View Full Version : my correspondance with the senate-S. 1310, the Dietary Supplement and Labeling Act

10-26-2011, 06:16 PM
heres what i wrote

Supplements have an unrivaled safety record. Statistics show they're safer than drugs, safer than medical devices, safer than cosmetics, and even safer than food.

The FDA cannot define New Dietary Ingredients so broadly. According to these guidelines, almost everything is a New Dietary Ingredient. This will strangle innovation and deprive consumers of the supplements they depend on for their health.

The FDA did nothing about new dietary ingredients for 17 years. Now they want to wipe out 17 years' worth of innovation and 17 years' worth of benefits to the consumer.

When the Dietary Health Supplement Education Act was passed, Congress intended a simple notification process for new dietary ingredients. The FDA is turning this into a pre-approval scheme, which goes against the intent of the law.

The FDA already has ample regulatory authority to take action against a product if it's unsafe. They don't need to have this pre-approval power, too.

These could be disastrous to public health. At a time when preventative measures are even more important to health care costs, the FDA is limiting access to preventative health care.

The cost of complying with these guidelines would be astronomical. Experts estimate that the studies required would cost between $100,000 and $200,000 per ingredient notification. That adds up to millions of dollars per supplement company. Smaller companies would not be able to afford this and would go out of business.

The economy is already hurting and we have high unemployment. Experts estimate that this could cost the economy tens of billions of dollars and result in the loss of tens of thousands of jobs.

The government's resources are already stretched. We have record budget deficits and record debt. Why enact more regulations when there are no safety issues here?

I request that Congress direct the FDA to carefully review their draft guidance. If they do not amend the guidance to reflect my concerns, I request that Congress call hearings at the end of the review process. I also call on Congress to write legislation that would "grandfather" all supplements currently on the market.

Thank you for your time.

and my responses

Thank you for contacting me about the Dietary Supplement Labeling Act of 2011 (S. 1310). I appreciate hearing from you.

As you may know, Senator Richard Durbin (D-IL) introduced S. 1310 on June 30, 2011. Among its provisions, this measure would require dietary supplement manufacturers to register their products with the Food and Drug Administration (FDA) and establish new labeling requirements. I understand your concerns about S. 1310, which is currently pending before the Senate Committee of Health, Education, Labor and Pensions for review. While I am not a member of this panel, please be assured that I will keep your thoughts in mind as this measure progresses through the legislative process.

Thank you again for your correspondence. Please do not hesitate to contact me in the future if I can be of assistance.


Pat Toomey
U.S. Senator, Pennsylvania

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 individualís 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 manufacturers 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. In the 112th Congress, Senator Richard Durbin introduced S. 1310, the Dietary Supplement and Labeling Act. This legislation would require manufacturers of dietary supplements to register their products with the Food and Drug Administration and makes improvements to the labeling requirements for dietary supplements. The bill is intended 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 of dietary supplements with the importance of ensuring consumer safety. The bill has been referred to the Committee on Health, Education, Labor and Pensions, of which I am a member. Please be assured that I will keep your concerns in mind as the committee continues its review of this legislation.

As always, I appreciate your views, thoughts and concerns as they assist me in understanding what is important to the people of Pennsylvania. Please do not hesitate to contact me in the future about this or any other matter of importance to you.

If you have access to the Internet, I encourage you to visit my web site, http://casey.senate.gov. I invite you to use this online office as 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.

Bob Casey
United States Senator

cutn' heads
10-27-2011, 08:40 AM
did you sign it "palehorse"? lol

nice to see people get involved.