December 12, 2003 Letter to Senators Warner and Allen
and Representative Moran
and Representative Moran
PO Box 8208
Alexandria, VA 22306-8208
December 12, 2003
The Honorable John William Warner
United States Senate
225 Russell Senate Office Building
Washington, DC 20510-4601
The Honorable George F. Allen
United States Senate
204 Russell Senate Office Building
Washington, DC 20510-4604
The Honorable James P. Moran
U.S House of Representatives
2239 Rayburn House Office Building
Washington, DC 20515-4608
Dear Senators Warner and Allen and Representative Moran:
As a constituent and one of 190 million users of dietary supplements in the United States , I am alarmed by the discussions in Congress to change the law governing these safe, affordable and effective products, including vitamins, minerals, herbal and specialty products.
Although the safety record for dietary supplements far surpasses all drug products and many conventional foods, some in Congress seem intent upon imposing standards that in some cases exceed those for over-the-counter and prescription drugs. This translates into higher costs for me, the consumer, and fewer product choices.
The law governing supplements, the Dietary Supplement Health and Education Act, clearly gives the Food and Drug Administration all the authority it needs to police the marketplace and keep bad products from being sold. I urge you to support any legislation that would give the FDA more resources to enforce DSHEA while leaving it intact.
Congress surely recognizes that there is a healthcare crisis in this country. And by supporting changes to the law that will limit the people’s access to products that help keep them healthy, you’re adding to it. Please don’t dismantle DSHEA.
Sincerely,
James Landrith
Subject: Correspondence From Senator Allen
From: senator_allen@allen.senate.gov
To: james@jameslandrith.com
Date Sent: 12/29/2003 4:45:13 PM
December 29, 2003
Mr. James Landrith
Post Office Box 8208
Alexandria, Virginia 22306
Dear James:
Thank you for contacting me regarding the Dietary Supplement Safety Act. I appreciate your concerns and value the opportunity to respond.
I firmly believe in the right of the American people to determine the relative advantages and disadvantages of using legal nutritional products. The federal government should not dictate to a free people what they can or cannot purchase. I also believe, however, that the government plays an important role in keeping the public informed of the negative effects of certain supplements and regulating those that pose extreme health risks. When it is discovered that a certain supplement has exceedingly dangerous consequences, especially when children often use the substance, we must ensure the protection, safety and security of the American consumer.
As you may know, a bill has been introduced in the Senate – S. 722 – that would require manufacturers of dietary supplements to submit reports on adverse experiences with dietary supplements to the Food and Drug Administration. This bill would restrict health choices and increase the costs of health care. While I am working diligently to provide access to dietary supplements, public health and public choice should not be compromised under any circumstances.
As your Senator, I understand that both freedom of choice and safety of consumers can coexist, and I will work diligently to ensure that our laws never unduly sacrifice one for the sake of the other. Should legislation regarding nutritional supplement regulation come to the Senate floor for vote, please be assured that I will keep your thoughtful comments in mind. Thank you again for taking the time to contact me. If you would like to receive an e-mail newsletter about my initiatives to improve America, please sign up on my website (http://allen.senate.gov). It is an honor to serve you in the United States Senate, and I look forward to working with you to make Virginia and America a better place to live, learn, work and raise a family.
With warm regards, I remain
Sincerely,
A George Allen
January 28, 2004
Mr. James Landrith
P.O. Box 8208
Alexandria, Virginia 22306-8208
Dear Mr. Landrith:
Thank you for contacting me to express your thoughts regarding the federal regulation of dietary supplements. I appreciate your thoughtful inquiry.
Congress enacted the Dietary Supplement Health and Education Act (DSHEA) in 1994. DSHEA addressed supplement definitions, safety, ingredient and nutrition labeling, supplement claims, good manufacturing practices, new dietary ingredients, and established an Office of Dietary Supplements at the National Institutes of Health Since DSHEA’s passage, which changed the safety standard and placed the burden of proof for supplement safety on the agency, the Food and Drug Administration (FDA) issued alerts on several supplements to warn consumers of possible safety problems.
As you may know, S.722 was introduced on March 26, 2003, by Senator Durbin. This bill has been referred to the Heath, Education, Labor, and Pensions (HELP) Committee. The Dietary Supplement Act of 2003 would amend the Federal Food, Drug and Cosmetic Act to require each manufacturer and packer or distributor of a dietary supplement, whose name appears on the label of such supplement, to investigate and report serious adverse experiences to the Secretary of Health and Human Services. The act also amends the definition of a dietary supplement to exclude anabolic steroids, and includes other provisions. To date, there has been no action taken on this bill in the Senate.
Additionally, on July 31, 2003, Senator Harkin introduced $.1538, the DSHEA Full Implementation and Enforcement Act, which was also referred to the HELP Committee. This bill would authorize funding for the FDA to carry out the DSHEA. It would also require an annual report on the regulation of dietary supplements. To date, there has been no action taken on this bill in the Senate.
In related matters, Senator McCain introduced S.1002, the Amateur Sports Integrity Act on May 6, 2003. This bill, which was referred to the Senate Commerce, Science, and Transportation Committee, would establish a program to better research performance-enhancing drugs and to create better methods of detecting these substances in athletes. This bill would also establish a fund to educate children of all ages on the dangers and consequences of performance-enhancing drugs.
As a member of the Senate HELP Committee, please be assured that I will continue to closely evaluate legislation such as the Dietary Supplement Safety Act, that comes before the committee. I appreciate knowing your views on this issue and will be sure to keep your thoughts in mind should this legislation come before the committee or the full Senate.
Again, thank you for contacting me.
With kind regards, I am
Sincerely,
John Warner
JW/jkr