March 2004 | Feature Story
Ephedra Wars
How the Food and Drug Administration may be using ephedra as a first strike to remove other supplements—and your freedom to use them—from store shelves
BY FRANK LAMPE
Even before the U.S. Food and Drug Administration (FDA) released its final ruling on the herb ephedra, banning it for sale after April 12, the feeding frenzy had begun.
Many see the FDA’s action to prohibit the sale of ephedra, or ma huang, as the opening salvo of an attack on all supplements—especially botanicals—and the landmark law that protects them, 1994’s Dietary Supplement Health and Education Act (DSHEA). They fear if the supplement act is overhauled or rescinded, millions of consumers may be denied access to what are mostly safe, effective and inexpensive alternatives to prescription drugs.
“We’re not saying,‘don’t sell them.’ We’re saying,‘don’t sell them over the counter.’ Regulate them as you regulate prescriptions.” So said Rep. John Sweeney (R-N.Y.) at a Feb. 3 press conference announcing an initiative to extend the ephedra ban to what he and Sen. Charles Schumer, (D-N.Y.) called “copycat” formulations to ephedra.
Sweeney said “Congress made a mistake” when it passed DSHEA. Schumer added that if FDA fails to act, “We will move legislation in this regard.”
Critics say the products are unregulated or underregulated and pose untold risks to the health of a nation. Advocates of integrative medicine envision it another way. They see supplements as the cornerstone of a rational and overdue approach to healthcare.
The national healthcare system now consumes 15 percent of the nation’s overall spending—higher than any other industrialized country. Yet even as insurance companies continue the upward spiral of annual rate increases, 40 percent of the citizens in the richest country on Earth are without basic healthcare coverage.
Ephedra sinica. Love it or hate it, use it or not, no dietary supplement has raised the hackles of and polarized so many consumers, government officials, politicians, scientists and the industry that sells it. No supplement has ever been so misrepresented in mainstream media. And while the door on ephedra is closing, the face-off in this complex and emotionally charged story continues.
Curiously, the ban on ephedra will not affect the sale of over-the-counter and prescription medications containing the herb’s synthetically derived active compound ephedrine, which is used in decongestants and other bronchial remedies such as Sudafed.
An old familiar feeling
This situation looks strangely similar to the agency’s 1990 banning of the amino acid L-tryptophan. This then-popular dietary supplement, used to relieve depression, anxiety and PMS, plus control pain and induce natural sleep, was implicated—and then cleared—in the deaths of a number of users in the U.S. in 1989. Investigators found that a faulty manufacturing process at a Showa Denko facility in Japan was responsible for a contamination of the product, which caused a deadly flu-like condition called Eosinophilia-Myalgia Syndrome (EMS).
L-tryptophan is still available by prescription, but at a much higher cost, and it has been used—uninterrupted—in baby formulas and animal feed since the 1989 incident. In fact, in 1993, a U.S. patent was issued to use L-tryptophan to treat and cure EMS, the same condition that prompted the FDA to take L-tryptophan off the market in the first place. Go figure.
In its Feb. 6 ruling on ephedra, the FDA provided what it says is a blueprint for how the agency intends to regulate supplements in the future and remove from the market those it considers “an unreasonable risk” to public safety. While it’s too early to tell exactly how the agency will implement its new strategy, a few indicators signal trouble for the industry or consumers.
During a speech at the University of Mississippi in January, FDA Commissioner Mark McClellan said, "We will be doing more work in the coming months to more closely evaluate the potential safety risk of these products, and we could take further action to remove unsafe dietary supplements from the market." On the hit list: bitter orange, aristolochic acid and usnic acid—all used for weight loss—and chaparral, comfrey, willow bark and wormwood. No one knows what might be next.
The ban of ephedra marks the first time the agency has removed a dietary supplement under the supplement act, passed by Congress after many years of contentious, often hostile clashes from the two opposing sides. Through the spirited actions of citizen-based advocacy groups, industry companies and health food store retailers, hundreds of thousands of consumers communicated with their congressional representatives in the early ’90s demanding continued unfettered access to dietary supplements. The outpouring was unprecedented at the time, eclipsing everything but commentary over the Vietnam War years earlier.
