The following letter was sent by Senator Orrin Hatch, senior member of the HELP committee, to Senator John McCain on March 4, 2010, in large part as a result of the massively successful letter-writing campaign initiated by Citizens for Health and several other groups.
Dear Friend,
Today, you have the right to choose which vitamins, herbs, and supplements are best for you and your family. But your freedom to choose these products and your access to alternative and complementary treatment is under attack in Congress. Please donate to Citizens for Health today so that we can protect your rights and keep you informed.
Citizens for Health has a successful track record empowering consumers and defending your rights in law and policy. In 1994, we helped educate consumers and coordinate over 2.5 million letters to Congress supporting The Dietary Supplement Health and Education Act (DSHEA). Consumers won that hard-fought battle thanks to millions of people like you, who believe in their right to obtain and take dietary supplements.
We need your help again. Two weeks ago, Senators McCain and Dorgan introduced a bill called “The Dietary Supplement Safety Act ” which, if passed, will repeal key sections of DSHEA. Among other things it would give the FDA full discretion and power to compile a discreet list of supplements allowed to remain on the market while banning all others. You can learn more and sign our action request at http://www.citizens.org/?page_id=1868
Your donation today will help us educate and activate millions of people and protect your rights. We are posting frequent updates about the McCain and Food Safety bills at www.citizens.org, and will keep you informed.
The McCain bill, along with The Food Safety Bill (S. 510), represent a systematic attack on individual rights that directly impact how and what we choose to eat, prevent & treat disease and, promote our individual and family’s well-being. Indeed, in FDA hands, the authority created by these bills is likely to make both food and supplements less safe, less effective and much more costly.
Please donate online today at: www.citizens.org/?page_id=1779
Thank you for your support and solidarity!
Jim Turner
Tags: Jim Turner
By James Gormley, Senior Policy Advisor, Citizens for Health
More Info @ The Gormley Files
1. No phase-in period or “effective date”. Since legitimate dietary supplement companies and health-food stores would not have even one day to come into compliance with the new law, they would effectively be breaking the law the day after S. 3002 is passed.
2. Registration of supplement licensors. S. 3002 would require outfits that license dietary supplements to register their “facilities” under the FDA Food Facility program established by the Bioterrorism Act of 2002. Including these requirements would go against the purposes of the Bioterrorism Act and would serve no useful purpose other than creating more bureaucracy and red tape.
3. Registration of health-food stores. S. 3002 is unclear as to whether the current retailer exception to the Bioterrorism Act registration requirement is intended to be honored for supplement retailers.
4. Product and ingredient registration. The product/ingredient registration process included in S. 3002 is unclear in its use of the terms “ingredients” and “labeling.” As worded, S. 3002 would apparently require duplicate, therefore unnecessary, registration of every product at every point in its distribution! This would be an incredible burden, one that would mandate annual updates, and one that would not protect any proprietary information that is not required on product labels but that that may be required to be submitted in the registration process.
5. Replacement of new dietary ingredient (NDI) requirements with an FDA positive list. FDA received information between 1996 and 1998 from dietary supplement trade associations to record ingredients believed to be marketed in the U.S. prior to the passage of DSHEA. If there is any lack of clarity as to what dietary ingredients are “old,” the agency should initiate rulemaking to formally adopt the ingredients directly submitted by the trade associations.
6. Retailer evidence of compliance. The bill’s proposal to require health-food stores to obtain evidence of compliance with product registration and NDI notifications is would be ridiculously burdensome and something that is not required for other regulated goods.
7. Civil penalties. The bill would establish new, unnecessary civil penalties despite the fact that current law already imposes adequate fines and penalties for violations of the Food Drug and Cosmetic Act.
8. Non-serious adverse event reports. The FDA itself has made it clear that it would not be helpful for the agency to receive boatloads of minor or trivial (and probably not substantiated) adverse event reports associated with dietary supplements. Under current law, dietary supplement companies are already required to maintain records of all adverse event reports for 6 years and the FDA has the authority to inspect these records at any time.
9. FDA recall and “cease distribution” authority. S. 3002, as well as other food safety legislation already introduced in the 111th Congress (such as S. 510), would provide FDA with authority to mandate products recalls when health risks are presented by marketed products, which is fine. However, what is not fine is that S. 3002 would obligate the agency to issue a “cease distribution” order for any supplement identified as adulterated or misbranded, even in the absence of any perceived health risk.
