|
Double, Double, Toil and Trouble
by James Loftus They're at it again! The FDA and Pharmaceutical lobby seeks to take away your herbs and supplements You would have thought that the days of persecuting those wise in the ways of herbs and such were over by now. Well, apparently not. I recently received an email message that caught my attention more so than usual. It was titled “Under the Gun” and was from the Health Sciences Institute (www.hsibaltimore.com) regarding two bills now in the Senate, both of which deal with herbal supplements. Here’s the interesting part: Our very own Dick Durbin (D-IL) is the sponsor of bill S.722, which will broadly expand the FDA’s authority to control the dietary supplement market. If it is passed, this bill will seriously inhibit your freedom to make your own health care decisions. Fortunately, a second bill, S.1538, has been introduced in the Senate by Tom Harkin (D-IA) which challenges the need for S.722 and strengthens the 1994 legislation that was specifically designed to help protect the supplement industry from unnecessary constraints in the first place. If S.722 (the Dietary Supplement Safety Act of 2003) is passed in its current form, it will give the Food and Drug Administration new powers never intended in the original supplement legislation. For instance, FDA officials would be able to remove an entire class of supplements from the market if only one serious adverse reaction complaint is filed, even if the complainant is someone who used the supplement in disregard of the instructions and warnings of the manufacturer. This is the definition from the bill (emphasis added): ADVERSE DIETARY SUPPLEMENT EXPERIENCE - The term `adverse dietary supplement experience’ means an adverse event that is associated with the use of a dietary supplement in a human, without regard to whether the event is known to be causally related to the dietary supplement. There is no distinction made in the bill between supplements manufactured from different parts of a plant, nor for different manufacturing processes that may be employed; no reference to different sources for supplements by location or organic content. If one person complains of having an “adverse reaction” to a supplement, all of that class of supplement may be disapproved for sale to the public. If such a complaint was received, supplement makers (do you have any doubt that this also includes those who grow and harvest herbs?) are then required to demonstrate the safety of their products. The process for this is also outlined in the bill, and is one that would put a heavy financial burden on the accused manufacturer, for many sufficient to put them out of business. Further, supplement manufacturers are required to establish procedures to follow up on their products after they are sold, which may sound like a good idea, until you realize that this means keeping track of the people who use each item they make, or in the wording of the bill, “The Secretary may by order require a manufacturer of a dietary supplement to conduct postmarket surveillance for the dietary supplement ...” Once the FDA has been alerted by the manufacturer, the packer, or the distributor of the supplement — anyone whose name appears on the labeling is required to be involved — that someone thinks they may be having a problem, various reporting and evaluation actions come into play. For those supplements that reach the evaluation stage, the FDA sets the standards for the evaluations and then determines if the standards are met. The FDA would act as prosecutor, judge, and jury, while accused manufacturers would be forced to pay the costs. Senator Durbin says his bill will “save lives and restore America’s confidence in the use of dietary supplements.” As if we don’t already know that herbs and supplements are useful as they are, and more regulations will stop some from misusing ephedra or psuedoephedrine-containing “supplements” at football practice. Sorry. That, and controlling how people choose to maintain their health, are the sources of S.722. In fact, S.722 gives the FDA the opportunity, with a few later amendments driven by other tragic cases, to dismantle the dietary supplement freedom that we’ve enjoyed for almost a decade under the Dietary Supplement Health and Education Act (DSHEA). DSHEA classifies and regulates dietary supplements as food. Under DSHEA, the FDA and the FTC already regulate the manufacturing of supplements, as well as labeling and advertising. 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. Senate Bill 1538, titled “DSHEA Full Implementation and Enforcement Act,” was introduced by Senator Tom Harkin (D-IA) to help strengthen the original DSHEA of 1994, making S.722 irrelevant. Under S.1538, the FDA would receive additional funding to ensure that DSHEA is fully carried out as originally intended. S.1538 also increases funding for dietary supplement research and consumer information through the National Institutes of Health. What can you do to support S.1538 and defeat S.722? Both of these bills are expected be voted on soon, so now is the time to let your senators know that S.1538 is the reasonable, sensible approach to the dietary supplement debate. From my experience with legislators, phone calls and emails are largely ignored or answered with autoresponses. A letter, however, is regarded as a serious opinion and is paid some attention. Tell your Senators that you strongly support S.1538 (“DSHEA Full Implementation and Enforcement Act”) which will provide all the funding necessary to insure consumer protection under DSHEA. Tell them you hope they’ll support S.1538, while also opposing S. 722 (“Dietary Supplement Safety Act of 2003”), which will only limit our freedom to make our own health care choices with the responsible use of dietary supplements. Please ask your friends and family to help get the word out about these two important bills, also. Here are the addresses of the Senators from Illinois: Sen. Richard Durbin Sen. Peter Fitzgerald Sources: |
||||||||||||||||||||||
All content and articles copyright ©2002 by Lightworks Inc except where noted. All rights reserved.