In passing the Dietary Supplement Health and Education Act, Congress stated there may be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced healthcare expenses and disease prevention.
At the time of its passage, President Clinton said about DSHEA (pronounced “da-shay” for shorthand), “After several years of intense efforts, manufacturers, experts in nutrition and legislators, acting in a conscientious alliance with consumers at the grassroots level, have moved successfully to bring common sense to the treatment of dietary supplements under regulation and law.”
The legislation, in essence, amended the Federal Food, Drug and Cosmetic Act of 1938 to alter the way dietary supplements are regulated and labeled. DSHEA, for the first time, created a legal definition for dietary supplements as foods and not drugs. The law afforded specific, science-based structure/function claims on supplement labels, which allowed manufacturers (for the first time) to educate consumers about the health benefits of the products as they related to particular health conditions.
The passage of DSHEA was to mark the beginning of a golden era for supplements and natural health. Ten years later, that dream may be about to crumble.
Comparing benefits and risks
In trying to understand the heated debate on ephedra, supplements in general and the viability of DSHEA, one must understand the “benefit-to-risk ratio” of consumer products as part of public health policy. In the case of ephedra, FDA determined the herb, traditionally used to help alleviate allergy and asthma symptoms for more than 5,000 years, but now used mostly for weight loss, energy and performance enhancement, had no health benefits and created grave risks to public health. The major potential side effect is increased blood pressure that could lead to heart failure and disease.
At a press conference announcing the upcoming ephedra ban, Health and Human Services (HHS) Secretary Tommy Thompson said government scientists had concluded ephedra-based supplements "are simply too risky to be used."
By comparison, the agency’s stand on pharmaceutical drugs is that the benefits outweigh the risks because of all the supposed safety research required before drugs are released for public consumption. That hasn’t stopped the agency from releasing—and then recalling—a number of these purported “proven” substances.
A report commissioned by the FDA in 2003 and cited in its final ruling found that only five deaths could be directly attributed to the use of ephedra. Yet, media reports and supplements opponents, including the New York legislators mentioned above, quote the number of deaths attributed to ephedra use at 155. According to a report from the American Herbal Products Association (AHPA), 12 million to 17 million people in 1999 consumed approximately 3 billion servings of ephedra products.
In contrast, overmedication and adverse reactions to pharmaceutical drugs in hospitals killed 106,000 people in 1994. And this doesn’t include the number killed outside of hospitals or those deaths that went unreported.
It is estimated aspirin kills 1,000 people per year. And last year, allergic reactions to peanuts killed nearly 100. Apparently, the benefit-to-risk ratio of these products, both the domain of the FDA, is okay.
Contrary to the FDA’s contention in its final ruling, a good amount of scientific research shows that if taken according to label directions and strict dosage limitations (a maximum of 90 to 100 milligrams per day), ephedra is safe. As investigative journalist Mike Fillon, author of “Ephedra Fact & Fiction” (Woodland Publishing, 2003) points out, many of the deaths popularly attributed to the herb involved significant additional factors, making it unlikely ephedra was the main culprit.
It’s true that not all products are safe for everyone. Some people are allergic to or can’t tolerate certain foods, such as nuts, dairy or corn, to name but a few. This is true of some drugs and dietary supplements.
It’s a no-brainer that consumers who are pregnant or have a history of high blood pressure or heart attacks should not take ephedra. Responsible supplements companies have indicated this on their labels for years.
The bigger picture
"Ephedra is symbolic of a bigger issue, and that is how we look at the‘assured benefit’ versus the‘acceptable risk,’ " says Jim Turner, a Washington-based attorney, who is chair of the board of consumer-advocacy group Citizens for Health (CFH) and the Campaign for Better Health, a project of CFH. "The government has come in with a no benefit/high risk position and is now trying to spread that position to other supplements. It’s guilt by association. This is bad public policy from the consumer point of view.”
Turner says, "The problem is there is no way to divide the world of products that are safe and effective and unsafe and ineffective for everyone.”