Tags: James Gormley
By Shane Starling via www.nutraingredients-usa.com
Republican Senator John McCain of Arizona has issued a statement criticizing “lobbyists” of falsely attacking the Dietary Supplement Safety Act of 2010 he introduced at the beginning of the month, which seeks to amend DSHEA in several fundamental ways.
In the statement, McCain said: “Opponents have stated that the legislation would seek to limit consumers’ ability to purchase dietary supplements, vitamins, or prescription drugs. That is completely false…. If you take a vitamin now, this bill will in no way restrict your ability to take that vitamin.”
Senator McCain’s Bill requires companies to report non-serious adverse events to the Food and Drug Administration (FDA); gives immediate recall rights over products suspected of contamination; creates an Accepted Dietary Ingredients list in place of New Dietary Ingredients provisions and demands all facilities to register on a list annually.
It has drawn heavy criticism from industry which criticized it for being unnecessary, reactionary, regressive and potentially destructive of a healthy industry and the Dietary Supplement Health and Education Act (DSHEA) that governs it.
Senator McCain however said his Bill had been miscast and stated: “Opponents also claim the bill establishes a new regulatory structure for dietary supplements. That is completely false.”
Responding, the Alliance for Natural Health-US (ANH-US) said: “The broad regulatory framework for supplements at the moment is provided by DSHEA. McCain’s bill guts the protections provided by DSHEA and gives the FDA complete and arbitrary authority. If that isn’t a new regulatory structure, what is?”
The ANH-US pointed to Association of Poison Control Centers statistics that showed there were no dietary supplements-related deaths in 2008, the last year on record, despite claims from McCain that, “people have died from taking dietary supplements… and thousands have had to be hospitalized…”.
The bill can be found here.
Robust enforcement needed
Criticism of the Bill included that from founder and executive director of the American Botanical Council, Mark Blumenthal, who stated:
“It is understandable why legislators and others might feel the need to hold hearings and propose additional legislation to attempt to prevent or correct some of the problems in the dietary supplement industry.This includes the need to address problems of poor quality, intentional adulteration, exaggerated and unsubstantiated claims, and other excesses that exist in some pockets of the industry.”
He said the fact DSHEA had not in 15 years been, “adequately, uniformly, fully, and robustly enforced” fuelled the creation of such a Bill, but observed, “what is really needed is robust enforcement of existing laws and regulations, not more laws.”
A host of major sporting bodies including the National Football League (NFL) and Major League Baseball (MLB) have thrown their weight behind the Bill after Senator McCain said one of the motivations for introducing it was to combat contamination of sports supplements.
US Anti-Doping Agency chief executive officer Travis T Tygart stated: “The McCain bill is a fair and balanced approach that provides significant protections for all consumers of dietary supplements, while at the same time avoids placing unreasonable burdens on legitimate companies in the industry. We are grateful to Senator McCain for his strong leadership on this public health issue and urge other members of Congress to support this bill.”
Via www.examiner.com
Alternative remedies such as natural health supplements using vitamins and herbs, natural herbal remedies and holistic treatment are at risk. Coast-to-Coast just released a taped interview about the bill yesterday. Senator John McCain proposed The Dietary Supplement Safety Act (DSSA ), February 4, 2010, to put the Federal Drug Administration (FDA) in charge of regulating natural health supplements.
Alternative remedies bill
Alternative remedies are protected because they are classified as food. However, the new bill reduces potency a product with 1/2 carrot’s worth beta carotene for example and provides a list of acceptable ingredients.
FDA in charge?
This is the same FDA that allows dangerous prescription drugs on the market with long lists of side-effects. Watch any commercial on television that has 15 seconds on therapeutic effects of the drug and 45 seconds on side-effects including 4 hour erection and “sudden death.” Charles Krauthammer, Washington Post.
New natural health supplements at risk
The new bill even requires minor adverse effects from natural health supplements to be reported which is believed opens the door of harassment and allowing the FDA to pull products from shelves they deem appropriate. “A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless there is a history of use or other evidence of safety.”
This wording means new ingredients can be squashed. The difference between regulation of drugs and natural health supplements is astounding. What is suggested is drugs are safe and food is not. If alternative remedies are to be protected, many feel this bill needs to be stopped.
Protect alternative remedies by contacting legislators
To do so, contact your representatives and ask they do not vote for the Dietary Supplement Safety Act (S. 3002). Then contact your friends and ask them to do the same. The John Birch Society offers a very easy-to-use form to do both.
If complementary and alternative medicine is to remain viable and to continue to buy vitamins, then legislators need to know about this bill. Vitamins and herbs, nutrition products and natural health supplements are at risk for continued use as alternative remedies.