Wednesday, February 17, 2010

More Govt regulation. WHY? Govt is too big now.

SupplementsToGO.com vigorously opposes the well-intentioned but misdirected “Dietary Supplement Safety Act of 2010” (S.3002) introduced by U.S. senators John McCain (AZ) and Byron Dorgan (ND). We believe it is poor legislation because the real solution is enforcement of current laws, not adding to the mountain of governmental regulations.

Tell your Senators not to co-sponsor or support this bill. Tell your congressional Representative not to co-sponsor or support any House version of this bill, which is expected to be introduced in the future. You may do this online via the Alliance for Natural Health (ANH) website at www.anh-usa.org/new_site/?p=2307

• We support current regulations promoting the safety of dietary supplements and encourage the FDA to go after lawbreakers.

• The FDA already has adequate legal authority to enforce federal laws, including DSHEA, the Anabolic Steroids Control Acts, and the mandatory reporting of all serious adverse events for both dietary supplements and OTC drugs.

• But this bill targets controlled substances that the FDA says are actually drugs, which are not defined as dietary supplements under current law. It makes no sense to add more regulations to control dietary supplements when the stated purpose is to rein in already illegal mislabeled/unapproved drug products.

• Dietary supplement manufacturers already are registered with the government because existing bioterrorism regulations require this of all food manufacturers.

• Supplement label information is already available in the public domain of the marketplace and the Internet, and there are already legal requirements that documentation of all label claims be submitted to the FDA and that all product labels be accurate.

• Mandatory recall authority is already part of the Food Safety bill expected to pass Congress soon.

• While current law requires pre-market submission of all new ingredients to the FDA, this new bill would require dietary supplement manufacturers to use only ingredients appearing on an officially approved list and to seek approval for all new formulas. This model resembles the highly restrictive Canadian regulatory scheme that in 5 years has approved only 16,000 out of 42,000 product license applications and caused some American manufacturers to pull out of the Canadian market, forcing many Canadians to cross the border to buy certain multivitamins and other supplements here and smuggle them back home. Some safe products now sold freely in the U.S., like healthy vegetable oil capsules, have languished in the Canadian bureaucracy for over 4 years and are just now getting preliminary approval to submit product license applications.

• This bill would needlessly expand the federal government’s power and increase FDA bureaucracy and budgets, negatively affecting all law-abiding manufacturers of dietary supplements and tens of thousands of retail stores nationwide, leading to far fewer available products and higher consumer prices.

• This bill would strangle a successful market that grew and added jobs and exports during the current recession, helping Americans meet basic nutritional needs in a cost-effective manner that did not require government funding and may have actually decreased some Medicare spending, according to the conclusions of Lewin Group reports.

• This bill would start to harmonize US dietary supplement laws with unpopular CODEX rules, European Union and Canadian regulations that have historically restricted access to safe dietary supplements that have long been available in the U.S. This would force aggressive and unpopular foreign regulatory schemes on unwilling American citizens, instead of simply enforcing current laws that already prohibit unlabeled performance-enhancing drugs and mislabeled or adulterated dietary supplements.

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