A better approach would be a post-marketing, post-approval surveillance system for both pharmaceuticals and supplements to get the highest benefit-to-risk ratios at a reasonable cost, says Turner. Such a system would create an early warning system that would quickly weed out problem products.
Here’s a critical point that goes beyond personal health concerns: Failure to implement some workable system will ultimately bankrupt the country. Turner said it has been estimated that, at the current pace, 40 percent of the country’s gross spending will be on healthcare by 2050.
Adding more fuel to the fire in this debate are mainstream media, which appear to be taking an anti-supplement stance in their coverage. The New York Times, The New Yorker, the Associated Press and others have reported that the industry or a particular supplement product is “unregulated” by the FDA. Those statements are simply false. The FDA has always had the power to remove unsafe products from the market.
Not that certain members of Congress have heard the message either. At least five bills are currently afloat in the Capitol that would severely impact the viability of DSHEA. The most onerous of them is the inappropriately named The Dietary Supplement Safety Act (S 722). It was introduced by Sen. Richard Durbin (D-Ill.) and could restrict access to whole classes of supplements because of only one adverse event report, without proof that a dietary supplement was the cause of the adverse event (remember L-tryptophan?). In addition, the legislation would essentially halt investment in scientific research to prove the health benefits of supplements.
The good news is that Washington insiders report that Durbin’s bill has no chance of passage in this session of Congress. But there’s always next year, and the year after that.
Both FDA Commissioner McClellan and his boss, HHS Secretary Thompson, have made it clear that DSHEA is not sacrosanct. At the Dec. 30 press conference announcing the impending ephedra ban, McClellan said, “I do think that when FDA reaches a conclusion like this, we ought to be able to carry it out to provide the protection Americans need. And we will be doing our best to defend this in court. And if that’s not sufficient, it may be time to reexamine the act.”
“I’ve already indicated that I would like to see the law changed,” Thompson said in response to a question.
Not everyone thinks DSHEA needs to be altered. Sen. Orrin Hatch (R-Utah), a staunch supplements supporter and a key sponsor of the original DSHEA legislation, last year introduced—with fellow supplements advocate and DSHEA sponsor Sen. Tom Harkin (D-Iowa)—The DSHEA Full Implementation Act (S 1538). This legislation would give the FDA the federal funding it says it needs to fully implement and enforce DSHEA. Specifically, that translate to an adverse event reporting system, improved health claims analysis and the ability to enforce good manufacturing practices.
“DSHEA is a strong law that, properly implemented, will protect the interests of consumers,” Hatch told a Senate committee in October. “The law gives the FDA abundant tools to remove products that are unsafe from the market.
“In the nine-plus years since DSHEA was enacted, there has been too much talk that the law handcuffs FDA and too little effort to apply the law. It is impossible for this law to protect consumers if it is not enforced.”
With ephedra, it appears that the FDA is finally enforcing the law—at least its version of the law. The rest could well be up to the courts, as lawsuits and legal challenges are likely. And like most legal matters, it’s all in the interpretation.
Meanwhile, the supplements industry and millions of consumers are collectively holding their breath waiting to see how the FDA will use its legal authority to regulate supplements in the future. The fate of many products may hang in the balance.
“If it’s based on sound scientific principles and based on law, we’ll support it,” said Michael McGuffin, president of the American Herbal Products Association, just a few days before the final ruling was released.
Ana Micka, president and CEO of Citizens for Health and the Campaign for Better Health, presents another viewpoint and call to anyone who feels the right to buy supplements over the counter: “In spite of the high usage of supplements (more than 30 percent of the population) and alternative health (more than 40 percent) in the U.S., it’s not a visible community and not a block of voters.
“There are definitely competing voices in politics, and right now we’re not a loud, dominant voice. We have to do a lot of work as a community to organize and present our views for new health and wellness solutions in this country.”
Frank Lampe is the founding editorial director of the LOHAS Journal business magazine and has been covering the natural products industry for more than 16 years.
![[Send]](http://seattle.consciouschoice.com/sendlink/send.gif){kind=small}
Recommend this page to a friend
Top Ten pages recommended to friends:
