Legislators Push FDA Enforcement Funding
Published: Saturday, December 01, 2001
Championed by the industry’s top congressional allies, Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, two appropriations amendments to fund FDA’s efforts to finally put into effect components of existing Dietary Supplements Health and Education Act regulations could have a major impact in the way dietary supplements regulations are enforced.
Of the five pieces of legislation, one is already on its way to President Bush’s desk. On Nov. 15, the Senate Agriculture Appropriations Committee approved HR 2330, the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act 2002, which allocates money for the aforementioned activities during FY02 ending Sept. 30, 2002. Harkin and Hatch had previously proposed an amendment (2013) to the bill, which originally sought an increase of $3 million for upgrading the adverse-events reporting system for dietary supplements and $1 million for the FDA’s Center for Food Safety and Nutrition to enhance enforcement of requirements under DSHEA that are specifically related to the accuracy of product labeling, as well as the truthfulness and substantiation of claims.
Kevin Kraushaar, VP and director of government relations for the Washington-based Consumer Healthcare Products Association (CHPA), says that CHPA was lobbying primarily for items addressing FDA’s adverse-events reporting system. “Initially the administration asked for FDA to get $1 million to upgrade the reporting system, and the House agreed to that, but the Senate wanted it raised to $3 million,” Kraushaar says. “In the end, the committee reconciled and settled on a total of $2.5 million, with $500,000 allocated to the Center for Food Safety and Nutrition,” he says.
The enforcement of DSHEA has been the highlight of FDA’s infinitely controversial and often frustrating relationship with the dietary supplements industry, and some industry members hope these monies will give FDA the capability to enforce the regulations already in place. “With these additional resources, FDA will be better equipped to use its already existing statutory authority to regulate the outliers in the industry,” says Kim Smith, director of legislative affairs at the Newport Beach, Calif.-based National Nutritional Foods Association.
More Funds Needed
Although probable passage of these initiatives is a positive, Loren Israelsen, executive director of the Utah Natural Products Alliance, says they’re not enough to implement a broad regulatory program for dietary supplements. “We’re going to watch closely how this money is spent,” he says, adding that the industry could make it easier for FDA to spend the money it did receive in constructive ways. “We want GMPs [good manufacturing practices] to be completed, published and enforced.” Israelsen says. It is important for the industry and FDA to agree that those who do not comply with GMPs are problematic and that the industry will cooperate with FDA to point out the culprits, he adds. “We will join FDA publicly and privately to take noncompliers out and make sure it is known they are not welcome in the industry, that they won’t find sympathy or refuge here.”
While defending the amendment during committee, Harkin noted: “There is no question that there are some problems here, but I believe the majority of dietary supplements are upstanding products that are safe and accurately labeled. What we hope to convince our colleagues, though, is that problems in the marketplace are largely a failure of enforcement, and not law.”
Davis Bills Seen as
Redundant
In a separate attempt to regulate dietary supplements, Rep. Susan A. Davis, D-Calif., introduced two bills, which also aim to modify the legal framework for dietary supplements. HR 3065, The Dietary Supplement Education Act, focuses primarily on manufacturer and product registration with FDA, mandatory adverse-event reporting, consumer reporting, postmarket surveillance, inspection authority and good manufacturing practices.
The registration portion of the bill would require all manufacturers, packers and distributors of dietary supplements to register with FDA as well as submit a sample product label. It also gives FDA the authority to establish product registration regulations including a registration fee. Additionally, any adverse events resulting from the use of a dietary supplement would be required to be reported to FDA within 15 days. If a supplement is determined to have serious health consequences, FDA could require the manufacturer to conduct postmarket surveillances of the product.
Davis’ second bill, HR 3066, The Ephedrine Alkaloid Consumer Protection Act, would require a warning label on all products containing ephedrine alkaloids and a standardized nomenclature for the ephedrine ingredient to make it clear to consumers that the product contains ephedrine. Caffeine levels and/or other stimulant levels would also be required to be given on the labels. In addition to the warning label, the bill outlines specific restrictions on radio, television and nonlabel advertising, including a notice alerting consumers that a product contains ephedrine. Finally, the bill places a ban on the sale of ephedrine to individuals under the age of 18.
“Rep. Davis is well intended, but I don’t believe these bills will move very far or very fast. … I don’t believe it reflects a commercial reality,” Israelsen says. The real problem, he says, which most members of Congress understand, has been lack of enforcement. Prior to entertaining any new laws, existing laws must be implemented. “Most everyone feels that the proper enforcement of DSHEA is what is needed. With respect to ephedra, so much work is being done administratively that it seems ill-advised to jump ahead with legislation when all sides continue to work toward an administrative solution, which I suspect will serve the public interest better than throwing a new law at it,” Israelsen says.
In response to the Davis bills, the Washington-based Council for Responsible Nutrition (CRN) noted that it advocates the already existing partnership between FDA and the industry to remedy issues addressed in the bills and encourages FDA to implement
previously proposed actions regarding mandatory regulation of ephedrine, which
are consistent with DSHEA. Such actions would render the new legislation unnecessary, the group says.
Hatch and Harkin also dug their heels into the Labor-Health and Human Services Bill (HR 3061) in order to address the importance of the quality and scientific study of supplements, the necessity for the publication of GMPs, and the development of science regarding supplements. Their amendment allocated $500,000 to cover legal activities associated with enforcing DSHEA. The bill calls for $110 million to be designated to the National Institutes of Health, $20 million of which could end up in the Office of Dietary Supplements. The Labor Bill has been passed by both the House and Senate and, at press time, was in joint conference for debate.
Conservation Stressed in Agriculture Bill
Finally, progress was made on the Agriculture, Conservation, and Rural Enhancement Act of 2001 (S. 1628), also introduced by Harkin. The bill was approved by the Senate Committee on Agriculture, Nutrition, and Forestry on Nov. 15 with a vote of 12 to 9 and will be sent back to the Senate floor for further discussion. As it stands now, the bill includes key components, such as conservation, commodity income protection, energy and rural development. Most notable is the enlarged acreage for the Conservation Reserve Program to 40 million acres from 36.4 million and the doubling of acreage for the Wetlands Reserve Program.
Additionally, funding for the Environmental Quality Incentives Program was increased from $200 million per year to $1.25 billion per year. The energy component of the bill provides, for the first time ever, incentives for farmers to use renewable energy sources.
A grant/loan program will establish renewable energy cooperatives for farmers as well as assist in the purchase of renewable energy
systems, such as solar heat pumps and wind-turbines.
The Washington Post, however, reported that conservationists are disillusioned with the bill, saying that it “favors large-scale farmers at the expense of small producers and the environment.” Separately, Sen. Richard Lugar, R-Ind., said that the bill would depress prices and that the subsidies being proposed to farmers would go to the wealthiest farmers in Midwestern and Southern states, according to The Post.
For more information about dietary supplements legislation, visit: www.senate.gov, www.chpa-info.org, www.crn-usa.org, www.nnfa.org. For information and status reports on the Farm Bill, visit: www.senate.gov/~harkin, www.sustainableagriculture.net.