U.S. Senator Orrin Hatch (R-Utah) lead efforts to strike down an amendment that would dramatically overregulate the dietary supplement industry. Senator Dick Durbin (D-Ill.) introduced legislation that would unnecessarily expand the current registration requirements for anyone involved with the manufacturing, processing, packaging, or storage of dietary supplements to register with the U.S. Food and Drug Administration (FDA). The Durbin Amendment would also require that all registered facilities would need to submit to the FDA a list of all ingredients for each of the products they sell as well as a copy of every label. The Durbin Amendment drastically expands the regulation currently in place since 1994, the Dietary Supplement Health and Education Act (DSHEA), which Hatch authored. To watch Senator Hatch's speech click HERE.
Speaking on the Senate Floor in advance of a vote on the Durbin Amendment, Hatch said the Amendment “is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products.” Hatch added that instead of allowing the FDA to utilize the resources it already has under DSHEA, the Durbin Amendment “serves to punish all responsible companies with its overreaching mandates.”
Hatch added that 150 million Americans use dietary supplements regularly, and that multiple previous FDA commissioners feel that DSHEA provides the appropriate level of responsible oversight.
Below is the text of Hatch’s full speech delivered on the Senate floor:
Mr. President, I would like to briefly touch on another issue that is of great importance to me and to the people of Utah. Over 150 million Americans regularly consume dietary supplements as a means of improving and maintaining their health. The passage of the Dietary Supplement Health and Education Act — or DSHEA — in 1994 brought clarity, predictability, and a better understanding of what the FDA expected from industry and vice versa. DSHEA provides an appropriate structure that balances the risks and benefits to consumers with continued access and affordability.
Unfortunately, my colleague from Illinois, Senator Durbin, has filed an amendment to the current bill that would undo that well-balanced approach. As the author of DSHEA, I strongly oppose his amendment.
It would require facilities engaged in the manufacturing, processing, packing, or holding of dietary supplements to register with the FDA, provide a description with a list of all ingredients, as well as a copy of the labeling for each dietary supplement product. Additionally, the facilities must also register with respect to new, reformulated, and discontinued dietary supplement products.
While I appreciate my colleague’s commitment, his amendment is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products.
This is simply not the case.
Previous FDA Commissioners including Drs. Jane Henney, Mark McClellan, Les Crawford, and Andy von Eschenbach, as well as the former Deputy Commissioner, Dr. Josh Sharfstein, have all agreed that DSHEA provides an appropriate and sufficient level of oversight of this industry.
Under DSHEA, Congress set out a legal definition of what could be marketed as a dietary supplement and safety standards that products have to meet. It allowed the FDA to develop good manufacturing practice standards, and clarified what types of claims could be made.
And it provided the Secretary of Health and Human Services with the authority to impose an immediate ban on any dietary supplement that poses an imminent hazard to public health. DSHEA already provides the Secretary with the enforcement tools of seizure, injunction, or criminal prosecution for ingredients that pose an unreasonable risk of illness or injury, are poisonous or deleterious, contain unapproved drugs or food additives, or fail to meet good manufacturing practice standards.
Furthermore, under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a manufacturer, packer, or distributor whose name appears on the label is required to report a serious adverse event related to the use of a supplement within 15 business days to HHS; submit any related medical information received within one year of the initial report within 15 business days; maintain records related to each report for 6 years; and permit inspection of such records.
To me, that sounds like a whole lot of regulation.
The FDA already has a tremendous amount of regulatory oversight and enforcement tools when it comes to dietary supplements.
Yet instead of urging FDA to use its current enforcement authority to find and punish those companies that are not following the law, Senator Durbin’s amendment serves to punish all responsible companies with its overreaching mandates.
Finally, I would be remiss if I did not mention another obvious point, Senator Durbin’s amendment would have the devastating effect of piling on more work for an underfunded agency already struggling to keep above water with its current core responsibilities.
I will be voting against Senator Durbin’s amendment, and I urge my colleagues to do the same.