Bipartisan Amendment to Drug User Fee Bill Passes; Dietary Supplements Exempted

An amendment aimed at safeguarding the human and animal food supply chain in the wake of wide-spread contamination issues was approved in the U.S. Senate yesterday with an important exemption for dietary supplements.

“We’re glad the co-sponsors of this bill recognized that DSHEA [Dietary Supplement Health and Education Act] and the recently enacted adverse event reporting legislation provide the necessary legal framework to protect public health,” said David Seckman, executive director and CEO of the Natural Products Association. “We urged our champions in the Senate and their colleagues who sponsored this amendment to exclude dietary supplements and are pleased they were able to do so.”

The amendment, summarized below, will be attached to a reauthorization bill for prescription drug user fees. The larger bill, S. 1082 or “PDUFA,” as it is commonly referred to, was originally passed in 1992 to augment Food and Drug Administration funding for the oversight of prescription drugs. The law is updated and renewed or “reauthorized” every five years. Congress has until September 30 to approve the law, which is currently being debated in the Senate. Because PDUFA is essentially “must pass” legislation, it is a likely vehicle for amendments.

Although dietary supplements will not be affected by the amendment, human and pet food manufacturers will be required to more closely monitor food suspected of contamination and report such cases to the FDA.

“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,” said Seckman. “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.”

As a side note to the PDUFA legislation, some in the industry had raised concerns that the bill would negatively impact dietary supplements. Sens. Orrin Hatch and Tom Harkin, staunch supporters of dietary supplements and co-sponsors of DSHEA, put those concerns to rest yesterday in a discussion with colleagues on the Senate floor. In the discussion, or “colloquy,” which becomes part of the Congressional Record, Sen. Mike Enzi explained that he and other drafters of the PDUFA legislation “took great pains to make certain there would be no conflict with DSHEA.” Another author of the bill, Sen. Edward Kennedy, reiterated this intention by saying that the bill would not “override, overturn or conflict with the Dietary Supplement Health and Education Act.” After receiving assurances from both the chairman and ranking Republican of the Health, Education, Labor, and Pensions Committee that PDUFA would in “no way interfere with consumers’ access to dietary supplements,” Sens. Hatch and Harkin agreed to support the bill. To access the full colloquy, go to

Key Provisions of the Human and Pet Food Safety Amendment, S.A. 1022
This amendment to S. 1082, the prescription drug user fee bill, according to its sponsors, is designed to close some of the gaps in the FDA’s food safety system that have been identified following the recent recalls of spinach, peanut butter, and pet food.

  • Requires the FDA to set processing and ingredient standards for pet food and to update the labeling standards for pet food including nutritional and ingredient information. The provision would require FDA to set these standards in consultation with relevant stakeholders including the veterinarian medical associations, animal health organizations, pet food manufacturers and the American Association of Feed Control.
  • The section also directs the Secretary of Health and Human Services to establish an enhanced system capable of detecting pet food contamination and outbreaks of pet illness and death. This provision would, to the extent appropriate, be modeled on the existing human food contamination and detection infrastructure.
  • Requires the 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. Recall data would have to be consolidated into and presented in a searchable electronic format so that the public could easily and rapidly determine if a product in question is subject to a recall.
  • Directs the Secretary to work with States to collaborate on activities and programs that assist in improving the safety of raw agricultural commodities. The Secretary will share resources in this effort with States to improve State food programs and help States establish standards and procedures to ensure processed produce is safe for human consumption.
  • Requires the FDA to establish a registry to collect information on cases of potentially dangerous food adulteration or suspected adulteration to help improve risk-based surveillance of food safety and improve the speed with which consumers and firms are notified about adulterations. Importers and domestic processors and manufacturers of food would have to submit information pertaining to actual or suspected adulteration of food. The submission would be made to the FDA for inclusion in a centralized database through a convenient electronic portal. This section also clarifies that during inspections of facilities as part of an FDA investigation, inspectors have access to records for purposes of the investigation.
  • Requires the Secretary of HHS to submit annual reports to Congress with improved information on the numbers of inspectors, inspections, violations, and enforcement actions.
  • Establishes that nothing in the Act shall affect the treatment of dietary supplements.
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