New bill could remove supplements from marketplaceIf a new bill, the Dietary Supplement Safety Act, S. 3002 passes, it will amend the Dietary Supplement Health and Education Act (DSHEA) and have severe consequences for both suppliers and retailers.

• 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.