Why should we regulate pharmaceuticals?
Quote of note:
"The FDA can take action if supplements are proven unsafe," says John Hathcock, vice president for scientific and international affairs for the Council for Responsible Nutrition, a trade association for the dietary supplement industry.
…Wolfe counters by saying that approach is no solution at all. It amounts to "after-the-fact" power -- the ability to remove a product after harm has been done, in some cases fatal harm, he says.
"The FDA is part of the public health service, not part of the funeral industry," Wolfe adds.
Tougher Regulation of Supplements Sparks Dispute
By Kathleen Doheny
HealthDay Reporter
THURSDAY, March 13 (HealthDayNews) -- While both sides in the dietary supplement debate welcome the tough, new proposals for labeling and manufacturing set forth by the U.S. government last week, they disagree bitterly on what should come next.
The U.S. Food and Drug Administration (FDA) action came on the heels of recent deaths involving supplements containing the herb ephedra, although many have anticipated this move for years.
Ephedra has been implicated in more than 100 deaths, including high-profile tragedies such as the death of Baltimore Orioles pitcher Steve Bechler at spring training in February.
But the FDA proposal to require supplement makers to follow so-called "current good manufacturing practices" has actually been anticipated for almost nine years -- ever since passage of the 1994 Dietary Supplement Health and Education Act (DSHEA).
That federal law made supplements immune from the typical scrutiny the FDA requires of drugs before they can be sold, but gave the agency the power to regulate the supplements' labeling and testing standards.
The proposed new rules, which would cover vitamins and herbs such as ginkgo biloba and St. John's wort, among others, were announced March 7 following several findings that dietary supplements may not contain the amounts of ingredients the label suggests. In one instance cited by the FDA, soy products contained only 50 percent of the amount of isoflavones declared on the label.
Critics of the proposed new rules call them a start, but add that the supplement industry must also prove the products work and don't harm consumers.
"The largest problem is the products have not been shown to be safe and effective," says Dr. Sidney M. Wolfe, director of the Public Citizen Health Research Group.
But supplement industry representatives counter that there are already safeguards in place to protect the public against potentially harmful supplements.
"The FDA can take action if supplements are proven unsafe," says John Hathcock, vice president for scientific and international affairs for the Council for Responsible Nutrition, a trade association for the dietary supplement industry.
The FDA can take a product off the market immediately, Hathcock adds, or go through a more time-consuming process to prove it should be banned.
Wolfe counters by saying that approach is no solution at all. It amounts to "after-the-fact" power -- the ability to remove a product after harm has been done, in some cases fatal harm, he says.
"The FDA is part of the public health service, not part of the funeral industry," Wolfe adds.
"The law [DSHEA) should either be repealed entirely or so seriously modified ... that in a reasonable period of time these companies are going to put up or shut up," he says.
The proposed rule, experts note, is just that. During a 90-day comment period, the FDA will seek suggestions and feedback.
Typically, once the FDA has drafted a final regulation, companies are given time to implement it. Hathcock says that in a best-case scenario, it would be 18 months before the new labeling and manufacturing standards are in practice.
The supplement industry already adheres to many of the labeling and manufacturing proposals put forward by the FDA, says David Seckman, executive director of the National Nutritional Foods Association, which represents almost 5,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods and dietary supplements.
Like the Council for Responsible Nutrition, the National Nutritional Foods Association established its own "current good manufacturing practices" program, Seckman says, adding, however, that participation by members is voluntary.
Comparing the FDA's proposed regulations to the NNFA's program, Seckman says, "our quick analysis is, 85 percent of what we see in our GMP [good manufacturing practices] process is included in the government's proposed regulation."
An FDA spokeswoman says dietary supplement safety "is a high priority for this administration and the new commissioner, Dr. Mark B. McClellan."
Asked why it has taken nine years for the proposed labeling changes, she says, "I can't speak to what other commissioners have done."
