It seems as though our communications with Senators have succeeded re S.1082 and supplements - Thanks!
Posted: Sat May 05, 2007 3:20 am
From what I understand, discussion on the bill S.1082 was closed yesterday afternoon, having been amended (I THINK with general agreement by the full Senate) to specify that laws and guidelines presently in force in regard to dietary supplements would not be affected by this bill.
Apparently, senators got hundreds and hundreds of thousands of expressions of concern by their constituents about this bill affecting access to supplements, and they listened and acted.
So many thanks to everyone who took action – we appear at the moment to have been successful.
The bill has not yet been voted on by the full Senate and passed on to the House. So it’s still possible to find our interests in it sabotaged. But at the moment it sounds as though they wanted to lay this concern to rest.
The Dorgan amendment is also presently attached to this bill. This amendment says that individuals may import drugs from other countries. The Bush administration has said in writing it would veto S.1082 if it reached the president’s desk still containing this proviso. This amendment was added unanimously, 94-0, by the Senate. It’s possible that the Senate was acting to kill the Bill because of the President’s avowed intention to veto if that amendment were attached. Or they may be waiting for the House to remove the amendment before sending the bill back to the Senate. In any case, the President isn’t about to receive the bill today or tomorrow! The Senate sponsors have worked intently on this bill for more than two years, so I doubt that it will ultimately reach the President’s office in a form that will guarantee that the president will veto it. (Ah, politics!!).
Next step: Write to your Representative, and again say that this Bill, as it leaves the House, must continue to guarantee access to supplements, that this Bill cannot change the FDA’s regulations relative to dietary supplements without exciting tremendous outrage among the general public.
I’ve pasted below the section from the Senate proceedings where the Senate’s agreement to keep dietary supplements from being affected is summed up. (Proceedings of May 3, 2007).
Warmly, Rosemary
From the Congressional Register, May 3, 2007, Senate proceedings:
Senator Hatch: “For the edification of my colleagues, section 201ff of the Federal Food, Drug and Cosmetic Act, FFDCA, contains the definition of dietary supplements. That definition includes a proviso that supplements are to be considered foods, except in the instance when a product makes a drug claim. In other words, by Federal law, dietary supplements are generally considered to be foods.
It is for this reason that the language of the original Durbin amendment establishing a new adulterated food registry could have been read to apply to dietary supplements.
This raised problems for me, and indeed for our colleague Senator Harkin, since we had spent more than 2 years working with Senators DURBIN, KENNEDY, and ENZI to draft, pass and enact the Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462. That law authorizes a new program so that reports of serious adverse events related to the use of a dietary supplement or over-the-counter drug would be reported to the Food and Drug Administration, FDA, on a priority basis.
As I said, the Durbin amendment contemplates a new adulterated food registry. Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109-462. And so passage of the Durbin amendment could be seen to supersede the law we enacted last year for supplements, which I am relieved to hear was not the intent of our colleague, Senator Durbin.
Consequently, the amendment we adopted yesterday contains language that Senator Harkin and I suggested to make certain that dietary supplements would not be covered by the new food safety language and thus last year's law would not be superseded. To reassure those who are interested in the Dietary Supplement Health and Education Act, DSHEA, I wanted to take a moment to outline those changes.”
First, there is new language in the section establishing the adulterated food registry to express the sense of the Senate that: (1) DSHEA has established the legal framework to ensure that dietary supplements are safe and properly labeled foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act has established a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States; and (3) the adverse events reporting system under that act will serve as the early warning system for any potential public health issues associated with the use of these food products.
In addition, language contained in the Durbin amendment modifies the definition of supplement contained in 201ff of the FFDCA so that supplements will not be considered foods for the purpose of the new adulterated foods registry. This in no way would alter the time-honored conclusion of the Congress that supplements are to be considered foods. On the contrary, all it would do is exempt supplements from the registry.
These changes, all contained in the amendment which was approved yesterday, make clear that there are no new dietary supplement requirements in the Food and Drug Administration Revitalization Act. It is my hope this will reassure the many who have expressed concern that Congress was inadvertently repealing Public Law 109-462.”
(RCH NOTE: This Public Law is the DSHEA regulation providing access to supplements in the US without interference from the FDA.)
