Durbin Amendment Will Not Supersede AER Bill, Affect Supplements – Hatch

An amendment to the "Food and Drug Administration Revitalization Act" establishing an adulterated food registry does not apply to dietary supplements, Sen. Orrin Hatch, R-Utah, stressed in a statement before the Senate May 3.

The senator clarified the record during debate on the act, S. 1082, noting that a "number of questions have been raised" about how the amendment introduced May 2 by Sens. Dick Durbin, D-Ill., and Mike Enzi, R-Wyo., "would affect regulation of dietary supplements."

The "Human and Pet Food Safety Amendment," S.A. 1022, will not supersede the Dietary Supplement and Nonprescription Drug Consumer Protection Act, P.L. 109-462, which was sponsored by Durbin, Hatch and Sen. Tom Harkin, D-Ind. (¹ (Also see "Experts Give AER Prep Course, Discuss Potential Potholes At UNPA Seminar" - Pink Sheet, 29 Jan, 2007.), p. 4).

The original language of the amendment "could have been read to apply to dietary supplements," Hatch said. "I am relieved to hear [that] was not the intent of our colleague, Senator Durbin."

The food safety amendment that passed the Senate 94-0 "contains language that Senator Harkin and I suggested to make certain that dietary supplements would not be covered by the new food safety language," Hatch said.

"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,'" he said.

The Durbin amendment does contain language that modifies the definition of a supplement contained in the Food, Drug and Cosmetic Act amendment "so that supplements will not be considered foods for the purpose of the new adulterated foods registry," Hatch said.

However, "this in no way would alter the time-honored conclusion of the Congress that supplements are to be considered foods," he added. "On the contrary, all it would do is exempt supplements from the registry."

Congress has until Sept. 30 to pass the "FDA Revitalization Act," which is reauthorized every five years. It is currently being debated in the Senate.

"Because [S. 1082] is essentially 'must pass' legislation, it is a likely vehicle for amendments," the Natural Products Association told its members in an e-mail update shared with "The Tan Sheet."

"Public concern about the safety of the food supply following the recent recalls of pet food, spinach and other products has made this issue a top priority for Congress," NPA Executive Director and CEO David Seckman said.

"While this legislation is still far from being finalized and enacted, we can expect to see legislation passed this year that will allay consumer concerns about the safety of the foods they provide to their families and pets," he concluded.

Durbin, Enzi and cosponsor Sen. Edward Kennedy, D-Mass., all stressed the bill is only a first step in addressing food safety concerns.

"There is still more to be done to restore that faith [in the food safety system], and I look forward in the coming weeks and months to working with my colleagues to develop a comprehensive, effective strategy to enhance food safety," Enzi said in a May 2 press release.

The Durbin amendment is likely to serve as the basis for Congress' final action on food safety, an insider said, agreeing that more legislation may be in the works given the high degree of public concern.

It is hoped the situation will be a catalyst for a substantial increase in FDA's food budget, he added. According to the amendment, the Senate agrees: "It is vital to provide [FDA] with additional resources, authorities and direction with respect to ensuring the safety of the food supply of the United States," the bill reads.

It is the "sense of the Senate" that "additional inspectors are required to improve [FDA's] ability to safeguard the food supply of the United States," S.A. 1022 continues.

Additionally, "because of the increasing volume of international trade in food products the Secretary of Health and Human Services should make it a priority to enter into agreements with the trading partners of the United States with respect to food safety," it concludes.

"This pet food crisis was a warning sign, a signal to us in America that this dramatic increase in imports of food products leaves us vulnerable," Durbin said May 2 before introducing the bill. "We are naive to believe that any problem in the pet food industry can't possibly make it to the human side of the equation," he said.

According to Durbin, he and several other senators began working on the amendment following Congress' Easter recess. Sens. Herb Kohl, D-Wisc., and Robert Bennett, D-Utah, realized "the importance of this issue" after the pet food crisis started, Durbin noted.

The Center for Science in the Public Interest and the Coalition for a Stronger FDA are among the organizations that helped draft the amendment, he said.

"I wish to tell my colleagues that there were things I wanted to add in with this amendment, but in the interest of avoiding political conflict and in the interest of not slowing down this important legislation and in the interest of making certain that we did achieve something, I am saving those arguments for another day," Durbin said during debate on S. 1082.

One of the issues is mandatory recall power for FDA, he said. "Our government and its agencies do not have the power to recall contaminated food from the shelves. I believe that law needs to be changed."

Durbin and several other lawmakers introduced bills May 1 to give this power to the agency.

However, FDA is given a number of new responsibilities in the amendment.

The amendment requires FDA establish an Adulterated Food Registry "to which instances of reportable adulterated food may be submitted by [FDA] after receipt of reports of adulteration, via an electronic portal," the bill reads.

The bill also requires FDA "to work to develop efficient and effective communications plans to better coordinate with veterinarians and other relevant stakeholders during outbreaks of both pet and human food," a release from Health, Education, Labor and Pensions Chairman Kennedy explains.

"Recall data would have to be consolidated into and presented in a searchable format so that the public could easily and rapidly determine if a product in question is subject to recall," the release adds.

The amendment also requires FDA establish processing and ingredient standards for pet foods and update standards for labeling of pet food that includes nutritional and ingredient information.

Additionally, FDA must establish an early warning and surveillance system to identify "adulteration of the pet food supply and outbreaks of illnesses associated with pet food."

Provisions concerning the improvement of fresh and processed produce are also included.

Finally, FDA must submit an annual report to Congress with information about its inspection and enforcement activities.

Specifically, the agency must provide Congress with the "number and amount of food products regulated by [FDA] imported into the United States, aggregated by country and type of food," and "a listing of the number of [FDA] inspectors of imported food products ... and the number of [FDA] inspections performed on such products."

"Aggregated data on the findings of such inspections, including data related to the Federal Food, Drug and Cosmetic Act ... and enforcement actions used to follow up on such findings and violations," must also be included in the report.

Industry has also been given new responsibilities under the food safety amendment, primarily in the area of recordkeeping.

Food importers and firms that manufacture, process, package or store the products are required to maintain records "related to each report received, notification made and report submitted" to FDA, permit inspection of the records and make the records available during an inspection, the amendment says.

- Katia Fowler ([email protected])