Dietary Supplements Exempted

[Guest guest]

…sorry all, I meant to send this last week.

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 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,

which is 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. 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 www.naturalproductsassoc.org/PDUFA.

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.