasting money to protect the public from a relatively small health threat on the part of dietary supplements. Statistics show that even food is more dangerous than dietary supplements as it causes 5,000 deaths and over 80 million hospitalizations a year in the US, according to the Centers for Disease Control.
The American Association for Health Freedom encourages the dietary supplement industry to report their adverse events and believes that over-the- counter medications should have a mandatory adverse event reporting process. S.3546, however, is not what is best for the American public.
The American Association for Health Freedom is a 501(c)4 nonprofit organization that advocates citizen access to a wide range of healthcare and prevention methods. AAHF is politically active at both the federal and state levels and is concerned with the protection of patient and practitioner rights.
Contact your representative today through the AAHF website:
http://www.healthfreedom.net.
American Association for Health Freedom
http://www.healthfreedom.net AER for Diet Pill