Από: Senator Robert P. Casey, Jr. [[email protected]] Αποστολή: Δευ 26/08/2013 21:03 Προς: vassilios gikas Κοιν.: Θέμα: Response from Senator Casey Συνημμένα: Dear Dr. Gikas: Thank you for taking the time to contact me about dietary supplements. I appreciate hearing from you about this issue. Dietary supplements are intended to enhance an individual’s diet and provide nutrients. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements do not need approval from the Food and Drug Administration (FDA) before they are marketed. Rather, firms are responsible for determining that the dietary supplements it manufactures or distributes are safe. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Congress frequently considers legislation proposing changes to how dietary supplements are regulated. On August 1, 2013, Senator Richard Durbin of Illinois introduced S. 1425, the Dietary Supplement Labeling Act. This legislation would require manufacturers of dietary supplements to register their products with the FDA and would make improvements to the labeling requirements for dietary supplements. The goal of the bill is to help consumers decipher between products that are safe and those that could contain potentially dangerous ingredients. It also seeks to meet the challenge of balancing consumer access to dietary supplements with the importance of ensuring consumer safety. In July of 2011, the FDA published a draft guidance for industry entitled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” According to the Drug Enforcement Administration (DEA), the guidance will aid industry “in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary and in preparing premarket safety notifications.” The FDA accepted comments from the public until December 2, 2011 and will consider these comments before finalizing the draft guidance. There is a great deal of debate on how best to ensure the safety of dietary supplements, and I value hearing from you as I continue work on this issue. Another bill relevant to dietary supplements is S. 1031, the Family and Retirement Health Investment Act of 2013. Introduced by Senator Orrin Hatch of Utah, S. 1031 would make several changes to current health care laws. One change would be to allow funds from Health Savings Accounts and Flexible Spending Accounts to be spent on dietary supplements without a prescription. S. 1031 has been referred to the Committee on Finance, of which I am a member. Please be assured that I will keep your views in mind as the Committee considers this legislation. Again, thank you for sharing your thoughts with me. Please do not hesitate to contact me in the future about this or any other matter of importance to you. For more information on this or other issues, I encourage you to visit my website, casey.senate.gov. I hope you will find this online office a comprehensive resource to stay up-to-date on my work in Washington, request assistance from my office, or share with me your thoughts on the issues that matter most to you and to Pennsylvania. Sincerely, Bob Casey United States Senator
Posted on: Mon, 02 Sep 2013 16:22:45 +0000
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