Products promising seniors sexual stamina, more memory and reduced risk of cancer came under fire during a recent Capitol Hill hearing.
Sen. John Breaux, D-La., chairman of the Senate Special Committee on Aging, heard testimony in September from government officials and members of the medical community concerning the possibility that unscrupulous marketers use loopholes in the law to scam seniors into buying supplements. The hearing focused on Almon Glenn Braswell, whose direct-mail newsletter, The Journal of Longevity, touted the healing powers of his company's products.
The subject at issue was not alternative medicine per se, said Scott Mulhauser, press secretary for the committee. "This hearing was about unscrupulous marketing of unproven products to senior citizens."
Braswell and Ron Tepper, editor of the journal, were subpoenaed by the committee but both declined to comment under protection of the 5th Amendment.
No representatives from the natural products industry were invited to testify, but David Seckman, executive director and CEO of the National Nutritional Foods Association, heralded the committee's work. "We support all acts by the government to crack down on the bad apples in this business."
Along with testimony from the FDA and FTC, Breaux commissioned the Government Accounting Office to investigate whether fraudulent marketers were harming seniors, in particular. The GAO study determined that, indeed, the elderly might be at greater risk.
That age group faces physical harm, because they are more likely to be taking prescription drugs and have multiple conditions, two circumstances that can cause adverse events. Significant economic damage could also ensue as the products are often expensive and many seniors live on fixed budgets.
Despite the committee's stated focus, several who testified steered toward a second subject: regulatory oversight of the supplements industry, specifically the shortcomings of the Dietary Supplement Health and Education Act.
Joyce C. Lashof, M.D., who serves on the editorial board of the University of California, Berkeley Wellness Letter, called the 1994 legislation "ill-conceived." Lashof said it "pushed the floodgates open to allow anyone to market almost anything as a dietary supplement."
Representatives from the FDA and FTC said the statute had hampered their efforts. Breaux later said that even though only a small percentage of manufacturers are at fault, it might be time to tighten regulations.
Sen. Larry Craig, R-Idaho, minority chair of the committee, urged caution however. "We should remain wary of calls for regulations that may restrict an individual's freedom to make his or her own health decisions."
And Seckman, echoing a point made in the GAO report, said the FDA simply needs more money to do the job with which it is charged by the legislation. "The problem is that DSHEA has never been fully implemented," Seckman said. "And those agencies need to receive sufficient resources in order to do that."
Fight Over FDA Chief Likely To Ensue
Battle lines are being drawn in the fight to find a new head of the Food and Drug Administration.
The National Food Processors Association assailed Sen. Edward Kennedy, D-Mass., for telling President George W. Bush that he would oppose any nominee for FDA commissioner who had previously held office for a company that is regulated by the agency.
"It's extremely unfair and arbitrary to put [industry experience] down," said Kelly Johnston, executive vice president for government affairs and communications for the Washington, D.C.-based association, in a prepared statement. She added that industry veterans have knowledge of food safety issues, as well as economical and technologically sound methods for protecting the food supply.
With the recent switch in party control of the Senate, Kennedy once again chairs the powerful Health, Education, Labor and Pensions Committee, which has authority to hold hearings reviewing the qualifications of any potential FDA commissioner. Without a hearing from Kennedy's committee, no nominee could be recommended to the full Senate for a confirmation vote.
"We understand that a number of candidates are under serious consideration," Kennedy wrote the president earlier this summer. "We would emphasize, however, that it would be unprecedented for the commissioner to be appointed from an industry regulated by the FDA.
"To do so could raise irresolvable conflicts of interest, undercut public confidence, and undermine the agency's worldwide reputation as the gold standard of public health regulators."
Bernard A. Schwetz, D.V.M., Ph.D., has been Acting Principal Deputy Commissioner since the new administration took over.
Harkin Pushes For Food Safety
A proposed amendment to the 2002 agriculture spending bill, which would further the cause of improved food safety, has some industry officials from the conventional arena agitated.
Sen. Tom Harkin, D-Iowa, longtime advocate for the natural products industry, plans to attach an amendment to the annual funding legislation that would give USDA undisputed authority to set and enforce microbial contamination limits. If passed into law, it would overturn the controversial Supreme Beef Court decision, which struck down the agency's salmonella performance standard for companies participating in the school lunch program.
"I plan to keep pushing forward on this," Harkin said. A similar amendment in last year's funding bill failed by one vote in the Senate. The senator expressed dismay that the USDA's authority to regulate food safety has been assailed in the courts. "Standards are useless if we don't enforce them," he said.
Opponents are hoping that enough senators will withhold support because the National Academy of Sciences and a scientific advisory committee that advises USDA and FDA are currently assessing the best use of microstandards as regulatory tools. Those panels are expected to deliver opinions till next year.
Natural Foods Merchandiser volume XXII/number 10/p. 1, 9