Senate Allocates $1 Million to Implement DSHEA 40693

Senate Allocates $1 Million to Implement DSHEA

WASHINGTON--As part of a new bill that passed in mid-October, $1 million was appropriated for ensuring that proper labeling and substantiated claims appear on dietary supplements (for a copy of this bill, visithttp://thomas.loc.gov/home/thomas.htmland conduct a keyword search). Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) introduced to the Senate Agriculture Appropriations Bill the amendment (No. 2013) that directed $1 million to the Center for Food Services and Applied Nutrition(CFSAN) at the Food and Drug Administration (FDA) to "enhance enforcement" of the Dietary Supplement Health and Education Act(DSHEA). The monies would be spent on supporting accurate product labeling and truthful, substantiated claims. The amendment was in the form of a written letter to the Senate.

Harkin began, "This is an area of extreme importance to American consumers, literally millions of whom regularly take dietary supplements to maintain their health."

Both senators cited studies and statistics that supported the reasoning behind giving money to implement DSHEA, as well as reporting on recent events that would have benefited from better labeling and substantiated claims on dietary supplements. In fact, Hatch cited the example of the recent conference given by the Senate's Committee on Aging, which stated that there were discrepancies in marketing dietary supplements to the elderly.

Not only were concerns about the elderly addressed, but also those about athletes and sports enhancing products. "I was dismayed to read last week that the [International Olympic Committee] warned athletes to avoid dietary supplements because of what it called 'lax quality control and labeling,'" Hatch stated. "This is a situation that should not be occurring, and our amendment today will help rectify that situation."

The senators both recognized the power DSHEA had given FDA to regulate supplements, but they also reported that FDA might not have taken advantage of that power. "It is amazing to me, and a complete indication of how little-enforced DSHEA is, that the FDA has apparently never invoked this section of the law," Harkin said. "We hope to correct that deficiency with our amendment."

The amendment would give $1 million to FDA to hire additional staff to better implement DSHEA. "Despite the best efforts of those of us who serve on the appropriations committee, the FDA is not getting the budget it deserves," Harkin explained.

Hatch and Harkin added that many media reports have stated that DSHEA "deregulated" dietary supplements. The senators hope with the appropriated funding, FDA could better implement DSHEA by making certain dietary supplements "are safe and accurately labeled."

The senators also stated that FDA's pending Good Manufacturing Practices (GMPs) could relieve this problem by ensuring that products are accurately labeled. Harkin stated, however, that the senators have written, called and implored the Office of Management and Budget (OMB) and the Department of Health and Human Services (HHS) to release these regulations, which they understood have been ready in near-final form for almost a year.

The industry concurred that FDA has been dragging its feet on the federally proposed GMPs. "[We] share the senators' frustration with the FDA's languor in issuing a GMP regulation," said David Seckman, executive director and chief executive officer of the National Nutritional Foods Association (NNFA). "NNFA has always maintained that DSHEA provides ample consumer protection--if it's fully enforced. This amendment not only provides much-needed funding, it sends a clear message that the FDA needs to start flexing its regulatory muscles."

"We cannot allow the very few products of poor quality to cast a negative shadow over the rest of the industry, which is so law-abiding," Hatch concluded.