On February 3, 2010, Sen. John McCain (R-Ariz.) announced that he would be introducing legislation that would amend the Dietary Supplement Health and Education Act (DSHEA) to give the U.S. Food and Drug Administration (FDA) additional powers over retailers and suppliers in the dietary supplements industry.
Over the past few years, several pieces of legislation have made people nervous, but this is by far the most serious threat we’ve seen. Even the Natural Products Association, who has supported several pieces of recent legislation, is strongly opposed to this bill.
Here are some of the details from the NPA:
- All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.
- For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.
- Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.
- The bill introduces severe monetary penalties for all involved in the supply chain including ingredient suppliers and manufacturers, up to two times their gross profit for failing to comply even with minimal technical requirements. These include oversights in registration, recordkeeping or reporting that have no effect on the safety of a product.
- Suppliers would be required to report all adverse events, not just those that are “serious.” Reporting of all adverse events, including even minor complaints, would provide no additional consumer safety. However, it will add a significant burden to manufacturers in recordkeeping and reporting, as well as exposure to potential product liability lawsuits.
- Introducing new or innovative dietary supplements or dietary ingredients will be subjected to a much more rigorous approval process.
My greatest concern is that in the name of “consumer protection” the government will limit access of effective natural products through explicit or implicit rules. Not cool.
[Read entire bill] (pdf)
Tell your Senator to oppose this bill by clicking here.
- All dietary supplements, whether vitamins, minerals, herbal products and others that were previously allowed under DSHEA, could be removed from the market under S. 3002. This legislation would mandate that every dietary supplement would have to go through a brand new process of government review (yet to be defined) in order to remain on store shelves.
- For the first time in the history of food or drug law, retail establishments would need to register with the FDA. Failing to register could result in severe monetary penalties, up to two times your gross profit. Not complying with even minimal technical requirements, such as minor errors in registration, recordkeeping or reporting could be considered a criminal offense.
- Retailers would also be required to obtain “adequate written evidence” from suppliers that each dietary supplement product meets all regulatory requirements. Again, failure to do so could result in severe monetary penalties.
- The bill introduces severe monetary penalties for all involved in the supply chain including ingredient suppliers and manufacturers, up to two times their gross profit for failing to comply even with minimal technical requirements. These include oversights in registration, recordkeeping or reporting that have no effect on the safety of a product.
- Suppliers would be required to report all adverse events, not just those that are “serious.” Reporting of all adverse events, including even minor complaints, would provide no additional consumer safety. However, it will add a significant burden to manufacturers in recordkeeping and reporting, as well as exposure to potential product liability lawsuits.
- Introducing new or innovative dietary supplements or dietary ingredients will be subjected to a much more rigorous approval process.
Clearly this story is a complete fabrication by the Liberal Media. Everyone knows Republicans are in favor of less government intrusion into our daily lives.
Right?
Well, I’ll leave that discussion for Jon Stewart to answer.
But for the record there is a co-sponsor across the aisle – Sen. Byron Dorgan (D-N.D.). So I guess in this case it’s a bi-partisan effort to potentially restrict access!
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