Apparently, senators got hundreds and hundreds of thousands of expressions of concern by their constituents about this bill affecting access to supplements, and they listened and acted.
So many thanks to everyone who took action – we appear at the moment to have been successful.
The bill has not yet been voted on by the full Senate and passed on to the House. So it’s still possible to find our interests in it sabotaged. But at the moment it sounds as though they wanted to lay this concern to rest.
The Dorgan amendment is also presently attached to this bill. This amendment says that individuals may import drugs from other countries. The Bush administration has said in writing it would veto S.1082 if it reached the president’s desk still containing this proviso. This amendment was added unanimously, 94-0, by the Senate. It’s possible that the Senate was acting to kill the Bill because of the President’s avowed intention to veto if that amendment were attached. Or they may be waiting for the House to remove the amendment before sending the bill back to the Senate. In any case, the President isn’t about to receive the bill today or tomorrow! The Senate sponsors have worked intently on this bill for more than two years, so I doubt that it will ultimately reach the President’s office in a form that will guarantee that the president will veto it. (Ah, politics!!).
Next step: Write to your Representative, and again say that this Bill, as it leaves the House, must continue to guarantee access to supplements, that this Bill cannot change the FDA’s regulations relative to dietary supplements without exciting tremendous outrage among the general public.
I’ve pasted below the section from the Senate proceedings where the Senate’s agreement to keep dietary supplements from being affected is summed up. (Proceedings of May 3, 2007).
Warmly, Rosemary
From the Congressional Register, May 3, 2007, Senate proceedings:
Senator Hatch: “For the edification of my colleagues, section 201ff of the Federal Food, Drug and Cosmetic Act, FFDCA, contains the definition of dietary supplements. That definition includes a proviso that supplements are to be considered foods, except in the instance when a product makes a drug claim. In other words, by Federal law, dietary supplements are generally considered to be foods.
It is for this reason that the language of the original Durbin amendment establishing a new adulterated food registry could have been read to apply to dietary supplements.
This raised problems for me, and indeed for our colleague Senator Harkin, since we had spent more than 2 years working with Senators DURBIN, KENNEDY, and ENZI to draft, pass and enact the Dietary Supplement and Nonprescription Drug Consumer Protection Act, Public Law 109-462. That law authorizes a new program so that reports of serious adverse events related to the use of a dietary supplement or over-the-counter drug would be reported to the Food and Drug Administration, FDA, on a priority basis.
As I said, the Durbin amendment contemplates a new adulterated food registry. Under the provisions establishing that registry, reports of adulterated foods would be made by many, if not all, of the same parties who are required to file reports of serious adverse events associated with the use of dietary supplements under Public Law 109-462. And so passage of the Durbin amendment could be seen to supersede the law we enacted last year for supplements, which I am relieved to hear was not the intent of our colleague, Senator Durbin.
Consequently, the amendment we adopted yesterday contains language that Senator Harkin and I suggested to make certain that dietary supplements would not be covered by the new food safety language and thus last year's law would not be superseded. To reassure those who are interested in the Dietary Supplement Health and Education Act, DSHEA, I wanted to take a moment to outline those changes.”
First, there is new language in the section establishing the adulterated food registry to express the sense of the Senate that: (1) DSHEA has established the legal framework to ensure that dietary supplements are safe and properly labeled foods; (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act has established a mandatory reporting system of serious adverse events for nonprescription drugs and dietary supplements sold and consumed in the United States; and (3) the adverse events reporting system under that act will serve as the early warning system for any potential public health issues associated with the use of these food products.
In addition, language contained in the Durbin amendment modifies the definition of supplement contained in 201ff of the FFDCA so that supplements will not be considered foods for the purpose of the new adulterated foods registry. This in no way would alter the time-honored conclusion of the Congress that supplements are to be considered foods. On the contrary, all it would do is exempt supplements from the registry.
These changes, all contained in the amendment which was approved yesterday, make clear that there are no new dietary supplement requirements in the Food and Drug Administration Revitalization Act. It is my hope this will reassure the many who have expressed concern that Congress was inadvertently repealing Public Law 109-462.”
(RCH NOTE: This Public Law is the DSHEA regulation providing access to supplements in the US without interference from the FDA.)
